Does anyone else remember the 90’s and early 2000’s when it seemed like the whole world (OK, just Oprah and perhaps local news sources) were going buckwild about the safety issues surrounding silicone boobies? No? Just me. Anyway, here’s a recap: they weren’t such a good idea back then, and then doctors, ladies, and trannies alike starting turning to saline implants as the solution to bigger boobs. But now, in the year the world might end, according to the FDA website:
…there are now three FDA-approved silicone gel-filled breast implants in the U.S. manufactured by Allergan, Mentor and Sientra.
“Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” said William Maisel, M.D., M.P.H., deputy director for science in the FDA’s Center for Devices and Radiological Health.
“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.” said Maisel.
The FDA based its Sientra approval on three years of clinical data from 1,788 participants. Complications and outcomes reflected those found in previous studies of other breast implants and included tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection.
In June 2011, the FDA released a report that included preliminary safety data from post-approval studies from earlier breast implant approvals. The experience collecting and analyzing data from these studies informed the design and structure of post-approval studies for Sientra breast implants.