Since the fall of 1988, Public Citizen has opposed the use of silicon gel breast implants. After receiving numerous documents from FDA scientists concerned about their safety, Public Citizen petitioned the FDA to ban the implants. The FDA has heightened knowledge about the adverse safety and health information relating to the implants, including the high rates of rupture, the need for repeat surgery, clear evidence of lymph node infiltration, and lymph node damage by leaked silicone. The recent approval makes a mockery of the legal standard requiring a “reasonable assurance of safety.”
The approval of the silicone breast implants ends more than two decades of tight restrictions on the use of the devices. Unfortunately, the women who will most likely be interested in using the devices are too young to remember the high-profile health concerns and litigation the silicone implants ignited at their introduction to the market.
Additionally, the approval of the implants also reinforces concerns about the poor performance of FDA’s Center for Devices and Radiological Health. The Center continues to approve devices despite opposition and adverse evidence. On top of that, the FDA is not nearly strict enough with medical device recalls. This is doubly worrisome because not only are ineffective and dangerous devices being approved, but the FDA is also slow to recall them once serious issues arise.