In 1992, the FDA banned silicone breast implants over claims that they caused various illnesses, including lupus, cancer and arthritis. Five years ago, the agency decided to let them back on the market and now they've declared they were right to do so - even though critics say there isn't enough research to prove they're safe.
The Los Angeles Times reports that the FDA announced silicone implants have a "reasonable assurance of safety and effectiveness", based on research by Allergan and Mentor, which manufacture the implants. Supposedly the data shows that silicone implants are not linked to breast cancer, connective tissue disease or infertility.
The studies don't exactly inspire confidence. From the Wall Street Journal:
Allergan and Mentor enrolled about 40,000 women each with implants in studies, but the companies have lost contact with many of the participants since the studies, intended to last about 10 years, began several years ago. The FDA said Allergan had followed about 60.5% of the women for two years, while Mentor has followed 21% over three years. Both companies said they were trying to improve follow-up.
But they may not be trying all that hard, since their products have already been approved. FDA scientists say they also looked at other smaller studies that started prior to 2006. Dr Diana Zuckerman, president of National Research Center for Women & Families, still says that some of the manufacturers studies are "unusable" and when it comes to safety claims, "There's a lot of wishful thinking."
The FDA also reported that many women suffer complications after receiving silicone implants, including hardening of the breast, scarring, and infection. Saline implants feel less natural, but they deflate when the bag is ruptured. Silicone implants can tear and slowly leak into the body undetected. Women with silicone implants are supposed to have MRIs every two years to check for these "silent ruptures", but many don't. A significant number of patients wind up having the implants removed after several years:
20% to 40% of women receiving implants for augmentation had a reoperation in the first eight to 10 years after getting the implants. The figure was 40% to 70% for women who got implants for reconstruction, including after cancer surgery.
The FDA said in its analysis that, "despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make well informed decisions about their use." It's obvious that jamming foreign objects into your chest may lead to some complications, but it's frustrating that the FDA can't present solid, independent research on precisely what the risks are.