Tue Apr 12, 2005 10:08 AM ET

By Susan Heavey and Lisa Richwine

GAITHERSBURG, Md. (Reuters) - Inamed Corp. told U.S. health experts on Tuesday that its silicone breast implants are safe enough for regulators to lift a 13-year-old ban and allow widespread sales.

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

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

The company's pitch followed nearly 12 hours of emotional testimony on Monday from women who linked the implants to chronic, disabling illnesses and 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 that women tie to the devices.

Nevertheless many patients are convinced that leaking silicone and the platinum catalyst used to turn it into a gel have caused their chronic diseases, and numerous patients and family members warned of suicide risk, extreme fatigue and silicone oozing from their scars.

Inamed's Chief Scientific Officer Patricia Walker urged to the Food and Drug Administration advisory panel to focus on the company's data.

The advisers will discuss the research and give their opinion on the company's implants, but the FDA will have the final say.

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

She echoed earlier testimony from several women and plastic surgeons who said on Monday the silicone gel-filled devices have a more natural look and feel than saline-filled breast implants available in the United States.

Both 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.

Walker also said the new version of the implants have a 14 percent expected likelihood of rupturing after 10 years.

But last week FDA reviewers questioned that analysis and said it did not take into account aging of the product. The staff cited estimates that anywhere from 21 percent to 74 percent could rupture after 10 years.

An agency panel said in October 2003 that Inamed's silicone implants were safe enough to be sold, but the FDA rejected the application and asked all makers to further study when and how often the devices break.

Since 1992, only breast cancer survivors and others needing reconstruction or implant replacements have received silicone implants through clinical trials.

According to the American Society of Plastic Surgeons, more than 264,000 cosmetic implant procedures and nearly 63,000 breast reconstructions were performed in 2004.

On Wednesday, the panel will review Mentor's studies.

Inamed shares were up 10 cents at $65.75 on the Nasdaq market in early trading on Tuesday. Mentor shares were down 16 cents at $34.40 on the New York Stock Exchange.