Earlier this year, the FDA approved a new type of silicone gel breast implants, with a thicker type of silicone gel on the inside. Although they’re not at all related to the popular squishy colored candy, one surgeon from L.A. nicknamed them “gummy bear implants”, and the name has stuck. Technically, gummy bear implants are more properly known as “generation 5 implants”, or “form-stable gel implants”.
FDA approves Sientra silicone gel breast implants
The firmer gel permits the creation of a teardrop shaped implant, as well as the usual round shaped implant. The teardrop implant is particularly helpful for breast reconstruction after mastectomy. The round implant, made by Sientra, is slowly becoming more popular with our patients who want breast enhancement.
Studies from Europe and the U.S. show that the new implants work well, with a high rate of patient satisfaction. One study suggests that the rate of capsule formation may be slightly less than historical controls – but that finding will need to be checked in a direct comparison study. The main feature that interests patients is the leak-resistance of the firmer gel. Should the implant shell crack or break, the thicker gel is unlikely to leak out and spread into the tissues, according to the manufacturer.
Some worry that the thicker gel may create an overly firm breast. Our experience with these implants is that this concern is not the case – the patients are pleased with their results.
The implants do require a slightly larger incision – but only about another ¼” in length. And the cost of the gummy bear implants is the same as the standard gel implants….unlike some, we don’t up-charge for these new implants.
On the minus side, these implants are relatively new to the U.S. Not all surgeons are convinced of their superiority. In particular, the teardrop implants can rotate within the pocket in 3-5% of patients, leading to re-operation. And some question whether the gel that is firm and cohesive now will maintain those properties as the decades go by. And of course, no implant lasts forever. Follow-up imaging studies are still required for the women that select these implants, just like with standard silicone gel implants.
One of the requirements of the FDA approval of these implants was mandatory follow-up studies for all the manufacturers. So, we’ll get more information as time goes on. But based on European experience and scientific studies, the “gummy bear” implants are a good alternative for both cosmetic and reconstructive breast patients.
If you are interested in breast augmentation with a “gummy bear” implants, please give us a call at the office (407-339-3222) for a consultation with Dr. Fiala.
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