Silicone breast implants now have a new player.According to one online industry article the newest FDA approved silicone breast implant is not coming to market without controversy. After reported continued protests at home and abroad, the FDA cleared silicone breast implants made by Sientra, making it the 3rd company with regulatory clearance to sell the controversial products in the U.S. The Santa Barbara, Calif.-based cosmetic device maker joins Johnson & Johnson and Allergan in offering silicon-based breast implants to U.S. patients. “For the first time in 20 years, Sientra has successfully broken the existing duopoly in the U.S. by offering surgeons and patients a new choice,” founder & CEO Hani Zeini said in prepared remarks. “And today, Sientra becomes the 1st and only company in the U.S. to provide a full portfolio of commercially-available breast implants, including shaped implants in addition to standard round implants.”
Silicone Breast Implants One of The Most Researched Medical Devices
Silicone Breast implants have been at the center of the media claims of a growing public outcry since last summer, when the FDA warned that, although the products are still considered safe and effective, women could be under-informed about their risks, including what some opponents of silicone breast implants describe as “hardened skin around the implant, wrinkled or ruptured implants, scarring, pain and infection that may lead to reconstruction or removal”.Consumer groups, such as the National Organization for Women Foundation, petitioned the FDA to recall the devices on the grounds that implant makers hadn’t kept up with promises to collect post-market data. This request was denied.
Silicone Breast Implants Should Be Discussed in Detail with the Doctor
Silicone breast implants remain one of the most researched medical devices used and available today. The fact that another silicone breast implant will be introduced into the market after rigorous FDA testing can prove promising for patients. Patients should use discretion when making the decision to select their own breast implants based on their own research. It is important to remember that each plastic surgeon should make a recommendation based on their ability and their best medical judgment based on each individual patient. Dr. Seify explains silicone breast implant options to patients in detail during their initial breast augmentation and/or breast lift consultation. Patients are also advised to review the information on the FDA silicone breast implant web page that details the FDA approval as well as the recommendations. While patients should remain diligent concerning new products and information concerning silicone breast implants, patient can be reasonably assured that ongoing research continues to find the devices to be reasonably safe. Dr. Seify reminds patients that silicone breast implants are not expected to last forever, and that patients should be prepared for a breast implant exchange or reoperation at some point during their lifetime.