The FDA announced today that it had approved the use of Sientra’s silicone gel breast implants for cosmetic use in patients over 22 years old and reconstruction in any age group. This brings my New Jersey breast implant patients choices of implants from 3 different manufacturers.
The more exciting news is that this approval is not only of round silicone implants but also of anatomic shaped implants. Since the 2006 Mentor and Allergan silicone gel approval, only round silicone implants have been available. Anatomic (or teardrop) shaped saline implants have continued to be available but until today only silicone round implants have been available for general use. Prior to 2006 as part of the silicone gel studies I routinely used silicone anatomic implants especially in reconstruction patients. While I have always preferred round implants in the vast majority my NJ cosmetic surgery patients.
Only time will tell about whether or not this third player in the implant business will make much of a difference. I am extremely happy with the quality of both Mentor’s and Allergan’s implants. Mentor is a quality operation (now owned by Johnson & Johnson) with implants made in the United States with strict quality control. Allergan is a huge global company (also the maker of Botox) with an incredible safety record. I do not know much about Sientra and while it is a Santa Barbara, California company with a 30 year track record of safety according to its corporate website, for now I personally do not know much about them. With the recent PIP breast implant scandal in France, safety should be everyone’s first question. Undoubtedly the FDA looked at the company’s safety data carefully.
Any new approval is exciting such as this! This is not just another choice of implants but the availability of a different shape of implants. For certain patient body types this may be a distinct advantage.