FDA: Approves Saline Breast Implants with Warnings
The FDA announced on Wednesday that it will allow saline breast implants to remain on the market "despite relatively high complication and failure rates," USA Today reports (Rubin, 5/11). David Feigal, director of the FDA's Center for Devices and Radiological Health, cautioned, "Women should understand that breast implants do not last a lifetime" (Lueck, Wall Street Journal, 5/11). McGhan Medical Corp. and Mentor Corp., the two largest saline implant manufacturers, must provide "detailed brochures" explaining the product's limitations. Both companies conducted studies in which approximately 20% of breast implant patients required additional surgery and 8% asked for their implants to be removed after three years. Women who received implants for reconstruction following breast cancer surgery experienced even greater complications: Among 416 women receiving Mentor's breast implants for reconstructive surgery, 40% required additional surgeries and 27% requested implant removal (Stolberg, New York Times, 5/11). However, the FDA noted in its approval that "despite the complications experienced by some women, the majority of those women still in the (clinical studies) after three years reported being satisfied with their implants" (Kaufman, Washington Post, 5/11). In 1998, more than 130,000 women received saline implants, and "numbers have been increasing rapidly," according to an association of plastic surgeons.
Advocates Boo Decision
"This decision really sets the FDA standard of safety at a new low," Diana Zuckerman of the National Center for Policy Research for Women and Families, said. "If they'll approve something like this product, you can't assume that anything the FDA approves is really safe," she added. Government officials defended their decision, citing the Institute of Medicine's 1998 findings that failed to determine a link between breast implants and serious diseases (Washington Post, 5/11). "With the data that have been presented, women and their physicians will be able to make informed decisions about whether the benefits are worth the risks," FDA Commissioner Jane Henney said (Rubin, USA Today, 5/11).