Q: Are Breast Implants Approved by the FDA?In November 2006, after a 14-year ban on their sale due to safety concerns, FDA approved silicone breast implants. Over that time period, no convincing evidence emerged to prove conclusively that silicone implants were safe. But neither were they proved harmful, which cleared the way for their return to the market. At the time of approval, however, the FDA announced that it would conduct a study of 80,000 women over 10 years to determine the safety of silicone implants once and for all, an acknowledgment that the agency needed to gather more information about their long-term impact on women’s health. In the meantime, potential recipients would be free to use their judgment and get them if they wish. FDA approved saline implants in 2000, after a review process that looked at two-years worth of data for a device that resides in women’s bodies for decades. In 2003, the head of the FDA’s Center for Devices and Radiological Health, Dr. David Feigal, said in relation to implants: People have the misconception that an FDA-approved product is safe, but, actually, the agency evaluates products to see if risks outweigh benefits and then it’s up to “the consumer to decide whether or not they’re willing to take those risks.” And further back in 2000, in a press release announcing FDA approval of saline implants, Dr. Feigal said, “It’s clear from these studies that there is a possibility that a substantial number of women who get these implants will require additional surgery at some point to remove or replace their implants because of complications.” So, yes, both saline and silicone implants have FDA approval, but this should not be interpreted as an endorsement of safety. It is the responsibility of women considering implant surgery to assess the available safety information before going through with the procedure. | |
