The Food and Drug Administration (FDA) ended its 14-year ban on the cosmetic use of silicone-gel breast implants Friday, despite lingering...
WASHINGTON — The Food and Drug Administration (FDA) ended its 14-year ban on the cosmetic use of silicone-gel breast implants Friday, despite lingering safety concerns from some health advocates.
Approval had been expected, as silicone implants are available in most other countries, where they have quickly replaced the saline-filled alternatives. But it came with conditions and warnings.
The FDA is requiring that manufacturers tell women the implants “are not lifetime devices” and most will need at least one additional surgery to remove or replace any implants they receive.
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Donna-Bea Tillman, director of the FDA office that evaluates medical devices, emphasized that the implants are subject to breakdown within the body, and that the surgery itself can cause complications, including painful contracture of the breasts, the shrinkage of scar tissue that forms around implant shells.
The agency also is requiring the makers, Mentor and Allergan, to conduct an extensive study of at least 40,000 implant recipients over the next 10 years and supply the findings to the government.
More than 264,000 women had breast implants last year with saltwater-filled devices, whose availability was never limited. Medical experts predict that Friday’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 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 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, was pushed into bankruptcy because of lawsuits stemming from the devices.
Michael Ball, president of Allergan, said, “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.
Diana Zuckerman, president of the National Research Center for Women & Families, said the approval was the product of corporate lobbying rather than good science.
Zuckerman, a former Capitol Hill staff member 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 Schultz, director of the FDA’s center for devices and radiological health.
The National Academy of Science’s Institute of Medicine reviewed many studies and concluded 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 device. Among 344 who underwent MRI scans to examine the state of their implants, 69 percent experienced rupture of at least one.
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 placed. 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 for the initial surgery and for regular MRI screenings to ensure that the devices aren’t leaking, as well as replacement surgery when they have reached their life span.
Staff researcher Madonna Lebling contributed to this report.
Material from the Los Angeles Times is included in this report.