FDA Ends Ban on Silicone Implants
Safety Concerns Led to '92 Moratorium


By David Brown and Christopher Lee
Saturday, November 18, 2006, page 1


The Food and Drug Administration ended its 14-year ban on the cosmetic use of silicone breast implants yesterday, despite lingering safety concerns from some health advocates.

The FDA is requiring that manufacturers tell women that the implants "are not lifetime devices" and that most recipients will need at least one additional surgery to remove or replace their implants. The agency is requiring the makers, Mentor Corp. and Allergan Inc., to conduct an extensive study of at least 40,000 implant recipients over the next decade and provide their findings to the government.

More than 264,000 women had breast implant surgery last year with saltwater-filled devices, whose availability was never limited. Medical experts predict that yesterday's approval will increase that number because silicone-gel implants, which are considered more natural and appealing, will prove popular. The FDA is allowing the devices for breast augmentation for women who are least 22 years old and for all breast-reconstruction patients.

Silicone implants were first marketed more than 30 years ago, but a moratorium was placed on them in 1992 after many women who had received them reported pain, deformity and serious illness caused when the implants ruptured or leaked. At the time, the FDA concluded there was "inadequate information to demonstrate that breast implants were safe and effective." A major implant manufacturer, Dow Corning Corp., was pushed into bankruptcy because of lawsuits stemming from the problematic devices.

Michael Ball, president of Allergan, said that "science has prevailed here" and added: "The FDA set an extremely high bar for approval. . . . There's a huge body of scientific data there."

He said the worldwide market for breast implants is $540 million annually and has grown less than 10 percent a year, but he expects double-digit growth now.

Critics were disappointed by the FDA's decision, which had been expected for months.

Diana Zuckerman, president of the National Research Center for Women and Families, said the approval was the product of corporate lobbying rather than good science.

Zuckerman, a former Capitol Hill staffer who has worked on breast implant safety issues for more than 15 years, said too little is known about the long-term health risks of the implants. She said what is known indicates that some women will experience joint pain, chronic fatigue and leakage.

In recent years, the FDA has allowed silicone implants only for women whose breasts were reconstructed after cancer or trauma. At the same time, the FDA, the manufacturers and many academic researchers gathered data on the devices.

"The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices," said Daniel G. Schultz, director of the FDA's center for devices and radiological health.

The National Academy of Sciences' Institute of Medicine reviewed many studies and concluded that there was no convincing evidence that leaking silicone led to autoimmune diseases or cancer, as some researchers had feared. But less severe complications were common.

For example, in a study of 907 Alabama women with silicone implants, one-third reported they had at least one operation to remove or replace the devices. Among 344 who underwent MRI scans to examine the state of their implants, 69 percent experienced rupture of at least one implant.

"Women deciding to have these implants need to be prepared to have additional surgery. That is a key point we want to transmit," Schultz said yesterday.

A spokesman for Mentor said the company will replace all leaking or ruptured implants, which cost $800 to $950 each. It will also defray $1,200 of the cost of a repeat operation in the five years after an implant is put in. The surgery itself costs about $8,000.

Critics noted that health insurers are unlikely to pay for breast implants for cosmetic reasons, leaving women to pay tens of thousands of dollars not only for the initial surgery but also for regular MRI screenings to ensure that the devices aren't leaking and for replacement surgery when they have reached their life span.

Susan F. Wood, who served five years as the FDA's top official for women's health, said she was disappointed by the approval because she does not believe there is enough data to demonstrate that the implants are safe. She said it is crucial that the FDA require the companies to carry out the planned long-term studies of the implants.

"Given that the approval has gone through, we have to insist on getting adequate information for both patients and surgeons so that we ultimately will know whether or not these are products that women should be using," said Wood, now a research professor at George Washington University's School of Public Health and Health Services.

Staff researcher Madonna Lebling contributed to this report.