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****** DATA-MÉDICOS **********
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IMPLANTES MAMARIOS, LA PIEL Y LA SALUD 
BREAST IMPLANTS, THE SKIN AND HEALTH
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****** DERMAGIC-EXPRESS No.44 ******* 
****** 31 MARZO DE 1.999 ********* 
31 MARCH 1.999
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EDITORIAL ESPAÑOL:
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Hola amigos del DERMA CYBER, DERMAGIC con ustedes de nuevo. El tema bastante interesante, IMPLANTES MAMARIOS, LA PIEL Y LA SALUD.

Los senos, grandes o pequeños siempre generan una opinión. La mujer de hoy día por cuestiones de estética, recurre a los implantes para mejorar su figura, están muy de moda hoy día les senos exuberantes. En otros casos se recurre al implante luego de extirpación de lesiones en ellos.

Lo cierto del caso es que todavía se discute su efecto nocivo para el cuerpo.

Estas 38 referencias nos hablan de los pro y contra de estos implantes, espero que las disfruten.. los senos seguirán dando que hablar por mucho tiempo...!!! 

En el attach 1 lamina ilustrativa de la referencia No. 0: Sézary síndrome tras la ruptura de una prótesis mamaria de gel de silicona.

Nos veremos en la red en una nueva oportunidad !!!

Saludos a TODOS !!!

Dr. José Lapenta R.,,,

EDITORIAL ENGLISH:
=====================
Hello friends of the DERMA CYBER, DERMAGIC with you again. The quite interesting topic, BREAST IMPLANTS, THE SKIN AND HEALTH.

The breasts, big or small they always generate an opinion. The woman of nowadays for aesthetics questions, decides to implant them to improve their figure, they are very in fashion nowadays the exuberant breasts. In other cases it
is used the implants after extirpation of lesions in them.

The truth of the case is that today many people still discusses their noxious effect for the body. These 38 references speak us the pro and cons of these implant, I hope you enjoy them..

The breasts will continue giving to speak for a lot of time...!!!

In the attach 1 illustrative sheet of the reference No. 0: Sézary syndrome following rupture of silicone gel breast prosthesis

We will see in the net in a new opportunity !!!

Greetings to ALL, !!

Dr. José Lapenta R.,,


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DERMAGIC/EXPRESS(44)
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IMPLANTES MAMARIOS, LA PIEL Y LA SALUD / BREAST IMPLANTS, THS SKIN AND THE HEALTH 
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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 mothers with 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 from exposure to silicone and silica.
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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. 

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8.) Breast augmentation: a risk factor for breast cancer? [see comments] 
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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. 

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9.) Clinical and laboratory features of patients with scleroderma and silicone implants.
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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.

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10.) A clinical and immunologic evaluation of women with silicone breast implants and symptoms of rheumatic disease [see comments].
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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

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11.) Systemic sclerosis after augmentation mammoplasty with silicone implants. [Review]
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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

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12.) Antinuclear autoantibodies in women with silicone breast implants.
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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.

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13.) Antibodies to silicone elastomers and reactions to ventriculoperitoneal shunts [published erratum appears in Lancet 1992 Sep 26;340(8822):800].
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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.

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14.) Outcome study of the psychological changes after silicone breast implant removal.
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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.

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15.) [Hashimoto's thyroiditis and silicone breast implants: 2 cases] Thyroidite de hashimoto et protheses mammaires en silicone: 2 observations.
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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.  T

he 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.

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16.) Cellular immune reactivities in women with silicone breast implants: a preliminary  investigation [see comments]
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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.

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17.) Unusual masses found within ruptured silicone gel breast prostheses.
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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.

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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)

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19.) Capsular contracture with textured versus smooth saline-filled implants for breast  augmentation: a prospective clinical study.
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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.

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20.) Lymphocyte response to silica among offspring of silicone breast implant  recipients.
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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.

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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.

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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.

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23.) Breast implantation and the incidence of upper extremity somatic complaints.
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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.

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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)

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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.
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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.

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26.) Explantation of silicone breast implants.
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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.

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27.) Neurosarcoidosis following augmentation mammoplasty with silicone.
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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.

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28.) Are breast implants anticarcinogenic? A 14-year follow-up of the Los Angeles Study.
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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.

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29.) [Silicone breast implants and breast cancer] Silikonebrystproteser og brystkraeft.
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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)

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30.) Lack of evidence of systemic inflammatory rheumatic disorders in symptomatic women  with breast implants.
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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.

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31.) Breast implants in patients with differentiated and undifferentiated connective  tissue disease.
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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.

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32.) Epidemiology of systemic sclerosis.
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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)

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33.) Use of antipolymer antibody assay in recipients of silicone breast implants.
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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.

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34.) Complications leading to surgery after breast implantation [see comments]
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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.

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35.) Silicone gel and octamethylcyclotetrasiloxane (D4) enhances antibody production to  bovine serum albumin in mice.
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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.

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36.) Visualization of silicone gel in human breast tissue using new infrared imaging  spectroscopy.
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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.

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37.) The epidemiology of scleroderma among women: assessment of risk from exposure to  silicone and silica.
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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.

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DATA-MÉDICOS/DERMAGIC-EXPRESS No (44) 31/03/99 DR. JOSÉ LAPENTA R. 
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