FDA Rethinks Breast Implants Ban

This week, the U.S. Food and Drug Administration will consider lifting its ban on silicone breast implants.

Right now, only the U.S. and Canada do not allow their use outside of special studies or for reconstructive surgery. However, that doesn't mean breast augmentation has faded in popularity: nearly 237,000 women underwent the procedure last year, according to the American Society of Plastic Surgeons.

During this week's hearing, the FDA panel will look at the science behind silicone implants to determine their future availability.

Revisiting the emotionally charged issue, the FDA will hear testimony essentially pitting woman against woman - some who say the implants broke apart to leave lasting scars, others who want implants they say feel more natural to reconstruct breasts savaged by cancer.

Leading the fight against silicone implants is Sybil Niden Goldrich, a breast cancer survivor who after a mastectomy had four sets of implants put in and four sets taken out.

"It would be very hard to convince me that the silicone wasn't the problem, because once the implants were removed, the problems I had went away," Goldrich told CBS' Early Show.

Proponents say implants have been thoroughly studied and exonerated as disease-causers, and that recipients are well aware that breast implants, just like pacemakers or metal hips, don't last forever.

"There are some moral judgments being played on here about women who choose to have their breasts enlarged," said Dr. James Wells, president of the American Society of Plastic Surgeons.

Due to so many health complaints, the FDA banned silicone implants in 1992, except for cancer patients and women who wanted to participate in studies.

Inamed Corp. of Santa Barbara, Calif., reopened the controversy by asking the FDA for permission to sell its version of the implants in the United States, like it long has in Europe. A competitor also is expected to seek FDA approval soon.

Inamed says the breast implants are safe and effective. Inamed says its studies show silicone gel-filled implants are as good as or better than the salt water-filled models now on the market. "We believe women should be able to have that choice," said JoAnn Kuhne, a top company official.

But some in the medical community remain concerned. National Cancer Institute research shows women with implants were much more likely to commit suicide or die from lung and brain cancers compared to other plastic surgery patients. With protesters marching on the streets, Inamed will have to convince a lot more people than just the FDA that their products are safe when the hearings begin later this week.

Feminist groups and other critics say questions about long-term side effects when silicone gel leaks from the implants haven't yet been settled, and that at the least, women face pain and repeated surgeries when the implants break. Newspaper and TV ads set to run nationwide depict implants as ticking bombs in women's bodies and charge that the FDA is bowing to industry pressure to restart sales.

Implant recipients "are really gambling with their health because there isn't really good long-term research on safety," said Diana Zuckerman of the National Center for Policy Research for Women & Families.