Silicone-gel breast implants may return.

2003 NOV 6 - (NewsRx.com & NewsRx.net) -- Silicone-gel breast implants may soon return to the U.S. market after an 11-year, near-total ban now that government advisers have recommended reluctantly that sales resume under very strict conditions.

Topping the list of requirements is that Inamed Corp., the manufacturer seeking an end to the ban, would have to operate a registry to track the health of all implant recipients. Women also would have to get annual doctor's exams to ensure the implants aren't silently leaking silicone. Women would have to be given detailed advice about the implants' known risks, including very high rates of repeated surgeries and lingering safety questions, before their operation, the advisers to the U.S. Food and Drug Administration (FDA) said October 15, 2003.

And because most women who report pain, broken implants, and other side effects do so within 10 years of getting the devices, Inamed would have to extend its current safety study from the current 3 years of tracking to a full decade.

The decision was approved on a 9-6 vote after the FDA's advisers spent 2 days hearing wrenching stories of dozens of women who blame silicone implants for permanent disfigurement, as well as others desperate to have what they consider a more natural-looking option to repair cancer-ravaged breasts or make healthy breasts bigger.

The decision was far short of a ringing endorsement and even supporters were adamant about the need for continued research to settle lingering questions.

After 16 hours of testimony and debate on October 14, the advisers cited a big problem: research by FDA and others suggest implants really start breaking and leaking 7 years after women receive them, but Inamed hasn't tracked women's health for nearly that long.

"A decade has passed and we sat here today talking about 2- and 3-year data. I'm flabbergasted," said Dr. Thomas Whalen of the Robert Wood Johnson Medical School, the advisory panel's chairman.