Women generally undergo breast implantation and augmentation post cancer or due to severe breast abnormality. With respect to this procedure, the US Food and Drug Administration (FDA) has approved of a new silicone gel-filled breast implant developed by Sientra.
However, post-approval studies have been placed as a condition for issuing the consent by FDA. This implant could be used for increasing breast size among women aged a minimum of 22 years. It can also be used to reconstruct breast tissue in women, irrespective of age. The post-approval studies mentioned above refer to the trials gauging the risks, usability, safety and effectiveness of the aforesaid breast implant.
“Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness. It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential,†commented William Maisel, M.D., M.P.H., deputy director for science in the FDA’s Center for Devices and Radiological Health.
To provide the approval, clinical information from nearly 1,788 subjects was studied. The side-effects of Sientra implants included stiffness in the portion of surgery, implant removal, re-operation, asymmetry and infection.
There is also a list of obligations put forth by the team for Sientra along with the studies to be conducted post approval. The manufacturer’s silicone gel-filled breast implant now joins the league of Allergan and Mentor breast implants used in the US.