US keeps limits on implants

The US Food and Drug Administration has declined to lift its strict limits on silicone breast implants, rejecting the recommendation of an advisory panel and expressing concerns about how often the devices rupture.

But yesterday agency officials did not rule out future approval of the implants, which were severely restricted in 1992 after thousands of women with serious illnesses such as lupus or fibromyalgia said that leaking implants were the cause.

The officials declined to discuss why they refused to allow California-based Inamed to resume selling silicone implants. But they said that before they would approve any implant, they would need more information on how soon and why the devices rupture and more data on any resulting complications in the surrounding tissue.

In comments to reporters and to the company, FDA officials indicated they were less concerned about links with systemic diseases, such as lupus, because of accumulated studies showing little connection with the implants.

"It's important that the people who use these products know how they will perform," said Dr. David Feigal, director of the Center for Devices and Radiological Health at the FDA. "Women who have complications from these types of products should understand what they can expect."

The decision was a surprise because last October an FDA advisory panel of doctors, scientists, and ethicists had voted 9-6 in favor of approval, finding that the risk of complications was no greater than that of saline implants, which have never been restricted. The FDA follows the advice of its advisers in more than 90 percent of cases.

Inamed officials, who learned of the rejection late Wednesday night, said they would continue to seek approval for their implants.

"We see this as a setback, but by no means do we see this as the end of the road," said Nick Teti, Inamed's chairman. "We are confident we can provide the information requested by the FDA."

A second company, Mentor, also of California, applied to the FDA last month for approval to market silicone breast implants. Both companies also make saline implants, which women say look and feel less natural than silicone. In 2002, nearly 300,000 American women had breast implants, up from 62,000 in 1992, according to the American Society of Plastic Surgeons. About three-quarters were for cosmetic reasons, the rest for reconstruction. Since the FDA restricted silicone implants in 1992 to women who agreed to enroll in company-run safety studies, about 50,000 women have received them. Thousands of others rushed to have implants removed, and companies, including Inamed, collectively paid billions to settle lawsuits alleging harm.

The FDA's actions this week brought strong words from women on both sides of the decades-long battle over the safety of the implants.

"The voice of the women has been heard," said Martie Carnie, a Milton resident who suffered arthritis, hair loss, and breathing problems after getting silicone implants in 1988 following a double mastectomy. The symptoms gradually disappeared after the implants were removed in 1992.

"There are a lot of problems associated with the implants," she added. "There's a lot of pain for a little bit of look-good."

But Dr. Marcia Angell, former editor of the New England Journal of Medicine and author of a book that suggested politics had highjacked science in the debate over implants, said the FDA was holding the implants to a higher standard than other products.

"They've just shifted the goal posts," she said. "What was at issue in 1992 was whether they caused systemic disorders. This has been assiduously studied since, and they do not. Now, they're focusing on local complications. But local complications have been well examined, and the women who've had them often go back and get another set of implants.

"It's a patronizing attitude to deny women this choice," she said.

Inamed officials declined to release the FDA's letter to them or to disclose its contents. But separate guidance issued yesterday by the FDA to all companies seeking approval of breast implants indicates that companies will need to provide much more information on implant durability, on whether ruptures can be predicted or reduced using different materials or surgical techniques, and on treating patients when ruptures do occur.

Inamed presented data last fall that showed that between 20 percent and 46 percent of patients needed a second operation within the first few years to fix problems, including rupture. Other studies show that 26 percent to 55 percent of silicone implants rupture if they're in the body for at least 10 years.

Referring to the intense controversy over the devices, Feigal of the FDA said the new guidance "is based on science," but he acknowledged that concerns raised by FDA advisers, some in an unusual fashion, contributed to the FDA's actions.

A few weeks after the advisers recommended conditional approval of Inamed's implants, the panel chairman, Dr. Thomas Whalen, head of pediatrics at the Robert Wood Johnson Medical Center in New Jersey, wrote to FDA Commissioner Mark McClellan, urging the FDA to reject the implants. Whalen had not voted during the panel's October meeting, because as chairman he wanted to remain outwardly neutral.

In the letter, Whalen said the devices' long-term safety had not been proven, and he faulted the FDA for not requiring Inamed to submit 10-year safety data. Whalen issued a one-line statement yesterday saying he was pleased with the FDA's decision.

A member of the advisory panel who voted in favor of returning implants to the market, Dr. Phyllis Chang, said that Whalen "used the weight of his chairmanship, and that undermined part of the process of fairness."

"Dr. Whalen's letter, public outcry, questions from senators all weighed in and had some impact on the decision," Chang said.

The panel's recommendation, she added, was based on the safety data the FDA required Inamed to submit, but the FDA changed those guidelines yesterday. "Because of public outcry, rightly or wrongly, the rules of the game have changed," said Chang, a plastic surgeon at the University of Iowa.

Dr. Rod Rohrich, president of the American Society of Plastic Surgeons, which supported approval of Inamed's silicone implants, said the FDA's decision will disappoint many women. "It's going to defer the passage of silicone implants for several years," he said.

Cancer survivors have lobbied hard for wider access to silicone implants, saying that too many women are not able to get them after mastectomies. "The breast cancer patient has so many traumas," said Kay Wissmann, a breast cancer survivor and advocate with the Y-Me National Breast Cancer Organization. "This is not a trauma that they should have to face."

But Dr. Sidney Wolfe, director of the health arm of Public Citizen, a consumer group that petitioned the FDA in 1988 to ban the implants, said the action would protect women.

"It would have been the most defective, dangerous device ever approved by the FDA," he said. "Even though saline implants rupture, as well, what comes out in the body is salt water, as opposed to silicone gel, a highly reactive foreign substance that causes scar tissue."

Christopher Rowland of the Globe staff contributed to this report. Alice Dembner can be reached at Dembner@globe.com.