FDA panel backs silicone implants: long list of conditions.(News)

GAITHERSBURG, MD. -- In a 9-6 vote, a federal advisory panel recommended--with a long list of conditions--the approval of one brand, of silicone gel-filled breast implants but emphasized the need for more long-term safety data on the product.

At the end of a 2-day public meeting, the Food and Drug Administration's General and Plastic Surgery Devices Panel backed the approval of the Inamed Corp.'s silicone gel-filled breast implants. The recommendation for approval came with a detailed list of conditions, including a stipulation that Inamed continue to study patients for at least 10 years and evaluate them for ruptured implants and side effects.

Other conditions include requirements that the manufacturer develop a model informed consent form, with input from the FDA and some panelists, and that women have follow-up exams at 1-2 year intervals after surgery to check for signs of rupture.

The FDA usually follows the advice of its panels, which is not binding.

The sale of all silicone gel-filled breast implants has been banned in the United States since 1992, after concerns over possible toxic effects and health problems relating to ruptured implants led to a moratorium on the implants in 1991. Also in 1992, the FDA made silicone implants available to patients undergoing reconstruction or revisions after breast cancer surgery only if they were enrolled in clinical trials evaluating the implants.

During the meeting, more than 100 people testified for or against bringing the implants back onto the market. Implant recipients and representatives of advocacy groups blamed ruptured silicone implants and leakage of silicone gel for debilitating ailments, but other women described extremely positive experiences with silicone implants. Some women who had also had saline-filled breast implants commented that the silicone implants were superior to the saline devices, which they described as hard, with a less natural appearance.

For their part, the panelists noted how difficult it was for them to come to a decision about approval. Panelists said they were comfortable with the short-term safety data presented at the meeting, but then unanimously agreed that more long-term safety data are needed.