The Food and Drug Administration has rejected Inamed Corp.’s application to sell silicone breast implants.
The agency yesterday issued guidelines seeking more information and a longer study before it will consider lifting a ban it placed on silicone implants in 1992 amid fears they cause health problems when they leak.
The guidelines follow a “not-approvable” letter the agency on Wednesday sent to Santa Barbara, Calif., breast-implant manufacturer Inamed Corp. for its bid to sell a silicone gel-filled model.
The FDA wanted more information regarding:
How long breast implants will last before rupturing.
The rates and kinds of possible ruptures.
The causes of an implant leak and the health consequences to women.
Available treatments to remove a burst implant.
“We think a lot of information has been developed over the past 10 years that has increased our assurance of certain aspects of safety, but additional information is necessary before the product passes the threshold we consider ‘open marketing,’” Daniel Schultz, director for the FDA’s Office of Device Evaluation, said in a conference call yesterday.
Inamed President and Chief Executive Nick Teti said in a different conference call that the company plans to “work aggressively and cooperatively” to get the product approved.
“We see this as a setback, not the end of the road,” he said. Mr. Teti said it was too early to give a definite plan and would not disclose the FDA’s specific requests.
Shares of Inamed fell 12 percent yesterday to close at $44 on the Nasdaq Stock Market, down $5.80 from Wednesday’s price of $49.80.
Several industry analysts said they were disappointed the government proposed more intensive studies after an FDA advisory panel in October approved the implants. Currently, silicone implants can be used by women only in clinical studies or with certain conditions like breast cancer.
“What I want to know is why this information wasn’t detailed earlier to the company,” said Daniel Owczarski, an analyst at Belmont Harbor Capital, a Chicago research firm.
While analysts were expecting the FDA to request follow-up studies, Mr. Owczarski said the new guidelines “are a little overwhelming.”
He said he did not think Inamed or competitor Mentor Corp., also headquartered in Santa Barbara, Calif., would meet the new guidelines within the next two years.
John Calcagnini, senior medical device analyst at the Los Angeles office of CIBC World Markets, added the FDA did not fully specify why it overruled the panel’s decision.
“They focused on rupture in the implants but they didn’t elaborate further on what rupture rates were considered safe or unsafe,” Mr. Calcagnini said.
Public health groups hailed the updated guidelines as a victory, but said they do not stop Inamed from resubmitting their silicone implants for market use.
“The FDA appears to be raising the threshold of approval by requiring these companies to provide more information,” said Sidney Wolfe, director for the health research group at the Public Citizen, Ralph Nader’s consumer advocacy group.
Some 237,000 women had their breasts enlarged through procedures like saline implants, filled with a salt water solution, in 2002, according to the American Society of Plastic Surgeons.
