BREAST PROSTHESIS, CANCER AND OTHER DISEASES. /PROTESIS DE MAMA, CANCER Y OTRAS ENFERMEDADES.

 

Breast Implants, Cancer and other Diseases. ! 

 

Implantes mamarios, cancer y otras enfermedades. !

 

 

EDITORIAL ENGLISH

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Hello friends of the network, DERMAGIC EXPRESS with another hot topic and very important: BREAST IMPLANTS, CANCER AND OTHER DISEASES, mainly dedicated to women who have these BREAST IMPLANTS and those like you who want to do it to improve their esthetics.

For many years, it has been said that these prostheses, commonly called SILICONES, induce the appearance of CANCER, and other abnormalities in the body, not simply because it is a foreign body in our organism, we speak of the composition or material of Which are manufactured, and the rupture thereof.

It is important that you know that BREAST IMPLANTS are made with materials TOTALLY DIFFERENT FROM OTHER PROSTHESIS THAT ARE USED IN MEDICINE, HIP PROSTHESIS, KNEE, HEART VALVES, ETC.

And perhaps that is the reason why today 2.017 scientific studies point to the fact that these implants in a percentage that has been increasing over time are involved with the induction or appearance of CANCER specifically LYMPHOMA, commonly called cancer of the blood .

It is also interesting to know that this information I am giving you is not NEW, since 1.998

and maybe before, have been reported several diseases associated with breast implants, which I describe:

1.) CUTANEOUS T- CELL LYMPHOMA (SEZARY SYNDROME).

2.) SYSTEMIC SLERODERMA.

3.) ANTINUCLEAR ANTIBODIES.

4.) SCARRING DYSTROPHY OF THE ARM.

5.)  HASHIMOTO'S THYROIDITIS.

6.)  INFLAMMATORY REACTIONS AND CAPSULAR CONTRACTURE.

7.) REGIONAL LYMPHADENOPATHIES.

8.) SYSTEMIC LUPUS ERYTHEMATOSUS.

9.) RHEUMATOID ARTHRITIS.

10.) SJOGREN SYNDROME.

11.) MORPHEA.

12.) MALIGNANT LYMPHOMA.

13.) LARGE ANAPLASIC CELL LYMPHOMA.

14.) AUTOIMMUNE DISEASES.

You should also remember the famous PIP (POLY IMPLANT PROSTHESIS) scandal, year 2010, 2011, defective prosthetics of FRENCH origin, which were shown to be fraudulent made of improper material with a higher rupture rate than expected, and that REPLACEMENT OF THE SAME WORLDWIDE.

 These PIP PROSTHESIS are included in the topic FAKE MEDICINS A NEW WORLD PANDEMIC.! (read here), because it was discovered and showed that it was an INDUSTRIAL FRAUD, probably to make money regardless of people's health.

The most important thing to know is that today for FEBRUARY, 2.017 have reported about 200 patients with a LARGE ANAPLASIC CELL LYMPHOMA (BI-ALCL) associated with breast implant.

It is a RARE T-CELL LYMPHOMA that develops around the mammary prosthesis. The study was done in 37 countries representing the majority of breast implant markets worldwide with reports of adverse events available.

This goes beyond the PIP prosthesis and its poor quality, reports on this type of lymphoma (blood cancer) involve all types and brands of silicone, it means that it has not been associated with any type of prosthesis Specified.

This is perhaps the most interesting fact, it would mean that the POSSIBLE INVOLVING ELEMENT IS A COMMON COMPONENT present in all prostheses.

If we analyze the percentage reported with the number of prostheses placed around the world, it is low, so the surgeons say, and it is true.

This biblographic review is dedicated to all women who have BREAS IMPLANTS or want to place them to improve their esthetics, the percentage is low, but you could be one of those. ! Not counting the other diseases that there put you ... So that:

Before placing BREAST IMPLANTS, it is good that you know EVERYTHING about it, BENEFITS AND ITS RISKS, the choice is in your hands.

Read these references well to learn about these IMPLANTS and in the attached: a case of SEZARY SYNDROME associated with breast implant.

Greetings to all.

Dr. Jose Lapenta.

EDITORIAL ESPAÑOL

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Hola amigos de la red, DERMAGIC EXPRESS con otro tema bien caliente y muy importante: IMPLANTES MAMARIOS, CANCER Y OTRS ENFERMEDADES, dedicado principalmente a las mujeres que tienen estos IMPLANTES MAMARIOS y aquellas como tu que desean hacerlo para mejorar su estetica (de cualquier tipo y marca).

Desde hace muchos años se viene hablando que estas  protesis, comunmente denominadas SILICONAS, inducen la aparicon de cancer,  y otras anomalias en el organismo, no simplemente por el hecho de ser un cuerpo extraño en nuestro cuerpo, se habla de la composicion o material del cual estan fabricadas,  y la ruptura de las mismas.

Es importante que conozcas que los IMPLANTES MAMARIOS estan fabricados con materiales TOTALMENTE DIFERENTES A OTRAS PROTESIS QUE SE USAN en medicina, como PROTESIS DE CADERA, RODILLA, VALVULAS CARDIACAS, ETC.

Y quiza esa sea la razon por la cual hoy dia 2.017 los estudios cientificos apuntan al hecho de que estos implantes en un porcentaje que ha ido aumentando con el tiempo esten involucrados con la induccion o aparicion de CANCER especificamente LINFOMA, comunmnete llamado cancer de la sangre.

Tambien es interesante que sepas, que este dato que te estoy dando no es NUEVO, desde 1.998 y quiza antes se vienen reportando diversas enfermedades asociadas a los implantes mamarios, las cuales te describo:

1.) LINFOMA CUTANEO DE CÉLULAS T (SÍNDROME DE SEZARY).

2.) ESLERODERMIA SISTEMICA.

3. ANTICUERPOS ANTINUCLEARES.

4.) DISTROFÍA CICATRICIAL DEL BRAZO

5.) TIRROIDITIS DE HASHIMOTO.

6.) REACCIONES INFLAMATORIAS Y CONTRATACION CAPSULAR.

7.) LINFADENOPATÍAS REGIONALES.

8.) LUPUS ERITEMATOSO SISTEMICO.

9.) ARTRITIS REUMATOIDE.

10.) SÍNDROME DE SJOGREN.

11.) MORFEA.

12.) LIMPFOMA MALIGNANO.

13.) LINFOMA ANALÁSICO DE CELULAS GRANDES.

14.) ENFERMEDADES AUTOINMUNES.

Tambien debes recordar el famoso escandalo de las PIP ( POLY IMPLANT PROTESIS),  año 2.010, 2.011, protesis defectuosas de origen FRANCES, las cuales se demostro que eran fraudulentas fabricados con material inadecuado con un porcentaje de ruptura mayor al esperado, y que motivo EL REMPLAZO DE LAS MISMAS A NIVEL MUNDIAL.

 Estas PIP PROTESIS quedan inlcuidas dentro del tema FALSAS MEDICINAS UNA NUEVA PANDEMIA MUNCIAL.! (lee aqui), pues se descubrio y demostro que se trataba de un FRAUDE INDUSTRIAL, probablemente para ganar dinero sin importar la salud de las personas.

Pro lo mas importante que debes saber es que hoy dia para FEBRERO, 2.017 se han reportado unos 200 pacientes con un LINFOMA ANAPLASICO DE CELULAS GRANDES (BI-ALCL) asociado a implante mamario.

Se trata de un LINFOMA DE CELULAS T RARO que se desarrolla alrededor de las prótesis mamarias.  El estudio se hizo en 37 países que representan la mayoría de los mercados de implantes mamarios en todo el mundo con informes de eventos adversos disponibles.

Ya no se trata de las PIP protesis y su mala calidad, los reportes sobre este tipo de linfoma (cancer de la sangre) involucran a todos los tipos y marcas de silicona, quiere decir esto que no se le ha asociado a algun tipo de protesis especifica.

Este es quiza el dato mas interesante, significaria esto que el POSIBLE DESENCADENANTE ES UN COMPONENTE COMUN presente en todas las protesis.

Si analizamos el porcentaje reportado con la cantidad de protesis colocadas en todo el mundo, es bajo, eso siempre dicen los cirujanos, y es cierto.

Esta revision biblografica va dedicada a todas las mujeres que tienen IMPLANTES MAMARIOS o desean colocarlos para mejorar sus estetica, el porcentaje es bajo, pero tu podrias ser una de esas. ! Sin contar las otras enfermedades que alli te coloque... De modo que:

Antes de colocarte IMPLANTES MAMARIOS, es bueno que conozcas TODO acerca de ello, SUS VENTAJAS Y SUS RIESGOS, la desicion esta en tus manos.

Lee bien estas referencias para que aprendas sobre estos IMPLANTES y en el adjunto: un caso de SINDROME DE SEZARY asociado a implante mamario.

Saludos a todos.

Dr. Jose Lapenta.

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 REFERENCIAS BIBLIOGRAFICAS / BIBLIOGRAPHICAL REFERENCES 
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 0.) Sézary syndrome following rupture of silicone gel breast prosthesis
1.) Carcinogenic potential of silicone breast implants: a Connecticut statewide study.
2.) Cutaneous T-cell lymphoma in association with silicone breast implants.
3.) Atypical chest pain syndrome in patients with breast implants.
4.) Serum antinuclear antibodies in women with silicone breast implants [see comments]
5.) Silicone gel filled breast implants and connective tissue disease: an overview [see comments]
6.) Silicone breast implant-associated scarring dystrophy of the arm.
7.) Sclerodermalike esophageal disease in children breast-fed by motherswith silicone breast implants [see comments]
8.) Breast augmentation: a risk factor for breast cancer? [see comments]
9.) Clinical and laboratory features of patients with scleroderma and silicone implants.
10.) A clinical and immunologic evaluation of women with silicone breast implants and symptoms of rheumatic disease [see comments].
11.) Systemic sclerosis after augmentation mammoplasty with silicone implants. [Review]
12.) Antinuclear autoantibodies in women with silicone breast implants.
13.) Antibodies to silicone elastomers and reactions to ventriculoperitoneal shunts.
14.) Outcome study of the psychological changes after silicone breast implant removal.
15.) [Hashimoto's thyroiditis and silicone breast implants: 2 cases]
16.) Cellular immune reactivities in women with silicone breast implants: a preliminary
investigation [see comments]
17.) Unusual masses found within ruptured silicone gel breast prostheses.
18.) Silicone breast implants: pathology.
19.) Capsular contracture with textured versus smooth saline-filled implants for breast
augmentation: a prospective clinical study.
20.) Lymphocyte response to silica among offspring of silicone breast implant recipients.
21.) Ruptured or intact: what can linear echoes within silicone breast implants tell us?
22.) Inflammatory reaction and capsular contracture around smooth silicone implants.
23.) Breast implantation and the incidence of upper extremity somatic complaints.
24.) A review of the possible health implications of silicone breast implants.
25.) [The value of sonography for the discovery of complications after the implantation of silicone gel prostheses for breast augmentation or reconstruction]
26.) Explantation of silicone breast implants.
27.) Neurosarcoidosis following augmentation mammoplasty with silicone.
28.) Are breast implants anticarcinogenic? A 14-year follow-up of the Los Angeles Study.
29.) [Silicone breast implants and breast cancer]
30.) Lack of evidence of systemic inflammatory rheumatic disorders in symptomatic women with breast implants.
31.) Breast implants in patients with differentiated and undifferentiated connective tissue disease.
32.) Epidemiology of systemic sclerosis.
33.) Use of antipolymer antibody assay in recipients of silicone breast implants.
34.) Complications leading to surgery after breast implantation [see comments]
35.) Silicone gel and octamethylcyclotetrasiloxane (D4) enhances antibody production to bovine serum albumin in mice.
36.) Visualization of silicone gel in human breast tissue using new infrared imaging  spectroscopy.
37.) The epidemiology of scleroderma among women: assessment of risk fromexposure to silicone and silica. 38.) Global Adverse Event Reports of Breast Implant-Associated ALCL: An International Review of 40 Government Authority Databases.
39.) United States Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma.
39.) Anaplastic large T-cell lymphoma and breast implants: a review of the literature.
40.) Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant-Associated Anaplastic Large-Cell Lymphoma.
41.) Anaplastic large-cell lymphoma in women with breast implants.
42.) Breast implant-associated anaplastic large cell lymphoma: a systematic review.
43.) Anaplastic large-cell lymphoma associated with breast implants: a unique entity within the spectrum of peri-implant effusions.
44.) Breast implant-associated anaplastic large cell lymphoma: review of a distinct clinicopathologic entity.
45.) Variable presentation of anaplastic large-cell lymphoma in patients with breast implants.
46.) Breast Implant-Associated Anaplastic Large Cell Lymphoma: Proposal for a Monitoring Protocol.
47.) Implant-associated anaplastic large cell lymphoma: beyond breast prostheses.
48.) Bacterial Biofilm Infection Detected in Breast Implant-Associated Anaplastic Large-Cell Lymphoma.
49.) The Poly Implant Prothèse breast prostheses scandal: Embodied risk and social suffering.
50.) The impact of poly implant prothèse fraud on breast cancer patients: a report by the institut curie.
51.) [Poly Implant Prothèse (PIP®) incidence of complications in breast reconstructive surgery: A retrospective comparative analysis].
52.) PIP breast implant removal: a study of 828 cases.
53.) Silicone breast implant materials.
54.) Silicone lymphadenopathy after breast augmentation: case reports, review of the literature, and current thoughts.
55.) [Outcome at 18 months after the recall of Poly Implant Prosthesis. Experience of a cancer center].
56.) The ruptured PIP breast implant.
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0.) Sézary syndrome following rupture of silicone gel breast pro sthesis
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Author: A. ledo, E. Sendagorta
Department of Dermatology Hospital »Ramón y Cajal«, Madrid, Spain
Case report.
A 48-year-old women underwent augmentation mammoplasty with silicone gel
prosthesis in February 1980. Three months later she developed scaling of
the palms and soles. This per-sisted until she progressively developed a
generalized pruritic, erythematous, scaly eruption in March 1983, when we
first studied this patient (Fig. 1). Physical ex-amination also showed
onychodystrophy and left axillary and bilateral inguinal nodes. There was
no evidence of hepato-splenomegaly. Breast implants were re-moved 3 months
later because of a sus-pected inflammatory reaction to the
silicone. The left implant was found to be ruptured; poorly encapsulated
gel was re-moved by sacrificing surrounding breast tissue. It was
impossible to determine if ah extravasated gel had been removed. A complete
work-up for erythroderma was done. The peripheral blood smear showed Sézary
celís from 1 to 4%; the total leuko-cyte count varying from 12,500 to
17,000/ mm3. Several skin biopsies showed only non-specific dermal
inflammation (Fig. 2). Bone marrow smear was normal. A biopsy
Fig. 1. Generalized erythroderma with edema and scaling of the skin.
Fig. 2. 5km biopsy showing nonspecific dermal inflammation. H & E x5()
(See the attach)
from a right inguinal node was diagnostic of dermatopathic lymphadenopathy.
De-layed hypersensitivity skin test were alí negative
Pre-Sézary erythroderma was diag-nosed, and treatment was started with
topical steroids with modest improvement. In September 1985 the
erythroderma be-come more severe but with no change in general status. The
absolute Sézary celí count was 3,552/mm3 at that time. A skin biopsy had
some features suggestive but not diagnostic of cutaneous T-cell lympho-ma.
A diagnosis of Sézary syndrome was made and therapy was started with 4 mg/
day chlorambucil and 20 mg/day of oral prednisone. Within the last 6 months
the Sézary celí counts have been substantially reduced with this combined
therapy.
Comment. Early forms of cosmetic breast augmentation surgery involved the
direct injection of liquid silicone into the breasts, often causing an
intense local inflammatory reaction (1). Although the advent of elastomeric
silicone envelope prosthesis reduced this severe reaction, it is well known
that silicone particles can still get from such implants into the
surrounding tissues and to regional lymph nodes (2) with resultant
inflammatory reactions. Silicone is a potentially antigenic material, and 2
cases of contact dermatitis to silicone have been described in the
literature (3, 4). Silicone may also provoke an autoimmune response by
conversion to silica, a substance known to exert pro-found effects on the
imifiune system. A variety of autoimmune diseases has been described in
association with cosmetic surgery, including progressive systemic
sclerosis, systemic lupus erythematosus, rheumatoid arthritis, thyroiditis,
Sjógren's syndrome and morphea (5). Digby and Wells (6) reported a case of
malignant lymphoma developing in a regional lymph node 9 years after
insertion of silicone finger prosthesis. They also cited a similar case
that had been brought to their notice but not reported. Benjamin et al. (7)
have
also described one patient with silicone lymphadenopathy with concomitant
malig-nant lymphoma following rupture of silas-tic joint implants.
That chronic stimulation of the immune system may lead to tumour formation
has been known for years. Tan et al. (8) suggested that mycosis fungoides
repre-sents a chronic granulomatous response to persistent unidentified
antigen. Epidemiologic observations have found that the incidence of prior
allergic condi-tions such as contact allergy, urticaria and drug allergy,
is notably increased in pa-tients with mycosis fungoides. Buechner and
Winkelmann (9) have recently de-scribed 7 patients with pre-Sézary
ery-throderma evolving to Sézary syndrome; interestingly, these patients
had a history of multiple allergic reactions.
We believe that the present case repre-sents a model of chronic lymphoid
stimula-tion that progressed from an inflammatory (pre-Sézary erythroderma)
to a prolifera-tive (Sézary syndrome) stage. Although an association
between the development of Sézary syndrome and the inflammatory reaction to
the silicone is not positively established, we would like to draw
atten-tion to the need for awareness of possible complications whenever
foreign materials are implanted into the body.
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1.) Carcinogenic potential of silicone breast implants: a Connecticut
statewide study.
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Kern KA; Flannery JT; Kuehn PG
Department of Surgery, Hartford Hospital, Connecticut, USA.
Plast Reconstr Surg (UNITED STATES) Sep 1997 100 (3) p737-47;
discussion 748-9
ISSN: 0032-1052
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9711
Subfile: AIM; INDEX MEDICUS
To clarify the carcinogenic potential of silicone breast implants, 680
implant
procedures performed on women in Connecticut with no prior history of
cancer were
correlated with the subsequent development of primary breast and nonbreast
cancers.
Neoplastic events after the placement of silicone breast implants during
the 13-year
interval from October 1, 1980, through September 30, 1993, were quantified
using a
retrospective, linked-registry method. ICD-9-CM discharge codes contained
in the Uni
formed Hospital Discharge Data Sets (UHDDS) from 34 hospitals across
Connecticut were
linked to procedure codes for unilateral and bilateral implants, and to
medical
histories for new malignancies after the implant procedures. Data were
cross-linked
to the Connecticut Tumor Registry to confirm the clinical history of each
cancer.
The rates of breast and nonbreast cancers in patients with silicone breast
implants
were compared with those of a control population drawn from the UHDDS of
1022 women
undergoing sterilization by tubal ligation between 1981 to 1985. Ages
(mean +/- SD)
were similar in the implant group (34 +/- 10 years) and in the
sterilization group
(32 +/- 6 years). The mean follow-up in the implant group (4.6 years) was
also
similar to that of the control group (5.4 years). Compared with the
control group,
the implant group demonstrated lower rates of breast cancer (0.59 versus 0.88
percent, p = 0.35) and nonbreast cancer (0.59 versus 2.7 percent, p =
0.001).
Correspondingly, the implant group had a lower relative risk of breast cancer
(relative risk = 0.67, 95 percent, confidence interval = 0.20 to 2.17) and
nonbreast
cancer (relative risk = 0.21, 95 percent, confidence interval = 0.07 to
0.60). Based
on these data, it was concluded that silicone breast implants are not
carcinogenic,
because they are not associated with increased rates of either breast or
nonbreast
cancers. The validity and threats to the conclusions are discussed, and
the results
are placed into context with similar findings from other studies.
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2.) Cutaneous T-cell lymphoma in association with silicone breast implants.
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ARTICLE SOURCE: J Am Acad Dermatol (United States), Jun 1995, 32(6) p939-42
AUTHOR(S): Duvic M; Moore D; Menter A; Vonderheid EC
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: BACKGROUND: Cutaneous T-cell lymphoma (CTCL) is a chronic
malignancy of helper T cells with the CD4 phenotype. It occurs less
frequently in young women but is increasing in incidence for unknown
reasons. Silicone breast implants have been associated with T-cell-mediated
autoimmune reactions. OBJECTIVE: Our purpose was to suggest the hypothesis
that CTCL may arise after breast implants and that different patients with
CTCL may be stimulated by different antigens. METHODS: Investigators with
many patients with CTCL were queried regarding the occurrence of CTCL in
women after breast implants. RESULTS: Three cases of confirmed CTCL after
breast implants were identified and are reported. In one patient with
Sezary syndrome and CTCL, the disease went into remission after removal of
implants, resolution of chronic staphylococcal infection, and initiation of
photopheresis and interferon alfa therapy. Another patient had progressive
disease. CONCLUSION: CTCL may occur in association with breast implants in
young female patients, but causality is unknown. If CTCL is antigen driven,
then it is likely to result from several different antigens in different
groups of patients. 
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3.) Atypical chest pain syndrome in patients with breast implants.
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ARTICLE SOURCE: South Med J (United States), Oct 1994, 87(10) p978-84
AUTHOR(S): Lu LB; Shoaib BO; Patten BM
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: Eleven patients, aged 36 to 55 years, with silicone breast
implants had episodes of severe chest pain similar to heart attacks 6 weeks
to 7 years after breast implantation; one patient had a severe attack 1
month after explantation. The chest pain, which was not related to physical
exertion, lasted from 15 minutes to 4 days, and descriptions of it varied
from a "pressing" type of pain to "stabbing" pain with radiation to the
shoulders, left arm, and jaw. The associated symptoms were diaphoresis,
nausea, vomiting, dyspnea, and palpitations. All of the patients had a
normal electrocardiogram (ECG) with the exception of one, whose ECG showed
nonspecific ST changes. Ten had cardiac evaluations, all of which yielded
normal results. All had implant removal, and five were found to have at
least one ruptured implant. Nine had an implant capsule biopsy; all had
chronic inflammatory rinds, and five had free silicone in tissue whether or
not the implants were ruptured. All eight who had a pectoralis major muscle
biopsy had abnormal results: (neurogenic atrophy [six], fasciitis [three],
myositis [one], chronic inflammation [one], free silicone [one], and
neuroma [one]). We concluded that silicone breast implants may cause an
atypical chest pain syndrome, probably due to local inflammatory reactions
and neuroma formation. 
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4.) Serum antinuclear antibodies in women with silicone breast implants
[see comments]
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COMMENTS: Comment in: J Rheumatol 1995 Feb; 22(2):198-200
ARTICLE SOURCE: J Rheumatol (Canada), Feb 1995, 22(2) p236-40
AUTHOR(S): Cuellar ML; Scopelitis E; Tenenbaum SA; Garry RF; Silveira LH;
Cabrera G; Espinoza LR
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: OBJECTIVE. Recent evidence suggests that immunologic
abnormalities are not uncommon in individuals with silicone breast
implants. The purpose of our study was to evaluate in a consecutive manner,
the prevalence of autoimmunity as assessed by the presence of antinuclear
antibodies in a larger number of patients with silicone breast implants.
METHODS. Antinuclear antibody (ANA) testing using an indirect
immunofluorescence technique was performed on 813 individuals with silicone
breast implants. All subjects except for 3 transsexual males, were female.
The overwhelming majority, over 99%, were white. The average age of the
subjects was 46.2, with a range of 17 to 72 years. RESULTS. ANA positivity
was found in 244 of 813 individuals (30%) using a mouse kidney substrate;
and in 470 of 813 (57.8%) using a HEp-2 cell line. The most common
immunofluorescent pattern found using HEp-2 was speckled, present in 341
(72.5%) individuals, followed by homogeneous pattern in 113 (24%),
nucleolar in 63 (13.4%), and 5 (1.06%) were anticentromere. Anti-dsDNA
antibodies measured by an ELISA assay were found in 6 of 71 patients (8%).
Rheumatoid factor and C-reactive protein were found above healthy controls
in less than 10% of cases studied. The high prevalence of ANA found in
patients with silicone breast implants agrees with similar observations by
others. The finding of anticentromere and nucleolar patterns has great
interest and relevance. These fairly distinct ANA patterns are most
commonly seen in the idiopathic form of scleroderma and related conditions.
CONCLUSION. These findings suggest that ANA positivity is relatively common
in individuals with silicone breast implants, and may support the existence
of autoimmune mechanisms in the pathogenesis of the clinical manifestations
seen in this population. 
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5.) Silicone gel filled breast implants and connective tissue disease: an
overview [see comments]
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COMMENTS: Comment in: J Rheumatol 1994 Oct; 21(10):1979-80
ARTICLE SOURCE: J Rheumatol (Canada), Feb 1994, 21(2) p239-45
AUTHOR(S): Spiera RF; Gibofsky A; Spiera H
PUBLICATION TYPE: JOURNAL ARTICLE; REVIEW (79 references); REVIEW, TUTORIAL
ABSTRACT: OBJECTIVE. To review the literature examining the association of
silicone gel filled implants and connective tissue disease. METHODS.
Computerized literature searches and manual review of bibliographies.
RESULTS. Numerous concerns have arisen regarding the safety of silicone gel
filled breast implants. The structure of these prostheses is reviewed.
Silicones are not biologically inert. Injectable as well as implantable
silicones have proven capable of eliciting inflammatory and
fibroproliferative responses. Silicone leakage from silicone gel filled
implants is well documented as is distant migration of silicone in the
host. In the past decade, over 60 cases of connective tissue disease
following mammoplasty with silicone gel filled implants have been reported.
About half of these patients developed scleroderma or scleroderma-like
illnesses. This reported overrepresentation of scleroderma compared to
other rheumatic diseases mimics the Japanese experience with injectable
silicones. Possible biological rationale for the association is presented.
CONCLUSION. The physical and biological properties of silicone gel filled
implants and their behavior in vivo is compatible with the hypothesis that
they may contribute to the development of connective tissue disease. The
association seems most likely with scleroderma; however, there is as yet
inadequate epidemiological data to definitively establish causality. 
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6.) Silicone breast implant-associated scarring dystrophy of the arm.
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ARTICLE SOURCE: Arch Dermatol (United States), Jan 1995, 131(1) p54-6
AUTHOR(S): Teuber SS; Ito LK; Anderson M; Gershwin ME
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: BACKGROUND: Breast implants have been known to rupture after
trauma or closed capsulotomy with spread of the gel down the arm or
abdominal wall. Nodular foreign-body granulomatous reactions have been
reported in these cases. We report the unique occurrence of significant
overlying scarring and ulceration following silicone gel migration down the
affected arm. OBSERVATIONS: A 47-year-old woman experienced rupture of her
right silicone gel implant with migration of the silicone down her arm 10
years before our examination. Skin changes with atrophic hidebound scarring
and ulceration slowly progressed over the last 7 years. Radiographs and
magnetic resonance imaging scans demonstrated material consistent with
silicone in the soft tissues. CONCLUSIONS: Silicone is not an inert
substance and can rarely result in devastating local tissue destruction
where migration has occurred. The possibility of significant silicone gel
migration should be considered during evaluation of patients with ruptured
implants. 
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7.) Sclerodermalike esophageal disease in children breast-fed by mothers
with silicone breast implants [see comments] [published erratum appears
in JAMA 1994 Sep 14; 272(10):770]
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ARTICLE SOURCE: JAMA (United States), Jan 19 1994, 271(3) p213-6
AUTHOR(S): Levine JJ; Ilowite NT
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: OBJECTIVE--To determine whether breast-fed children of mothers
with silicone implants are at increased risk for the development of
sclerodermalike esophageal involvement compared with children not exposed
to silicone implants. DESIGN--Case-series [corrected].
SETTING--Referral-based pediatric gastroenterology clinic. PATIENTS--Eleven
children (mean age, 6.0 years; range, 1.5 to 13 years; six boys and five
girls) referred for abdominal pain who were born to mothers who had
silicone breast implants (eight breast-fed children and three bottle-fed)
were compared with 17 patients (mean age, 10.7 years; range, 2 to 18 years;
11 boys and six girls) with abdominal pain who were not exposed to silicone
implants. METHODS--All children underwent esophageal manometry and upper
intestinal endoscopy with esophageal biopsy and were tested for antinuclear
antibody and autoantibodies to Scl-70, centromere, ribonucleoprotein, Sm,
Ro, La, and phospholipid. RESULTS--Six of the eight breast-fed children
from mothers with silicone implants had significantly abnormal esophageal
motility with nearly absent peristalsis in the distal two thirds of the
esophagus and decreased lower sphincter pressure. Upper esophageal
pressures and motility were normal. Compared with controls, the breast-fed
children had significantly decreased lower sphincter pressure and abnormal
esophageal wave propagation. These manometric abnormalities were not seen
in the three bottle-fed children. There was no difference in the expression
of autoantibodies in the breast-fed children compared with the bottle-fed
children or controls. CONCLUSIONS--A relationship appears to exist between
breast-feeding by mothers with silicone implants and abnormal esophageal
motility. Studies evaluating larger numbers of children are needed to
determine the extent of the risk. 
========================================================================
8.) Breast augmentation: a risk factor for breast cancer? [see comments]
========================================================================
ARTICLE SOURCE: N Engl J Med (United States), Jun 18 1992, 326(25) p1649-53
AUTHOR(S): Berkel H; Birdsell DC; Jenkins H
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: BACKGROUND. A relation between breast augmentation and the
subsequent risk of breast cancer has been postulated. Since an estimated 2
million women in the United States alone have received breast implants,
even a small increase in the risk of breast cancer could have considerable
public health consequences. METHODS. We performed a population-based
nonconcurrent cohort-linkage study. All women in Alberta, Canada, who
underwent cosmetic breast augmentation from 1973 through 1986 were included
in the implant cohort (n = 11,676). This cohort was compared with the
cohort of all women in Alberta in whom a first primary breast cancer was
diagnosed (n = 13,557). The expected number of breast-cancer cases in the
implant cohort was estimated by applying age-specific and calendar
year--specific incidence rates of breast cancer (obtained from the Alberta
Cancer Registry) to the implant cohort. Standardized incidence ratios were
calculated by dividing the observed by the expected number of breast-cancer
cases in the implant cohort. RESULTS. Forty-one patients with implants were
subsequently found to have breast cancer. The expected number was 86.2. The
standardized incidence ratio was thus 47.6 percent, significantly lower
than expected (P less than 0.01). The average length of follow-up in the
implant cohort was 10.2 years, and the average length of time from breast
augmentation to the diagnosis of breast cancer was 7.5 years. CONCLUSIONS.
Women who undergo breast augmentation with silicone implants have a lower
risk of breast cancer than the general population. This finding suggests
that these women are drawn from a population already at low risk and that
the implants do not substantially increase the risk. 
========================================================================
9.) Clinical and laboratory features of patients with scleroderma and
silicone implants.
========================================================================
AU: Field-T; Bridges-AJ
AD: Department of Medicine, University of Wisconsin Hospital, Madison
53792, USA.
SO: Curr-Top-Microbiol-Immunol. 1996; 210: 283-90
AB: We reviewed the available clinical and laboratory data from 56 patients
with scleroderma and silicone implants from the English medical literature
and 19 cases which have not been previously reported. The average age of
onset of scleroderma was 43.6 +/- 10 years (range 20-73). Patients had
silicone implants for an average of 9 +/- 4 years prior to the development
of scleroderma (range 1-32). Most patients had limited scleroderma (41%).
Twenty three percent had intermediate scleroderma and 36% had diffuse
scleroderma. Clinical findings included: Raynaud's phenomenon in 77%,
esophageal dysfunction in 53%, and pulmonary involvement in 47%. Cardiac
and renal involvement were uncommon. Antinuclear antibodies by
immunofluorescence were found in 83 percent of patients. The
immunofluorescence pattern was speckled in 53%, centromere in 31% and
nucleolar in 9%. Other antibodies (Scl-70, RNP, SSA/Ro, PM-Scl) were found
in only a small proportion of patients. A clinical, serologic and
immunogenetic comparison of patients with silicone implants and scleroderma
and patients with idiopathic scleroderma is needed to better understand the
pathogenesis of this disorder.
========================================================================
10.) A clinical and immunologic evaluation of women with silicone breast
implants and symptoms of rheumatic disease [see comments].
========================================================================
AUTHOR(S): Bridges AJ; Conley C; Wang G; Burns DE; Vasey FB.
SOURCE: Annals of Internal Medicine 1993 Jun 15;118(12):929-36
OBJECTIVE: To describe the clinical and serologic features of women with
silicone breast implants who were referred for symptoms of rheumatic
disease. DESIGN: A case series. SETTING: University and private
rheumatology practices. PATIENTS: A total of 156 women with silicone breast
implants and rheumatic disease complaints. Controls for the serologic
studies included women with silicone implants and no rheumatic symptoms (n
= 12) and women with fibromyalgia without silicone implants (n = 174).
MEASUREMENTS: Complete physical examination and testing for
immunoglobulins; complement; C-reactive protein; rheumatoid factor; and
autoantibodies by indirect immunofluorescence, immunodiffusion, and Western
blot. RESULTS: Three subgroups of patients were defined based on clinical
and laboratory findings: joint and muscle pain (n = 95), joint swelling (n
= 32), and connective tissue disease (n = 29). Most women had normal
immunologic studies. The patients with joint swelling had mild, asymmetric,
rheumatoid-factor-negative synovitis that did not meet American College of
Rheumatology criteria for rheumatoid arthritis. Fourteen patients had a
scleroderma-like illness and anti-centromere or anti-PM-Sci antibodies by
Western blot. Ten patients had a positive Western blot for BB' polypeptide,
a small nuclear ribonucleoprotein (snRNP), but did not meet criteria for
systemic lupus erythematosus. No autoantibodies to known disease-related
polypeptides were detected on Western blot in the control groups.
CONCLUSION: Most women with silicone implants and rheumatic complaints had
normal results of serologic tests and nonspecific symptoms, suggesting no
serious connective tissue disease. However, a subset of women had clinical
signs and serologic tests that were unusual even for referred patients.
These observations suggest, but cannot establish, that some women with
silicone breast implants may develop atypical immunologic reactions.40
========================================================================
11.) Systemic sclerosis after augmentation mammoplasty with silicone
implants. [Review]
========================================================================
AUTHOR(S): Varga J; Schumacher HR; Jimenez SA.
SOURCE: Annals of Internal Medicine 1989 Sep 1;111(5):377-83
We describe four women who presented with systemic sclerosis several years
after cosmetic augmentation mammoplasty with silicone-gel implants. The
interval between implantation mammoplasty and the onset of systemic
sclerosis ranged from 6 to 15 years. All patients fulfilled the criteria
established by the American Rheumatism Association for systemic sclerosis
and had Raynaud phenomenon, arthralgia, and evidence of pulmonary or
gastrointestinal involvement. Enlargement of lymph nodes draining the
prostheses was noted in two patients. Antinuclear antibodies were detected
in three patients and showed speckled or nucleolar patterns. Removal of the
prostheses in two cases did not result in improvement of systemic
sclerosis. Evidence of silicone leakage from the implants included the
following. The observation by light microscopy of refractile particles in
tissues distant from the prostheses, the observation by electron microscopy
of electron-dense structures consistent with silica, and the definitive
identification of the element silicon by energy-dispersive analysis in
these electron-dense structures. A marked, chronic inflammatory infiltrate
containing lymphocytes, "foamy" histiocytes, and larger numbers of
multi-nucleated giant cells with vacuoles and asteroid bodies was found at
the same sites. Our demonstration that silicone escapes from
elastomer-silicone-gel breast implants and appears to be closely associated
with a chronic inflammatory reaction suggests that silicone plays a role in
the development of certain cases of systemic sclerosis. [References: 32]130
========================================================================
12.) Antinuclear autoantibodies in women with silicone breast implants.
========================================================================
AUTHOR(S): Press RI; Peebles CL; Kumagai Y; Ochs RL; Tan EM.
SOURCE: Lancet 1992 Nov 28;340(8831):1304-7
Clinical syndromes resembling autoimmune diseases have been reported in
women who have had breast augmentation procedures. To see whether there is
a humoral immune response in these diseases that is similar to the immune
response in their idiopathic counterparts, we assessed the immunological
specificity of antinuclear antibodies (ANAs) and certain epidemiological
features in 24 patients, all of whom (with 1 exception) had received
silicone gel breast implants. ANA specificities were identified by indirect
immunofluorescence, immunodiffusion, western blot analysis, and
immunoprecipitation of radiolabelled intracellular proteins. Of 11 patients
who had symptoms and signs that met criteria for defined autoimmune
diseases, 7 had scleroderma or subsets of this disorder and the others had
systemic lupus erythematosus, rheumatoid arthritis, or overlapping
autoimmune diseases. High ANA titres were present in 10 of these 11
patients and the ANA specificities were similar to those found in the
idiopathic forms of the corresponding autoimmune diseases. Trauma, with
resultant rupture of implants, accelerated onset of symptoms. 13 other
patients had autoimmune disorders of a less clearly defined nature and low
titres of ANAs whose specificities could not be identified. ANAs are
associated with the development of autoimmune complications in women with
silicone breast implants. Further studies are needed to see whether this
relation is one of cause and effect and whether ANAs might be early
serological markers preceding development of autoimmune symptoms.
========================================================================
13.) Antibodies to silicone elastomers and reactions to
ventriculoperitoneal shunts [published erratum appears in Lancet 1992 Sep
26;340(8822):800].
========================================================================
AUTHOR(S): Goldblum RM; Pelley RP; O'Donell AA; Pyron D; Heggers JP.
SOURCE: Lancet 1992 Aug 29;340(8818):510-3
Silicone elastomers used to make medical implants and prostheses are
generally believed to be biologically inert. However, we have seen two
patients who showed severe, apparently immunemediated, reactions to
ventriculoperitoneal (VP) shunts. We used an enzyme-linked immunosorbent
assay in which Silastic tubing served as the solid-phase antigen to test
serum from the two patients, five other VP shunt patients without
inflammatory reactions, and nine healthy adults. IgG binding to Silastic
tubing was consistently higher in the two patients than in the healthy or
patient controls. The IgG seemed to be binding specifically, since IgG Fab
fragments also bound to the tubing, and preincubation of serum with
Silastic or silylated proteins removed most of the activity. These findings
show that specific immune reactivity to elastomers of polydimethylsiloxane
can develop in human beings.
========================================================================
14.) Outcome study of the psychological changes after silicone breast
implant removal.
========================================================================
Roberts C; Wells KE; Daniels S
Department of Psychosocial Oncology, H.Lee Moffitt Cancer Center and
Research
Institute, Tampa, Fla, USA.
Plast Reconstr Surg (UNITED STATES) Sep 1997 100 (3) p595-9 ISSN:
0032-1052
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9711
Subfile: AIM; INDEX MEDICUS
INTRODUCTION: The purpose of this longitudinal study is to determine if
there are
changes in psychological well-being after breast implant removal. METHODS:
Thirty-
seven women underwent breast implant removal and completed a preoperative
baseline,
early postoperative (4 to 9 months), and late postoperative (> 10 months)
Brief
Symptom Inventory, a measure of psychological distress. RESULTS: After
breast
implant removal the mean Global Severity Scores on the Brief Symptom
Inventory of
women undergoing implant removal increased over the three time periods,
indicating
increasing psychological distress. When the group was divided into those
who had
breast reconstruction after implant removal (implant replacement with
saline-filled
implants or TRAM flaps) and those who did not have reconstruction, both
groups had
increasing psychological distress, but the women who had reconstruction had
slightly
higher scores. Women with a history of psychiatric treatment showed the
greatest
increase in psychological symptoms. CONCLUSION: Breast implant removal did
not have
psychological benefits in this group of women. Breast reconstruction after
removal
did not appear to be psychologically beneficial to this cohort.
========================================================================
15.) [Hashimoto's thyroiditis and silicone breast implants: 2 cases]
Thyroidite de hashimoto et protheses mammaires en silicone: 2 observations.
========================================================================
Vayssairat M; Mimoun M; Houot B; Abuaf N; Rouquette AM; Chaouat M
Hopital Tenon, Paris.
J Mal Vasc (FRANCE) Jul 1997 22 (3) p198-9 ISSN: 0398-0499
Language: FRENCH Summary Language: ENGLISH
Document Type:
JOURNAL ARTICLE English Abstract
Journal Announcement: 9711
Subfile: INDEX MEDICUS
The silicone implant controversy wavers between reassuring
epidemiological studies
and about 300 case reports of patients developing a definite or
incomplete/atypical
connective tissue disease (CTD) after receiving a silicone gel-filled
breast implant
(SBI). Since Hashimoto's thyroiditis (HT) is rarely reported in this
context, we
report here two new cases of HT associated with a history of bilateral
cosmetic SBIs.
The first patient was a 45-year-old white woman who had SBIs in 1976. In
1991 she
developed HT, evolving to thyroid deficiency which was compensated with
levothyroxine
treatment. In addition, the patient complained of fatigue, arthralgia,
morning
stiffness and developed a sicca syndrome necessitating artificial tears.
The 1995
evaluation disclosed the presence of antinuclear antibodies at a titre of
1/640, and
high level anti-thyroid microsomal antibodies (1/256,000). Gamma globulins
rose to
22.6%. Thyroid ultrasonography showed an enlarged thyroid gland with a
diffusely
hypoechogenic pattern. The implants were painful, and in 1996 they were
removed.
Microscope examination of the fibrous capsule surrounding the prostheses
showed
extremely dense connective tissue with fibrosis. The second patient was a
55-year-
old white woman who had SBIs in 1984. In 1995, she developed HT with
clinical pain
and tenderness of the thyroid gland, with mild hyperthyroidism and positive
antithyroglobulin antibodies, and was given corticosteroid treatment for 5
months.
In 1996, the implants were again painful and the patient developed positive
antinuclear antibodies with a titre of 1/200. Ultrasonography showed a
heterogeneous
thyroid gland, and implant removal was advised. Hashimoto's thyroiditis is
recognized as a subset of chronic auto-immune thyroiditis, and its
association with
SBI is rare. In these 2 observations, an association without relation is
possible,
but a future survey of similar cases seems warranted.
========================================================================
16.) Cellular immune reactivities in women with silicone breast implants: a
preliminary
investigation [see comments]
========================================================================
Ellis TM; Hardt NS; Campbell L; Piacentini DA; Atkinson MA
Department of Pathology, University of Florida, Gainesville 32610-0275, USA.
Ann Allergy Asthma Immunol (UNITED STATES) Aug 1997 79 (2) p151-4
ISSN: 1081-
1206 Contract/Grant No.: R01AI/DK39250--AI--NIAID; R29DK45342--DK--NIDDK
Note: Comment in: Ann Allergy Asthma Immunol 1997 Aug;79(2):89-90
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9711
Subfile: INDEX MEDICUS
BACKGROUND: Surgical implantation of silicone breast prostheses has been
conducted
and considered safe for over 30 years. Some implant recipients, however,
complain of
a group of symptoms similar to those observed in connective tissue disorders,
rheumatoid arthritis, systemic lupus erythematosus, or polymyositis. To
date,
immunologic sequelae have not been confirmed and remain controversial.
OBJECTIVE: To
examine an autoimmune-like basis for the "silicone associated disease"
reported by
some women with silicone breast prostheses. METHODS: Proliferative
responses of
peripheral blood mononuclear cells against a panel of control and
connective tissue
proteins and to compounds common to silicone prostheses were measured in 26
women who
received silicone breast implants (with implants in place an average of 166.4
[standard deviation (SD) 58.3] months), and 23 age-matched and sex-matched
healthy
controls. RESULTS: The frequency and intensity of cellular immune
responses against
collagen I, collagen III, fibrinogen, and fibronectin were significantly
increased in
silicone breast implant recipients versus controls. In implant subjects,
the highest
frequency of immune reactivity was directed against collagen I (11/26, 42%)
with
collagen III being the most immunostimulatory self-antigen with a mean
stimulation
index (SI) of 8.2 [95% confidence interval (95% CI) 3.2]. In addition,
10/26 (39%)
of the implant recipients responded to more than one of the connective tissue
antigens versus 0/23 (0%, P = .0007) healthy controls. Immunologic
reactivities to
other antigens, including silicone-based compounds, were remarkably similar.
CONCLUSIONS: The identification of self-reactivity towards these connective
tissue
antigens may provide important information for attempts at associating
silicone
breast implants with disease.
========================================================================
17.) Unusual masses found within ruptured silicone gel breast prostheses.
========================================================================
Hughes KC; Calabretta AM; Hirai T; Manders EK
Division of Plastic and Reconstructive Surgery, Milton S. Hershey Medical
Center,
Hershey, Pa., USA.
Plast Reconstr Surg (UNITED STATES) Aug 1997 100 (2) p525-8 ISSN:
0032-1052
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9711
Subfile: AIM; INDEX MEDICUS
Imaging of breast implants has assumed more importance in medicine than
ever before.
Radiologists and surgeons alike have struggled to accurately identify folds
in
prostheses, rupture of prostheses, and migration of gel. Here we present two
patients with an unusual presentation of masses within the gel of ruptured
silicone
gel-containing prostheses. In one instance, the mass was an organized
hematoma. In
the other, two round, calcified masses were found that we presume are
hematomas that
have become calcified over time. Radiologists and surgeons identifying
spherical or
ovoid masses seemingly within gel breast prostheses should entertain the
possibility
that the mass represents an organized hematoma and that the implant is
ruptured.
========================================================================
18.) Silicone breast implants: pathology.
========================================================================
Raso DS; Greene WB
Department of Pathology, Medical University of South Carolina,
Charleston, USA.
Ultrastruct Pathol (UNITED STATES) May-Jun 1997 21 (3) p263-71 ISSN:
0191-3123
Language: ENGLISH
Document Type: JOURNAL ARTICLE; REVIEW; REVIEW, TUTORIAL
Journal Announcement: 9709
Subfile: INDEX MEDICUS
Questions as to the bioreactivity of silicone breast implants (SBIs) have
recently
been intensely scrutinized, most notably by the media and legal system.
Pathologists
must be aware of the controversy and treat each SBI and associated tissue
as a
potential lawsuit. Grossly, silicone is a clear, viscous substance that
may be
observed either within or extruding from a silastic bag. By light
microscopy,
silicone is a nonstainable, nonpolarizable, refractile substance. Thicker
sections,
especially when viewed by non-Kohler illumination, phase-contrast, and
darkfield
microscopy will enhance visualization. Ultrastructurally, silicone is an
electron-
dense, amorphous substance often located within phagocytic vacuoles or
extracellularly within the stroma. Correlating electron probe
microanalysis allows
for reliable identification. In most cases, a fibrous capsule surrounds
the SBI,
with the interface lining varying from a virtually acellular to a
synovial-like
lining composed of phagocytic and secretory cells. Silicone can often be
identified
within the fibrous capsule and also in distant tissues biopsied for suspected
autoimmune disorders, such as synovium, skin, and lymph nodes, often without
ultrastructural evidence of cytologic effects. This study has demonstrated
that
silicone accumulates at distant tissue sites due to preexisting
inflammation acting
as a stimulus. Thus, silicone is not a primary inducer of inflammatory
disease
processes. These findings are supported by various large epidemiologic
studies. (46
References)
========================================================================
19.) Capsular contracture with textured versus smooth saline-filled
implants for breast
augmentation: a prospective clinical study.
========================================================================
Tarpila E; Ghassemifar R; Fagrell D; Berggren A
Department of Plastic Surgery, University Hospital, Linkoping, Sweden.
Plast Reconstr Surg (UNITED STATES) Jun 1997 99 (7) p1934-9 ISSN:
0032-1052
Language: ENGLISH
Document Type: CLINICAL TRIAL; JOURNAL ARTICLE; RANDOMIZED CONTROLLED
TRIAL
Journal Announcement: 9709
Subfile: AIM; INDEX MEDICUS
Texturization of silicone-filled breast implants has been shown to reduce
the
incidence of capsular contracture. A double-blind clinical study was
undertaken to
compare this incidence in saline-filled implants with textured or with smooth
surfaces. Twenty-one women underwent mammary augmentation with a textured
implant in
one breast and a smooth implant in the other. The implants were placed
subglandularly. All operations were performed by the same surgeon and all
follow-up
examinations by another. Breast hardness was evaluated 6 months
postoperatively with
applanation tonometry, using Baker's grading, and after 12 months, now also
with a
questionnaire concerning the patient's evaluation. Capsular contracture
(Baker 3)
had occurred in 33 percent of the breasts at the end of the study, and was
bilateral
in five cases. The incidence of contracture and the patients' views on the
results
did not differ between textured and smooth prostheses or between right and
left
breasts. Five patients requested reoperation, two of them because of
breast hardness.
Texturization of saline-filled implants thus did not reduce the incidence
of capsular
contracture.
========================================================================
20.) Lymphocyte response to silica among offspring of silicone breast implant
recipients.
========================================================================
Smalley DL; Levine JJ; Shanklin DR; Hall MF; Stevens MV
Baptist Memorial Health Care System, University of Tenessee, Memphis, USA.
Immunobiology (GERMANY) 97 1996 196 (5) p567-74 ISSN: 0171-2985
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9709
Subfile: INDEX MEDICUS
The current study evaluated immune response to silicon dioxide in
children born to
women with silicone breast implants. In part one of the study, the T
lymphocytes of
21 of 24 such children were significantly stimulated by silicon dioxide
(silica).
Part two consisted of eleven children, four born preimplantation and seven
born
postimplantation. None of the preimplant offspring showed T cell responses
to
silica; five of the seven postimplant children were positive for T cell
memory for
silica. Part three was a blinded study based on statistically significant
differences in T cell stimulation with silicon dioxide between postimplant
children
and controls. These findings indicate a common immune reaction, that of T
cell
memory, occurs in mothers and their children born after exposure to
silicone mammary
implants placed prior to pregnancy. Since not all such children were
breast fed the
result favors transplacental passage of immunogens such as silicone
oligomers or
through maternofetal cellular traffic.
========================================================================
21.) Ruptured or intact: what can linear echoes within silicone breast
implants tell us?
========================================================================
Palmon LU; Foshager MC; Parantainen H; Everson LI; Cunningham B
Department of Radiology, University of Minnesota Hospital and Clinic,
Minneapolis,
MN 55455, USA.
AJR Am J Roentgenol (UNITED STATES) Jun 1997 168 (6) p1595-8 ISSN:
0361-803X
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9708
Subfile: AIM; INDEX MEDICUS
OBJECTIVE: During sonographic evaluation of silicone breast implants for
possible
rupture, we have frequently encountered several patterns of linear echoes
within the
implants. To our knowledge, the significance of this finding has not been
established in the literature. The purpose of this study was to determine
whether
internal echoes are significant in predicting implant rupture. SUBJECTS
AND METHODS:
Thirty-three patients with 64 silicone implants were prospectively entered
into a
study that included gray-scale sonography of the implants and subsequent
surgical
removal. Echo patterns within the implants were retrospectively evaluated
on hard-
copy films and compared with the integrity of the implant at surgery.
RESULTS: Three
categories of internal echo patterns were identified: "thick linear
echoes." "thin
linear echoes," and "commas." One or more of these echo patterns were seen
in 57
(89%) of the 64 implants. Thick linear echoes were seen in 23 (36%) of the
64
implants, thin linear echoes were seen in 33 (52%) of the 64 implants, and
commas
were seen in 47 (73%) of the 64 implants. All echo patterns were seen in
intact and
ruptured implants with nearly equal frequency. We found no statistical
significance
for any echo pattern in predicting whether an implant was ruptured or
intact. Of the
64 implants, four were entirely free of internal echoes. All four implants
were
intact. CONCLUSION: A variety of linear echoes can be seen in most
silicone breast
implants on gray-scale sonography. The presence or absence of linear
echoes is not
useful in predicting implant rupture. Complete absence of internal echoes,
while
highly predictive of an intact implant, is infrequently seen.
========================================================================
22.) Inflammatory reaction and capsular contracture around smooth silicone
implants.
========================================================================
Carpaneda CA
Aesthetic Plast Surg (UNITED STATES) Mar-Apr 1997 21 (2) p110-4 ISSN:
0364-216X
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9708
Subfile: INDEX MEDICUS
Histologic studies were performed on capsular tissue resected from 21
patients who
were implanted with smooth silicone prostheses filled with gel. The results
disclosed a nonuniform response to the implants. The granulomatous
reaction to the
silicone showed important variations along the same surface of the
implants, between
the plane and the concave surfaces, between equivalent points at the right
and left
sides, and among the patients. Also, a significant difference was observed
between
reactions and capsules in early and late stages. The author believes these
variations of the capsular inflammatory reaction promote different sites of
contraction between cell-to-cell, or cell-to-collagen-to-cell. These
adding forces
result in vectors of different intensities and directions around the
implants which
explains the various clinical grades of capsular contracture.
========================================================================
23.) Breast implantation and the incidence of upper extremity somatic
complaints.
========================================================================
Kulick M; Daneshmand H
Department of Plastic and Reconstructive Surgery, Saint Francis Memorial
Hospital,
San Francisco, California 94108, USA.
Aesthetic Plast Surg (UNITED STATES) Mar-Apr 1997 21 (2) p105-9 ISSN:
0364-216X
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9708
Subfile: INDEX MEDICUS
Attention has been drawn to elevated laboratory tests of inflammation as
indicators
of a possible reaction to silicone breast implants. These patients have
complaints
of joint pain, pain, and myalgia that were possibly caused by a reaction to
silicone.
This study is a retrospective review of 100 consecutive patients (79
female, 21 male)
who were evaluated because of a purported industrial injury to the upper
extremity.
Patients were examined by a single examiner and all had laboratory
screening for
indicators of inflammation (sedimentation rate, anti-nuclear antibody
levels, C-
reactive protein, anti-streptolysin, rheumatic factor), endocrine
abnormalities
(thyroid panel), and serum glucose. None of the patients had any history
of breast
augmentation with any implant. Of the 79 female patients, 50 had an
identifiable
clinical diagnosis and 18 of them had elevation of at least one of the
indicators of
inflammation. The remaining 29 did not have an identifiable diagnosis and
21 of them
had elevation of at least one indicator of inflammation (P < 0.01). There
were 74
out of 79 females with subjective complaints of upper extremity pain, joint
pain, and
aching. Forty-five of these patients had an identifiable diagnosis and 17
of them
had elevation of at least one inflammatory indicator. Of the 74 female
patients, 29
had no identifiable diagnosis and 21 of them had elevation of at least one
inflammatory indicator (P < 0.01). In summary, there were a high number of
female
patients with complaints of upper extremity symptoms with no prior exposure
to
silicone from breast implantation. There was a statistically significant
correlation
in these patients who had no identifiable diagnosis and elevated indicators
in
inflammation. This study suggests these markers of inflammation should not
be used
as indicators of a reaction to silicone from breast implantation in
patients with
upper extremity subjective complaints.
========================================================================
24.) A review of the possible health implications of silicone breast implants.
========================================================================
Noone RB
Department of Surgery, University of Pennsylvania School of Medicine,
Philadelphia,
USA.
Cancer (UNITED STATES) May 1 1997 79 (9) p1747-56 ISSN: 0008-543X
Language: ENGLISH
Document Type: JOURNAL ARTICLE; REVIEW; REVIEW, TUTORIAL
Journal Announcement: 9707
Subfile: AIM; INDEX MEDICUS
BACKGROUND: The silicone gel breast implant has long been an important
method of
reconstruction for the mastectomy patient. Because of concerns about
possible health
implications of the implant, the Food and Drug Administration banned its
use for
augmentation mammaplasty and limited its use in the mastectomy patient to a
research
protocol study. This article reviews the recent literature about the
possible health
hazards of the silicone implant. METHODS: In this review of the
literature, specific
attention was directed toward structural failure of the device as well as the
diagnosis of rupture, tissue response to silicone, systemic immunologic
response to
silicone, the relationship of silicone to connective tissue diseases, and the
association of the silicone implant with breast carcinoma in both the
augmentation
mammaplasty patient and the patient undergoing postmastectomy
reconstruction. A
total of 88 works were reviewed. RESULTS: The literature fails to support an
association between silicone gel breast implants and systemic diseases.
Although
implants may cause local symptoms, rupture over time, or be associated with
an
immunologic reaction, comprehensive epidemiologic studies have concluded
that there
is no connection between breast implants and the known connective tissue
diseases or
between the implants and breast carcinoma. There is no increase in the
risk of
recurrence in mastectomy patients reconstructed with implants and no delay
in the
detection of recurrences. Recent laboratory studies in animals suggest
that silicone
may have anticarcinogenic effects. CONCLUSIONS: Silicone gel breast
implants may
rupture and cause local symptoms, but they have not been demonstrated to be a
systemic health hazard for patients who have undergone augmentation
mammaplasty or
postmastectomy reconstruction. (88 References)
========================================================================
25.) [The value of sonography for the discovery of complications after the
implantation of silicone gel prostheses for breast augmentation or
reconstruction]
Stellenwert der Sonographie fur die Aufdeckung von Komplikationen nach
Implantation
von Silikongelkissen zur Mammaaugmentation bzw. -rekonstruktion.
========================================================================
Lorenz R; Stark GB; Hedde JP
Abteilung fur Diagnostische Radiologie, Stadt. Krankenhaus Solingen.
Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr (GERMANY) Mar 1997
166 (3)
p233-7 ISSN: 0936-6652
Language: GERMAN Summary Language: ENGLISH
Document Type:
JOURNAL ARTICLE English Abstract
Journal Announcement: 9707
Subfile: INDEX MEDICUS
PURPOSE: To determine sensitivity and specificity of real-time
ultrasonography in
detecting breast implant complications. MATERIAL AND METHODS: The results of
preoperative ultrasonography of 121 silicone implants in 65 patients were
compared
with the results after operative implant removal. RESULTS: With a
sensitivity of
89.25% and a specificity of 92.1%, complications such as gel bleeding (n =
43),
rupture with leakage (n = 63), and implant dissolution (n = 4) become
manifest.
Capsule formation, fibrosis, siliconoma and calcifications were often
underestimated
in their extent. Negative ultrasonography findings were found in 10.7% (n
= 13) with
positive clinical findings. CONCLUSIONS: The combination of clinical and
ultrasonography findings leads to the detection of implant complications.
========================================================================
26.) Explantation of silicone breast implants.
========================================================================
Thomas WO 3rd; Harper LL; Wong SW; Michalski JP; Harris CN; Moore JT;
Rodning CB
Department of Surgery, College of Medicine/Medical Center, University of
South
Alabama, Mobile, USA.
Am Surg (UNITED STATES) May 1997 63 (5) p421-9 ISSN: 0003-1348
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9707
Subfile: INDEX MEDICUS
Silicone gel-filled breast implants have been employed clinically for
decades for
aesthetic augmentation or postmastectomy reconstruction. Most patients and
surgeons
attest to the efficacy and safety of these devices. However, more recently
in the
medical literature and popular media, silicone gel-filled breast implants
have been
claimed to incite an array of clinical sequelae such as capsular formation,
granulomatous disease, arthritis, arthralgia, fibromyalgia, autoimmune
collagen
vascular disease, human adjuvant disease, siliconosis, silicone-related
disease, and
silicone implant-associated syndrome. During a recent 24-month period, 25
referred
patients underwent explantation of bilateral silicone gel-filled prostheses
at the
University of South Alabama. Patient-reported symptoms and signs included
mastodynia, arthralgia, fibromyalgia, xerophthalmia, xerostomia,
hypesthesia, and
amblyopia. Clinical examination and mammography were reliable in
diagnosing implant
rupture, but only re-exploration reliably detected implant leakage. Most
patients
underwent concurrent replacement with saline-filled devices. Histopathologic
analyses of all tissue samples revealed chronic inflammation. Subjective
improvement
of patient-reported symptoms and signs occurred over the course of months
postoperatively. There was no mortality associated with explantation, with
or
without replacement, but an overall morbidity incidence of 20 per cent (5
of 25) was
observed. Predicated upon review of the available scientific literature
and analysis
of this modest number of patients, the following perspectives are germane.
1) A
small cohort of patients of status postimplantation of silicone gel-filled
devices
will manifest chronic morbidity. Identifying such patients prospectively
remains
problematic. 2) Whether or not silicone gel incites adverse systemic
phenomena is
unproven, although it has been implicated. 3) Symptomatic patients with
silicone gel-
filled implants in place should be considered for removal, with full
knowledge of the
morbidity associated with revisional procedures. 4) Patients currently
undergoing
breast augmentation or reconstruction employing prosthetics are perhaps
best served
by insertion of saline-filled devices. 5) Patient-physician dialogue
regarding the
risk-benefit analysis of prosthetic implantation is imperative. Patients
consenting
to such procedures must be willing to assume risks.
========================================================================
27.) Neurosarcoidosis following augmentation mammoplasty with silicone.
========================================================================
Yoshida T; Tanaka M; Okamoto K; Hirai S
Department of Neurology, Gunma University School of Medicine, Japan.
Neurol Res (ENGLAND) Aug 1996 18 (4) p319-20 ISSN: 0161-6412
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9707
Subfile: INDEX MEDICUS
We report a patient with neurosarcoidosis, which developed 22 years after
augmentation mammoplasty by the injection of silicone gel. She presented
with
bilateral hilar lymphadenopathy, left-sided lower cranial nerve palsies
(8th, 9th,
and 10th), and vestibular ataxia, which improved following the
administration of
prednisolone. Biopsy of the breast nodules showed granulomatous changes
identical
with those of sarcoidosis, while infrared spectrophotometry disclosed that
the
nodules contained polydimethylsiloxane, a major component of the silicone gel
injection. This is the first report of neurosarcoidosis following silicone
mammoplasty.
========================================================================
28.) Are breast implants anticarcinogenic? A 14-year follow-up of the Los
Angeles Study.
========================================================================
Deapen DM; Bernstein L; Brody GS
Department of Preventive Medicine, School of Medicine, University of
Southern
California, Los Angeles, USA.
Plast Reconstr Surg (UNITED STATES) Apr 1997 99 (5) p1346-53 ISSN:
0032-1052
Contract/Grant No.: CA-14089--CA--NCI; CA-17054--CA--NCI
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9707
Subfile: AIM; INDEX MEDICUS
Despite decades of use, the long-term safety of breast implants in women
remains a
concern. While the incidence of breast cancer among women has increased
dramatically
in the past decade, the implant-related risk of carcinoma of the breast
only recently
has received widespread attention. An additional concern is that the
presence of the
implant may delay tumor detection. This study allows examination of breast
cancer
risk and detection issues among patients with long-term exposure. We
conducted a
record linkage cohort study of cosmetic breast implant patients. We
abstracted the
records of the private practices of 35 broad-certified plastic surgeons in
Los
Angeles County, California. We included 3182 white women who received
cosmetic
breast implants between 1953 and 1980. Spanish-surnamed women,
nonresidents of Los
Angeles County, and patients with prior subcutaneous mastectomy or breast
cancer were
excluded. Cancer outcomes through 1991 have been ascertained through
record linkage
with the Los Angeles County Cancer Surveillance Program. With a median
follow-up of
14.4 years, 31 breast cancer cases were observed, compared with 49.2
expected, based
on Los Angeles County population-based incidence rates (standardized
incidence ratio
= 63.0 percent; 95 percent confidence limits: 42.8 and 89.5 percent). The
distribution of stage of disease at diagnosis among women with implants did
not
differ from that of all similar breast cancer patients in Los Angeles
County. In Los
Angeles County, augmentation mammaplasty patients experience a
significantly lower
than expected risk of breast cancer and no delay in breast cancer detection
after an
average of 14.4 years of exposure. While the linkage methodology allows the
possibility of failing to detect diagnosed cancer cases and does not permit
collection of some pertinent risk factors, the six other published
epidemiologic
studies on the topic also report breast cancer risk to be at or below the
expected
rate.
========================================================================
29.) [Silicone breast implants and breast cancer]
Silikonebrystproteser og brystkraeft.
========================================================================
Kjoller KH; Krag C; Friis S
Plastikkirurgisk afdeling V, Amtssygehuset i Herlev.
Ugeskr Laeger (DENMARK) Mar 17 1997 159 (12) p1744-8 ISSN: 0041-5782
Language: DANISH Summary Language: ENGLISH
Document Type:
JOURNAL ARTICLE; REVIEW; REVIEW, TUTORIAL English Abstract
Journal Announcement: 9706
Subfile: INDEX MEDICUS
Sarcomas have been shown to develop next to foreign body implants, silicone
included, in animal experiments. However, this carcinogenesis is not
believed to
have any human relevance. A review of the existing epidemiological studies
suggests
that women with silicone breast implants have a reduced risk for developing
breast
cancer. However, the presence of breast implants does obscure mammographic
visualization as well as palpation of mammary tissue. This has led to the
assumption
that breast cancer detection could be compromised in women with breast
implants. In
the few studies that have dealt with this issue, women with breast implants
were
diagnosed with the same stage of disease as women without implants.
However, the
percentage of false negative mammographies was increased in one study. In
conclusion, there is currently no evidence of an association between breast
implants
and cancer or postponed breast cancer detection. (37 References)
========================================================================
30.) Lack of evidence of systemic inflammatory rheumatic disorders in
symptomatic women
with breast implants.
========================================================================
Blackburn WD Jr; Grotting JC; Everson MP
Research Service, Birmingham VA Medical Center, Ala, USA.
Plast Reconstr Surg (UNITED STATES) Apr 1997 99 (4) p1054-60 ISSN:
0032-1052
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9706
Subfile: AIM; INDEX MEDICUS
Breast implants containing silicone have been used for approximately 30
years for
breast augmentation or reconstruction. In general, the implants have been
well
tolerated and reports have indicated a high degree of patient satisfaction.
Nonetheless, there have been anecdotal reports of patients with
musculoskeletal
complaints that have been attributed to silicone breast implants. To
investigate
this further, we prospectively examined 70 women with silicone breast
implants who
had complaints that they or their referring physicians thought were related
to their
implants. On clinical examination, the majority of the patients had
fibromyalgia,
osteoarthritis, or soft-tissue rheumatism. One patient had rheumatoid
arthritis,
which predated her implants, and one had Sjogren's syndrome. Because many
of our
patients had myalgic symptoms, we further evaluated these patients by
measuring
circulating levels of soluble factors including interleukin-6,
interleukin-8, tumor
necrosis factor-alpha, soluble intercellular adhesion molecule-1, and soluble
interleukin-2 receptor, which have been previously found to be elevated in
patients
with inflammatory diseases. We found that the levels of these molecules in
women
with silicone breast implants were not different from those seen in normal
subjects
and were significantly less than those seen when examining chronic
inflammatory
disorders such as rheumatoid arthritis or systemic lupus erythematosus. In
summary,
our clinical and laboratory evaluation of symptomatic breast implant
patients argues
against an association of silicone breast implants with a distinctive
rheumatic
disease or a systemic inflammatory disorder. Given these findings and the
clinical
picture, it is our impression that most symptomatic women with silicone
breast
implants have well-delineated noninflammatory musculoskeletal syndromes.
Moreover,
these data fail to support the concept that their symptoms are due to a
systemic
inflammatory response related to their implants.
========================================================================
31.) Breast implants in patients with differentiated and undifferentiated
connective
tissue disease.
========================================================================
Williams HJ; Weisman MH; Berry CC
University of Utah School of Medicine, Salt Lake City 84132, USA.
Arthritis Rheum (UNITED STATES) Mar 1997 40 (3) p437-40 ISSN: 0004-3591
Contract/Grant No.: 1-AM-6-2228--AM--NIADDK
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9706
Subfile: AIM; INDEX MEDICUS
OBJECTIVE: To assess the frequency of breast implantation and the
relationship of
the implants to the onset of symptoms in patients with differentiated and
undifferentiated connective tissue disease (CTD). METHODS: We evaluated an
inception
cohort of patients with differentiated and undifferentiated CTD and
symptoms of < 12
months duration when enrolled in 1983-1987. The risk of having breast
implants in
those patients with early symptoms of CTD was determined in comparison with
that in a
non-concurrent control group. RESULTS: Only 3 of 323 women in the cohort had
historical, physical, or chest radiographic evidence of breast
implantation. In 1 of
the 3 patients, the symptoms of CTD began before the breast implantation.
The odds
ratio was calculated at 1.15, with a 95% confidence interval ranging from
0.23 to
3.41. CONCLUSION: This study showed an absence of significant risk for
prior breast
implantation surgery in patients with well-defined or undifferentiated CTD.
========================================================================
32.) Epidemiology of systemic sclerosis.
========================================================================
Silman AJ; Newman J
University of Manchester, ARC Epidemiology Research Unit, School of
Epidemiology
and Health Sciences, UK.
Curr Opin Rheumatol (UNITED STATES) Nov 1996 8 (6) p585-9 ISSN:
1040-8711
Language: ENGLISH
Document Type: JOURNAL ARTICLE; REVIEW; REVIEW, TUTORIAL
Journal Announcement: 9705
Subfile: INDEX MEDICUS
There have been few recent studies of the descriptive epidemiology of
systemic
sclerosis, but in recent work the limited form of the disease seems more
prominent
than reported in previous studies. Molecular genetic investigation of
systemic
sclerosis remains disappointing in identifying susceptibility alleles.
There are
some associations in relation to HLA class II alleles, specifically DP, DQ,
and DR.
These associations, however, seem to be more important in predicting the
nature of
the autoimmune response rather than describing disease susceptibility
itself. The
study of occupational and environmental influences has been dominated by
studies on
the role of silicone gel breast implants. These studies, driven by
medicolegal
constraints, have overwhelmingly failed to prove any association. Other
studies
confirm the continuing likelihood that organic solvents are implicated, at
least in a
proportion of cases. (38 References)
========================================================================
33.) Use of antipolymer antibody assay in recipients of silicone breast
implants.
========================================================================
Tenenbaum SA; Rice JC; Espinoza LR; Cuellar ML; Plymale DR; Sander DM;
Williamson
LL; Haislip AM; Gluck OS; Tesser JR; Nogy L; Stribrny KM; Bevan JA; Garry RF
Department of Microbiology and Immunology, Tulane University School of
Medicine,
New Orleans, LA 70112, USA.
Lancet (ENGLAND) Feb 15 1997 349 (9050) p449-54 ISSN: 0140-6736
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9705
Subfile: AIM; INDEX MEDICUS
BACKGROUND: Local complications (encapsulation, rashes, rupture, and
leakage) can
occur after placement of silicone gel-containing breast implants (SBI).
Whether SBI
exposure results in systemic manifestations in some recipients is
controversial. We
have carried out a blinded study to assess whether there is any difference
between
SBI recipients and non-exposed controls in the proportions positive for serum
antibodies directed against polymeric substances. METHODS: We recruited
female SBI
recipients (including those without symptoms) who presented to a single
rheumatology
clinic. A physician global assessment was used to classify SBI recipients
who did
not meet criteria for specific autoimmune diseases according to the
severity of local
and systemic signs and symptoms. Controls were recruited from among clinic
staff and
their acquaintances. Results of the antipolymer antibody (APA) assay were
compared
with those of an assay for antinuclear antibodies (ANA) and with the
severity of the
signs and symptoms. FINDINGS: Positive APA results were found in one (3%)
of 34 SBI
recipients with limited symptoms, two (8%) of 26 with mild symptoms, seven
(44%) of
16 with moderate symptoms, and 13 (68%) of 19 with advanced symptoms. Four
(17%) of
23 healthy non-SBI-exposed controls and two (10%) of 20 non-exposed women
with
classic autoimmune diseases were positive for APA. Thus, women with
moderate or
advanced symptoms were significantly more likely than those with limited or
mild
symptoms, or non-exposed controls to have APA (p < 0.001). The proportion
with
positive ANA results was higher for women with classic autoimmune diseases
14 (70%)
of 20 than for any SBI-exposed subgroup (0-33%). INTERPRETATION: The APA
assay can
objectively contribute to distinguishing between SBI recipients with
limited or mild
signs and symptoms. SBI recipients with more severe manifestations, and
patients
with specific autoimmune diseases. Further studies will be needed to
define the
signs and symptoms associated with exposure to SBI.
========================================================================
34.) Complications leading to surgery after breast implantation [see comments]
========================================================================
Gabriel SE; Woods JE; O'Fallon WM; Beard CM; Kurland LT; Melton LJ 3rd
Division of Rheumatology and Internal Medicine, Mayo Clinic and Mayo
Foundation,
Rochester, MN 55905, USA.
N Engl J Med (UNITED STATES) Mar 6 1997 336 (10) p677-82 ISSN: 0028-4793
Contract/Grant No.: AR30582--AR--NIAMS
Note: Comment in: N Engl J Med 1997 Mar 6;336(10 ):718-9
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9705
Subfile: AIM; INDEX MEDICUS
BACKGROUND: Local complications that require additional surgical
procedures are an
important problem for women with breast implants. METHODS: We studied 749
women who
lived in Olmsted County, Minnesota, and received a first breast implant at
the Mayo
Clinic between 1964 and 1991. We identified complications that occurred
after the
initial procedure and after any subsequent implantation. A complication
was defined
as a surgical procedure performed for any of the following reasons: capsular
contracture; rupture of the implant; hematoma or bleeding; infection or
seroma of the
wound; chronic pain; extrusion, leakage, or sweating of the implant;
necrosis of the
nipple, areola, or flap; malfunction of the filler port of a tissue
expander; and
wound dehiscence. RESULTS: During follow-up (mean, 7.8 years; range, 0 to
25.8), 208
(27.8 percent) of the women underwent 450 additional implant-related surgical
procedures. Ninety-one (20.2 percent) were anticipated, staged procedures
or were
done because the patient requested a size change or aesthetic improvement,
and 359
procedures (79.8 percent) had at least one clinical indication (thus
constituting a
complication). Complications occurred in 178 (23.8 percent) of the 749
women and
involved 274 (18.8 percent) of the 1454 breasts with implants and 321 (18.8
percent)
of the 1703 implants. The most frequent problem was capsular contraction
(272
cases), followed by rupture of the implant (60), hematoma (55), and wound
infection
(23). The rate of complications was significantly lower (P<0.001) among
women with
cosmetic implants (6.5 percent at one year, 12 percent at five years) than
among
women who underwent implantation after mastectomy for breast cancer (21.8
percent at
one year, 34 percent at five years) or prophylactic mastectomy (17.3
percent at one
year, 30.4 percent at five years). CONCLUSIONS: Women who have had breast
implantation frequently experience local complications during the
subsequent five
years. Complications were significantly less frequent among patients who
received
implants for cosmetic reasons than among those who received implants after
mastectomy
for cancer or for cancer prophylaxis.
========================================================================
35.) Silicone gel and octamethylcyclotetrasiloxane (D4) enhances antibody
production to
bovine serum albumin in mice.
========================================================================
Nicholson JJ 3rd; Hill SL; Frondoza CG; Rose NR
Department of Molecular Microbiology and Immunology, Johns Hopkins
University,
Baltimore, Maryland 21239, USA.
J Biomed Mater Res (UNITED STATES) Jul 1996 31 (3) p345-53 ISSN:
0021-9304
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9705
Subfile: INDEX MEDICUS
The purpose of the present study was to determine whether components of
silicone
breast implants [silicon (polydimethylsiloxane) oil, silicone gel, and
octamethylcyclotetrasiloxane (D4)] potentiate the antibody response to
bovine serum
albumin (BSA) in mice. Seventy A/J mice were divided into seven groups which
received the following: group I--phosphate buffer solution (PBS); group
II--20
centistoke (cs) silicone oil; group III--50% silicone gel homogenized in
silicone
oil; group IV--incomplete Freunds' adjuvant (IFA); group V--IFA mixed with
an equal
volume of silicone oil; group VI--D4; and group VII--IFA mixed with an
equal volume
of DA. Each 0.1 mL of treatment material(s) was mixed or emulsified with
an equal
0.1-mL volume of 250 micrograms/mL BSA in PBS solution. Antibodies to BSA
were
measured using an enzyme-linked immunosorbent assay. Our study
demonstrates for the
first time that both D4 and the silicone gel potentiate antibody production
to BSA in
mice. Histopathologic evaluation of the injection sites reveals granulomas
for mice
injected with IFA and D4 preparations. Whether D4 or silicone gel acts as an
adjuvant against self-antigens has yet to be determined.
========================================================================
36.) Visualization of silicone gel in human breast tissue using new
infrared imaging
spectroscopy.
========================================================================
Kidder LH; Kalasinsky VF; Luke JL; Levin IW; Lewis EN
Laboratory of Chemical Physics, National Institute of Diabetes and
Digestive and
Kidney Diseases, National Institutes of Health, Bethesda, Maryland
20892-0510, USA.
Nat Med (UNITED STATES) Feb 1997 3 (2) p235-7 ISSN: 1078-8956
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9705
Subfile: INDEX MEDICUS
Between 1 and 2 million women in the United States have silicone breast
implants.
Complications include capsular contracture and calcification and possibly
connective
tissue diseases such as scleroderma and rheumatoid arthritis, a subject of
some
controversy. In order to accurately assess the role of silicone in any
histopathologic change, it is necessary to confirm its presence and to
identify other
foreign materials in the capsular tissue. Although light microscopy is
used to
visualize regions of tissue containing foreign inclusions, their chemical
identity
can only be determined using analytical techniques such as infrared or Raman
microscopy. However, these conventional microprobe techniques record
spectra only at
single points and require an a priori knowledge of the locations of the
inclusion to
be probed. To significantly extend the capabilities of both infrared
spectroscopy
and optical microscopy, we have developed a new infrared imaging system that
completely integrates these two methods. In this manuscript we highlight
the ability
of the technique to screen rapidly and to determine accurately the
presence, size and
chemical composition of silicone gel inclusions in human breast tissue.
========================================================================
37.) The epidemiology of scleroderma among women: assessment of risk from
exposure to
silicone and silica.
========================================================================
Burns CJ; Laing TJ; Gillespie BW; Heeringa SG; Alcser KH; Mayes MD; Wasko
MC;
Cooper BC; Garabrant DH; Schottenfeld D
Department of Epidemiology, University of Michigan, Ann Arbor, USA.
J Rheumatol (CANADA) Nov 1996 23 (11) p1904-11 ISSN: 0315-162X
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9705
Subfile: INDEX MEDICUS
OBJECTIVE: To investigate the relationship between exposure to silicone
(including
breast implants) and silica and the development of scleroderma (systemic
sclerosis,
SSc) among women. METHODS: A population based case-control study was
conducted among
women in Michigan. 274 confirmed cases of SSc diagnosed between 1985 and
1991 were
identified by contacting rheumatologists, hospitals, and a scleroderma
support group.
These cases and 1184 controls were interviewed by telephone to ascertain past
exposures to silicone or silica. RESULTS: Silicone in the form of breast
implants
was not associated with significantly increased risk of SSc (adjusted odds
ratio,
1.30; 95% confidence interval, 0.27 to 6.23). Among 20 other potential
silicone
exposure surveyed, self-reported exposure to silicone based glues,
sealants, and
caulks, manufacture or repair of windows or windshields, repairing or
frequently
using photocopy machines, consumption of simethicone-containing antacids, and
implanted medication delivery pumps were significantly associated with SSc.
However,
blinded assessment of all job and hobby descriptions in terms of their
potential for
silicone exposure failed to support the first 3 associations, antacid
consumption may
have been confounded by esophageal dysmotility before the diagnosis of SSc,
and other
silicone containing device categories (pacemakers, central nervous system
shunts,
other shunts and catheters) were not significantly associated with SSc.
Surgically
implanted metallic fixation devices were associated with significantly
reduced risk
for SSc. No association was detected between SSc and silica dust exposure.
CONCLUSION: Consistent with other studies, we found no increased risk of
SSc among
women with silicone breast implants, equivocal evidence of risk from other
silicone
exposures, and no evidence of risk from silica exposure.

======================================================
38.) Global Adverse Event Reports of Breast Implant-Associated ALCL: An International Review of 40 Government Authority Databases.
=======================================================
Plast Reconstr Surg. 2017 Jan 20. doi: 10.1097/PRS.0000000000003233. [Epub ahead of print]
Srinivasa DR1, Miranda RN, Kaura A, Francis AM, Campanale A, Boldrini R, Alexander J, Deva A, Gravina P, Medeiros LJ, Nast K, Butler CE, Clemens MW.
Author information
1
1. Department of Plastic Surgery, University of Michigan, Ann Arbor, Michigan, srinivad@med.umich.edu 2. Department of Hematopathology, The University of Texas M.D. Anderson Cancer, Center, Houston, Texas; roberto.miranda@mdanderson.org and ljmedeiros@mdanderson.org 3. Oakland University William Beaumont School of Medicine, Rochester, MI, askaura@oakland.edu 4. Department of General Surgery, The University of Texas, Houston, Houston, Texas, ashleigh.m.francis@uth.tmc.edu 5. Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections, Roma, Italy, vigilance@sanita.it 6. Plastic & Reconstructive Surgery Branch, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Janette.Alexander@fda.hhs.gov 7. Department of Plastic Surgery, Macquarie University, Sydney, Australia 8. Medical School of Federal University of Bahia, Salvador, Brazil 9. Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, United States Food and Drug Administration, Karen.Nast@fda.hhs.gov 10. Department of Plastic Surgery, M.D. Anderson Cancer Center, Houston, TX; mwclemens@mdanderson.org; cbutler@mdanderson.org.
Abstract
BACKGROUND:
An estimated 200 patients have been reported with breast implant associated anaplastic large cell lymphoma (BI-ALCL), a rare T-cell lymphoma developing around breast prostheses. The purpose of this study was to review federal database submissions relating to BI-ALCL in 37 countries representing the majority of breast implant markets worldwide with available adverse event reporting.
METHODS:
Database queries were performed for Australia, Brazil, Canada, China, Columbia, Japan, Mexico, National Competent Authorities of the European Member States, New Zealand, South Korea, and United States. Demographics, device characteristics, pathology, treatment modalities, and outcomes were assessed when available.
RESULTS:
The United States MAUDE database included 459 entries in total for the search terms "Anaplastic" and "ALCL" as of September 2015. Excluding for duplicate entries, the MAUDE database had 258 unique cases of BI-ALCL of which 130 had pathologic markers performed. Implant surface was textured significantly more than smooth (50% vs. 4.2%, p=0.0001). Treatment, when reported (n=136), included explantation (n=125, 91.9%), chemotherapy (n=42, 30.8%), radiation (n=25, 18.4%), and/or stem cell transplant (n=9, 6.6%) and 5 deaths were reported. For the 40 countries queried, 340 unique cases were reported for lymphoma associated with breast implants.
CONCLUSIONS:
Worldwide federal reporting of BI-ALCL has significant limitations in providing data regarding clinical history, treatment, and oncologic follow up. Country-specific total implant and textured implant sales data is needed in order to determine critical incidence and prevalence analysis. Detailed BI-ALCL patient registries such as American Society of Plastic Surgeon's PROFILE and centralized tissue banking are necessary in acquiring accurate complete data for sound decision
==============================================
39.) United States Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma.
=============================================
Plast Reconstr Surg. 2017 Jan 20. doi: 10.1097/PRS.0000000000003282. [Epub ahead of print]
Doren EL1, Miranda RN, Selber JC, Garvey PB, Liu J, Medeiros LJ, Butler CE, Clemens MW.
Author information
1
1 Department of Plastic Surgery, Medical College of Wisconsin, Tosa Center, Ste T2600, 1155 N Mayfair Rd, Milwaukee, WI 53226 2 Department of Hematopathology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 0072, Houston, TX 77030-4905 3 Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, 1400 Pressler, Unit 1488, P.O. Box 301402, Houston, TX 77230-1402.
Abstract
BACKGROUND:
Breast implant-associated anaplastic large-cell lymphoma (BI-ALCL) is a distinctive type of T-cell lymphoma that arises around breast implants. Although rare, all cases of BI-ALCL with adequate history have involved a textured breast implant. The objective of this study is to determine the United States incidence and lifetime prevalence of BI-ALCL in women with textured breast implants.
METHODS:
This is a retrospective review of documented cases of BI-ALCL in the United States from 1996 to 2015. The incidence and prevalence of BI-ALCL was determined based on a literature and institutional database review of BI-ALCL cases and textured breast implant sales figures from implant manufacturers' annualized data.
RESULTS:
One hundred pathologically confirmed BI-ALCL cases were identified in the United States. Mean age at diagnosis was 53.2±12.3 years. Mean interval from implant placement to diagnosis was 10.7±4.6 years. Forty-nine patients had breast implants placed for cosmetic reasons, 44 for mastectomy reconstruction, and 7 for unknown reasons. Assuming BI-ALCL occurs only in textured breast implants, the incidence rate is 2.03 per 1,000,000 person-years (203 per 100 million), which is 67.6 times higher than that of breast ALCL (3 per 100 million; p<0.001). Lifetime prevalence was 33 per million persons with textured breast implants.
CONCLUSIONS:
This study suggests a statistically significant association between textured breast implants and BI-ALCL. Although women with a textured breast implant have a low risk of developing BI-ALCL, the current United States incidence is significantly higher than that of breast ALCL in the general population.
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39.) Anaplastic large T-cell lymphoma and breast implants: a review of the literature.
====================================
Plast Reconstr Surg. 2011 Sep;128(3):651-61. doi: 10.1097/PRS.0b013e318221db81.
Jewell M1, Spear SL, Largent J, Oefelein MG, Adams WP Jr.
Author information
1
Jewell Plastic Surgery Center, Eugene, OR, USA.
Abstract
BACKGROUND:
Anecdotal reports and one case-control study suggested an association, without evidence of causation, between breast implants and anaplastic lymphoma kinase-negative anaplastic large T-cell lymphoma (ALCL), a rare non-Hodgkin's lymphoma. This review summarizes the published evidence, including case reports and epidemiologic studies.
METHODS:
A PubMed search limited to English language articles was conducted using the search terms "breast implant" and "lymphoma," "primary T-cell breast lymphoma," or "breast implant and ALCL" to identify all published cases of breast-associated ALCL.
RESULTS:
A total of 18 publications were retrieved describing 27 cases of ALCL in breast implant recipients. Breast-associated ALCL occurred in women with and without implants. Approximately 78 percent of cases (21 of 27) were CD30 anaplastic lymphoma kinase-negative, with an indolent clinical course. Both saline- and silicone-filled devices were identified; however, implant style and surface texture were largely unreported. The tumor stage at diagnosis was I in 16 of 27, II or higher in seven of 27, or unreported in four of 27. No prospective epidemiologic study has linked implants and ALCL; however, a single case-control study in Dutch women reported increased odds of association between ALCL and implants, and an estimated frequency of one in 1 million women with and without breast implants.
CONCLUSIONS:
An association, without evidence of causation, was reported between breast implants and ALCL. Further study is required to confirm this association. Breast-associated ALCL occurred rarely in women with and without breast implants and had a primarily indolent clinical course, which may provoke a revision of the World Health Organization nomenclature for lymphoma; however, aggressive clinical behavior was also reported. The cases of ALCL were not confined to a specific type of implant.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, V.
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40.) Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant-Associated Anaplastic Large-Cell Lymphoma.
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J Clin Oncol. 2016 Jan 10;34(2):160-8. doi: 10.1200/JCO.2015.63.3412. Epub 2015 Nov 30.
Clemens MW1, Medeiros LJ1, Butler CE1, Hunt KK1, Fanale MA1, Horwitz S1, Weisenburger DD1, Liu J1, Morgan EA1, Kanagal-Shamanna R1, Parkash V1, Ning J1, Sohani AR1, Ferry JA1, Mehta-Shah N1, Dogan A1, Liu H1, Thormann N1, Di Napoli A, Lade S1, Piccolini J1, Reyes R1, Williams T1, McCarthy CM1, Hanson SE1, Nastoupil LJ1, Gaur R1, Oki Y1, Young KH1, Miranda RN2.
Author information
1
Mark W. Clemens, L. Jeffrey Medeiros, Charles E. Butler, Kelly K. Hunt, Michelle A. Fanale, Jun Liu, Rashmi Kanagal-Shamanna, Jing Ning, Summer E. Hanson, Loretta J. Nastoupil, Yasuhiro Oki, Ken H. Young, and Roberto N. Miranda, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Horwitz, Neha Mehta-Shah, Ahmed Dogan, and Colleen M. McCarthy, Memorial Sloan Kettering Cancer Center, New York, NY; Dennis D. Weisenburger, City of Hope National Medical Center, Duarte, CA; Elizabeth A. Morgan, Brigham and Women's Hospital and Harvard Medical School; Aliyah R. Sohani and Judith A. Ferry, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Vinita Parkash, Yale School of Medicine, New Haven, CT; Hui Liu, Xuzhou Medical College, Xuzhou, People's Republic of China; Nora Thormann, Fundacao Universitaria Mario Martins, Porto Alegre, Brazil; Arianna DiNapoli, Sant'Andrea Hospital, Sapienza University, Rome, Italy; Stephen Lade, University of Melbourne, Melbourne, Victoria, Australia; Jorge Piccolini, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina; Ruben Reyes, Kansas University Medical Center, Kansas City, KS; Travis Williams, St Luke's Mountain States Tumor Institute, Meridian, ID; and Rakesh Gaur, St Luke's Hospital, Kansas City, MO.
2
Mark W. Clemens, L. Jeffrey Medeiros, Charles E. Butler, Kelly K. Hunt, Michelle A. Fanale, Jun Liu, Rashmi Kanagal-Shamanna, Jing Ning, Summer E. Hanson, Loretta J. Nastoupil, Yasuhiro Oki, Ken H. Young, and Roberto N. Miranda, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Horwitz, Neha Mehta-Shah, Ahmed Dogan, and Colleen M. McCarthy, Memorial Sloan Kettering Cancer Center, New York, NY; Dennis D. Weisenburger, City of Hope National Medical Center, Duarte, CA; Elizabeth A. Morgan, Brigham and Women's Hospital and Harvard Medical School; Aliyah R. Sohani and Judith A. Ferry, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Vinita Parkash, Yale School of Medicine, New Haven, CT; Hui Liu, Xuzhou Medical College, Xuzhou, People's Republic of China; Nora Thormann, Fundacao Universitaria Mario Martins, Porto Alegre, Brazil; Arianna DiNapoli, Sant'Andrea Hospital, Sapienza University, Rome, Italy; Stephen Lade, University of Melbourne, Melbourne, Victoria, Australia; Jorge Piccolini, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina; Ruben Reyes, Kansas University Medical Center, Kansas City, KS; Travis Williams, St Luke's Mountain States Tumor Institute, Meridian, ID; and Rakesh Gaur, St Luke's Hospital, Kansas City, MO. roberto.miranda@mdanderson.org.
Erratum in
ERRATUM. [J Clin Oncol. 2016]
Abstract
PURPOSE:
Breast implant-associated anaplastic large-cell lymphoma (BI-ALCL) is a rare type of T-cell lymphoma that arises around breast implants. The optimal management of this disease has not been established. The goal of this study is to evaluate the efficacy of different therapies used in patients with BI-ALCL to determine an optimal treatment approach.
PATIENTS AND METHODS:
In this study, we applied strict criteria to pathologic findings, assessed therapies used, and conducted a clinical follow-up of 87 patients with BI-ALCL, including 50 previously reported in the literature and 37 unreported. A Prentice, Williams, and Peterson model was used to assess the rate of events for each therapeutic intervention.
RESULTS:
The median and mean follow-up times were 45 and 30 months, respectively (range, 3 to 217 months). The median overall survival (OS) time after diagnosis of BI-ALCL was 13 years, and the OS rate was 93% and 89% at 3 and 5 years, respectively. Patients with lymphoma confined by the fibrous capsule surrounding the implant had better event-free survival (EFS) and OS than did patients with lymphoma that had spread beyond the capsule (P = .03). Patients who underwent a complete surgical excision that consisted of total capsulectomy with breast implant removal had better OS (P = .022) and EFS (P = .014) than did patients who received partial capsulectomy, systemic chemotherapy, or radiation therapy.
CONCLUSION:
Surgical management with complete surgical excision is essential to achieve optimal EFS in patients with BI-ALCL.
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41.) Anaplastic large-cell lymphoma in women with breast implants.
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JAMA. 2008 Nov 5;300(17):2030-5. doi: 10.1001/jama.2008.585.
de Jong D1, Vasmel WL, de Boer JP, Verhave G, Barbé E, Casparie MK, van Leeuwen FE.
Author information
1
Department of Pathology, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam 1066CX, The Netherlands. d.d.jong@nki.nl
Abstract
CONTEXT:
Recently, we identified 2 patients with anaplastic large T-cell lymphoma (ALCL) negative for tyrosine kinase anaplastic lymphoma kinase (ALK-negative) in the fibrous capsule of silicone breast prostheses, placed for cosmetic reasons. Similar cases have been reported in the literature. Although an increased risk of ALCL in patients with breast prostheses has been speculated, no studies have been conducted so far.
OBJECTIVE:
To determine whether ALCL risk is associated with breast prostheses.
DESIGN:
A search for all patients with lymphoma in the breast diagnosed in The Netherlands between 1990 and 2006 was performed through the population-based nationwide pathology database. Subsequently, we performed an individually matched case-control study. Conditional logistic regression analysis was performed to estimate the relative risk of ALCL associated with breast prostheses.
SETTING AND PATIENTS:
Eleven patients with breast ALCL were identified in the registry. For each case patient with ALCL in the breast, we selected 1 to 5 controls with other lymphomas in the breast, matched on age and year of diagnosis. For all cases and controls (n = 35), pathological and clinical information was obtained with special emphasis on the presence of a breast prosthesis.
MAIN OUTCOME MEASURE:
Association between breast implants and ALCL of the breast.
RESULTS:
The 11 patients with ALCL of the breast were diagnosed between 1994 and 2006 at a median age of 40 years (range, 24-68 years). In 5 of these patients, bilateral silicone breast prostheses had been placed 1 to 23 years before diagnosis. All received prostheses for cosmetic reasons. Lymphoma classes of 35 eligible control patients were 12 diffuse large B-cell lymphomas, including 1 T-cell rich B-cell lymphoma; 5 Burkitt lymphomas; 10 mucosa-associated lymphoid tissue-type lymphoma; 3 follicular lymphomas; 3 peripheral T-cell lymphomas; and 2 indolent B-cell lymphomas, unclassified. One of 35 control patients had a breast implant placed before diagnosis of lymphoma. The odds ratio for ALCL associated with breast prostheses was 18.2 (95% confidence interval, 2.1-156.8).
CONCLUSIONS:
These preliminary findings suggest an association between silicone breast prostheses and ALCL, although the absolute risk is exceedingly low due to the rare occurrence of ALCL of the breast (11 cases in The Netherlands in 17 years). These findings require confirmation in other studies.
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42.) Breast implant-associated anaplastic large cell lymphoma: a systematic review.
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Plast Reconstr Surg. 2015 Mar;135(3):713-20. doi: 10.1097/PRS.0000000000001037.
Gidengil CA1, Predmore Z, Mattke S, van Busum K, Kim B.
Author information
1
Boston, Mass.; and San Francisco, Calif. From RAND Health, RAND Corporation; the Division of Infectious Diseases, Boston Children's Hospital; and the Division of Hematology-Oncology, University of California, San Francisco.
Abstract
BACKGROUND:
There is substantial evidence that a type of anaplastic large cell lymphoma (ALCL) is associated with breast implants. However, the course in patients with breast implants seems to be unusually benign compared with other systemic ALCL. The purpose of this study was to identify and analyze recently published cases of breast implant-associated ALCL, with an emphasis on diagnosis, staging, treatment, and outcomes.
METHODS:
The authors conducted a systematic literature review of reported cases of ALCL in patients with breast implants. Publications were identified with a search algorithm and forward searches. Case-based data were abstracted independently and reconciled by multiple investigators.
RESULTS:
Of 248 identified articles, only 102 were relevant to breast implant-associated ALCL, and 27 were included in this study. Fifty-four cases of ALCL in patients with breast implants were identified. Detailed clinical information was lacking in many cases. Most presented with a seroma (76 percent), and approximately half were associated with the capsule (48 percent). Most presented as stage IE (61 percent). All but one case were ALK-negative. Most received chemotherapy (57 percent) and radiation therapy (48 percent), and 11 percent received stem cell transplants. Approximately one-quarter recurred, and 9 percent died.
CONCLUSIONS:
Since the publication of guidance related to breast implant-associated ALCL in 2010, a number of cases have been reported. Despite the typically benign course, many of the cases have been treated with radiation therapy and/or chemotherapy. Increasing awareness of this disease entity among clinicians would be helpful, along with standardizing an approach to diagnosis, staging, and treatment.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, V.
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43.) Anaplastic large-cell lymphoma associated with breast implants: a unique entity within the spectrum of peri-implant effusions.
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Diagn Cytopathol. 2014 Nov;42(11):929-38. doi: 10.1002/dc.23152. Epub 2014 Mar 31.
Chai SM1, Kavangh S, Ooi SS, Sterrett GF, Cull G, Plunkett M, Spagnolo D, Amanuel B, Joske D, Leslie C, Barham T, Frost F.
Author information
1
Department of Anatomical Pathology, PathWest Laboratory Medicine, QEII Medical Centre, Nedlands Western Australia, Australia.
Abstract
Anaplastic large-cell lymphoma (ALCL) is a rare and newly described complication associated with breast implants. Patients often present with a peri-implant effusion, which is amenable to fine-needle aspiration. The laboratory handling of peri-implant effusions for cytology and ancillary studies is as crucial as recognizing the characteristic cytology of ALCL. All cases of peri-implant effusions were retrieved from the PathWest database between January 2003 and May 2013, yielding four cases of breast implant-associated ALCL and six benign samples. The cytological features were evaluated and information from ancillary studies collated. Clinical and follow-up histology was available in all cases. All ALCL cases contained highly atypical lymphoid cells including 'hallmark' cells. In contrast, benign peri-implant effusions showed a mixture of inflammatory cells, being either neutrophil-rich (three cases) or lymphocyte-rich (three cases). A CD30 positive, ALK1 negative immunophenotype was demonstrated in all cases on cell block immunohistochemistry. Flow cytometry and T-cell receptor clonality studies confirmed aberrant T-cell immunophenotype in four of four and clonally rearranged T-cell receptor antigens in three of three cases. ALCL was identified in three of four subsequent capsulectomies. Staging confirmed disease limited to the capsular tissue or peri-implant effusion in all cases. None of the six patients with benign peri-implant effusions developed lymphoma during follow-up. Cases of ALCL accounted for 40% of peri-implant effusions received over a 10-year period, indicating the rarity of these samples and the high likelihood of malignancy. Awareness of this entity and its presentation should allow for appropriate triage of these specimens and definitive diagnosis on effusion specimens.
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44.) Breast implant-associated anaplastic large cell lymphoma: review of a distinct clinicopathologic entity.
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Arch Pathol Lab Med. 2014 Jun;138(6):842-6. doi: 10.5858/arpa.2013-0068-RS.
Xu J1, Wei S.
Author information
1
From the Department of Pathology, University of Alabama at Birmingham.
Abstract
Primary breast anaplastic large cell lymphoma (ALCL) is rare but is more commonly seen in patients with implants; fewer than 50 cases of breast implant-associated ALCL have been reported in the English language literature. Breast implant-associated ALCL is not a disease of the breast parenchyma, but instead is a disease of the fibrous capsule surrounding the implant. The patients usually present with an effusion around the implant and, rarely, with a solid mass. Morphologically, the neoplastic cells are large, epithelioid, and pleomorphic, with abundant cytoplasm, vesicular irregular nuclei, and frequent mitoses. Occasional "hallmark" cells may be present. The lesional cells typically show strong and diffuse immunoreactivity for CD30 and often express T-cell markers, cytotoxic-associated antigens, and epithelial membrane antigen. Almost all reported cases are negative for anaplastic lymphoma kinase. Molecular genetic analyses have demonstrated T-cell receptor gene rearrangements. The differential diagnosis essentially includes poorly differentiated carcinoma, other lymphomas, and chronic inflammation. Once a diagnosis of lymphoma is established, it is important to exclude systemic anaplastic lymphoma kinase-negative ALCL involving the breast, primary cutaneous ALCL, and other CD30(+) lymphoproliferative disorders. The patients with effusion-associated ALCL often have an indolent course and excellent prognosis, responding well to excision of the fibrous capsule around the implant (capsulectomy) and implant removal. In contrast, patients who present with a distinct mass may have a more aggressive course and poor prognosis, requiring chemotherapy and/or radiation therapy.
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45.) Variable presentation of anaplastic large-cell lymphoma in patients with breast implants.
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ANZ J Surg. 2015 Apr 1. doi: 10.1111/ans.13074. [Epub ahead of print]
Locke MB1, Lofts J.
Author information
1
Department of Surgery, South Auckland Clinical Campus, Middlemore Hospital, University of Auckland, Auckland, New Zealand.
Abstract
BACKGROUND:
Anaplastic large-cell lymphoma (ALCL) has recently been reported in women with breast implants. The incidence of breast implant-related ALCL is extremely rare and most surgeons would not expect to see this disease in their career. However, the senior author has had three women present to his practice with ALCL over a 2-year period.
METHODS:
The three patients and their presentation were reviewed to establish the presenting complaint in each case of subsequently diagnosed ALCL. Literature was reviewed to establish appropriate treatment protocols for any subsequent patients.
RESULTS:
The average time between first implant placement and presentation with breast implant-associated ALCL was 13.3 years (range: 10-16 years) and age at presentation was 49 years (range: 45-53 years). Each presentation was somewhat different, being a palpable mass, a painless seroma and a painful seroma. Both patients with seroma underwent ultrasound-guided aspiration of fluid which confirmed ALCL. All patients underwent implant removal and complete capsulectomy. The patient with a mass at presentation initially declined adjuvant treatment but subsequently developed an ALCL-associated seroma and was treated with surgery and post-operative chemotherapy.
CONCLUSION:
Patients with breast implant-associated ALCL can present with different clinical signs and symptoms. Late seroma is a relatively common presentation of breast implant-associated ALCL. While firm guidelines for the management of breast implant-related ALCL are lacking, we suggest that any late seroma in the absence of infection should be managed with aspiration and cytological analysis of the fluid.
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46.) Breast Implant-Associated Anaplastic Large Cell Lymphoma: Proposal for a Monitoring Protocol.
================================================
Plast Reconstr Surg. 2015 Aug;136(2):144e-151e. doi: 10.1097/PRS.0000000000001416.
Santanelli di Pompeo F1, Laporta R, Sorotos M, Di Napoli A, Giovagnoli MR, Cox MC, Campanale
A, Longo B.
Author information
1
Rome, Italy From the Plastic Surgery Unit, the Pathology Unit, Department of Clinical and Molecular Medicine, and the Hematology Department, Sant'Andrea Hospital, School of Medicine and Psychology, "Sapienza" University of Rome; and the Plastic Surgery Department, OORR Hospital, University of Foggia, loaned employee at the Italian Ministry of Health, Pharmaceutical Services, and Safety in Health Care.
Abstract
BACKGROUND:
The authors report four cases of breast implant-associated anaplastic large cell lymphoma (ALCL) from a single institution and propose a multidisciplinary protocol.
METHODS:
From 2012 to 2014, four breast implant-associated ALCL cases were diagnosed. The authors performed the original operation, and no patients were referred to their practice. Cases 1, 2, and 4 were CD4/CD30/ALK ALCL with previous textured-implant reconstruction, whereas case 3 was CD8/CD30/ALK ALCL with previous polyurethane-implant augmentation. A retrospective study of all patients who underwent breast implant positioning was performed to identify any misdiagnosed cases.
RESULTS:
Of 483 patients, 226 underwent reconstruction with latissimus dorsi flap and prosthesis, 115 had skin-sparing/nipple-sparing mastectomy and prosthesis, 117 underwent an expander/implant procedure, and 25 underwent breast augmentation. Fifty-eight cases (12 percent) underwent implant replacement for capsular contracture, 15 (3.1 percent) experienced late-onset seroma, and four (0.83 percent) had both capsular contracture and seroma. Seventy-seven symptomatic patients (16 percent) underwent surgical revision (capsulectomy/capsulotomy) and/or seroma evacuation. The second look on histologic specimens did not identify misdiagnosed cases. A multidisciplinary protocol for suspected implant-associated ALCL was established. Ultrasound and cytologic examinations are performed in case of periprosthetic effusion. If implant-associated ALCL is diagnosed, implant removal with capsulectomy is performed. If disseminated disease is detected through positron emission tomography/computed tomography of the total body, the patient is referred to the oncology department.
CONCLUSIONS:
A multidisciplinary protocol is mandatory for both early diagnosis and patient management. Until definitive data emerge regarding the exact etiopathogenesis of breast implant-associated ALCL, the authors suggest offering only autologous reconstruction if patients desire it.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.
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47.) Implant-associated anaplastic large cell lymphoma: beyond breast prostheses.
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Ann Plast Surg. 2014 Oct;73(4):461-4. doi: 10.1097/SAP.0b013e31827faff2.
Kellogg BC1, Hiro ME, Payne WG.
Author information
1
From the *Institute for Tissue Regeneration, Repair, and Rehabilitation, Bay Pines VAHCS, Bay Pines; and †Division of Plastic Surgery, University of South Florida, Tampa, Florida.
Abstract
OBJECTIVE:
Anaplastic large cell lymphoma (ALCL) is a rare form of non-Hodgkin T-cell lymphoma potentially associated with silicone-shelled breast implants. The low incidence of ALCL has prevented establishment of causality. Many implantable devices are constructed with biomaterials similar to those used in breast prostheses. The purpose of this paper is to identify reports of ALCL in association with other types of implantable devices.
METHODS:
A literature review was conducted using PubMed to identify reports of non-Hodgkin lymphoma in association with various implantable devices.
RESULTS:
One case of ALCL was identified in association with a stainless steel internal fixation plate. Diffuse large B-cell lymphoma was widely reported in association with various implantable biomaterials and chronic inflammation.
CONCLUSION:
The neoplastic response associated with breast prostheses appears substantively different from other implantable devices. Physicians caring for patients with silicone elastomer-containing implants should have increased suspicion for implant-associated ALCL and report all pertinent cases in the literature.
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48.) Bacterial Biofilm Infection Detected in Breast Implant-Associated Anaplastic Large-Cell Lymphoma.
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Plast Reconstr Surg. 2016 Jun;137(6):1659-69. doi: 10.1097/PRS.0000000000002010.
Hu H1, Johani K, Almatroudi A, Vickery K, Van Natta B, Kadin ME, Brody G, Clemens M, Cheah CY, Lade S, Joshi PA, Prince HM, Deva AK.
Author information
1
Boston, Mass.; Los Angeles, Calif.; Houston, Texas; Indianapolis, Ind.; Sydney, New South Wales, and Melbourne, Victoria, Australia; and Riyadh and Qassim, Kingdom of Saudi Arabia From the Boston University School of Medicine and Roger Williams Medical Center; the University of Southern California; the University of Texas M. D. Anderson Cancer Center; Meridian Plastic Surgery; the Surgical Infection Research Group, Macquarie University, Peter MacCallum Cancer Center, University of Melbourne, and the Department of Allergy and Immunology, Children's Hospital at Westmead; the Division of Microbiology, Prince Sultan Military Medical City, and the Department of Medical Laboratories, College of Applied Medical Sciences, Qassim University.
Abstract
BACKGROUND:
A recent association between breast implants and the development of anaplastic large-cell lymphoma (ALCL) has been observed. The purpose of this study was to identify whether bacterial biofilm is present in breast implant-associated ALCL and, if so, to compare the bacterial microbiome to nontumor capsule samples from breast implants with contracture.
METHODS:
Twenty-six breast implant-associated ALCL samples were analyzed for the presence of biofilm by real-time quantitative polymerase chain reaction, next-generation sequencing, fluorescent in situ hybridization, and scanning electron microscopy, and compared to 62 nontumor capsule specimens.
RESULTS:
Both the breast implant-associated ALCL and nontumor capsule samples yielded high mean numbers of bacteria (breast implant-associated ALCL, 4.7 × 10 cells/mg of tissue; capsule, 4.9 × 10 cells/mg of tissue). Analysis of the microbiome in breast implant-associated ALCL specimens showed significant differences with species identified in nontumor capsule specimens. There was a significantly greater proportion of Ralstonia spp. present in ALCL specimens compared with nontumor capsule specimens (p < 0.05). In contrast, significantly more Staphylococcus spp. were found associated with nontumor capsule specimens compared with breast implant-associated ALCL specimens (p < 0.001). Bacterial biofilm was visualized both on scanning electron microscopy and fluorescent in situ hybridization.
CONCLUSIONS:
This novel finding of bacterial biofilm and a distinct microbiome in breast implant-associated ALCL samples points to a possible infectious contributing cause. Breast implants are widely used in both reconstructive and aesthetic surgery, and strategies to reduce their contamination should be more widely studied and practiced.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, V.
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49.) The Poly Implant Prothèse breast prostheses scandal: Embodied risk and social suffering.
===============================================
Soc Sci Med. 2015 Dec;147:150-7. doi: 10.1016/j.socscimed.2015.10.068. Epub 2015 Nov 2.
Greco C1.
Author information
1
École des Hautes Études en Sciences Sociales, 190-198 Avenue de France, 75244 Paris Cedex 13, France; CERMES3 - Centre de recherche, médecine, sciences, santé, santé mentale, société, 7 Rue Guy Môquet, BP 8, 94801 Villejuif Cedex, France. Electronic address: cinzia.greco79@gmail.com.
Abstract
This article examines the 2010 scandal surrounding the use and subsequent recall of adulterated Poly Implant Prothèse (PIP) silicone breast prostheses in France. It uses a mixed method approach that includes 12 interviews with French PIP prosthesis recipients, analyses of medical literature, policy documents of French and EU regulatory agencies, and an online forum for PIP recipients. These data are used to explain how the definition of "acceptable risk" in the silicone implants controversy of the 1990s in the US influenced the PIP scandal later on in France. Additionally, PIP recipients had an embodied experience of risk that clashed with the definition of risk used by authorities and some surgeons. The coverage of re-implantation was also defined at different policy levels, leading to variation in patients' suffering. The combination of fraud and lack of recognition from part of the medical system constitutes an example of social suffering for the patients involved. The PIP scandal is a useful case for analyzing the interconnection of embodied experience and professional and public policy definitions of medical risk through the concepts of moral economy and biological citizenship.
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50.) The impact of poly implant prothèse fraud on breast cancer patients: a report by the institut curie.
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Plast Reconstr Surg. 2013 Apr;131(4):690-5. doi: 10.1097/PRS.0b013e3182827605.
Reyal F1, Feron JG, Leman Detour S, Pourcelot AG, Valentin M, Phillippe AC, Levy-Zauberman Y, Agman A, Monier S, Blondel A, Cothier-Savey I, Guihard T, Le Masurier P, Fitoussi A, Couturaud B.
Author information
1
Institut Curie, Paris 75005, France.
Abstract
In March of 2010, French authorities suspended the use of breast implants made by the company Poly Implant Prothèse. Institut Curie is a large cancer center, and Poly Implant Prothèse was one major silicone-filled breast implant brand used. This report describes the impact of the fraudulent implants worldwide and more specifically on patient care at the authors' unit. From 2002 to 2009, the median number of Poly Implant Prothèse implants removed per year was 32. Since the first alert in March of 2010, 252 of these breast implants were removed in 2010 and 2011. The breast implants removed were mainly reported as normal, with a rupture rate of less than 5 percent before 2008. However, the annual rupture rate has increased from 2008 to 2011 (8, 14, 20, and 23 percent, respectively). The Institut Curie, in conjunction with breast cancer patients, has organized a management plan to deal with this major industrial fraud. Its surveillance program of breast cancer patients facilitated the management of patients during this difficult time.
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51.) [Poly Implant Prothèse (PIP®) incidence of complications in breast reconstructive surgery: A retrospective comparative analysis].
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Ann Chir Plast Esthet. 2015 Dec;60(6):478-83. doi: 10.1016/j.anplas.2015.08.007. Epub 2015 Oct 21.
[Article in French]
Fenoll C1, Leclère FM2, Hivelin M3, Atlan M4, Cothier-Savey I5, Lantieri L3, Le Masurier P5.
Author information
1
Service de chirurgie reconstructrice, hôpital René-Huguenin, institut Curie, 35, rue Dailly, 92210 Saint-Cloud, France; Service de chirurgie plastique, hôpital Saint-Joseph, 185, rue Raymond-Losserand, 75014 Paris, France. Electronic address: claire.fenoll@gmail.com.
2
Service de chirurgie plastique reconstructrice et esthétique, chirurgie de la main, chirurgie de réassignation sexuelle, centre François-Michelet, CHU de Pellegrin Bordeaux, 33000 Bordeaux, France; Laboratoire d'anatomie, université de Bordeaux, 33000 Bordeaux, France. Electronic address: franckleclere@yahoo.fr.
3
Service de chirurgie plastique reconstructrice et esthétique, HEGP, 20, rue Leblanc, 75015 Paris, France.
4
Chirurgie plastique reconstructrice et esthétique, CHU Tenon, 75020 Paris, France.
5
Service de chirurgie reconstructrice, hôpital René-Huguenin, institut Curie, 35, rue Dailly, 92210 Saint-Cloud, France.
Abstract
INTRODUCTION:
On 29 March 2010, the Poly Implant Prothèse (PIP(®)) breast prosthesis was withdrawn from the market by the ANSM. In this study we review our experience with PIP(®) implants in breast reconstruction. We compare our complications with other types of breast implants used during the same period at our institution.
PATIENTS AND METHOD:
This is a retrospective study conducted at the Hospital René Huguenin of the Institut Curie (Paris, France). It includes 327 prostheses, from 268 patients who underwent surgery for breast reconstruction between February 2008 and February 2012: 69 PIP(®) (Group 1), 82 Mentor(®) (Group 2) and 179 Allergan(®) (Group 3). The objective of the study was to compare the rates of early and late complications for each prosthesis. Our results are compared with the current literature.
RESULTS:
With regard to the rate of early complications (hematoma, infection, seroma, wound dehiscence), no difference was observed between the three groups (P not significant). However, the study found that 100% of the 13 PIP(®) implants with early complications required surgical revision. There were too few late complications (capsular contracture, prosthetic rupture) in our cohort to allow statistical comparison between the three groups (P not significant). We compare our results with the current literature.
CONCLUSION:
This study highlights the lack of significant difference in the occurrence of early adverse events between the three groups of implants. This may explain the time taken for surgeons to become aware there was a problem with the PIP(®) implants. The low rate of late complications in our series does not allow statistical analysis between the three groups of implants.
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52.) PIP breast implant removal: a study of 828 cases.
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J Plast Reconstr Aesthet Surg. 2014 Mar;67(3):302-7. doi: 10.1016/j.bjps.2013.12.016. Epub 2013 Dec 30.
Oulharj S1, Pauchot J2, Tropet Y2.
Author information
1
Department of Orthopedics, Traumatology, Plastic and Reconstructive Surgery and Hand Support, Besancon University Hospital, Besancon, France. Electronic address: sarahoulharj@gmail.com.
2
Department of Orthopedics, Traumatology, Plastic and Reconstructive Surgery and Hand Support, Besancon University Hospital, Besancon, France.
Abstract
In March, 2010, the French Health Products Safety Agency suspended the sale of prefilled silicone breast implants manufactured by Poly Implants Prosthèse Prothese (PIP) because of a high failure rate and the use of an inappropriate silicone gel that did not comply with CE marking. These findings led to an international medical crisis. In France, 30,000 female patients had PIP implants. In our Department, 1150 PIP breast implants had been implanted in 630 patients since 2001. A retrospective study was conducted to define the rupture rate of these implants and the complications that arise. The women included in the study underwent implant removal from May 2010 to September 2012 for preventive or curative reasons. Data were collected from medical records that included: results of clinical examination, breast ultrasound before removal, rates of implant rupture, results of biopsy of periprosthetic capsule and pericapsule tissue and postoperative complications. A total of 828 PIP breast implants were removed in 455 patients. The rate of ruptured implants was 7.73% (64/828), corresponding to 11.6% of patients. A periprosthetic effusion was associated with rupture in 44% of cases. Breast ultrasound indicated a rupture for 87 implants; 32% were true positives and 3% were false negatives. Periprosthetic capsule biopsy demonstrated the presence of a foreign body, which seemed to be silicone, in 26% of cases and the presence of inflammation in 13% of cases. No siliconoma-type lesion was identified in the pericapsular tissue at biopsy. A total of 14 implants presented perspiration at removal. A statistically significant difference was found between the rates of rupture for texturised implants as compared to the smooth-surfaced implants. There were eight post-revisional-surgery complications (1%) and three cases of breast adenocarcinoma. The preventive explantation of PIP breast implants is justified given the high failure rate (7.73%) and given patients' exposure to silicone gel that did not comply with CE standards in the absence of rupture, through the early perspiration of implants.
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53.) Silicone breast implant materials.
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Daniels AU1.
Author information
1
University of Basel, Switzerland. au.daniels@unibas.ch
Abstract
This opinion article has been written on request because of the recent public controversy over silicone breast implants produced by a now-defunct company, Poly Implant Prosthese (PIP) in France. More than 300,000 PIP devices have been implanted. The purposes of my article are to (1.) provide a general overview of silicone breast implant materials, (2.) to describe the general safety of these materials as reported to date, and (3.) to summarise current publicly available information about these aspects of the PIP prostheses. The materials covered are the silicone rubber from which the implant shells are made and the silicone gel used to fill the shell. The materials safety issues are biocompatibility (especially of the gel) and biodurability of the shell. The literature reviewed indicates that biocompatibility is not an issue with other current generation implants. However, biodurability is. A rough estimate of implant shell rupture rate is ~10+% at 10 years. Information is still emerging about the PIP implants. Initial regulatory disclosures suggest the PIP implants may have both biocompatibility and biodurability problems. They also suggest that PIP implants may have been produced using silicone materials not certified as medical grade. Governmental health and regulatory agencies are just now in the process of deciding what actions should be taken to protect patients.
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54.) Silicone lymphadenopathy after breast augmentation: case reports, review of the literature, and current thoughts.
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Aesthetic Plast Surg. 2013 Apr;37(2):278-89. doi: 10.1007/s00266-012-0025-9. Epub 2013 Jan 26.
Zambacos GJ1, Molnar C, Mandrekas AD.
Author information
1
Artion Plastic Surgery Center, Athens, Greece. gz@aestheticsurgery.gr
Abstract
BACKGROUND:
Silicone lymphadenopathy after implantation of silicone breast implants is a foreign body reaction due to the release or migration of silicone into the tissues surrounding the breast implant.
METHODS:
For the study, 14 cases of silicone lymphadenopathy were identified from the authors' files. Four patients had been implanted before 2000 and had various types of implants. The remaining 10 patients all were implanted between 2006 and 2009, and all had Poly Implant Prothèse (PIP) implants. In addition to an analysis of the authors' own cases, a thorough bibliographic search was initiated to identify all reports of lymphadenopathy related to silicone breast implants.
RESULTS:
The implant age of the four patients implanted before 2000 was 12-34 years (mean, 17.25 years). The implant age of the 10 patients implanted after 2000 was 2-6 years (mean 3.45 years). The literature search identified 29 papers with case reports of silicone lymphadenopathy published between 1978 and 2012, with a total of 175 cases. Usable data were extracted from 164 of the 175 cases. Of these patients, 159 were implanted before (and including) the year 2000 and had a mean age of 11 years at presentation or explantation, and 5 of these patients were implanted after the year 2000 and had a mean age of 4.6 years at presentation or explantation . After inclusion of the authors' own cases, the mean age of the implants at presentation or explantation was 10.56 years in a total of 178 cases. Of these patients, 163 were implanted before (and including) the year 2000 and had a mean age of 11.16 years at presentation or explantation, and 15 of these patients were implanted after the year 2000 and had a mean age of 4.06 years at presentation or explantation.
CONCLUSIONS:
Current breast implant technology has minimized the release of silicone gel due to rupture or bleeding of silicone and its migration into the surrounding tissues, thus reducing the rate of silicone lymphadenopathy in the last 10 years. The PIP implant scandal highlights the fact that disregard for the implant manufacturing technologies and standards in favor of higher profits increased rupture rates and gel diffusion, leading to increased local complication rates. Silicone lymphadenopathy is a foreign body reaction that does not warrant treatment unless it is symptomatic or interferes with breast cancer detection.
LEVEL OF EVIDENCE III:
This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authorswww.springer.com/00266 .
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55.) [Outcome at 18 months after the recall of Poly Implant Prosthesis. Experience of a cancer center].
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Ann Chir Plast Esthet. 2012 Feb;57(1):9-15. doi: 10.1016/j.anplas.2012.01.001. Epub 2012 Jan 27.
[Article in French]
Crouzet C1, Gangloff D, Chaput B, Grolleau JL, Garrido I.
Author information
1
Institut Claudius-Regaud, 20-25, rue Pont-Saint-Pierre, 31052 Toulouse cedex, France.
Abstract
INTRODUCTION:
On March 30, 2010, AFSSAPS (sanitary French) issued a medical alert about breast implants "Poly Implant Prothese" (PIP), because it was shown that its failure rate was higher than of other manufacturers. This alert was accompanied by a suspension of sales and use of breast implants PIP. Since the announcement of this decision, the Institut Claudius Regaud (ICR) has set up a crisis unit to best meet the demands and questions concerning patients who had PIP implants. After 18 months of the beginning of the crisis, we decided to review the consequences of this decision.
PATIENTS AND METHODS:
This is a retrospective study of all patients who underwent breast reconstruction with a prosthesis PIP since 2006. We are interested in managing of the crisis, the fate of patients and the problems of implants.
RESULTS:
In total 128 PIP prostheses were implanted on 116 patients. These were all cases of asymmetric anatomic implants placed in 91 cases in immediate breast reconstruction and of breast-delayed reconstruction in 25 cases. Twelve patients had a contralateral PIP prosthesis. After careful analysis of the records, we found that 18 patients (16%) had received a change of prosthesis or simple removal of the prosthesis before the beginning of the crisis. No prosthesis was broken. After the retrospective chart review we found that we reoperated 61,2% of patients and explanted 59,4% of prostheses PIP. In 31 cases (26,7%), another surgery was associated with the change of prosthesis. Of the 76 explanted prostheses, ten of them had an abnormality (13,1%). Three implants (3,9%) were ripted. Six implants (7,9%) had a phenomenon of perspiration. The average life span of these prostheses was of 21,3 months. Among patients who were reoperated, we observed three postoperative complications (3,9%).
CONCLUSION:
More than 18 months after the withdrawal on the market of breast implants PIP, we reviewed almost all patients implanted at our institution. To date, 60% of patients no longer have this prosthesis in place, but 16% of patients with this specific breast implant had already been remove before March 2010. Eighteen percent of implants had an abnormality and three had a rupture. In this retrospective study we also found that the care of our patients could be improved, including the legibility of the monitoring and in the administrative field.
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56.) The ruptured PIP breast implant.
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Clin Radiol. 2013 Aug;68(8):845-50. doi: 10.1016/j.crad.2013.03.012. Epub 2013 Apr 25.
Helyar V1, Burke C, McWilliams S.
Author information
1
Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, Westminster Bridge Road, London SE1 9RT, UK.
Abstract
Public concern erupted about the safety of Poly Implant Prothèse (PIP) breast implants when it was revealed in 2011 that they contained an inferior, unlicensed industrial-grade silicone associated with a high rate of rupture. There followed national guidance for UK clinicians, which led to a considerable increase in referrals of asymptomatic women for breast implant assessment. In this review we discuss possible approaches to screening the PIP cohort and the salient characteristics of a ruptured implant.

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