New York — More than half of nearly 800 women recently surveyed say they are willing to wait for the Food and Drug Administration to approve cohesive gel — or “gummy bear” — breast implants, according to a poll taken by ImplantInfo.com.
The devices, also known as form-stable gel silicone breast implants, are already approved for use in Europe and Canada, but have yet to earn FDA approval. ImplantInfo.com — a breast implant and augmentation information site — reports that manufacturers’ clinical trials for safety and efficacy have generated promising data, according to a statement released by the American Society for Aesthetic Plastic Surgery.
An article posted on ImplantInfo.com quotes Los Angeles plastic surgeon Steven Teitelbaum, M.D., who is involved in the trials, as saying the implants “are longer-lasting and maintain a more attractive and predictable shape, (and) the gel they’re made of is less liquid-like and more solid-like than even today’s other cohesive silicone gel implants.”
Dr. Teitelbaum says other benefits of the implants include their ability to resist gravity, less frequent hardening of scar tissue due to capsular contracture, and the fact that the devices are unlikely to leak. On the other hand, “gummy bear” implants cost more, require longer incisions and may have a firmer texture than other types of implants.
Dr. Teitelbaum told ImplantInfo.com that FDA approval of the devices hinges on product safety. “When fiascos like those with PIP (French implants that were filled with industrial-grade silicone) happen, it delays the process because it worries everyone,” he says. “But the data from (gummy bear) implants are better than for any other implants to date. It seems inevitable that they will get approved.”
But, he noted, “Many people have predicted imminent approval of gummy bear implants for years.”
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