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FDA Panel's Breast Implant Ruling Puzzles, Pleases

Debate surrounds decision to choose one product over another

THURSDAY, April 14, 2005 (HealthDayNews) -- A Food and Drug Administration advisory panel recommendation Wednesday that silicone-gel breast implants from one manufacturer, Mentor Corp., be approved for sale in the United States has left some observers stunned and confused, and others pleased.

The recommendation followed by a day the panel's decision not to approve a similar product from another manufacturer, Inamed.

The ruling is the first step to reintroducing silicone breast implants to the U.S. market after a 13-year ban.

"It's a very illogical and conflicting message to the FDA, and a confusing message to women across the country who might have breast implants," said Diana Zuckerman, president of the National Research Center for Women and Families.

Noting that both companies provided different kinds of data, Zuckerman added, "The company that provided more research information was the one that didn't get approved. The company that provided less information got recommended for approval. That sends a really bad message. That's just silly."

But panel member Stephen Li, a Florida medical device-testing expert, explained the two companies' devices are different and Mentor's studies were more thorough, the Associated Press reported.

"We are holding it to higher standards than other implants," he said. "This device [breast implants] has a 30-year history that, at best, is checkered. Given that history, it behooves us to have a higher standard."

A major deciding factor for the panel was the rupture rate of implants from each company. However, the companies didn't present data covering the same period. The statistics presented by Inamed looked at implants over three years; during that time, the rupture rate was highest in the third year. Mentor's data covered only two years, and showed a much lower rupture rate.

Critics of implants have long contended that broken implants allow silicone to seep into a woman's body, creating the potential for serious health problems.

The FDA typically follows the recommendations of its advisory panels. But concerns about rupture rates prompted the full FDA in January 2004 to reject an advisory panel's recommendation to allow the devices back on the market.

Inamed Vice President Dan Cohen said the advisory panel had made "bizarre and strange decisions" this week. Inamed would pursue approval, he told the AP.

Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, said neither product should have gotten the panel's approval. According to Wolfe, while the Mentor implant may have shown less risk of rupture in the first couple of years after insertion, its long-term rupture rate is probably no better than the Inamed implant, which showed a high rupture rate in the third year.

He blamed the advisory panel for not holding the two products to the same standard. "My guess is if they had done the same extrapolations for the Mentor device they would have voted the same way."

"We are the group that asked the FDA to ban silicone-gel breast implants in 1988," Wolfe said. "Now there are studies showing dangers."

Wolfe added that this week's hearings failed to show any significant improvement in quality of life from silicone implants. "If there is no benefit and there are these known risks, rupture and local complications, what's the point of having these things on the market," he said.

Wolfe said he believes the manufacturers are putting pressure on the FDA to approve implants. "Plus, plastic surgeons make a lot of money putting these things in," he said.

Silicone implants have a more natural look and feel, proponents say. "They [plastic surgeons] would rather be putting in the silicone-gel, not the saline ones," Wolfe said.

The American Society of Plastic Surgeons applauded the panel's recommendation. "We are pleased that the panel based its decision on scientific evidence, not on special interests, emotion or anecdotes," Dr. James Wells, the society's past president, said in a prepared statement.

Wolfe believes that ultimate FDA approval is uncertain, however. "It's highly unlikely that they are going to approve both [Mentor and Inamed] of them," he said. "But it's a real dilemma for them if they approve one and not the other."

The advisory panel set certain conditions for ultimate FDA approval, including informed consent forms from patients acknowledging that their implants may break. In addition, Mentor can sell silicone implants only to board-certified plastic surgeons who complete special training to insert implants in a way that minimizes the chance of breakage.

Mentor must also maintain a registry to track how patients do over the long-term, and it must study how often implants rupture within 10 years, something nobody yet knows. The panel also urged women who receive these implants to get regular MRI exams to check for ruptures and leaking silicone.

FDA spokeswomen Kathleen Quinn said the process for acting on the panel's recommendations was just beginning. "Before the FDA can approve these recommendations, the FDA has to review all of the information for both companies," she said. That process will take several months, at least, she added.

Both implants will be considered separately, Quinn said. "It's two different companies. It's two different products. It's two sets of data; each one is independent of the other."

Silicone gel implants entered the U.S. market in 1962, before the FDA monitored safety issues closely. Thirty years later, the agency banned all of these devices except those used for breast cancer reconstruction, citing fears that leaks might be responsible for autoimmune diseases and even cancer. Other concerns included the fact that many women needed repeat operations to deal with painful scar tissue.

By 1998, more than 170,000 lawsuits had been filed against implant manufacturers by women claiming their silicone implants had caused immune system disorders and chronic diseases such as rheumatoid arthritis and systemic lupus. Four companies paid out millions of dollars in settlements to the women, and one of them, Dow Corning, filed for bankruptcy to pay $3.2 billion to settle its claims.

Studies by the Mayo Clinic, Harvard Medical School and the Institute of Medicine (IOM) panel from the National Academy of Sciences subsequently found no evidence that leaked silicone from gel implants caused systemic disease.

More recent research, however, has focused on the problems of scar tissue developing at the site of the implant and on the rate of rupture.

More information

The FDA has more about breast implants.

SOURCES: Sidney M. Wolfe, M.D., director, Public Citizen Health Research Group, Washington, D.C.; Kathleen Quinn, spokeswomen, U.S. Food and Drug Administration, Washington, D.C.; Diana Zuckerman, Ph.D., president National Research Center for Women and Families, Washington, D.C.
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