More pressure to lift 13 year near-ban on silicone-gel breast implants

Apr 13 2005

Hot on the heels of the FDA's rejection of Inamed's attempt to have its Silicone-gel breast implants re-instated, a second manufacturer Mentor has also tried to convince sceptical federal health advisers to the Food and Drug Administration to lift a 13-year near-ban on silicone-gel breast implants.

FDA's advisers decided by a 5-4 vote that Inamed's study into how likely implants are to break apart was not for a long enough period and did not settle lingering questions of the consequences when silicone leaks into the breast or beyond. Inamed so far has tracked implant recipients for three or four years.

Mentor's pitch has come a day after the FDA's advisers refused to allow one of the nation's most controversial medical devices back on to the U.S. market and the same panel is judging Mentor's request to allow its own silicone implants onto the market.

Mentor has told advisers to the Food and Drug Administration that the newer versions of the implants only rarely break in the first few years after they're put into place, and provide enough benefit to the women who seek them to outweigh that risk and say women's self-esteem is as integral to health and well-being as any medical issue. Only 1.4 percent of patients in its main study had their implants break within three years.

Mentor officials do acknowledge that implants will fail more often as they age and have cited a British doctor who tracked 100 of his own patients with Mentor implants, and found 5.4 percent had broken by around nine years. FDA scientists say Mentor's data is too limited to be of value in settling the key durability issue.

Silicone-gel breast implants began selling in 1962 which was before the FDA required proof that all medical devices are safe and effective. By 1992 the number of complaints that the implants broke and caused illnesses prompted the FDA to ban gel implants except for patients with breast cancer or a few other conditions, those with them were enrolled in strict research studies.

Since then silicone implants have in the main been exonerated of causing serious or chronic illnesses such as cancer or lupus.

Apart from the risk of breakage, they also can cause infection and painful, rocklike scar tissue.

Last year, some 264,000 breast augmentations and 63,000 breast reconstructions were performed in the United States, most with salt water-filled implants that are sold without restriction.