Third “Gummy Bear” Implant approved by the FDA

Posted on July 8, 2013 by Cynthia M. Poulos, M.D.

Mentor Corporation, one of the largest manufacturer of breast implants in the US, announced on June 14, that its version of the “gummy bear” silicone gel implant has been approved by the FDA for women 22 years of age and older, both for reconstructive and cosmetic use. Boston area breast augmentation patients now have one more option for implant choice.

A 6-year study of nearly 1,000 women proved reasonable safety and effectiveness of the implant, with risks similar to other implants of capsular contracture, asymmetry and wrinkling. The FDA requires post-approval studies that focus on long-term safety as it has with other implants.

What’s in a name?

The nickname “gummy bear implants” refers to the consistency of the gel inside the silicone shell. It’s more like a candy gummy bear than other implants. The benefits are supposedly that of a thicker, tighter and firmer breast implant that reduces visibility and rippling, which are issues especially for thinner women, and the assurance that if the outer shell should break, no silicone will leak, as it’s firmer in texture.

The approval of this implant gives consumers three cohesive gel options including the Allergan 410 and the Sientra Highly Cohesive silicone implants.

To your health and beauty,
Dr. Cynthia Poulos
Board Certified Plastic Surgeon in Northborough, near Boston, MA