FDA Advisory Committee To Review New Studies on Silicone Breast Implants
An FDA advisory committee in April will review new safety studies on silicone breast implants, which the agency banned in 1992, according to officials from California-based Inamed, the AP/Long Island Newsday reports (Recer, AP/Long Island Newsday, 12/6).
FDA in January rejected the recommendation of an advisory committee to allow market re-entry for implants manufactured by Inamed and said that the company must conduct new studies to prove the safety of the products. 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 reconstruction surgery as part of clinical trials can receive silicone breast implants (California Healthline, 1/9).
Dan Cohen, an Inamed vice president, said that the company in April will present the FDA advisory committee with new studies that examine the causes of implant leaks and ruptures and the efficacy of new mechanical tests on the products. According to Cohen, the studies found that among women who received implants for breast augmentation, about 26% required new or additional surgery and 7.5% had the implants removed. In addition, the studies found that only 1.2% of the implants ruptured.
Inamed also has resubmitted for FDA approval a modified gel implant currently on the market in Europe, according to company President Nick Teti. "Our goal is to get these devices back on the market," Cohen said. Representatives for Mentor, which manufactures silicone breast implants, also will testify before the FDA advisory committee in April (AP/Long Island Newsday, 12/6).