FDA Nod Followed By Adoption Of Allergan’s “Gummy Bear” Breast Implants

Dr Obi with Gummy Bears

In short

Manufactured by Allergan™, Natrelle® 410 “Gummy Bear” breast implants have been used successfully in Europe and Canada for more than a decade. Last month we reported their clearance for market in the United States. Now we report on uptake.

Background

The FDA approved Allergan’s Natrelle implants based on a study conducted on 941 females over a seven-year period. According to a Florida plastic surgeon, Dr Lewis Obi, these implants address some of the 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 reportedly 75 percent less apt to occur with the new implants. Indeed patient approval of the solid shape stable “Gummy Bear” implants is 96.5 percent in primary augmentations.

The implants are suitable for women aged 22 or older and are effective both for both cosmetic augmentations and breast reconstruction after mastectomy. According to board-certified Obi, 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.

Obi received his supply of Natrelle 410 implants days after FDA approval and has since performed several surgeries using the new implants.

Source: Business Wire