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Advocates Tell FDA to Slow Down on Implants

Wednesday, August 10, 2005

Consumer advocates threatened Tuesday to file a lawsuit against the FDA if it approves the marketing of silicone gel breast implants without adequate safety data.

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Consumer advocates threatened Tuesday to file a lawsuit against the FDA if it approves the marketing of silicone gel breast implants without adequate safety data.
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Martha Burk

WASHINGTON (WOMENSENEWS)--A coalition of consumer, health and women's advocates banded together Tuesday to insist that the Food and Drug Administration postpone its final decision on allowing the marketing of silicone gel breast implants until more is known about the implants' potential health hazards.

"How many times have women been told before that something affecting their health and lives is safe and later we find it wasn't true?" asked Martha Burk, head of the National Council of Women's Organizations, an umbrella group in Washington, D.C. "The data were not there or the data were there and they were not being made public."

Sidney Wolfe, a doctor and head of the Health Research Group of Public Citizen, a consumer advocacy group in Washington, D.C., threatened to file a lawsuit against the FDA to block approval of silicone gel implants.

Members from other organizations affiliated with the coalition--which in addition to Burk's organization included the National Organization for Women, the National Women's Health Network and the National Research Center for Women and Families--said they would back up a lawsuit.

FDA spokesperson Julie Zawisza said the agency is not likely to alter its decision in response to the groups' complaints. "We really have to base our decision on the data, on the science," she said. "Obviously public input is a very critical component of the process but at the end of the day what we have to make a scientific decision."

The health consequences of silicone gel implants are not fully known, say critics who are concerned about risks for women if they leak or rupture inside the breast.

Similar concerns prompted the FDA to restrict the use of silicone implants in 1992 in response to health concerns. Since then, women who have sought augmentations have used implants made of a saline solution, devices that manufacturers say create a less natural-looking augmented breast than silicone counterparts.

But critics of silicone implants say they could lead to public health tragedies similar to earlier ones that led to the loss of women's lives because of insufficient medical data. Critics pointed to the Dalkon Shield, an intrauterine device that was recalled in the 1970s after it was linked to illness and in some cases death. A few years later, certain tampons were found to contain an ingredient that caused Toxic Shock Syndrome, a disease that also led to illness and death.

"Women's groups are concerned," Burk said. "No one wants another Dalkon Shield. No one wants another (tampon scare). Yet these devices were said to be safe as well. The manufacturer told us there was no problem, and what happened. Millions of women were affected, lives were endangered, and lives were lost."


Response to July 28 Letter

The joint press conference came in response to a July 28 letter by the Food and Drug Administration that gave a conditional green light to Mentor Corporation, a Santa Barbara, Calif., manufacturer of silicone gel implants and other medical devices.

The FDA indicated that Mentor would receive approval to market and sell the implants if it met certain conditions that have not been disclosed, according to a statement posted on the agency's Web site.

"We are very encouraged by this communication from the FDA, and view this letter as a positive sign for women and their surgeons that another option will soon be available," said Mentor President Joshua H. Levine, in a press release. "We thank the FDA and its Advisory Panel for the rigorous and objective review of our data and related science."

The "approvable" letter could lead to the reversal of the precedent set in 1992 and upheld for the past 13 years.

In April, a smaller advisory panel made a recommendation in favor of granting Mentor approval to market the device but against a similar appeal from Santa Barbara-based Inamed, another leading implant manufacturer.

Its July 28 letter, regulators stated that federal laws prohibit discussion of the conditions that Mentor must meet before it wins approval.


Releasing Conditions

Rankled by the secrecy surrounding the decision, advocates demanded that the FDA release the conditions of the decision They also called for an expanded congressional investigation into the FDA's safety review of the implants and demanded that the FDA release all documents relating to a criminal investigation it had undertaken of Mentor. The groups also pledged to submit federal information requests to obtain the information.

Some 2 million women now have breast implants, according to Diana Zuckerman, president of the National Research Center for Women and Families. The procedure is growing more popular, thanks to what Burk decried as a popular culture with restaurants like Hooters--which advertises buxom waitresses--and a media and entertainment industry that hires women in part by their bust size.

The procedure is becoming increasingly popular, Burk added. Some 334,000 breast augmentation surgeries were performed last year, a 19 percent increase over last year, Burk said. Of those, almost 4,000 were performed on young women aged 18 and younger. "Breast implants are getting to be a popular graduation gift," Burk said.


Lack of Analysis

Proponents of silicone gel implants point to a study conducted by the Institute of Medicine in 1999 that showed no clear evidence that breast implants cause disease.

Mentor cites a quotation from the Institute stating: "There is no evidence that silicone implants are responsible for any major diseases of the whole body. Women are exposed to silicone constantly in their daily lives."

But critics find fault with that study, noting that it was funded by Dow Corning, a Silicone manufacturing company based in Michigan that was sued for faulty silicone breast implants. The study looked at small numbers of women who had breast implants for only short periods of time and did not conduct medical examinations on the women, Zuckerman said. Subsequently, scientists at the National Institutes of Health, the National Cancer Institute and the FDA conducted their own studies of women who had implants for at least six years. The findings showed that women with breast implants were twice as likely to die of brain cancer and three times as likely to die of lung cancer, compared to other plastic surgery patients, said the National Research Center's Zuckerman.

Mentor and Inamed, however, did not include those findings in their presentation to the FDA, Zuckerman said. They did, however, include their own findings about women with implants who suffered more autoimmune problems--such as joint pain, fatigue and memory loss--than they had before the implants.

Moreover, critics have alleged that Mentor destroyed reports showing high rupture rates and falsified other data.

A spokesperson for Mentor did not immediately return a call for comment.

The biggest problem, critics said, is lack of sufficient data. "Reasonable safety has not been demonstrated," the coalition of more than a dozen groups said in a joint statement. The FDA "is basing its decision about 'reasonable safety' on data that is at best inadequate and at worst intentionally inaccurate."

Allison Stevens is Washington bureau chief at Women's eNews.

For more information:

Teens Getting Breast Implants for Graduation:
http://www.womensenews.org/article.cfm/dyn/aid/1861/