Information for Women About the Safety of Silicone Breast Implants (2000) / Chapter Skim
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and look than today's saline-fi~led implants. But this same silicone gel has caused controversy because of fears that it produces ill effects in women receiving breast implants.
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~ Implant Mammary Gland ~ U hi M E N ~ ~ 1C ~ O N But other women have experienced upsetting complications that require surgery or even removal of the implant, such as: ~ implant rupture, which can cause the silicone gel to leak out into neighboring tissue and even into other parts of the body; capsular contracture, an often painful distortion and shrinkage of fibrous tissue surrounding the implant; saline-fi~led implants that deflate, spilling the harmless solution into the body; or pain, from many causes, including postoperative muscular spasms and severe capsular contracture. Some women have claimed even more potentially serious problems, alleging that the silicone in implants, particularly the silicone gel inside the implant sac, can cause connective tissue or other autoimmune diseases such as rheumatoid arthritis and lupus, neurological disorders, cancer, and even new silicone-related diseases.
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In 1997, the U.S. House of Representatives asked the federal Department of Health and Human Services to sponsor an extensive study of silicone breast implants.
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An important task of the committee was to study and review thousands of published scientific reports. The committee also studied selected industry research reports on silicone breast implants and heard presentations from the public, including representatives of consumer groups, researchers, and women with silicone breast implants.
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Some of the committee's major findings are summarized below. Silicone Implants Do Not Cause Major Disease Evidence clearly shows that silicone breast implants do not cause breast cancer or the recurrence of breast cancer.
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(The committee did find that if an implant ruptures, localized problems such as scarring and nerve compression can occur in the breast or arm areas.) The committee also concluded that because there are more than 1.5 million American women with silicone breast implants, it would be expected that some of these women would develop connective tissue diseases, cancer, neurological -diseases, or other systemic complaints or conditions during their life.
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and somewhat less pleasing cosmetic results, but there is the potential for concern. Breast Implants Have Improved Over Time, Reducing Some Health Risks There have been many changes and improvements in silicone implants since they were first introduced in 1963.
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ImDIant Some saline implants used in reconstruction have valves, designed to be inflated gradually after surgery as new tissue forms around the pocket created. Early valves often leaked, resulting in deflation or possible bacterial contamination of the saline.
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At the end of its investigation, the IOM committee concluded that the silicones found in breast implants do not provide a basis for concern at doses reasonably to be expected. The committee also reported on its findings regarding the health problems that can occur in women with implants.
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Local Complications Are Frequent with Gel-Filled Silicone Implants Women with gel-fi~led silicone implants and those undergoing reconstructive surgery appear to have a greater chance of complications than do women who have saline implants or implants for augmentation. The operation for immediate reconstruction is more serious because it involves a significant surgical procedure (mastectomy or removal of the breast)
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Still, the frequencies are high. A study of 2,855 women with modern saline implants showed 18% of augmented women and 36% of those with reconstruction had complications within a year of receiving their implants in one of four categories: infection, severe contracture, deflation, and implant removal.
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or when the breast is severely squeezed or compressed either during procedures to break up fibrous tissue (capsular contracture) around the implant, or because of trauma caused by an automobile accident or even, some say, a too-tight hug.
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Ruptures, leaks, and deflations may be more common in gel-fi~led implants than in current saline-fi~led models, although one team of investigators showed that only 67% of saline implants were still in place at the end of 10 years, causing the researchers to comment that their study "confirms the obvious: Inflatable breast implants deflate with time." The IOM committee concluded that deflation of modern first-year saline implants might run from 1 to 3% and that this percentage would rise steadily with time. The report strongly recommends that more studies be conducted to answer questions about today's implant rupture and deflation rates.
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Additional surgery comes with its own risks, including infection, possible ruptures, and the hazards of anesthesia. Some of these medical procedures particularly "closed capsulotomy," where strong pressure is applied to the outside of the breast to help break up the fibrous capsule are performed repeatedly on the same women.
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The silicone used in implants has also been named as a culprit in contracture capsules formed around gel implants. The IOM committee noted that most studies agree that baseline levels of silicon are found in all normal breast and other tissue.
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One study demonstrated that the rate of contracture is 30% with submammary implants versus 10% with submuscular implants. The lower incidence of severe contracture with submuscular implant placement is important.
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The use of steroids to reduce capsular contracture is not recommended. Steroids placed inside saline implants may carry other health risks and are not approved for use by the FDA.
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Sometimes the implant has to be removed, or a capsule forming under the chest muscles may result in more compression and pain and lead to more surgical procedures. Much of the pain with a late onset is caused by capsular contracture, but it can also be indicative of bacterial infections or rupture.
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