Silicone Gel Breast Implants Approved

by Jane Sprague Zones

On Friday afternoon, November 17, 2006, the Food and Drug Administration (FDA) announced its decision to allow open marketing for silicone gel-filled breast implants. This was the first time the FDA had ever approved this product for general use. Initially, when silicone implants were first put on the market, medical devices were not regulated by the FDA and did not need approval. In 1992, amid concern about rupturing or leaking implants, the FDA imposed a marketing moratorium on silicone implants, and they were no longer available to the general public. The recent approval of the product by the FDA was announced on a Friday afternoon. Friday afternoon announcements are generally considered an indication of a desire to avoid publicity and negative feedback.

Although most breast implants are used for cosmetic augmentation of healthy breasts, about 20 percent of the devices are used for reconstruction after mastectomy. Breast Cancer Action has fought for many years to require manufacturers to develop safer implants and to proceed with long-term safety testing.

The products that were approved are manufactured by Mentor and Allergan (formerly Inamed); they have been studied for relatively short periods and have appalling failure rates. Risks of resurgery in the first three years after initial implantation are 46 percent for Allergan’s product, and 8 percent of reconstruction patients underwent three or more surgeries following implantation. Resurgery rate for Mentor’s product was even worse. Many of these resurgeries were required due to the high rupture rates for the devices—25 percent after two years for the Mentor devices. The FDA’s own scientists project a possible 93 percent rupture rate after ten years for the Allergan implants.

For women undergoing augmentation, there are additional concerns specific to breast cancer. Notably, silicone breast implants obscure mammograms. Recent research found a two-thirds reduction in the ability to detect tumors in women with breast augmentation. This may affect stage at diagnosis, although the data on this are not yet clear. Also women with silicone breast implants who have breast cancer are not considered good candidates for sentinel node biopsy. Silicone breast implants also limit options for breast-conserving treatment (lumpectomy). Most augmentation patients receiving a lumpectomy have unsatisfactory cosmetic results. Additionally, lumpectomy patients are treated with radiation, which signifi cantly increases capsular contracture
(tightening of the scar tissue that forms) around the implants. This often requires corrective surgery that has limited success because of radiation damage to the tissues as well as radiation-related wound-healing problems. For more information, read “Project Impact: Education, Support, and Advocacy for Women With Problem Implants” in BCA Newsletter #23, April 1994.

In the early 1980s, the FDA began to review the safety and effectiveness of silicone breast implants and urged manufacturers to conduct long-term controlled clinical trials. In response, the manufacturers and the American Society of Plastic Surgeons (formerly known as the American Society of Plastic and Reconstructive Surgeons) responded by funding public relations campaigns to put pressure on the FDA and to counteract negative publicity surrounding the product. Research that has been published is by and large weak and characterized by conflict of interest. BCA is alarmed and concerned that the FDA has once again erred on the side of industry at the expense of women’s health.

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