Las Vegas Plastic Surgery
And then there were three: Sientra gets its portfolio of Silimed brand silicone breast implants approved by FDA.
Today Sientra, silicone gel breast implants made by Silimed, joins the existing companies Allergan, who provide the Natrelle brand, and Mentor, maker of the Memory Gel brand, as the third FDA approved silicone breast implant brand available to patients in the United States.
Hani Zeini, founder and CEO of Sientra, commented on the FDA approval of his silicone breast implant line in an official statement:
“For nearly two decades, this now FDA-approved portfolio has been an established option for plastic surgeons worldwide, with over 1.5 million satisfied patients across the globe. The Sientra focus, plus Silimed’s 33-year manufacturing commitment to safety and quality, along with the rigorous FDA-approval process, provides you and your patients the assurance of choice and the highest quality implants.
This approval signifies a major milestone for plastic surgeons in the United States: For the first time in 20 years, Sientra has successfully broken the existing duopoly hold in the U.S. market by providing a new alternative for you and your patients. We are truly excited to offer you a choice of innovative products and business focus, backed by company leadership steeped in the tradition of the specialty.”
Breast Implants are one of the most studied and scrutinized medical devices available to the public. Internal manufacturer product research plus rigorous safety trials performed by the FDA are conducted to ensure that breast implants are healthy for female patients. The thorough FDA testing process provides plastic surgeons with confidence that they are providing their patients with a cosmetic enhancement that is also safe.
Recent approval of Sientra silicone breast implants by the FDA suggests that there is a healthy demand for silicone breast augmentation devices. In order for Sientra to go through the arduous FDA approval procedure, it is practical to assume they projected a significant upside at the end of the process.
It will be interesting to see how the silicone breast implant market responds to the news, and if an increased demand for breast augmentation is one of the harbingers of a rebounding economy.
Jeffrey J. Roth, M.D., F.A.C.S.