FDA Approves New “Gummy Bear” Implants

Cincinnati, Ohio – June 10, 2013 – The FDA has recently approved the new “form stable” or “highly cohesive” silicone breast implants. Often referred to as “gummy bear” implants, these highly cohesive implants have been in use throughout Europe, Canada and other parts of the world for 18 years.

Dr. Joel Maier, a plastic surgeon who practices at Advanced Cosmetic Surgery & Laser Center in Cincinnati, is particularly enthusiastic about these new implants, and their potential use in breast reconstruction surgery. Says Maier, “I recently performed my first reconstructive breast surgery on a mastectomy patient using the form stable implants with tremendous results. Because the breast tissue in mastectomy patients has been completely removed, the highly cohesive implants are inserted into the breast pocket, which works exceptionally well. The inserts are teardrop shaped, firmer, slightly tapered, and tend to hold their shape much better than the traditional smooth silicone implants, particularly for mastectomy patients. Additionally, the manufacturers, (Allergan, Mentor and Sientra), indicate that there is less chance for leakage if ruptured, as the silicone layering is a bit thicker than with traditional gel implants.”

Maier adds, “The incision for a “form stable” breast implant is approximately 6cm, versus, 4cm for the traditional gel implant. However, mastectomy patients already have large incisions from the breast removal, so this should not be a huge concern. The new implants are also slightly more expensive, but then again, if the procedure is reconstructive rather than cosmetic in nature, insurance should cover the incremental charges.”

Says Maier, “The reconstructive surgery itself takes about one hour per side, whether using the form stable implants or original smooth implants. One major difference is that during reconstructive surgery, the first stage involves insertion of a tissue expander where saline is added gradually in small increments, rather than all at once. A mastectomy patient has weak blood supply in the area from which the breast has been removed, and it is important to not put too much tension on the skin at the onset. For this reason, we monitor the patient closely, and add small amounts of fluid every few weeks via a small valve located within the implant over a three-month period.”

Maier predicts that most patients seeking cosmetic breast augmentation surgery will still prefer the traditional smooth implants. Also, there are some technical and patient selection nuances in using the new implants so plastic surgeons are likely to select only the best candidates initially. This will likely be a patient who is undergoing augmentation for the first time, wishes to have proportionate breasts for her body, and is concerned about having a natural slope to the upper pole of the breast. More complex situations where form stable implants may be beneficial are in patients experiencing visible rippling, or who have capsular contracture, (hardening of the breast implants). Says “Maier, “One situation where form stable implants is not recommended is in patients who have laxity and sag in their breasts which may also need a lift. I believe that the more flexible standard silicone implant is still a very good choice for most patients seeking cosmetic enhancement.”