FDA Approved as of March 2012 and available for augmentation procedure.
Sientra (Silimed) breast implants are made in Brazil and are the most popular implants in that country and the third most popular worldwide. Dr. Teitelbaum was an investigator in their U.S. clinical trial, which is now closed. In March of 2012, the FDA approved these implants which are now available for use for breast augmentation procedure.
While the 410 and the CPG only comes in a textured teardrop implant, the Sientra implants come in a smooth round, a textured round, and a textured anatomic shape. Dr. Teitelbaum has used all of these and has followed his patients every year since he first implanted these implants.
There is some confusion about the terms Silimed and Sientra. Silimed is the name of the manufacturing company in Brazil, and is the name that the implant is sold under throughout the world. When patients received these implants during the American clinical trial, they were called Silimed. Subsequently, in U.S. distribution, the name of these implants was changed from Silimed to Sientra, but the implants remain the same.
Sientra breast implants were approved for sale in the United States in March 2012.