FDA Expected To Approve Silicone Breast Implant Manufactured by Mentor
FDA on Thursday indicated that it likely will to approve an application from medical device maker Mentor to market silicone breast implants if the company meets certain conditions, the New York Times reports. Donna-Bea Tillman, director of FDA's Office of Device Evaluation, said the agency sent Mentor an "approvable" letter, but she did not specify the conditions for approval (Harris, New York Times, 7/29). Mentor CEO Joshua Levine in a statement said the conditions were "generally consistent" with recommendations made in April by an agency advisory panel, which voted 7-2 for conditional approval (Alonso-Zaldivar, Los Angeles Times, 7/29).
Among the panel's conditions were ensuring women were aware of potential risk with the implants, recommending women get regular MRIs to check for ruptures and allowing only plastic surgeons with specialized training to implant the devices (Schmid, AP/Long Island Newsday, 7/29). The panel's recommended conditions also included the continued study of 1,000 women who had received the implants in a Mentor study (Rubin, USA Today, 7/29).
Levine said, "We are very encouraged by this communication from the FDA and view this letter as a positive sign for women and their surgeons that another option will soon be available" (AP/Long Island Newsday, 7/29). He did not say how long it would take the company to meet the conditions (USA Today, 7/29).
FDA limited the availability of silicone breast implants in 1992 to consider safety concerns, such as the effects of implants with leaks or ruptures. Under current FDA rules, only women who seek breast enlargement or reconstructive surgery as part of a clinical trial can receive silicone breast implants (California Healthline, 4/14).
On Thursday, Sens. Dianne Feinstein (D-Calif.), Barbara Boxer (D-Calif.), Hillary Rodham Clinton (D-N.Y.), Mary Landrieu (D-La.), Debbie Stabenow (D-Mich.), Blanche Lincoln (D-Ark.), Barbara Milkulski (D-Md.), Olympia Snowe (R-Maine) and Kay Bailey Hutchison (R-Texas) sent a letter to FDA Commissioner Lester Crawford urging him to "protect the health and well-being of American women" and not approve the implants.
The letter said, "Silicone implants, while providing a prosthetic with more natural characteristics, bear greater risks than saline implants." It continued, "Such implants can interfere with mammography. In addition, when failure occurs ... this usually occurs without symptoms and is detected only via [MRI] -- and even MRI does not detect some rupture" (Los Angeles Times, 7/29).