Patients seeking breast augmentation surgery now have a new option for breast implants. Prior to March 2012, there were only two FDA approved breast implant manufacturers: Mentor and Allergan. However, Sientra, a California-based company that manufacturers all types of plastic surgery implants known internationally as Silimed, recently gained FDA approval for their breast implants. Sientra offers an innovative type of breast implants made out of high-strength cohesive silicone gel, which will be available to appropriate Southern Plastic Surgery patients.
Breast implants have been somewhat controversial since the first silicone breast implants were designed in the 1960s by plastic surgeons Drs. Frank Gerow and Thomas Cronin due to safety concerns and the fact that plastic surgery was not as widely accepted back then as it is now. The fear of a silicone breast implant rupturing and leaking silicone into the body inspired the development of saline breast implants, which are made out of a silicone elastomer shell filled with sterile saline solution.
The safety debate continued, and in 1976, Congress passed an amendment to ensure the safety of medical devices by requiring FDA premarket notification. Between 1988 and 1991 the FDA battled with the breast implant classification requiring premarket approval and eventually submission of premarket approval applications. In 1992, silicone breast implants were actually taken off the market due to lack of data on their safety, but after 14 years of clinical studies, silicone breast implants were declared safe by the FDA and placed back on the market.
While Sientra’s newly designed implants are similar to other devices manufacturers have previously designed, they are the first to gain FDA approval and are currently the only cohesive gel implants available in the U.S. In fact, you may have already heard the term “gummy bear” breast implants, which originated in Europe to describe a similar type of breast implant that are slightly thicker than Sientra’s. Although Sientra does not use this description for their implants, their consistency can be compared to that of a gummy bear, and they are known for their singular shape retention and natural, soft feel.
High-strength silicone implants are also the only shaped silicone breast implants available in the U.S. Before Sientra designed these implants with a solid-like structure, shaped breast implants were only available with saline. Although some patients can achieve desired results with round breast implants, some prefer shaped breast implants for more natural results. Sientra’s breast implants are available in smooth, textured, moderate projection and high projection. The moderate and high projection implants show promise for women with very underdeveloped breast or those looking to correct breast sagging without breast lift surgery.
Plastic surgeons across the country are hoping high-strength silicone breast implants will be the solution for breast implant ruptures or leaks and more natural looking results. In wake of the recent French breast implant (PIP implants) recall, it’s important for patients to understand that the Sientra breast implants spent years in clinical trials and similar implants have been safely used for the past 30 years outside of the U.S. However, it is also essential for patients to understand all surgical procedures carry risks and breast implant complications are fairly common, but often avoidable. It’s imperative for patients to find a board certified plastic surgeon to minimize complication risk.