Allergan Inc.'s "Gummy Bear" Breast Implants Receive FDA Approval

Published: Mar 20, 2013

JACKSONVILLE, Fla.--(BUSINESS WIRE)-- In February, Dr. Lewis Obi, a board-certified plastic surgeon based in Jacksonville, was notified that the FDA approved the Natrelle 410 “Gummy Bear” breast implants for use in the United States. As a result, Obi has become one of the first plastic surgeons in the U.S. to become certified to use these implants with his patients.

Obi has researched “Gummy Bear” implants for several years. Manufactured by Allergan™, these implants have been used successfully in Europe and Canada for more than a decade. The FDA approved them after reviewing a study conducted on 941 females over a seven-year period. There have been significant complications observed in previous types of breast implants, including implant removal, tightening of the area around the implant, uneven appearance and a high incidence of re-operation and infection. The capsular contracture (hard distorted breasts) incidence is 75 percent less apt to occur with the new implants. Patient approval of the solid shape stable “Gummy Bear” implants is 96.5 percent in primary augmentations.

Obi received his supply of Natrelle 410 implants days after FDA approval and has since performed several surgeries using the new implants. These implants are suitable for women aged 22 or older and are effective both for both cosmetic augmentations and breast reconstruction after mastectomy. There is a slightly greater cost for these implants and the surgical technique has to be executed in a very precise manner. Because of the solid and highly cohesive filler material of the 410 implant, a larger breast fold incision is required for most patients. However, expert placement and incision closure avoids noticeable scars in the vast majority of patients.

Based in Jacksonville, Florida, Dr. Lewis Obi is a board-certified plastic surgeon with an extensive background in aesthetic and reconstructive breast surgery. He established the first licensed comprehensive surgery center in Florida and is one of the few plastic surgeons who integrates a multitude of techniques and technologies in the breast including the use of advanced lasers, stem cell fat grafts and PRP, and the most advanced implants.

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