THURSDAY, Jan. 8, 2004 (HealthDayNews) -- The controversy over silicone breast implants took a surprising turn Thursday with the announcement that the U.S. Food and Drug Administration (FDA) would not follow an advisory panel's recommendation to let the devices back on the market at this time.
Inamed Corp., which makes the implants, said it had received a "not approvable" letter from the FDA.
"The letter outlines the additional information that Inamed must provide prior to the FDA's further review of its pre-market approval application (PMA) for silicone gel-filled breast implants," a statement from the Santa Barbara, Calif.-based company said. "According to the letter, submission of this requested information and data will place the PMA in approvable form and allow the FDA to conduct further review of Inamed's PMA."
Inamed Chairman, Chief Executive Officer and President Nick Teti said in a statement, "Although we are disappointed with the current outcome, we appreciate the serious and thorough review of our PMA by the Food and Drug Administration. The FDA letter that we received provides directions for us to follow, and we intend to work cooperatively with the agency to place the PMA in approvable form."
The FDA made it clear at a press conference Thursday that it is not closing the door on silicone gel implants. "Not approvable is not a final action, so this is still an application that is under review," said Dr. David Feigal, director of the FDA's Center for Devices and Radiological Health, who otherwise would not comment on the Inamed application.
At the same time, the agency laid out a new guidance document for all makers of breast implants that include new recommendations for mechanical testing, modes and causes of rupture, clinical study information, post-approval requirements and labeling.
"There is additional information that we think is necessary in order for this product to pass the threshold of what we would consider ready for open marketing," said Dr. Daniel Schultz, director of the Office of Device Evaluation, part of the FDA's Center for Devices and Radiological Health. Schultz said he did not necessarily see the new guidance as more restrictive.
"What we see is making things clear, because the best way to get to approval is to be able to provide sufficient data to demonstrate the safety and effectiveness of the product," he said. "The clearer we can be, we think that's the way we're going to get devices to market faster."
Silicone gel implants were taken off the market in 1992 amid fears that leaks might be responsible for autoimmune diseases and even cancer. Other problems included the fact that many women needed repeat operations to deal with painful scar tissue. Inamed was seeking approval to start selling the devices again for aesthetic purposes.
On Oct. 15, the FDA's General and Plastic Surgery Devices Advisory Panel of the FDA's Medical Device Advisory Committee voted to let the devices back on the market, albeit with a series of strict conditions. These included warnings to users and more safety tests.
Soon after, however, panel chairman Dr. Thomas Whalen publicly disagreed with his own panel's decision by sending a letter to FDA Commissioner Mark McClellan and five members of Congress citing his "strong reservations" about the vote and "imploring" them not to approve the product.
"What was most troubling is that here we had this device pulled for lack of long-term safety data and we were sitting in a room for a day and a half without any long-term safety data," Whalen said in an interview in early November. "Without that long-term safety data, we shouldn't be approving this."
In fact, the committee vote was far from unanimous, with nine voting for letting the implants back on the market and six voting no. Even among the "yes" voters there were considerable reservations. "This was a relatively closely voted panel," Whalen said in early November. "One person had to leave early and I don't know what they would have voted. It is suspected it would have been against. It might have been 9-8 if I had been able to vote."
Whalen felt Feigal was "fairly skeptical of what was going on."
The FDA's move did not even stun members of the panel who had voted to let silicone implants back into the market.
"I'm not surprised the FDA did this, given the degree of public outcry, given the extraordinary letter by the chair of the panel and given interested senators," said Dr. Phyllis Chang, a panel member and an associate professor of plastic surgery at the University of Iowa College of Medicine. "It was a difficult decision. I mentioned that I wasn't sure how I would vote the day before."
Chang eventually voted yes, she said, because of the conditions that were put on the approval. "I thought, what more can the manufacturer do?" she recalled.
"I hate to see the silicone gel breast implants not on the market because obviously, as a panel member, I felt they were safe and effective," said Dr. Michael Olding, chief of plastic surgery at George Washington University Medical Center. "However, the FDA has not said that they're not safe and effective. They said simply that we need some more information."
The latest FDA move set off a new flurry of responses.
Public Citizen commended the agency. "As the group that petitioned the U.S. Food and Drug Administration in 1988 to ban silicone gel breast implants, we commend the FDA for the non-approvable letter it released today concerning Inamed silicone gel breast implants," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a prepared statement.
Dr. Nolan Karp, an associate professor of plastic surgery at New York University School of Medicine in New York City, expressed disappointment. "We all hoped that these would be approved but that's not what's going to happen," he said. "It means a lot of time, a lot of money, a lot of effort if [Inamed] wants to get these things back on the market."
Karp uses the implants as part of a study involving women who need reconstruction after breast cancer surgery. "I think the implants are really terrific. For certain people they allow them to live a normal life," he said. "I wish they would loosen it up a little for the people who have cancer and need reconstruction."
"This decision has the potential to convince implant makers to try to develop a safer breast implant, and that is good for consumers and good for the companies," Dr. Diana Zuckerman, president of the National Center for Policy Research for Women and Families, said in a statement. "If the Inamed implants had been approved without proof of long-term safety, there would be no incentive to develop a safer product."