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 a ban that had limited the products to reconstructive surgery and clinical trials. The FDA said the companies' implants can be used in women 22 and older for cosmetic augmentation and that safety studies will continue.

Women seeking implants now have a choice of gels that feel more like natural tissue than the saline-filled devices that remained on the market. U.S. implant sales may more than double in the next few years, analysts said. Critics object to the quality of the data the FDA used to decide to lift the ban.

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, in an interview. ``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 previous high of $117.99, set March 20. Mentor rose $5.17, or 11 percent, to $52.75.

Silicone Leakage

The FDA stopped allowing silicone implants for cosmetic use in 1992 after reports that women were injured by leakage. 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 FDA approved the implants after carefully reviewing safety data over the past decade, said Daniel Schultz, who heads the FDA's medical device division.

``From a scientific standpoint, the decision we're making tonight is in fact in the best interest of American women,'' Schultz told reporters on a conference call.

Women getting the implants probably will need at least one additional surgery in their lifetime, Schultz said.

The FDA decided to limit cosmetic sales to women 22 and older to ``make sure that breast development had been completed before these devices are implanted'' and ``to make sure that there was actually data on the augmentation patients in the age groups in which it was being approved,'' Schultz said.

There are no restrictions on sales for reconstructive purposes, such as after a mastectomy.

`Real Science'

``When all the dust settled, the real science said, there doesn't appear to be a lot of risk here,'' said Thomas Gunderson, an analyst with Piper Jaffray & Co. in Minneapolis, in an interview. ``It does take some risk out of the investor's risk- reward equation.''

As a condition of the implants' approval, each company agreed to conduct a study a study tracking 40,000 women for 10 years after receiving silicone implants, according to the FDA. The companies also must continue lab studies on implant failures.

U.S. Representative Rosa DeLauro, a Democrat from Connecticut, called the FDA's decision ``very disturbing'' because of safety concerns.

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

`Most Defective Product'

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

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

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.

The implants come with risks. Complications can include hardening of the breast tissue, pain, shape and position change, lost sensation, infection, calcium deposits, muscle pain and fatigue. The FDA didn't link the implants to connective-tissue diseases, as did allegations against Dow Corning.

Sales Forecast

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.

``It's definitely a very good thing for the industry as a whole because it offers more options,'' said Jose Haresco, an analyst with Merriman Curhan Ford & Co., in San Francisco, in an interview. ``This isn't a slam dunk,'' he added. ``There are still a lot of undetermined risks with these products.''

Haresco said he expects worldwide sales of about $650 million next year for Allergan and Mentor combined, up from about $550 million this year.

Allowing implant sales is ``very good news for the doctors and the patients,'' said Scott L. Spear, chief of plastic surgery at Georgetown University Medical Center in Washington and a consultant to Allergan, in an interview before the decision.

Increase in Surgeries

About 290,000 women received cosmetic implants in 2005, a 37 percent increase in five years, 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 women to seek implants.

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

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.

The Dow Corning settlement involved patients with connective-tissue and auto-immune diseases believed linked to the implants, although debate remained 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

Last Updated: November 17, 2006 20:39 EST