FDA Approves a New Breast Implant: Sientra Implants Join Allergan’s Naturelle and Mentor
At the beginning of March, the FDA approved a new breast implant manufactured by Sientra Inc. (Santa Barbara, California). This brings the number of available approved brands of breast implants to three in the United States. The presence of a new implant option is always a good thing; it drives public interest as well as academic research and regulatory oversight in the field. The newly approved Silimed® line is currently limited to silicone gel implants in a range of sizes and profiles, although internationally the line also includes a group of saline implants that are still moving through the FDA approval process . While the true long-term results of these implants will take many years to assess, Sientra is not a newcomer to the science of silicone implants, and has been a manufacturer of solid facial and body implants for many years. Leakage and capsular contracture rates are simulated experimentally and studied in the short term but cannot be formally assessed until widespread long-term clinical experience is recorded and evaluated. While this new implant line may not add products that are distinctly different from those currently available, it is a sign that the FDA has resolved a lot of issues involving what data they want to see in order to approve an implant and be convinced of its safety and efficacy. This is good news, as a variety of innovative implants types that may offer unique advantages are more likely to be developed in the coming years if companies have more insight into the requirements for FDA consideration and approval.