No Recall for Breast Implants, FDA says, Mass Device, September 1, 2011
Despite the fact that there are no long-term safety data, the FDA announced there will be no recall for silicone breast implants. That announcement was made a after a two-day panel of the General and Plastic Surgery Devices group reports Mass Device. Allergan Inc and Johnson & Johnson had promised to track long-term safety but had failed, said consumer groups. The FDA told manufacturers to ramp up their efforts to track devices postmarket.
The two companies won clearance for silicone breast implants in 2006 based on the condition they would be gathering post market safety data on 40,000 patients for up to 10 years. Patient complaints to the FDA have included hardening skin around the implant, ruptured implants, scarring, infection and pain.