Dr. Paul Wigoda Reviews New FDA Approved Silicon Breast Implant Gels

saline vs. silicon

Painless breast implant specialist Dr. Paul Wigoda says he will wait a couple years to see how the Sientra brand of silicone gel-filled breast implants perform before adding them as an option for his breast surgery patients.

Although breast implants have been around in one form or another since the 1960’s, only two silicone-based implants have made the U.S. Food and Drug Administration’s (FDA) short list of approved devices. But women looking to enhance their figures now have a third option available to them. The FDA recently released a statement announcing the conditional approval of a silicone gel-filled breast implant by Sientra, Inc.

The approval is based on clinical trials conducted over three years with 1,788 participants. The results of these studies fell in line with other breast implants already on the market. However, the approval from the FDA is based on additional studies that will measure the long-term effects or complications that may arise from using the product.

William Maisel, deputy director for science at the FDA’s Center for Devices and Radiological Health stated that the data indicates there was reasonable assurance of safety and effectiveness but that women should still endeavor to fully understand the risks associated with breast implants before undergoing a breast augmentation procedure. But the real question is how eager are plastic surgeons to try out these new implants?

“It’s always nice to have more options and for there to be competition between businesses so they strive to provide the best products possible. The two primary breast implant companies today are Allergan and Mentor. Both of them have excellent products that have been tested over many years,” comments Fort Lauderdale Plastic Surgeon Dr. Paul Wigoda, “With any new implant I personally would wait a few years to see how it performs before I’d use it on a patient. If these new implants are found to be better in some way than what the other companies offer, then it certainly would be something I’d consider using. At this time I don’t know of any reason to change from the implants I currently use.”

While it is always nice to play with a shiny new toy when you first get it, sometimes it’s good to stick with the tried and true for awhile. If you are thinking about breast augmentation surgery, talk to an experienced plastic surgeon like Dr. Paul Wigoda about the many options currently available to you.