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Debate Still Rages Over Safety of Silicone Breast Implants

November 15, 1991

Undated (AP) _ The debate persisted Friday about the safety of silicone-gel breast implants after a federal panel recommended that the devices remain available to meet a public health need while more tests are done.

″A massive human experiment has been going on with women. At the very least, it is outrageous women continue to be experimented on,″ said Dr. Sidney Wolfe, head of the Public Citizen Health Research Group in Washington, D.C.

But an official with the American Society of Plastic and Reconstructive Surgeons hailed the recommendation because it underscored the medical worth of silicone implants.

″We’re delighted with the outcome. It’s nice to know common sense does work,″ said Dr. Garry Brody, secretary of the 4,000-member ASPRS, which represents 90 percent of the nation’s certified plastic surgeons.

″The greatest victory is the recognition that silicone implants have serious value for cosmetic as well as reconstructive surgery,″ Brody said. ″To suggest these women are guinea pigs is absurd. It’s an insult.″

A Food and Drug Administration advisory panel on Thursday unanimously recommended keeping silicone implants on the market while more research is done on their safety. The FDA has until Jan. 6 to consider the recommendation.

The agency has never approved breast implants. They were already on the market in 1976 when Congress empowered the FDA to regulate them. In the past 35 years, about 2 million women have had breast implants, and about 150,000 of the operations are now done each year. Most of them are done to enlarge breast size; about 20 percent are used to reconstruct breasts removed by surgery.

Public Citizen asked the government to ban silicone implants three years ago after receiving complaints the devices leak, sometimes cause breast tissue to harden and may pose a health risk, including cancer and immune system disorders. The Americian Medical Association and the American Cancer Society say they have no evidence of health risks.

The FDA panel’s recommendation allowed wrangling factions to claim partial victory.

″It’s a step forward,″ said Cindy Pearson, program director of the National Women’s Health Network. ″It’s disappointing the FDA has allowed this experiment to go on. But at least they’ve admitted there’s no proof that these things are safe.″

Dow Corning Wright, the leading maker of silicone-gel implants, welcomed the recommendation. However, the FDA panel earlier rejected the company’s data that its devices were safe.

″The panel’s decision was a victory for women’s choice as well as a victory for science,″ said Robert R. LeVier of Dow Corning Wright.

″We are pleased that the panel recognized that this option should not be taken away from women,″ LeVier said. ″I think the panel was also saying that it is time to take this decision out of the realm of politics and ‘junk science’ and return it to the solid ground of science.″

A number of plastic surgeons contacted by The Associated Press called the FDA panel’s recommendation appropriate. They also said they would give potential patients more information about the implants.

″I think that there was a lot more emotion than science in a lot of reaction to this whole investigation,″ said Dr. Ronald Berggren, a plastic surgeon in Columbus, Ohio.

″One of the best things that has come out of this whole thing is the awareness by patients of some of the imperfections and the awareness on the part of physicians that we should be explicit ... to explain the good and the bad,″ Berggren said.

Dr. Judith Zacher said she has done several hundred gel implants in Ohio since 1975 without complication, and hoped her patients would be relieved by the panel’s recommendation.

″My informed consent for the breast implants has been very elaborate. I will be having them sign a form that they have been fully informed,″ she said.

Dr. Rouchdi Rifai also said he may offer more detailed information about the risks and rewards to patients at his clinic in Southfield, Mich.

″I would give the choice to the patient now of some literature that has been available that explains a little more of why the FDA has gotten into the process of approval,″ Rifai said.

″The women of America were about to lose a very important right, and it’s a right to satisfy their goals,″ said Dr. Anthony Sokol, associate professor of plastic surgery at UCLA and a staff member of Cedars-Sinai Medical Center.

″I have never done in my life such a wonderful operation for self-esteem and self-fulfillment as breast augmentations,″ said Sokol, of Beverly Hills. ″It’s really sensationalism that has sold this issue negatively.″

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