Silicone implants may return to market

WASHINGTON, Oct. 9 (UPI) -- The Food and Drug Administration's plans to hold hearings next week to determine whether to lift restrictions on the sale of silicone gel breast implants for a California manufacturer has women's advocacy groups up in arms, but the opposition is not likely to prevail, experts say.

An FDA advisory panel will meet next Tuesday and Wednesday to discuss an application from INAMED Corporation, a Santa Barbara company specializing in products such as breast implants and facial aesthetics. INAMED has asked the agency to remove its current ban on the commercial sale of silicone gel breast implants for augmentation or cosmetic purposes.

Silicone gel implants currently are available only through clinical trials for augmentation or reconstructive surgery, such as for patients who have undergone mastectomies for breast cancer.

Several companies stopped selling the devices and lawsuits sprang up after numerous women claimed silicone gel breast implants had caused them injury and illness. Some reports had linked silicone implants to an increased risk of breast cancer and autism disorders, for example. However, many experts now say current research has found no evidence to support such claims.

Joann Kuhne, senior director for regulatory and clinical affairs for INAMED, said the evidence supporting the long-term safety of silicone gel breast implants already exists.

"Breast implants have been on the market for decades both in the United States as well as outside the United States," Kuhne told United Press International. "We've sold these breast implants to approximately 60 countries outside the United States and have been selling them for about 30 years."

Kuhne said the company has submitted its most recent clinical data on silicone implants to the FDA. "The FDA sets very high standards for devices and what companies have to comply with," she said. "The two-to-three years of data is a standard amount of time period for any product that goes through the FDA process."

INAMED stopped selling silicone implants for augmentation in 1997, but the devices were available for reconstructive needs via clinical research, Kuhne explained.

The company would not disclose its sales revenues from implants, nor from any other specific medical device, but an INAMED spokesman told UPI the company sells about $300 million a year in medical devices or products worldwide.

Should the FDA approve lifting the ban, it could pave the way for other health care companies waiting in the wings. For example, Mentor Corp., also of Santa Barbara, will be submitting its clinical data on silicone gel breast implants to the agency in December.

"We believe after careful and thorough review, the FDA will eventually approve the silicone gel implants, but we can't predict when that will happen," a company spokeswoman told UPI.

If FDA removes the restriction, companies that resume selling silicone gel breast implants could stand to make strong sales, explained David Bernstein, a professor at George Mason University Law School in Arlington, Va., who specializes in product liability and has published papers on the breast implant issue.

"There is a money-making opportunity for a company that can get FDA approval," Bernstein told UPI. The market will not be as flooded this time because fewer companies will be selling the implants. Several manufacturers bowed out after getting tangled in costly lawsuits, he said. "Dow Corning had to pay out billions of dollars for a product that all the evidence showed was ultimately safe. The safety concerns raised about it were all false, so you can't really blame them for being really leery about it."

Kevin Wiggins, spokesman and global manager of external relations for Dow Corning in Midland, Mich., said the company would not resume selling silicone gel breast implants even if other companies get the green light from the federal government.

"Oh, definitely not," Wiggins told UPI. "It wasn't a core business for Dow Corning. We've put this controversy behind us."

Despite the legal and financial imbroglio, Wiggins said, the company stands behind a product he says has strong scientific support. "The science is very definitive," he added.

The science remains the sticky issue for women's groups. Martha Burk, chair of the National Council of Women's Organizations in Washington, said the FDA will be examining clinical data that cover only two-to-three years after a woman has undergone implants. Burk argues that is not enough time to determine the long-term health consequences.

"The scientific evidence is clearly lacking," Burk told UPI. "The anecdotal evidence is overwhelmingly on the side of not approving these implants. Americans depend on the FDA to safeguard their health." An approval, she said, "will give women a false sense of security."

Burk charged the FDA with caving in to corporate influences.

"This is just another example how another regulatory agency has been captured by those it was chartered to regulate," she said. "It's a very disturbing trend in government. I think it's something particularly women voters will be paying attention to in next year's elections."

Burk was joined Wednesday by Kim Gandy, president of the National Organization of Women, at a rally by women's groups against the FDA's consideration.

"There's no question the FDA seems to be responding in an unprecedented way to pressure from the implant industry and the plastic surgery industry," Gandy told UPI. "It's like Halliburton started making implants," she said, referring to the international corporation formerly run by Vice President Richard Cheney. "Corporate interests are being treated, if not more important, then equally important with health interests," she commented. "The FDA is looking at far too little data."

Dr. Elizabeth Connell, professor emeritus of the department of obstetrics and gynecology at Emory University in Atlanta, who chaired the FDA advisory panel hearings on silicone gel breast implants in 1991 and 1992, said the latest scientific evidence supporting the safety of these products is overwhelming.

The advisory panel will not just be looking solely at NAMED's data next week, Connell explained, but also clinical data from scientists around the world. "Twelve years have gone by and we have excellent researchers addressing this," Connell told UPI. "The bottom line has been there's no danger."

The demand for silicone gel breast implants is high, Connell explained, because the alternative currently being used, saline implants, are not as desirable among both physicians and patients. "The saline ones if they rupture, the whole thing just disappears," she said. "They don't feel like natural breast tissue and the silicone ones are preferred by most people because they do feel like natural breast tissue. They don't slosh around like a bag of water, which the other ones are."

Even lawyers are convinced science favors the use of silicone gel implants, Bernstein said, so there is less fear from companies of potential lawsuits should restrictions be abolished.

"Most lawyers wouldn't go anywhere near those cases now because the evidence is just too strongly established on the other side," he said. A decade ago, when women were suing over silicone implants, "the science was immature." Now, he added, "the scientific evidence on implants is sufficiently strong. Juries will be a lot more skeptical."