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FDA rejects breast implant return to market
WASHINGTON -- The Food and Drug Administration rejected Inamed Corp.'s bid to bring silicone gel breast implants back to the market, more than a decade after they were first banned amid fears the devices harmed women.
The FDA apparently heeded criticism that Inamed hadn't studied the controversial implants thoroughly enough to settle questions about just how often they break apart in women's bodies and the resulting health effects from leaking silicone.
The FDA's move doesn't end strictly controlled research studies that make the implants available to some women with breast cancer and a few other conditions.
Nor does it mean silicone gel implants can never re-enter the market. Indeed, on Thursday the agency released new guidelines for Inamed and other implant manufacturers explaining exactly what scientific issues must be settled if the devices are ever to be sold widely.
New requirements will include: settling whether women whose implants leak silicone without symptoms need them removed, mechanical testing to predict how long implants will last before rupturing, more detailed exams of what happens to women's bodies when silicone gel leaks beyond the breast.
"We're quite convinced that there are women who have these products and get a very satisfactory result," FDA medical device chief Dr. David Feigal told The Associated Press. "What you really need to know is, for someone who has a rupture, what are the consequences of that?"
The decision surprised -- and delighted -- women's and consumer advocacy groups that had spent months lobbying FDA that the implants were too defective to open to more widespread use.
Adding to the lobbying pressure were plastic surgeons who call silicone gel implants more natural-looking and no more dangerous than today's main alternative, implants filled with salt water.
In keeping the implants off the market for the time being, FDA took the highly unusual step of rejecting the recommendation of its own scientific advisers, who in October had reluctantly agreed the devices should return despite some lingering questions about safety and durability.
Inamed, which said it learned of FDA's decision late Wednesday, said the company would seek approval again once it understood what additional data to provide.
"Although we are disappointed with the current outcome, we appreciate the serious and thorough review" of the application, said Nick Teti, Inamed's chief executive.
Inamed stock, meanwhile, fell nearly 14 percent on the news. The shares were down $6.80 at $43 in morning trading on the Nasdaq Stock Market.
A competitor, Mentor Corp., last month filed its own FDA application seeking to sell breast implants. It's not clear whether Mentor's application meets the FDA's new guidelines; calls to the company were not immediately returned.
Critics praised FDA's move.
"Their decision sends a crystal clear message to women that silicone gel breast implants are not proven safe," said Diana Zuckerman, of the National Center for Policy Research for Women and families.
Plastic surgeons expressed disappointment and questioned the timing of the new guidelines.
"It seems they're changing the rules in the middle of the game here," said Dr. Rod Rohrich of the University of Texas Southwestern Medical Center, who is president of the American Society of Plastic Surgeons. "It would have been laudable for the FDA to give these guidelines to the manufacturers a long time ago."
The FDA ended routine sales of the once highly popular silicone breast implants in 1992, restricting them to breast cancer patients and a few others in strictly controlled research studies because of complaints that the implants frequently broke, leaked and caused serious health problems.
Inamed sought to bring them back to the market by arguing that the implants break no more often than today's saline-filled options, and that they don't cause life-threatening health problems.
In 2002, 236,000 women in the United States had their breasts enlarged, a number that had been expected to increase if the FDA gave women the silicone-gel option.
In emotional testimony in October, dozens of women argued that the silicone gel implants left them permanently damaged while dozens more begged for access to them.
Studies to date show little evidence that gel implants cause major diseases, such as cancer. But FDA officials have worried that questions about rare diseases aren't settled, and that subsets of women whose silicone leaks beyond the breast might be more vulnerable to painful conditions like fibromyalgia.
More immediately, silicone implants do have clear complications.
Inamed's research showed that up to 46 percent of recipients needed additional surgeries because of painful scar tissue and other complications, and up to a quarter had to have the devices removed or replaced.
The research tracked women for only three years. FDA's advisers said tracking should be done for 10 years because it could take that long for the devices to begin breaking.
Inamed had pledged to continue that tracking while selling the implants -- an offer that helped sway FDA's advisers, on a 9-6 vote in October, to recommend sale of the devices. But ultimately, it wasn't enough for the government.