FDA panel advises OK for one type of silicone

Another brand of breast implant had been rejected

April 14, 2005|By Ricardo Alonso-Zaldivar | Ricardo Alonso-Zaldivar,LOS ANGELES TIMES

WASHINGTON - A day after rejecting another company's proposal, a Food and Drug Administration advisory panel recommended yesterday that silicone breast implants made by Mentor Corp. be approved - with conditions - for women having cosmetic surgery.

The 7-2 vote came with nine stipulations attached, including continuing safety monitoring studies, follow-up care of patients, special training for surgeons and voluntary tracking of every woman with implants.

But the expert advisers gave a mixed message to the FDA regulators, who must make the final decision on marketing the implants, because the same panel had voted 5-4 on Tuesday to recommend disapproval of silicone implants made by Inamed Corp. Many consider the risks and benefits of both products to be similar.

Both companies are located in Santa Barbara, Calif.

"It was a bizarre and strange decision by a handful of panel members who switched their votes, who Tuesday demanded longer-term data and Wednesday accepted shorter-term data," said Inamed Vice President Dan Cohen. Mentor provided two to three years of data on implant ruptures, he said, while Inamed offered three to four years of data.

But Josh Levine, Mentor's chief executive officer, said the vote showed that "these products are not all created equal." He said he was gratified by the decision but recognized that "there are still other hurdles to be passed" before his company can offer its implants to women seeking surgery to enhance the shape of their breasts.

"This is a great day for my patients, who will now have access to a better and safer product," said Dr. Scot Glasberg, a New York plastic surgeon and Mentor consultant. "There is no mixed message here. [Inamed's] presentation had problems." The two companies divide the $400-million-a-year U.S. breast implant market.

Mentor's shares rose 77 cents to close at $35.33 on the New York Stock Exchange. In after-hours trading, they rose as high as $39.60. By contrast, Inamed shares fell $2.90 on the Nasdaq, closing at $63.51, and dropped to $60.80 after hours.

The FDA had no immediate comment on the panel's recommendations. The time frame on the agency's decision to agree or disagree with its advisory panel's recommendations is six weeks to several months.

More than 250,000 American women have cosmetic breast surgery every year, but for the past 13 years the FDA has allowed them to use only implants filled with a liquid saline solution. The FDA ordered the silicone devices off the market in 1992 because of concerns about health problems possibly caused by silicone gel. Since then, silicone implants have been used for only women having breast reconstruction after cancer surgery or for those who agreed to participate in strictly controlled clinical trials.

Scientific studies have found no link between silicone implants, and cancer and other serious illnesses, but many women have other complications, including painful contracture of the breasts, scarring and rupture of the implants. Suspicion remains that, in a small group, silicone can prompt chronic fatigue symptoms.

Silicone implants are considered more natural in appearance and feel than liquid-filled ones.

Three of the panel's nine voting members voted for Mentor's proposal after voting against Inamed's. They were Barbara Manno, a professor of psychiatry at Louisiana State University, Dr. Joseph LoCicero, chairman of surgery at the University of South Alabama, and Stephen Li, president of a Sarasota, Fla., medical device company.

Li said he voted to approve the Mentor application because "they are two different devices." He said he was impressed by Mentor's failure rate of 1.4 percent and by a mechanical testing program the company has designed for its implants.

"They say they can last 61 years," Li said. "I don't believe that, but even if they are off by a fraction of four, that's still 15 years." He also praised Mentor's presentation, describing it as informative and responsive to the panel's concerns.

Indeed, Mentor appeared to have studied Inamed's elaborate presentation and decided to put forward a low-key alternative.

However, an FDA staff analysis of data from Mentor's clinical trials concluded that much of the information was of "limited value" in predicting whether implants would break after more than a few years in the body.

Panel member Dr. Amy E. Newburger, a Scarsdale, N.Y., dermatologist who voted against both products, said she did not have enough information to dispel doubts about their long-term safety.

"I don't understand why this was presented now," Newburger said, noting that the two companies' clinical trials are designed to last 10 years. "It's too soon to accurately define who has statistically significant signs and symptoms" possibly related to silicone. "There is not enough information at this time."

The Los Angeles Times is a Tribune Publishing newspaper.

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