On March 11th, 2012, the FDA approved Sientra brand silicone gel breast implants safe for use in the United States. Sientra’s Silimed brand implants are the combined efforts of years of research and a successful 33 year safety record of quality and reliability for medical products.
For years, women in the U.S. have been limited by their choices of breast implants to a duopoly of manufactures. This lack of choices has coincided with in creating a gap between foreign counterparts and what is available to the patient domestically.
According to William Maisel, M.D., M.P.H., deputy director for science in the FDA’s Center for Devices and Radiological Health, Stated:
“Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness.”
“It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”
Furthermore, The FDA has mandated that Sientra provide consistent data with a 10 year post-op approval study to gather important safety information and proper followup to their breast implants similar to other manufactures.