Healthy Skepticism Library item: 957

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Publication type: news

Mathews AW.
FDA Panel Backs Implant Restrictions
The Wall Street Journal 2005 Apr 13

Full text:

A Food and Drug Administration advisory committee voted 5-4 to retain tight restrictions on sales of silicone breast implants, saying there wasn’t enough long-term safety data to end the ban that has lasted for more than a decade.

Coming after the FDA’s 2004 rejection of the same Inamed Corp. implants that the panel considered yesterday, the narrow vote signals the current generation of silicone breast implants isn’t likely to return to widespread use anytime soon — despite years of litigation and studies that have failed to prove a link between the devices and systemic illnesses such as cancer.

Today, the panel is set to vote on silicone implants made by another company, Mentor Corp. But according to an FDA review, Mentor’s major study has about a year less safety data than the Inamed study, so panel members are likely to have the same questions.

SILICONE STORY • See major developments in regulation of silicone-gel breast implants. The devices, which have long presented an emotionally and politically charged issue, may face a particularly tough path because the FDA is under close scrutiny for its handling of safety matters. Over the last few months, the agency has taken several aggressive, public actions to respond to risks tied to drugs.

Dan Cohen, vice president of global government and corporate affairs for Inamed, said the company was “disappointed in the decision of the panel,” but plans to “continue to work with the FDA to get this into approvable form.” He said Inamed believes its data is “very strong.” He said the vote won’t affect the planned acquisition of Inamed, of Santa Barbara, Calif., by Medicis Pharmaceutical Corp., of Scottsdale, Ariz.

In 2003, the same advisory committee, though with several different members, recommended that the FDA approve the Inamed implants. But the FDA, which typically follows the advice of its committees, ended up rejecting the implants, and last year unveiled guidelines with tougher requirements for trials of the devices.

Thirteen years ago, the FDA effectively banned silicone implants from use in cosmetic augmentations after some women alleged that they caused serious medical problems, ranging from connective-tissue disorders, such as lupus, to cancer. Since then, research has failed to confirm such a tie, but there are still concerns about other possible effects of leaky implants.

Several panel members said they didn’t have enough information to feel confident that the silicone implants would be safe over the decades patients might have them in their bodies. Amy Newburger, a dermatologist in Scarsdale, N.Y., said she wasn’t “secure about the safety” of the implants and didn’t “feel at this point that patients can give informed consent,” since they didn’t have a full picture of the side effects. Stephen Li, the president of a medical-device testing company in Sarasota, Fla., said the implants were more likely to have problems as they got older: “It just makes sense that the longer something goes on, the more failures you’re going to get.”

Many committee members expressed strong reservations, particularly, about one of the Inamed implants, model 153, which appeared to rupture at higher rates. “I have very significant concerns” about that model, said Joseph LoCicero, a professor of surgery at the University of South Alabama. Inamed said it already planned design changes to model 153.

But other panel members argued that there was enough information about the possible risks of all of the Inamed silicone implants to justify making them available, so doctors and patients could make their own choices. “It’s a very individualized thing,” said Michael Miller, a plastic surgeon at the University of Texas’s Anderson Cancer Center. Patients with a favorable risk-benefit profile “should be allowed to have the device,” he said.

Much of the scientific discussion before the panel centered on the long-term projections for how likely the silicone implants were to rupture, and what would happen if they leaked. Inamed officials told the panel that they believed the rupture rate was low — about 2.5% of the devices after three years in their major study, with a projection that after 10 years, about 14% would have ruptures. The company also said that the single biggest cause of problems in the ruptured implants it reviewed was damage due to the surgical procedure itself.

But FDA reviewers questioned the company’s projections, arguing that it was difficult to know what would happen to the rupture rate over time. The agency offered three different potential analyses, with rupture rates of 21%, 43% and 77% after 10 years. “It is difficult to reasonably predict the probability of rupture by year 10,” said Pablo Bonangelino, an FDA reviewer.

The agency also said there wasn’t enough data in the main study to fully answer other questions about ruptures’ long-term effects.