Patricia Walker, chief scientific officer of Inamed, urged to the panel to focus on the company's data. "As horrible and heartbreaking as the testimonials are, we must rely on the science," she said.
The panel, however, heard divergent views about the science with Inamed and the FDA scientific staff at odds about how many ruptures women can anticipate. Using three years of its data and some longer international studies, the company estimated that about 14 percent of implants would fail within 10 years.
But FDA medical officers Sahar Dawisha and Pablo Bonangelino said that judging from the best available evidence, it is impossible to accurately project how many ruptures would occur. Depending on which assumptions are used, they said, the failure rate for breast enlargements could be as low as 21 percent and as high as 74 percent.
Complicating the issue is the growing understanding that up to 85 percent of silicone gel implants that fail do so "silently" -- leaving the women unaware, sometimes for years, that the implants have ruptured. Inamed officials said this was a positive thing and showed that the gel held together so well that it did not spill out. FDA officials and some panel members, however, said the silent leaks could be worrisome because small amounts of silicone could leak out over years.
Panel member Stephen Li, president of Medical Device Testing and Innovations LLC in Florida, who in 2003 voted in favor of the implants, yesterday voted against the application. He said he wanted to see more data on why implants rupture but was close to being convinced.
"I think you'll be there soon," he told Inamed officials.
Continuing a controversy over who should sit on agency advisory panels, the hearing began Monday with the announcement that Michael Olding, chief of the division of plastic surgery at the George Washington University School of Medicine, had left the panel at the last moment.
Olding told the FDA several weeks ago that he owned stock in Medicis Pharmaceutical Corp., which recently agreed to purchase Inamed.
Another implant maker, Mentor Corp., is scheduled to present its data to the panel today.
