FDA RESCINDS 14-YEAR BAN ON SILICONE IMPLANTS
The government on Friday rescinded a 14-year ban on silicone gel implants for cosmetic breast enhancement, a decision praised by some for providing women with a better product but criticized by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.
One possible problem is that silicone implants are prone to so-called silent ruptures, leaks that cannot be detected visually or by touch. As a result, the FDA recommended follow-up screening by magnetic resonance imaging -- MRI exams -- three years after the operation and every two years thereafter.
“If implant failure is noted, women should have it removed or replaced,” Schultz said.
Some experts are concerned that leaking silicone could prompt symptoms of chronic fatigue syndrome.
Schultz said the FDA would enforce a host of conditions on the manufacturers, including continuation of the original clinical studies that led to the approval of implants, convening focus groups to make sure patients understand the risks and benefits, lab tests to better understand how implants fail, and electronic tracking of implants.
Opponents of the FDA’s decision said some groups were considering litigation, but courts traditionally have deferred to the agency’s judgment in such matters. Most lawsuits over the earlier generation of breast implants have been settled.
“The message to women is let the buyer beware,” said Diana M. Zuckerman, president of the National Research Center for Women & Families, an advocacy group that opposed the decision. “Please understand that the FDA has not concluded that breast implants are safe, they have only concluded that they are ‘reasonably safe,’ and that’s not much assurance.”
Alonso-Zaldivar reported from Washington and Costello from Los Angeles.
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History of the ban
Jan. 1992: The Food and Drug Administration calls for a temporary halt to the sale and use of silicone gel breast implants while it evaluates their safety.
March 1992: Dow Corning Inc., the leading maker of silicone implants, ends production.
April 1992: The FDA severely restricts use of the silicone implants for cosmetic purposes but allows them to be used for reconstructive surgery.
March 1994: Dow Corning, Baxter International and Bristol-Myers Squibb sign a $3.75-billion settlement with lawyers representing thousands of women who contend they were seriously injured by silicone gel breast implants. It is the largest settlement of a product liability case in U.S. history.
May 1995: Dow Corning seeks federal bankruptcy protection, jeopardizing the settlement.
Nov. 1998: Dow Corning agrees to pay $3.2 billion to settle claims by more than 170,000 women who say the implants harmed their health.
Dec. 1998: A U.S. District-Court-appointed committee of scientists concludes there is no credible evidence that silicone implants cause disease.
June 1999: An independent scientific panel reports that silicone gel breast implants appear not to cause chronic disease.
Jan. 2004: The FDA, rejecting the recommendation of an advisory panel, refuses to lift its restrictions on the use of silicone gel breast implants, saying more research is necessary.
April 2005: An FDA advisory panel recommends that silicone implants made by Mentor Corp. be approved for cosmetic use, but advises against approval of those made by Inamed Corp.
July 2005: FDA gives Mentor tentative approval, subject to conditions, to sell implants for cosmetic breast enhancement.
Sept. 21, 2005: Inamed announces the FDA has given it tentative approval, subject to conditions, to sell implants for cosmetic use.
Nov. 17, 2006: The FDA rescinds a 14-year ban on silicone gel implants for cosmetic use.
Source: Times reporting