On Friday, March 9th, it was announced that the FDA has given approval to Sientra’s line of silicone gel-filled breast implants. The implants are approved for women at least 22 years of age for augmentation and for reconstruction in women of any age.
Up until now, there have been only two major brands of silicone implants that have been approved by the FDA – Mentor and Allergan. Both of these companies produce round silicone gel-filled implants that feature a cohesive gel filling. With the addition of Sientra’s line of implants, more choices will be available to patients. Of particular interest is that besides offering smooth and textured round silicone implants, Sientra’s line also includes implants with a tear drop or anatomic shapes. Shaped implants have applications for correcting breast asymmetries and are highly applicable for a number of patients going through breast cancer reconstruction.
The FDA based its approval on three years of clinical data from 1,788 participants.
As part of the approval process, Sientra will continue to conduct a 10-year study of 4,782 women on long term data pertaining to outcomes and observed complications. Sientra and the FDA are committed to collecting useful post-market data on long-term safety and effectiveness of the devices.
Orlando Cometic Surgery, LLC will keep you informed of the availability of these new devices as we evaluate them personally and work to get them approved for use in our affiliated surgical facilities and hospital systems.
For more information on Sientra’s silicone breast implants, please visit their website.
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The staff at Orlando Cosmetic Surgery, LLC
Convieniently located in beautiful Orlando, Florida.