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Executive Summary
Pages 1-12

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From page 1...
... In late 1997, the IOM agreed to carry out a comprehensive evaluation of the evidence for the association of silicone breast implants, both gel and saline filled, with human health conditions, assemble a comprehensive list of scientific references on this subject, and to consider recommendations for further research. Chapter 1 recounts this history and the steps taken by the IOM to form the committee on the Safety of Silicone Breast Implants and to arrange for the preparation of a report with national public and scientific input, standards for evaluating evidence, and appropriate committee deliberations.
From page 2...
... PDMS compounds are polymers, and the length and cross-linking of the polymer chains affect the physical properties of these substances. Implant shells are made from an elastomer, that is, a high molecular weight, cross-linked rubbery substance, and they are filled with silicone gel, a less cross-linked spongy substance permeated with lower molecular weight silicone fluids.
From page 3...
... Several studies of the distribution of silicones from depots of experimental gel implantation or fluid injection have shown that silicones remain localized where deposited and that low molecular weight silicones which may be mobile to a small extent, are cleared from the body after relatively short half-lives. Since the evidence is lacking or flawed that amorphous silica in breast implant shells is available to, or found in tissues of experimental animals or humans, or that crystalline silica is formed or present at any time in women with implants, the toxicology of silica has not been reviewed, although literature on silica is included in the references.
From page 4...
... A number of factors affect the integrity of the silicone elastomer implant shell. These include: shell thickness and strength which can vary considerably; untoward events such as needle sticks and other trauma associated with the vagaries of daily life, including closed capsulotomies, which the committee concludes should be abandoned; and the abrasion and wear of the implant shell in the body enhanced by wrinkling and fold flaws.
From page 5...
... The committee reached three major general conclusions regarding local and perioperative complications. First, these complications occur frequently enough to be a cause for concern and to justify the conclusion that they are the primary safety issue with silicone breast implants.
From page 6...
... These data are insufficient and a number of current epidemiological studies do not report an increase in immunoglobulin levels or multiple myeloma in such women. Reports of antinuclear antibodies and epidemiological studies of classical and atypical connective tissue or rheumatic disease in women with breast implants also do not provide any support for immunologic or autoimmune responses or diseases associated with silicone breast implants.
From page 7...
... Epidemiological studies have not found elevated relative risks for breast cancer in women with implants. In fact, some of these studies, now evaluating women two decades or more after implantation, have found fewer breast cancers than expected, and some animal studies have suggested that breast implants might be associated with lower frequencies of breast cancer.
From page 8...
... Two epidemiological studies of neurologic disease in women with implants provide limited support for a conclusion that there is no elevated relative risk for any association, and the committee concludes that with the exception of local problems caused by the migration of gel from ruptured implants, evidence that silicone breast implants cause neurologic signs, symptoms, or disease is lacking or flawed. In an overall consideration of the epidemiological evidence, the committee noted that because there are more than 1.5 million adult women of all ages in the United States with silicone breast implants, some of these women would be expected to develop connective tissue diseases, cancer, neurological diseases, or other systemic complaints or conditions.
From page 9...
... A number of problems with the reports of this group have been identified, and an epidemiological study of esophageal disease in the children of mothers with implants found no elevated relative risk for esophageal disease. As noted, breast milk silicon concentrations in implanted women are normal.
From page 10...
... Second, risks accumulate over the lifetime of the implant, but quantitative data on this point are lacking for modern implants and deficient historically. Third, information concerning the nature and the relatively high frequency of local complications and reoperations is an essential element of adequate informed consent for women undergoing breast implantation.
From page 11...
... · There is no increase in primary or recurrent breast cancer in implanted women. · In an overall consideration of the epidemiological evidence, the committee noted that because there are more than 1.5 million adult women of all ages in the United States with silicone breast implants, some of these women would be expected to develop connective tissue diseases, cancer, neurological diseases or other systemic complaints or conditions.
From page 12...
... 3. The development of a national model of informed consent for women undergoing breast implantation should be encouraged, and the continuing effectiveness of such a model should be monitored.


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