Litigation Management

NO LINK BETWEEN BREAST IMPLANTS & SYSTEMIC DISEASE SAYS INSTITUTE OF MEDICINE IN ITS REPORT, SAFETY OF SILICONE BREAST IMPLANTS

Abstracted By:	Elizabeth B. Juliano
	James R. Fell

In an attempt to establish the facts concerning possible hazards connected with the use of silicone breast prostheses, the U.S. Department of Health and Human Services was charged by Congress to support a definitive study of implant safety through the Institute of Medicine of the National Academy of Sciences. Its Committee on the Safety of Silicone Breast Implants last summer issued a report of its findings, which has substantiated the position of defenders of these medical devices. Significantly, the Committee concluded no causal association can be determined between silicone breast implants and claims of systemic disease associated with their use.

"There does not appear to be even suggestive evidence for the existence of a novel syndrome in women with breast implants. In fact, epidemiological evidence suggests that there is no novel syndrome." p. 5

Safety of Silicone Breast Implants begins by noting that prior to 1992, mostly anecdotal evidence supported claims of systemic silicone breast implant-related disease. However, in the opinion of the Committee, since that date there have been adequate numbers of studies of suitable academic rigor that scientific knowledge can now replace conjecture. Specifically, the Committee concluded that there is no evidence to associate silicone breast implants with the development of:

T-cell antigen or T-cell autoantigens;
Antisilicone antibodies;
Increased serum immunoglobulin levels;
Antinuclear or other autoantibodies (The Committee stressed that a positive ANA is not in itself a disease diagnosis);
Delayed hypersensitivity reactions;
Multiple myeloma;
Breast or other cancers (limited evidence even suggests a possible lower incidence of breast cancer in breast implant recipients);
Connective tissue or rheumatic diseases;
Neurologic disorders;
Autoimmune diseases;
Human adjuvant disease;
Novel silicone breast implant syndrome or disease.

More importantly, the Committee commented that their investigation suggested the aforementioned conditions were no more prevalent in recipients of silicone breast implants than in non-recipients.

"Human adjuvant disease is not a defined disease, and the term should be abandoned." p. 4

The Committee was concerned over what it perceived as "relatively high frequencies" of local complications (i.e. rupture, contracture, elevated silicone concentrations in peri-implant tissues, pain, infection) in prosthesis recipients. Localized risks were found to be cumulative over the lifetime of the breast implant. In the belief of the Committee, these concerns were insufficiently analyzed by the earlier reports of both the Independent Review Group (see The M.I.M. Reporter, November 1998) and the National Science Panel. Over 50 pages of the Committee's report were devoted to a discussion of medical research pertaining to local complications, as well as the utility of past and present interventions to minimize some of these problems. Attorneys and medical experts will be interested in the sections discussing such practices as steroid use and prosthesis barrier coatings. In light of localized problems, the Committee recommended that the practice of closed capsulotomies be discontinued because of the greater danger of implant rupture and subsequent silicone leakage.

Data on silicone implants and breast imaging evaluations was also reviewed. Magnetic resonance imaging (MRI) was identified as the most accurate method to identify implant rupture, with mammography regarded as having limited utility. Little causal evidence was found to link mammographic procedures to implant rupture, although the presence of implants could hinder a full mammographic screening.

The report indicated there is no evidence to support claims that silicone implants contaminate breast milk in lactating mothers. Likewise, various health problems in children born of implant recipients cannot be attributed to prenatal silicone exposure.

This report is exceptional for its comprehensive inventory of breast implant publications. All citations listed were reviewed by the Committee in preparation of this analysis, although each publication was not necessarily directly referenced in the final report. It is stated that the biography is exhaustive through 1998, and for this reason alone, the report is a "must purchase" for all attorneys engaged in breast implant litigation.

The reference list itself is divided into two sections. The first contains 2264 peer-reviewed scientific publications, which the Committee set apart from 1077 additional resources consisting of letters, abstracts, industrial technical reports, and other documents. Each citation is followed by one or more staff-assigned keywords. These designations would facilitate filing of citations in a computerized database and subsequent medical legal research functions.

"The committee concludes that a review of the toxicology studies of silicones and other substances known to be in breast implants does not provide a basis for health concerns." p. 7

This analysis reinforces findings of previous breast implant reports compiled by other independent review groups. Medical evidence continues to accumulate effectively discounting allegations that silicone breast implants are causal agents in the development of various systemic diseases.

This report is available through the National Academy Press (1-800-624-6242) for approximately $44.95.

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