FDA ends ban on silicone implants

U.S. officials still urge screening for any breaks and eventual removal

November 18, 2006|By Jonathan D. Rockoff | Jonathan D. Rockoff,sun reporter

WASHINGTON -- Federal regulators lifted their 14-year ban on breast implants made from silicone gel yesterday, dismissing concerns about harmful effects from leaks as unsupported by extensive testing.

Officials at the Food and Drug Administration urged women who get the implants to undergo regular screenings to detect ruptures, and said to expect at least one surgery to remove or replace them.

The agency is requiring the two California companies that make the devices, Mentor Corp. of Santa Barbara and Allergan Inc. of Irvine, to continue studying the implants' long-term health effects.

Nonetheless, the officials said their review of study results made it clear that women age 22 and older can safely get the implants for cosmetic purposes. Women of all ages can have the implants for medical reasons, including reconstruction of breasts removed for cancer.

"From a scientific standpoint, the decision we are making tonight is in the best interest of American women," Dr. Daniel Schultz, director of the FDA office that regulates medical devices, said during a late-day conference call.

The FDA had banned silicone gel implants for cosmetic use in 1992, amid worries that the devices were rupturing and the leaking silicone contributed to lupus, multiple sclerosis and other serious diseases.

Since then, most women have been left to use those filled with saline, which is less popular than silicone because it doesn't feel as much like natural breast tissue. Almost 300,000 women had implants last year.

Most doctors and scientists, meantime, concluded there wasn't evidence to support the safety concerns, and they, too, had been waiting for the FDA to allow resumption of sales.

"We've been wondering what's been taking them so long," said Dr. Sheri Slezak, an associate professor of plastic surgery at the University of Maryland.

Doctors emphasized that silicone gel implants can rupture or cause scarring but praised the FDA for giving women the opportunity to make an informed decision after weighing the risks.

"Patients will be happy because it means they have a choice," said Dr. Gedge Rosson, an assistant professor of plastic surgery at the Johns Hopkins University School of Medicine. He said patients have a "clear preference" for silicone gel.

Despite the support of most medical authorities, the approval came under attack from Democrats in Congress and liberal groups, who accused the FDA of giving in to corporate pressure.

"When Congress reconvenes next session, it must examine the agency's approval process and ensure that the FDA makes decisions based on science and not on corporate and political considerations," said Rep. Rosa DeLauro of Connecticut.

Liberal groups said the FDA didn't collect enough information from the implant manufacturers to make a safety determination. "To the extent we have data, it's not very strong," said Amy Allina, program director of the National Women's Health Network.

Diana Zuckerman, president of the National Research Center for Women and Families, said the combination of known and unknown risks made the implants more dangerous than skydiving.

But FDA officials said their consideration - from analysis of studies of women with the implants to a review of scientific literature on the silicone gel, to inspections of the plants where they will be made - was lengthy and conclusive. They said their decision was based on science alone.

Agency officials stressed that their review will continue, because they are requiring the manufacturers to study their effects on 40,000 women for 10 years after surgery. They are also requiring each company to keep track of all implants sold.

Women should have magnetic resonance imaging three years after surgery and then every two years to look for "silent" ruptures - leaks they could not feel themselves, officials said. They estimated the life span of an implant to be 10 years.

"Women should know breast implants are not lifetime devices," said Schultz.

jonathan.rockoff@baltsun.com

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