Calling for Informed Consent on Silicone Gel Implants or an End to Sales

Diana Zuckerman, PhD, MAMM: Women, Cancer, and Community, Point of View column: March 2001

When women are diagnosed with breast cancer, they may not realize that one of their reconstruction options, silicone gel-filled implants, has never been approved by the Food and Drug Administration (FDA) as safe and effective. In fact, most doctors and patients probably do not know that there are remarkably few published studies on the safety of silicone breast implants for mastectomy patients.

Our think tank, the National Center for Policy Research (CPR) for Women and Families, has called for a moratorium on the sale of silicone gel implants until the FDA can assure that all women considering the implants are fully informed of the risks and the alternatives.

Women were clearly unaware of the risks when implants, which were initially designed for breast augmentation, were first sold in the 1960s. Implants were completely unregulated; it was not until 1976 that a new law required that the FDA determine which medical devices were safe and effective. Other devices took priority, and the FDA did not require silicone gel implant manufacturers to submit safety data until 1991.

In 1992, the FDA concluded that the implant studies were too poorly designed to prove that implants were safe. The law mandates that manufacturers prove that a medical product is safe; lack of proof that a product is dangerous is not sufficient. Nevertheless, the FDA decided that breast implants fulfilled a “public health need” and therefore made an exception, banning their use for most augmentation but allowing their continued sale as part of large clinical trials on mastectomy patients, women with breast deformities, and women with broken gel implants. The implant manufacturers have been conducting these trials ever since. Eight years later, none of the results have been published in a peer-reviewed journal.

Ironically, although the “public health need” for silicone implants was based primarily on the desire to help mastectomy patients, there is still almost no research at all on the safety of reconstruction with either silicone or saline breast implants. Most published epidemiological implant studies excluded mastectomy patients or include them only as a small proportion of patients studied. In such studies, any problems experienced by breast cancer patients may not be statistically significant.

Of the few studies of mastectomy patients with gel implants, one conducted by implant maker McGhan Medical showed that one out of four women had at least one additional implant-related surgery within the first year, and one out of four had at least one implant removed within two years. Since this study was never published, the information is unavailable to most doctors and patients.

Last year, an FDA study reported that many women with silicone implants do not realize their implants are broken and leaking. Using Magnetic Resonance Imaging (MRI), researchers determined that almost half (48 percent) of women who had silicone implants for only six to 10 years, and 79 percent who had implants for 11 to 15 years, had at least one ruptured implant. These women were unaware of the rupture, however, and had not sought any medical care. Since this study excluded women who had already reported implant problems or removal, the actual breakage rate is even higher.

Unfortunately, silicone gel and liquid can be impossible to totally remove, and medical journals have documented serious health risks and fatalities when silicone migrates to vital organs. The FDA study also found that 21 percent of the women had silicone “migrating” away from the broken implant to other parts of their body.

In addition to the risks of broken and leaking silicone implants, there are documented risks of implants that are true for either saline-filled or silicone gel-filled implants. These risks include those associated with surgery, such as infection, hematoma (blood or tissue fluid collecting around an implant), and the risks of repeated surgery to remove or replace implants that cause problems, as well as the risk of capsular contracture, in which a capsule of scar tissue tightens around the implant, often causing hardness and pain. Breast implants can also obscure the view of a breast tumor in mammography, thus potentially delaying a diagnosis of breast cancer. Even with specially trained technicians, some tumors will be hidden by the implants.

The safety of silicone implants should have been studied before they were sold to more than a million women. Mastectomy patients who received gel implants since 1992 are officially part of a clinical trial, but the objectivity of the study has been questioned by patients such as Kim Hoffman. In 1998, while testifying before the Institute of Medicine, a congressionally funded nonprofit, Hoffman said her implant problems were not reported to those analyzing the data. Unfortunately, problems are analyzed only if they are reported by the physicians (and in the case of rupture, the implant must be removed and then examined and reported by the manufacturer.

Obviously, the doctors and implant makers have a financial incentive to help prove that patients are satisfied and that implants are safe and problem-free. Despite congressional requests, no safety studies of mastectomy patients have ever been conducted by the National Cancer Institute. But if Congress hears from constituents, those studies might finally be conducted.

If the federal government allows the continued sale of silicone gel-filled implants without requiring long-term safety data, I believe it needs to at least make sure that all information about the risks of silicone gel-filled implants is provided to women in a clearly written consumer brochure and patient consent form, well before they undergo surgery. (That’s what the FDA requires with the recently-approved RU-486.) The FDA owes it to breast cancer patients to provide them with the same safeguards, so women can make a choice based on what is known and unknown about the risks.