The number of breast implant manufacturers has now officially increased to three. Twenty years ago there were as many as six companies that commercially sold breast implants for both cosmetic and reconstructive surgery. But when the silicone gel breast implant moratorium occurred in 1991 and the legal and financial fallout ensued, the number of manufacturers was reduced to two. Allergan (back then known as McGhan) and Mentor (now part of Johnson & Johnson) have supplied most breast implant needs for US patients since then…and all silicone breast implants since 2006 when they were re-introduced for commercial sale.
The US Food and Drug Administration (FDA) on March 9, 2012 approved a new silicone gel breast implant made by Sientra, a Santa Barbara California-based company and an arm of the international company, Silimed. Like Allergan and Mentor, the new silicone breast implant made by Sientra is to be used for elective cosmetic breast augmentation in women aged 22 years and older and for breast reconstruction in women of any age.
The FDA’s approval of the Sientra implant was based on the study of nearly 1800 women who were followed for 3 years after implantation. Their safety was determined by comparing complication rates such as capsular contracture, reoperation, implant removal, asymmetry, and infection to those known for the other two manufacturers. Just like when Allergan and Mentor got their silicone breast implants approved in 2006, Sientra has a lot of due diligence to do going forward. This includes studying the implanted women in the clinical trial for up to 10 years after surgery, evaluate a much larger patient sample for potential autoimmune disease and breast cancer, and provide further control studies on the potential link between silicone breast implants and other rare diseases.
From a patient’s perspective what does Sientra implants offer that the other two manufacturer’s don’t? It appears that the options of differing implant sizes, shapes and a smooth and textured surface are similar based on a review of their product offerings on their website, as would be expected. There would not be anything novel about the silicone gel or implant offerings as the FDA has approved the new silicone implant based on the principle of equivalency. Something truly novel would require a lot more clinical information than a simple three year clinical trial. But an additional manufacturer provides another option for both plastic surgeons and patients and that competition may result in lower breast implant prices.
Silicone breast implant manufacturers have been in the news recently with the fall of the French-company PIP breast implants who allegedly used substandard industrial-grade silicone in their implants. These implants were never sold commercially in the US however. But as one company does down, another emerges.
Dr. Barry Eppley
Indianapolis, Indiana