2. Safety Concerns
The media began reporting on women struggling with implant issues during the early 90s. There were doctors who had concerns about the safety of implants.
The studies conducted on these implants were then provided to the FDA and the FDA determined that the data was inadequate to receive FDA approval. It was in the year 2000 that the FDA finally started requiring implant makers to prove that the implants they were making were safe.
Silicone implants were approved in the fall of 2006. From 1992 through 2006, these implants were only used in clinical trials that were mainly for women who had broken implants and for breast cancer patients.
These patients were told that the implants they would be given were not yet FDA approved and they were regularly evaluated by plastic surgeons to ensure the implants were safe.
Silicone implants now have FDA approval, but there are still some restrictions including that a woman must be over 22 years old in order to receive them.