WEDNESDAY, Nov. 5, 2003 (HealthDayNews) -- The future of two major U.S. health initiatives -- one on silicone gel breast implants and the other on whether cloned animals should be allowed into the food supply -- has been thrown into doubt.
Last week, the U.S. Food and Drug Administration (FDA) released a preliminary document indicating that cloned animals were safe to let into the U.S. food supply. But this week, the FDA's Veterinary Medicine Advisory Committee decided there was simply not enough data to support this conclusion and called for more studies.
Even more startling was the public announcement Tuesday by the chairman of the FDA advisory panel on the silicone gel implants, disagreeing with the panel's support for letting the device back on the market.
"I feel morally compelled -- it sounds corny, but morally compelled -- to do something about it," Dr. Thomas Whalen, chairman of the FDA's General and Plastic Surgery Devices Advisory Panel, told the Associated Press.
Whalen took the highly unusual step of sending a letter sent to FDA Commissioner Mark McClellan and five members of Congress citing his "strong reservations" about the panel's vote and "imploring" the agency not to approve the product.
Silicone gel implants were taken off the market in 1992 amid fears that leaking might be linked to autoimmune diseases and even cancer. Other problems included the fact that many women needed repeat operations to deal with painful scar tissue.
Nevertheless, Inamed Corp. of Santa Barbara, Calif., is seeking approval to start selling the devices again.
Last month, the advisory panel voted 9-6 to allow the devices back on the market, albeit with a series of strict conditions. These included warnings to users and more safety tests.
As panel chairman, Whalen can only cast a vote in the event of a tie.
Calling this a "public health issue of no small import," Whalen, a professor of surgery and pediatrics at Robert Wood Johnson Medical School in New Brunswick, N.J., also said that "long-term safety, the concern that prompted the removal from the market 11 years ago, was clearly not demonstrated and to approve this device poses threats to women that are clearly unknown."
The FDA said it would review all the information it has on the implants, including Whalen's letter, as well as the company's application and the advisory committee decision.
"[The letter] would be another document involved in the process," said FDA spokeswoman Kathleen Quinn. She added the agency "in most cases" follows the recommendations of a committee, but it "depends on the science."
Diana Zuckerman, president of the National Center for Policy Research for Women & Families and an outspoken critic of the implants, called Whalen's action highly unusual.
"I think Dr. Whalen showed a great deal of courage and tenacity in doing this," she added. "I've never heard of this happening before."
Although FDA panels act solely in an advisory capacity, the agency often follows their recommendations.
In this case, however, the vote was already contentious enough that the FDA was "in a position of having to scrutinize the issue more carefully than it ordinarily would have," said Zuckerman, who attended both days of hearings before the vote.
There were the stringent conditions that needed to be met. Also, the committee members seemed to be split along specialty lines. "It was discouraging that the plastic surgeons all voted for approval and so did two breast surgeons," Zuckerman said. "Most of the scientists voted against."
While acknowledging that it was essential to include plastic and reconstructive surgeons on the panel, Whalen wrote, "It serves the reputation of the FDA in general, and the standing of the panel process in particular, exceedingly poorly to have had all of the plastic surgeons vote the PMA [pre-market approval] as approvable on such a close vote. Even in academic settings, plastic surgeons may stand to increase their own income with the use of these devices."
One topic of debate was the fact that there was only scientific data for two or three years on the implants and possible health risks.
The FDA selects the people to serve on its various advisory panels.
"This was absolutely under the FDA's control," Zuckerman said. "This is called an independent advisory panel, and I guess Dr. Whalen has shown that it can be quite independent, but it is selected by the FDA."
The silicone gel implant was at one time the preferred method of breast augmentation for women because of its soft, pliable texture. But in 1992, responding to hundreds of women's claims that ruptured implants had leaked silicone into their bodies and caused long-term chronic immune system disorders, the FDA banned the sale of the gel implants.
The ban and subsequent lawsuits against the four companies that manufactured the gel implants resulted in millions of dollars in settlements to the women. One company, Dow Corning, filed for bankruptcy to pay $3.2 billion to settle the claims against it.
But since then, numerous studies have failed to link the implants to health problems in women. They included studies by the Mayo Clinic, Harvard Medical School and, in 1999, the Institute of Medicine (IOM) panel from the National Academy of Sciences.
The studies found no evidence that leaked silicone from gel implants caused systemic disease, although they did report localized problems of pain and the potential for scarring at the site of the implant.
If the devices do make it back onto the market, lawsuits may no longer be an option for women who encounter problems, one legal expert said.
"One of the requirements will be that women be fully informed of virtually everything the FDA was informed on. That means the claim of failure to adequately be warned of real dangers is gone," said Robert Gordon, an attorney with Weitz & Luxenberg in New York City.
Gordon was appointed to the plaintiffs' steering committee in the Breast Implant Multi-District Litigation.
More information
The FDA has more on breast implants, as does the British Department of Health.
