Women kept in dark about safety of silicone implants
|
|
Eleven years after silicone-gel breast implants were forced off the market by women’s health complaints and broad safety concerns, a Food and Drug Administration advisory panel has recommended lifting the ban. If the FDA follows the panel’s advice, as it usually does, women will again have the choice of using silicone implants — instead of merely the saline-filled variety — for breast-augmentation surgery. The policy change, expected in the next several months, would include a new set of restrictions aimed at determining the long-term safety of silicone-gel implants. Which raises an obvious concern: Why aren’t those facts already known? The answer points to a glaring oversight that risks leaving women without adequate information to make an informed decision. After the FDA strictly limited the use of silicone breast implants in 1992, it squandered the chance to demand adequate long-term safety data from companies still providing silicone implants; a small group of women continued getting them as participants in clinical trials.As the government’s only watchdog over the safety of drugs and medical devices, the FDA has great influence with such manufacturers. They could have been pressured to provide data that could help put to rest concerns over the implants’ long-term health effects. Although one purpose of the moratorium was to collect needed safety research, women still don’t have solid answers to many of their most vexing questions about whether the controversial implants are harmful. Among them: More : usatoday.com |