Senate looks at FDA moves on implants

WASHINGTON -- Congress is investigating whether conflicts of interest led a panel to suggest relaxing a 13-year ban on silicone gel breast implants.

The investigation was launched by the Senate Health, Education, Labor and Pensions committee after complaints from 10 organizations, including the National Organization for Women. Among their concerns: A plastic surgeon who accepted money from a company seeking Food and Drug Administration approval to sell the implants was allowed to vote on the application and an FDA scientist critical of the implants was not called to testify.

''The committee is in the process of reviewing those allegations," said J. Craig Orfield, the Senate committee's spokesman.

Last week, the FDA signaled through an ''approvable letter" that Mentor Corp., based in Santa Barbara, Calif., will be allowed to market its implants subject to conditions. Silicone implants are thought to look and feel more natural than the saltwater-filled versions now available. The FDA banned silicone implants from general use in 1992 due to safety concerns.

The investigation into alleged conflicts of interest is the second recent confirmed inquiry into how the FDA handles disputed devices.

The Senate Finance committee wants to know why the FDA reversed itself and approved a controversial device made by Cyberonics to treat depression, despite objections of agency scientists.

''Congress has an important oversight role. The agency looks forward to cooperating fully with them," said Dr. Scott Gottlieb, FDA's deputy commissioner for medical and scientific affairs.

Letters exchanged between Senate Finance chairman Charles Grassley and the FDA also suggest an inquiry may be looming into how the FDA addressed risks posed by devices made by Guidant Corp.

Grassley, an Iowa Republican, said his interest in device safety is a natural extension of his push for safer prescription drugs.

''What we want this agency to do is have respect for the scientific process," he said. ''In other words, I shouldn't have to worry about whether something is safe. They've got scientists that are looking into that -- as long as they let the scientific process work."

Mentor's press release explaining the FDA's actions last week did not mention the Senate investigation.

Laura Martin, a spokeswoman for Mentor, declined to comment.

An analyst who tracks medical device manufacturers said that news of an investigation might have only a temporary drag on stock prices if the FDA eventually rules favorably on a new product, as it did for Cyberonics.

''They got final approval, and the risk has all but evaporated for Wall Street investors," said Thomas Gunderson, a senior research analyst at Piper Jaffray.

Until now, high-profile congressional FDA hearings have focused on the drug safety.

''This is new territory for us in devices," Gunderson said. ''There are very few precedents for us to go back and say, 'Oh, this is what happened when Senator Grassley investigated a company previously.' "

US Senator Michael Enzi, Republican of Wyoming, hired two investigators when he became Health, Education, Labor and Pensions committee chairman in January.

Diana Zuckerman, president of the National Research Center for Women and Families and a former US House investigator, was among those who filed complaints about Mentor and was interviewed by a Senate investigator.

''The impression I got -- and I say this as a former congressional investigator -- is that they are doing a comprehensive investigation," Zuckerman said.

But a former member of the FDA advisory panel on silicone gel implants said he does not expect the investigation will uncover significant industry conflicts.

''It's fueled by people who do not want to see silicone gel implants on the market," said Dr. Michael Olding, chief of the division of plastic surgery at the George Washington University Medical Faculty Associates. ''I think science will trump politics."

Olding, one of two plastic surgeons on the panel, stepped down as the advisory panel began hearings on applications that could boost annual sales of silicone gel implants by $75 million.

Olding amended a previous disclosure statement to reflect ownership of Medicis Pharmaceutical Corp. stock after Medicis said it sought to purchase Inamed, an applicant before the panel.

Diedtra Henderson can be reached at dhenderson@globe.com.