13 April 2005

WASHINGTON: Inamed Corp faced questioning from US health experts yesterday over whether its silicone breast implants are safe enough that regulators can lift a 13-year-old ban and open sales to many more American women than now qualify.

The United States Food and Drug Administration's panel of advisers is considering new data from Inamed after rejecting its bid 15 months ago. The review is part of a three-day meeting that began on Monday on whether silicone implants should return to the US market after a 1992 ban over health concerns.

The advisers were to consider the data and then vote later on Inamed's application, but the FDA will have the final say.

Company officials told the panel the silicone implants, widely available in other countries, were reasonably safe. In the US, since 1992, only breast cancer survivors and others needing reconstruction or implant replacements have received silicone implants, through clinical trials.

"We believe the risks are acceptably low," Dan Cohen, Inamed's vice president of global government and corporate affairs said. "The risks are largely related to the surgical procedure. . . rather than the nature of the device."

Breast implants and body image are more difficult to evaluate than a life-saving device, he added. Their value "depends on how one values the procedure itself."

But panelist Stephen Li, president of Medical Device Testing and Innovation LLC, said he was not convinced surgery caused more ruptures than the devices did.

"It is not at all obvious to me that the scalpel was even involved," he said. "I hear your words. I just don't see the evidence."

The company's pitch followed nearly 12 hours of emotional testimony on Monday from women who linked the implants to chronic, disabling illnesses and from others who touted them as safe and natural-looking.

Studies have failed to find links between silicone implants and lupus, arthritis or other chronic diseases.

Still many women are convinced that leaking silicone and the platinum catalyst used to turn it into a gel caused their illnesses, and numerous patients and family members warned of suicide, fatigue and silicone oozing from their scars.

Inamed's chief scientific officer Patricia Walker urged the panelists to focus on the company's data.

"As horrible and heartbreaking as the testimonials are, we must rely on the science," she said.

Walker echoed testimony from patients and surgeons who said the silicone devices look and feel better than saline-filled ones available in the US.

Inamed, which is being bought by Medicis Pharmaceutical Corp, and rival Mentor Corp have said new silicone implants are more durable, and the gel is stickier and less likely to migrate.

Today the panel will review Mentor's studies.

Walker said Inamed's devices have a 14 per cent expected likelihood of rupturing over 10 years, but several panelists said it was not clear how the company came to that conclusion.

"I'm a little confused," said panelist Michael Miller, a plastic surgeon at the University of Texas.

FDA reviewers also questioned the calculation, saying Inamed did not take into account product aging and based its estimate on a small number of ruptures.

"It is difficult to reasonably predict the probability of rupture by year 10 with the available data," an FDA statistician said.