FDA releases updated safety data on silicone breast implants
Posted in: Blog | July 7, 2011
On Wednesday 6/22/11, the Food and Drug Administration announced that early findings from an analysis of safety issues and adverse events associated with silicone-gel breast implants revealed no new concerns. Therefore, the agency said it will allow the devices to remain on the market.
The Los Angeles Times (6/23, Mai-duc) stated that the FDA said the analysis conducted on more than 80,000 women over 10 years by implant
manufacturers “indicates that they have a ‘reasonable assurance of safety and effectiveness’ when used properly. … ‘What we can say is the current data doesn’t indicate that silicone gel-filled breast implants are linked to breast cancer, connective tissue disease or infertility,’”
However, women considering breast augmentation with silicone breasts implants should discuss the risks, benefits, and alternatives with their plastic surgeon. It is important for women to understand that 20 percent to 40 percent of patients who have implants for cosmetic reasons will need another operation to modify or remove them within eight to 10 years. I always encourage women to do their research and have all their questions answered before proceeding with any cosmetic surgery procedure.
Dr. Cat Begovic M.D.