Date: Tue, 2 Nov 1999 17:09:53 -0600

Organization: TDN

Toxic Discovery Network 1906 Grant Lane Columbia, MO. 65203

Phone: (573) 445-0861 Fax: (573) 445-8539

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J Womens Health Gend Based Med 1999 Sep;8(7):933-9

Cosmetic and postmastectomy breast implants: Finnish women's experiences.

Hovi SL, Hemminki E, Swan SH Health Services Research Unit, National Research and Development Center for Welfare and Health, Helsinki, Finland. [Medline record in process]

The purpose of this study was to compare women's satisfaction with and short-term problems of silicone breast implants after cosmetic breast augmentation and after mastectomy. Women (n = 224) were recruited through advertising in mass media, and 91% responded to a questionnaire asking for their experiences, both positive and negative, with silicone breast implants. Approximately equal numbers of women received their implants for cosmetic reasons (augmentation group) and postmastectomy (113 and 111, respectively). Mean time from first implantation was 9 years (SD 7.3) in the cosmetic group and 8 years (SD 4.9) in the postmastectomy group. Women in the postmastectomy group received their implants at an older age than women in the cosmetic group (percent of women 45 and older, 59% and 3%, respectively). Women's overall preoperative knowledge of and postoperative satisfaction with their implants were similar in the two groups; 58% of women said that they had insufficient knowledge of breast implants preoperatively, 26% of women said they would not choose the implants again, and 44% of women expressed no dissatisfaction with their breasts. However, women in the cosmetic group were better informed about possible physical problems. One third of the women in the postmastectomy group had one or more reoperations, most frequently because of implant slippage (30%), encapsulation (26%), or implant size and shape (23%). Because insertion of breast implants is a lifelong decision, in-depth counseling about complication rates and possible risks should be given to women before implantation, and nonsurgical alternatives should be discussed, particularly for cosmetic implantation.

PMID: 10534295, UI: 20001862

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Exp Mol Pathol 1999 Sep;67(1):26-39

Dynamics of wound healing after silicone device implantation.

Shanklin DR, Smalley DL

Department of Pathology, University of Tennessee, Memphis 38163, USA.

A large surgical wound is required for implantation of silicone mammary devices. Formation of capsules around silicone devices follows wound healing processes except that the healing is conformed and significantly delayed by the physical presence of the implant. Multilayered capsules are thicker and lymphocytic and plasmalymphocytic vasculitis, markers for delayed hypersensitivity, also correlate with thicker capsules. Polyurethane-coated devices induce very thick capsules that remain so for over 20 years. By contrast, gel and saline content devices show maximum thickness at 6. 5 years. Active T(H) lymphocyte memory does not differ by implant type for individuals with devices in place and that for gel content devices peaks at 10.5 years. There was a significant decrease in T cell indexes only after the removal of saline content devices. Comparison of the rate of formation of the periprosthetic capsule with the healing time of large wounds of similar size indicates that silicone devices interfere with the healing process, requiring substantially more time. This extended period has the potential for enhancing autoimmune conversion as a consequence of persistent delayed hypersensitivity. Copyright 1999 Academic Press.

PMID: 10493890, UI: 99425256

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Silicone filled breast implants and the risk of fibromyalgia & rheumatoid arthritis.

Wolfe F, Anderson J

Arthritis Research Center and University of Kansas School of Medicine,

Wichita, KS 67214, USA. fwolfe@southwind.net

OBJECTIVE: The symptoms of what has been called silicone implant associated syndrome (SIAS) and fibromyalgia (FM) are similar. It has been hypothesized that silicone (filled) breast implants (SBI) might be causally related to the development of FM. This hypothesis was investigated by comparing 508 patients with FM with 1228 control subjects. We also studied the relationship of SBI to the subsequent development of rheumatoid arthritis (RA).

METHODS: Utilizing a longitudinal databank, implantation status was determined in 464 patients with RA, 508 with FM, 261 with osteoarthritis (OA) of the knee or hip, and in 503 randomly selected community controls. We obtained data on the type of implant and its temporal relationship to the onset of FM and RA. RESULTS: No association between SBI and RA was found (OR 1.66, 95% CI 0.33, 8.23, p = 0.538). No association between prior SBI and subsequent FM was found (OR 1.22, 95% CI 0.30, 4.89, p = 0.781). But one-third of the SBI in FM occurred after development of the syndrome. When all implants regardless of temporal relationship were considered, the overall relationship between any implant and the diagnosis of FM was significant at p = 0.095 (OR 2.45, 95% CI 0.86, 7.03). CONCLUSION: No relationship between prior SBI and the subsequent development of FM or RA was noted. But implants appear to be more common in patients with than in those without FM (p = 0.095). A common, predisposing set of psychosocial characteristics may be shared between those who have FM and those who undergo SBI.

PMID: 10493686, UI: 99421429

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Plast Reconstr Surg 1999 Sep;104(3):661-8

The deposition of talc in patients with silicone gel-filled breast implants.

Chandler PJ Jr

Ambulatory Plastic Surgery Center, Richardson, Texas 75080, USA.

This study was initiated to understand why talc was found in the entrance wounds and pericapsular scars of patients with silicone breast implants. Twenty-five surgical gloves made between 1977 and 1992 by a major glove manufacturer were evaluated with infrared spectroscopy. Seven gloves manufactured before early 1983 contained talc. Later manufactured gloves contained calcium carbonate instead of talc. Talc-containing gloves were submitted to independent laboratories for scanning electron microscopic examination and x-ray microanalysis to obtain finer detail. Remnants of the mold-release agent talc were found in the matrix of the patient-contact side of the glove. Wetting studies showed that silicone oil (gel bleed) immediately wet the surface of rubber glove. After donning, silicone oil was massaged between the thumb and index finger of each washed, talc-containing glove for 1 minute and then daubed from the glove to a microscopic slide. The slide was viewed with polarized light microscopy for the presence of talc crystals. Transfer of talc occurred using silicone oil, but not saline, in each talc-containing glove. Three factors were likely involved in the greater talc deposition that occurred with patients undergoing silicone gel-filled breast implantation than in patients undergoing other surgical procedures. (1) The wetting of the gloves with silicone gel bleed from implants loosened the talc in the glove matrix. (2) Hand-intensive surgical use freed the talc from the gloves. (3) Loose talc adhered to the silicone elastomer of the breast implants and was deposited with implant placement.

PMID: 10456515, UI: 99383418

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Aesthetic Plast Surg 1999 Jul-Aug;23(4):279-81

Buckled upper pole breast style 410 implant presenting as a manifestation of capsular contraction.

Hodgkinson DJ

The Cosmetic and Restorative Surgery Clinic, NSW, Sydney, Australia.

Recent experience with the cohesive gel implant has shown an interesting variation of capsular contracture. Instead of spherical contraction, the capsule formation around the 410 implant seems to cause a buckling of the superior pole of the implant. This buckling has been observed in four implants and presented clinically in 2 of 50 patients with a superior pole mass. The capsular contraction around the implant and the buckling are probably camouflaged by a subpectoral implantation and this presentation should be recognized by the surgeon, especially when considering placement of the cohesive gel implant in a subglandular position. Histological sections of a capsule around the implant show fragmented silicone, with a cellular reaction around the fragmented silicone.

PMID: 10441719, UI: 99373084

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J Biomed Mater Res 1999;48(3):354-364

Silicone gel breast implant failure and frequency of additional surgeries:

Analysis of 35 studies reporting examination of more than 8000 explants.

Marotta JS, Widenhouse CW, Habal MB, Goldberg EP

Biomaterials Center, Department of Materials Science and Engineering,

University of Florida, Gainesville, Florida.

Although it is well known that silicone gel breast implants (SGBIs) produce many "local" complications (i.e., pain, hard fibrous capsules, disfigurement, chronic inflammation, implant shell failure) and necessitate frequent surgical revisions, no large cohort retrospective quantitative analysis of clinical data has been reported to date, especially for the prevalence of failures and additional surgeries. Data from 35 different studies that encompass more than 8000 explanted SGBIs have now been analyzed and are reported here. Because examination of a prosthesis when explanted is the definitive method for determining shell integrity, the only studies that were used were ones that reported implant duration, the total number of SGBIs explanted, and the number of SGBIs for which shell rupture or failure ("not intact") was confirmed upon surgical removal. An exponential regression plot of data indicated a direct correlation of implant duration with percent shell failure (r2 = 0.63 and r = 0.79 ). SGBI failure was found to be 30% at 5 years, 50% at 10 years, and 70% at 17 years. The failure rate was 6% per year during the first 5 years following primary implant surgery. ANOVA comparison of three implant age groups (mean implant durations of 3.9, 10.2, and 18.9 years) indicated a highly significant statistical correlation of percent failure with implant duration (p < 0.001). Complications necessitating at least one additional surgery occurred for 33% of implants within 6 years following primary implant surgery. Shell failure was found to be an order of magnitude greater than the 4 to 6% rupture prevalence suggested by the AMA Council on Scientific Affairs in 1993, the 0.2 to 1.1% cited by manufacturers at that time, and the 5% rupture that was stated to be "not a safety standard that the FDA can accept." Copyright 1999 John Wiley & Sons, Inc.

PMID: 10398041

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