For the first time in 20 years, the FDA has approved a new manufacturer for Breast Implants in the US. Santa Barbara, California, based Sientra today received FDA approval for their Silimed brand breast implants. While Sientra, founded in 2007, may seem a relative new comer to the breast implant market, the Silimed product line has been available outside the US for 33 years, and their current portfolio of implants has been available for almost 20 years.
The FDA approval breaks new ground in that shaped implants have been included in the approved portfolio. When they will become available, and what requirements / training will be required, is yet to be announced. Over the next few weeks I expect to hear more, and will keep you informed.
Whether this means that the Allergan and Mentor versions of form stable implants are also soon to be approved, time will tell. Hey Gerry, it’s March!