Silicone-gel breast implants, virtually banned for 13 years, would return to the market if the government heeds a surprising recommendation from its scientific advisers.
After three days of wrenchingly emotional debate, advisers to the Food and Drug Administration said Mentor Corp. should be able to sell its gel implants -- but only if it meets strict conditions.
Topping that list: ensuring women understand the devices may silently break inside their bodies; recommending that they get regular, and expensive, MRI exams to check for those breaks; limiting implant insertion to specially trained plastic surgeons; and new studies to prove how long implants last.
Just a day earlier, the advisers narrowly rejected sale of rival manufacturer Inamed Corp.'s silicone implants, citing lingering questions about how long they last and what happens when silicone oozes into the breast, or beyond.
By a 7-2 vote, the FDA advisers said Mentor's research was more compelling than its competitors' that it was time to lift restrictions. Because of health concerns, use of gel implants have been limited to special research studies since 1992.
"Patients can determine whether or not for them it is worth it to have a device that might need to be replaced within a 10-year period of time," said Marilyn Leitch, M.D., a cancer surgeon at the University of Texas Southwestern Medical Center.
Mentor hasn't proved they'll last even 10 years, argued New York dermatologist Amy Newburger, M.D., who opposed lifting restrictions. Instead, it closely studied patients for just three years and didn't settle concern about the consequences of silicone leaks.
"I don't have the assurance that it's safe," Newburger said. "My concern was, since hundreds of thousands of patients will be exposed to this, I felt that the urgency (to sell) was not warranted at this time."
The FDA isn't bound by its advisers' recommendations. Just 15 months ago the FDA overruled a recommendation to bring back gel implants, telling manufacturers it needed better data on durability and silicone leakage.
Still, the decision was sure to delight patients who contend silicone-gel implants look and feel more natural than the salt water-filled implants sold without restriction.