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By Avram Goldstein and Justin Blum

Nov. 17 (Bloomberg) -- Silicone breast implants, made by Allergan Inc. and Mentor Corp., will again be sold for cosmetic use in the U.S., after regulators ended sales restrictions imposed 14 years ago for safety reasons.

The Food and Drug Administration today ended restrictions that had limited the products to reconstructive surgery and clinical trials. Silicone was the target of breast-implant litigation that cost Dow Corning Corp. $3.2 billion. The FDA said it will require makers to track patients for 10 years.

The FDA action, which may not end controversy over the devices, clears the way for U.S. sales of the implants to more than double in the next few years, analysts said. Women seeking implants will now have a choice of gels that feel more like natural tissue than saline-filled devices, so elective surgery may boom. Critics still object to the quality of the data the FDA used to decide whether to lift the restrictions.

The FDA ``has been very cautious about silicone gel breast implants for the 15 years that the companies have been trying to get approval,'' said Diana Zuckerman, president of the National Research Center for Women & Families, a Washington-based nonprofit. ``It's shocking that at a time when FDA is under such fire they would throw caution to the winds.''

Allergan shares rose $5.50, or 4.9 percent, to $118 in after-hours trading after the announcement, above the stock's all-time high of $117.99, set March 20. Mentor rose $5.17, or 11 percent, to $52.75.

`Not Lifetime Devices'

The FDA said in a conference call with reporters after the announcement that the implants are ``not lifetime devices'' and women getting the implants will probably need at least one additional surgery in their lifetimes.

``This appears to be yet another example of the FDA dismissing scientific evidence in order to appease corporate interests,'' said U.S. Representative Rosa DeLauro, Democrat of Connecticut, the top Democrat on the House Appropriations subcommittee in charge of the FDA budget.

She cited the allegations made by Public Citizen that one of the manufacturers failed to provide important safety information to the agency.

Silicone gel implants, like others filled with saline, are used to enlarge breasts for reconstruction after breast cancer surgery and for cosmetic reasons. Allergan, based in Irvine, California, and Mentor, based in Santa Barbara, California, say the silicone implants have a texture similar to breast tissue.

Risks Remain

The implants still come with risks of serious localized health complications, the FDA said.

Among the risks are hardening of the breast tissue, pain, shape and position change, lost sensation, infection, calcium deposits, muscle pain, fatigue and the likelihood of follow-up surgeries. The FDA didn't link the implants to connective-tissue diseases, as did allegations against Dow Corning.

Allergan and Mentor will sell silicone implants in the U.S. for about $600 each, about twice the price of saline implants, said Peter Bye, an analyst with Wachovia Securities in New York, in an interview before the FDA announcement. He estimated that the U.S. market for saline and silicone implants will grow to $542 million in 2009 from $215 million in 2005.

The FDA action ``essentially doubles Mentor's core earnings power,'' while making less difference to the larger and more diversified Allergan, Bye said. Mentor makes plastic surgery devices, and Allergan sells Botox anti-wrinkle injections, eye care products and skin treatments.

Mentor reported net income of $62.4 million on sales of $268.3 million for the fiscal year ended March 31. Allergan reported 2005 net income of $403.9 million on sales of $2.32 billion.

The FDA has allowed Mentor and Allergan's Inamed unit to sell silicone implants for women who lose breasts to cancer or have deformities. The sales were intended for research, known as adjunct studies. Reconstructive surgery for those women generally has been paid for by health plans. Cosmetic implant costs are paid fully by the patient.

``Silicone gel breast implants are the most defective medical device ever approved by the FDA,'' said Sidney Wolfe, director of the Health Research Group of Public Citizen, a consumer safety group. ``The approval makes a mockery of the legal standard that requires `reasonable assurance of safety.'''

Some members of Congress and consumer groups have criticized the agency over matters including its handling of Vioxx, a painkiller pulled from the market after being linked to heart attacks.

About 290,000 women received cosmetic implants in 2005, a 37 percent increase in a five-year period, according to the American Society of Plastic Surgeons, based in Arlington Heights, Illinois. The increase coincided with the proliferation of ``reality'' programs featuring the procedure on television, encouraging more teenagers to seek implants.

Last year, 58,000 women had breast reconstruction after mastectomies, the society said. During the same time, 25,000 women with cosmetic implants and 15,000 women with reconstruction implants had them surgically removed.

In 1999, the Institute of Medicine, a Washington-based group that provides policy advice to the federal government, reported that breast implants can't be linked to systemic diseases such as cancer and rheumatoid arthritis.

Stuart Bondurant, chairman of the Institute of Medicine panel and former medical dean at the University of North Carolina at Chapel Hill, said whether to permit sales of the implants has been ``a highly contentious issue with strong feelings on all sides.''

The emotionalism ``necessarily delays the resolution regardless of the state of the evidence,'' Bondurant said in an interview before the U.S. ruling.

An FDA medical advisory panel voted 5-4 against the Allergan application last year because it was troubled by the absence of long-term use data. Mentor's silicone implant was approved 7-2.

The companies lost track of most of the patients in the adjunct studies, and FDA staff last year said the research was of little or no value in determining a key safety question.

Silicone breast implants, which have a rubber shell filled with silicone gel, were already being sold in the U.S. in 1976 when Congress gave the FDA authority to regulate medical devices.

In 1998, Midland, Michigan-based Dow Corning agreed to pay as much as $3.2 billion over 16 years to settle claims of more than 300,000 women who said they were harmed by breast implants that ruptured with age and leaked silicone.

The settlement was for claimants with connective-tissue and auto-immune diseases believed linked to the implants, although there was still debate over whether silicone actually causes those conditions, according to the Web site of Leigh Day & Co., a London law firm with some clients in the litigation.

Dow Corning made breast implants and supplied silicone to other makers of the devices. The company is owned jointly by Dow Chemical Co. and Corning Inc.

To contact the reporters on this story: Avram Goldstein in Washington at agoldstein1@bloomberg.net ; Justin Blum in Washington at jblum4@bloomberg.net