Plastic Surgery Boca Raton Florida
Becker Breast Implants
M.D., F.A.C.S., F.R.C.S.
Board Certified Plastic Surgeon
Boca Raton, FL

FDA Approves Addition of New Single-Stage Reconstruction Implant to Mentor Adjunct Study


Mentor (Nasdaq: MNTR), announced today that it has been given approval by the FDA to add Smooth Becker breast implants to its Adjunct Study. The Mentor Adjunct Study is a clinical study to give women in need of breast reconstruction access to silicone breast implants through physicians participating in the study. Silicone gel-filled breast implants are investigational devices, limited by law to investigational use. These devices are available only to physicians participating in Mentor’s Adjunct Study.

Mentor is the only manufacturer to offer post-operatively adjustable breast implants for single-stage breast reconstruction. All other reconstruction procedures utilizing breast implants usually require two surgical procedures — the first to place the tissue expander, the second to replace the expander with a long-term implant. The Smooth Becker functions as both a tissue expander and long-term breast implant in single-stage breast reconstruction procedures. The implants have an outer lumen that is prefilled with silicone gel and an inner lumen that can be filled with saline. The fill volume in the saline lumen can be adjusted during routine office visits for up to six months after implantation to give patients their desired result.

Josh Levine, Vice President of Sales and Marketing for Mentor Aesthetic Products, believes the introduction of Smooth Becker breast implants will meet a key patient need. “The Smooth Becker implant allows reconstruction through a single procedure versus the usual two. The introduction of the Smooth Becker implant will provide additional surgical options for both patients and physicians.”

Becker breast implants were originally designed by Hilton Becker, MD, FACS, a board certified plastic surgeon currently in private practice in Boca Raton, Florida. Dr. Becker believes Mentor’s smooth-surface Becker implants may offer many benefits for both physicians and patients. “Breast reconstruction with the Smooth Becker implant may produce a more aesthetically pleasing result due to the post-operative adjustability of the implant.” Dr. Becker goes on to say, “For patients, smooth-surface Becker implants may offer a more normal feeling breast, similar to that of a smooth silicone gel implant.”