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NBC, MSNBC and news services

Updated: 9:01 p.m. ET Nov 17, 2006

WASHINGTON - Though "reasonably safe," silicone-gel breast implants won’t last a lifetime and women who get them probably will need surgery again, the government warned as it ended a 14-year virtual ban on what arguably are the nation’s most controversial medical devices.

Women must undergo repeated, costly MRI exams to check for broken, oozing implants and understand that there are other irreversible side effects, the Food and Drug Administration said Friday.

"Many of the changes to your breasts following implantation cannot be undone," warns the FDA’s special brochure that women are supposed to be given before undergoing the operation.

Still, the agency cleared manufacturers Mentor Corp. and Inamed Corp. — now part of Allergan Inc. — to start selling the implants again, more than a decade after the devices were yanked off the market for fears that they could cause myriad diseases.

The FDA approved the silicone-gel implants for women 22 and older, or those undergoing breast reconstruction surgery. The age minimum is because most women’s breasts have not fully developed before that age.

"There is reasonable assurance that Allergan and Mentor silicone-gel breast implants are safe and effective and there is adequate information to enable women to make informed decisions," said Dr. Daniel Schultz, FDA’s medical device chief.

Mentor called the decision a "historic moment." Allergan said it created new options for women.

However, Dr. Sidney Wolfe, a consumer activist and longtime opponent, called the implants "the most defective medical device FDA has ever approved." And a lawmaker called on Congress to investigate the FDA’s approval process.

The approvals came with conditions, including a requirement that the companies complete 10-year studies on women who have received the implants to study leaks. Companies are also required to begin new decade-long studies of the safety of the devices in 40,000 women.

Schultz called the implants "one of the most extensively studied medical devices."

The FDA warned that the implants are not without risk and that women may not immediately know if their implants break. That means women with the implants will need to undergo regular MRIs to catch those so-called "silent ruptures." Such MRIs typically cost several hundred dollars — a cost not always covered by insurance.

The FDA decision opens the implants to much wider use by women seeking to reconstruct or augment their breasts. Since 1992, the silicone implants had been available only as part of research studies.

Silicone-gel breast implants first went on the market in 1962, before the FDA required proof that all medical devices be safe and effective. Thirty years later, they were banned amid concerns about their safety.

At the time, there were fears about a possible connection to a variety of diseases, including cancer, lupus, arthritis and other so-called autoimmune diseases. Alarming cases of ruptures added to the concern.

Since then, most studies have failed to find a link between silicone breast implants and disease.

"There is no association between silicone breast implants and those type of diseases," says Dr. Sherine Gabriel, an epidemiologist and arthritis researcher with the Mayo Clinic. "So the scientific evidence on this point has been negative and quite consistent."

The rupture issue persists. An Institute of Medicine report in 2000 found rupture rates as high as 77 percent. The FDA’s Dr. Donna-Bea Tillman said women should expect them to last for the "reasonably foreseeable future," without elaborating.

Rep. Rosa DeLauro, D-Conn., called on Congress to investigate the FDA’s decision-making process to make sure it is "based on science and not on corporate and political considerations."

"From a scientific standpoint, the decision we are making tonight is in the best interests of American women," Schultz responded.

Women whose silicone implants ruptured have reported years of pain, swelling, numbness and other symptoms that they blame on the devices. Leaked silicone gel can migrate throughout the body, forming lumps. Implants also can cause infection and form hard, painful scar tissue that can distort the shape of a breast.

Some researchers also worry that the platinum used to manufacture the implants can seep into the body and cause harm. The FDA says there is no evidence of that.

Many plastic surgeons and their patients say the silicone implants look and feel better than the saline-filled substitutes that took their place. Those implants are sold without restrictions.

"It’s a hugely positive piece of news for plastic surgeons and for patients and for the company — all three — because it really allows us to turn a page and to work with what we have believed for a long time is a better technology and better device," said Dr. Scott Spear, head of plastic surgery at Georgetown University Hospital and an Allergan consultant.

Last year, the FDA told both companies their implants could be approved once they met additional, undisclosed conditions. Federal advisers had narrowly recommended that Inamed’s implants not receive FDA approval, citing concerns about the long-term durability. The same advisers endorsed Mentor’s implants.

In October 2003, FDA advisers had recommended allowing the implants to be sold again. The agency overruled that recommendation.

"We have more information than we had 14 years ago — more information about why these devices are safe and effective, more information about the risks and benefits that we can give to women so they can make informed choices," said Dr. Donna-Bea Tillman, director of the FDA’s Center for Devices and Radiological Health.

Breast implants have become more popular, despite a history of lawsuits. Last year, 291,000 women had their breasts surgically enlarged in the United States, a 37 percent increase since 2000, according to the American Society of Plastic Surgeons.

The popularity of implants for reconstructive surgery shrank over the same five-year period by 29 percent, to 58,000 procedures, according to Society statistics. Last year, 39,000 women had their implants removed.

Overall, the use of breast implants has grown since 1992 despite the FDA’s de facto ban.

Dow Corning Corp., once the major manufacturer of silicone breast and other implants, faced 19,000 lawsuits, pushing it into Chapter 11 in 1995. The company emerged from Chapter 11 in 2004, after setting aside $2.35 billion to settle claims.

Allergan Inc. shares rose $1.76, or 1.6 percent, in trading that was almost double its average volume to close at $112.50 on the New York Stock Exchange. Mentor Corp. shares increased $1.47, or 3.19 percent, also in heavy trading, closing at $47.58.

Nearly 365,000 women received breast implants for cosmetic reasons in the United States in 2005. Seen as an extreme byproduct of a beauty-obsessed culture by some and a valid method of self-enhancement by others, today's implants come out of a hundred-year history of efforts to enlarge the female bosom. Click on the timeline for key events.

Liquid silicone injections appear about the time of World War II among Japanese prostitutes, reportedly in an effort to appeal to American servicemen. The method, often performed by people without medical training using industrial-grade silicone, becomes popular among topless dancers in San Francisco and Las Vegas in the early 1960s. By the mid-'60s, reports of serious complications — including chronic inflammation and tumor-like lumps and infections that can necessitate mastectomy, as well as organ damage resulting from migration of the silicone — push the method out of mainstream medicine.

Houston plastic surgeons Drs. Thomas Cronin and Frank Gerow develop the first silicone breast prosthesis in conjunction with Dow Corning Corp. in 1961. The silicone rubber sac filled with a jelly-like silicone gel is first implanted the following year, and Dow Corning starts marketing the device in 1963. Dozens of improved models, with thinner, seamless sacs and thicker gel are developed over the next 30 years, but the basic design remains the same.

1992 stop to silicone

In response to concerns that silicone breast implants might precipitate autoimmune diseases, FDA commissioner Dr. David Kessler declares a voluntary moratorium on their use in January 1992. A few months later, after manufacturers are unable to prove safety to the government's satisfaction, the agency rules to severely restrict the availability of silicone gel-filled implants. They remain an option only for women who need a replacement for a failed implant or for those who desire reconstruction after cancer or injuries.

Dow Corning, once the biggest maker of silicone breast implants, settles a class action lawsuit brought by 170,000 women for $3.2 billion. The agreement is included in the company's bankruptcy plan.

The Institute of Medicine — the medical arm of the prestigious National Academy of Sciences — issues a 400-page report concluding there is no reason to believe that silicone breast implants cause major illnesses such as rheumatoid arthritis, lupus or other systemic diseases. The main safety concern, the report says, is the implants' tendency to leak or rupture, which can lead to infections, hardening and scarring of breast tissue.

FDA votes to continue its ban on most silicone gel breast implants, saying serious questions remain about how often the devices break apart and the physical damage that can result. The agency outlines new guidelines for all manufacturers on the scientific issues that must be settled if the devices ever are to return to the market.

The FDA lifs a 14-year virtual ban on silicone-gel breast implants, despite lingering safety concerns. Recent studies failed to find a link between the implants and diseases such as cancer and lupus, which had earlier been tentatively connected to them. Concerns about the silicone implants rupturing remain, however, and the FDA says eventually they must be removed or replaced. Proponents of the implants say silicone looks and feels more real than saline.