FDA panel rejects plan to market silicone implants

April 13, 2005|By Ricardo Alonso-Zaldivar | Ricardo Alonso-Zaldivar,LOS ANGELES TIMES

GAITHERSBURG - A Food and Drug Administration advisory panel recommended yesterday against allowing silicone breast implants back on the market, citing concerns about possible health effects and design problems that cause some to break prematurely.

The vote to disapprove the application by Inamed Corp. of Santa Barbara, Calif., to market the devices was 5-4.

"I don't feel secure about safety," said Dr. Amy E. Newberger, a Scarsdale, N.Y., dermatologist who offered the motion to disapprove the device.

It was the second time in less than two years that an advisory panel had voted on whether to make the devices available for widespread use. In 2003, the panel voted 9-6 to approve the devices, but that decision was overridden by the FDA, which asked for more data.

"Science won the day today," said Diana Zuckerman, president of the National Research Center for Women and Families and a leading critic of silicone implants. "They listened to the scientists who said there was no proof on whether implants were safe."

The advisory panel will vote today on a similar application by Mentor Corp., also of Santa Barbara, which had not previously sought FDA approval.

The FDA ordered the silicone devices off the market in 1992 amid controversy over health problems suffered by women who had the implants. Since then, silicone implants - which are considered more natural in appearance and feel than the saline-filled alternative - have been available only to women having breast reconstruction after cancer surgery or to those who agreed to participate in strictly controlled clinical trials.

One panel member, Dr. Michael J. Miller, a plastic surgeon at Houston's M.D. Anderson Cancer Center, said his experience in performing such reconstructive work led him to vote for approval.

"I am one of the few people on this panel for whom the care of these women is not theoretical," he said. "I would love to know everything about the device, but that is an impossible standard. I feel I have crossed that point."

Another panelist, Stephen Li, president of Sarasota, Fla.-based Medical Device Testing and Innovations LLC, had served on the 2003 advisory group and voted then in favor of approval. This time, though, he voted against it. "We really don't know why this device is failing when it fails," he said.

The panel's vote is not the final word. The FDA could reject its advice and approve the devices.

Dan Cohen, a lobbyist for Inamed, said he did not see the panel's vote as a rejection of the product. "The decision of the panel seems to be that they want more time," he said.

Inamed, he added, will continue to submit data and seek approval.

Although Inamed had worked diligently to dispel doubts about its silicone implants, a majority of the members expressed concern about one implant model which is known as "Style 153" and shown by the company's own data to be prone to rupture and leakage. Inamed said it has submitted to the FDA a plan for several changes to the model.

In their testimony to the panel today, FDA staffers acknowledged that Inamed had supplied the agency with considerably more information than was available two years ago about how and why its silicone breast implants rupture.

But medical reviewers for the agency said they still lacked enough data to answer some critical safety questions.

One dealt with what happens to silicone that escapes into the body. Some studies have found silicone in the lymph glands of women with breast implants.

"The FDA believes the answer to this question is crucial with respect to determining the safety of this device," said Dr. Sahar Dawisha, one of the FDA medical reviewers.

Another central question involved how implants deteriorate in the body, and whether they rupture at the same rate year after year or become more likely to fail after years of wear.

Dawisha testified that the agency was skeptical of claims by Inamed that rupture rates would remain fairly constant, in the low single digits, year after year. "FDA has questions about these assumptions," she said.

The Los Angeles Times is a Tribune Publishing newspaper.

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