FDA Approves Marketing of Silicone Gel-Filled Breast Implants
On November 17, 2006, after “rigorous” scientific review, the U.S. Food and Drug Administration (FDA) approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older. The products are manufactured by Allergan Corp., Irvine, California, and Mentor Corp., Santa Barbara, California. The approval has been highly criticized by consumer groups, including Public Citizen, which labeled them the "most defective medical device ever approved by the FDA" as well as a “terrible reminder of the double standard for women versus men” since the FDA has not approved silicone gel testicular implants because of the inadequacy of clinical trials.
Most breast implants, which often are given to women following a mastectomy to treat breast cancer, contain saline solution. Silicone breast implants were banned in 1992 because of safety concerns. "FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA. "The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions."
The FDA will continue to monitor the devices by requiring each company to conduct a large post-approval study following about 40,000 women for 10 years after receiving breast implants. In addition, as reported by Consumer Affairs, the approval of the silicone gel-filled breast implants includes a number of additional conditions, including requiring each company to continue its core study through 10 years, conduct a focus group study of the patient labeling, continue laboratory studies to further characterize types of device failure, and track each implant in the event, for example, that health professionals and patients need to be notified of updated product information.
For more information, see the FDA release as well as reports by Medical News Today and Public Citizen. If you or a family member has suffered injuries in connection with breast implants or related surgical procedures, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation. If you would like to receive our electronic newsletter, please click here.