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Fda Rescinds 14-year Ban On Silicone Implants

Offering `reasonable assurance' to their safety, the agency advises MRI tests.

Critic: `Buyer Beware'

November 18, 2006|Ricardo Alonso-Zaldivar and Daniel Costello | Times Staff Writers

WASHINGTON — The government on Friday rescinded a 14-year ban on silicone gel implants for cosmetic breast enhancement, a decision praised by some for providing women with a better product but criticized by others who still question their safety.

Approval by the Food and Drug Administration had been expected, with silicone implants available in most other countries, where they have quickly replaced the saline-filled alternatives. But the approval came with conditions and warnings.

After rigorous review, the FDA can offer a "reasonable assurance" that silicone implants are "safe and effective," said Donna-Bea Tillman, director of the FDA Office of Device Evaluation.

But she 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.

"Women [who get implants] will probably have to have additional breast implant surgery at least once," Tillman cautioned.

Silicone implants are regarded as having a more natural look and feel than saline-filled ones, but until now access to them in this country has been largely limited to women undergoing breast reconstruction because of cancer or other medical problems.

The agency approved silicone implants for cosmetic surgery in women 22 and older, and for reconstructive surgery in women of all ages. The age restriction for cosmetic surgery is so teenage girls will not get the implants until their bodies have fully developed, said Dr. Daniel Schultz, director of the FDA Center for Devices and Radiological Health.

Sales of breast implants -- mainly silicone ones -- reached $540 million worldwide last year. In the United States, more than 290,000 women had cosmetic breast enhancement surgery, nearly all with saline implants, in procedures that cost from $6,000 to $10,000, excluding expenses for follow-up care. Once within reach only of the wealthy, cosmetic enhancement is now increasingly popular among middle-class women, even though it is not covered by health insurance.

"I've been in practice for 28 years, and this is wonderful news," said Dr. Elizabeth Morgan, a Beverly Hills plastic surgeon. "The old silicone implants were often defective. They would leak," she said. "But they have made the shells better and thicker, and they don't release the gels like they once did."

Some women have been postponing breast enhancement surgery in anticipation of the announcement, Morgan said, adding that she expected to see an increase in patients as early as next week.

Concern about the health consequences of leaking implants prompted the FDA in 1992 to ban their use in cosmetic procedures. However, the implants remained available for cancer survivors, partly because doctors and patients insisted on it.

Studies have found no association between silicone implants and cancer or other life-threatening diseases, although the FDA said Friday that it will continue to monitor for any such risk.

The agency's approval is expected to be a boon to two Santa Barbara manufacturers, Mentor Corp. and Inamed Corp., acquired earlier this year by Irvine-based Allergan Inc. The two companies dominate the silicone implant market, which is roughly split between the two. Silicone implants sell for about $1,800 a pair, or roughly double the price of saline-filled ones. And double-digit sales increases are expected.

American "women now have the same options as women around the world have," said F. Michael Ball, Allergan's president. "This is arguably one of the most studied medical products, and it's clearly safe."

Joshua H. Levine, Mentor's president and CEO, said: "A lot of science exists behind these products, and we feel strongly about their safety and efficacy."

But Susan F. Wood, former head of the FDA's Office of Women's Health, said the long-term safety of silicone breast implants remained largely unproven. She noted that as a condition of approval the FDA required the manufacturers to conduct 10-year studies involving 40,000 women each to monitor for such possible consequences as cancer, connective tissue disease, problems with breastfeeding and even suicide.

"The fact that so many studies are being required seems to demonstrate that the data is limited," Wood said.

On Capitol Hill, several prominent female lawmakers expressed doubts about the decision. Rep. Rosa DeLauro (D-Conn.), said she may hold hearings into the decision next year. "This appears to be yet another example of the FDA dismissing scientific evidence in order to appease corporate interests," said DeLauro, who is in line to chair the panel that controls the FDA's purse strings.

Complications from implant surgery are generally more common among women who have had breast reconstruction as opposed to cosmetic enhancement. But neither type of procedure is risk-free.

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