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Next-generation products are already in use in Europe and Canada.

By COLIN STEWART

Allergan calls it the "Style 410." Mentor calls theirs the "Contour Profile Gel." And its technical name is the "cohesive gel implant."

But if and when it becomes available on the American market, it'll probably get a catchier nickname – "gummy bear."

The 'it,' in this case, is the next generation of breast implant.

At present, the only types of breast implants available in the United States are silicone and saline. But if implant makers like Irvine-based Allergan and Santa Barbara-based Mentor get their way, the U.S. Food and Drug Administration will let them market the gummy bear domestically within a year. It's already a hot seller in Europe and Canada.

Allergan has been testing them since 2001 and Mentor started its testing in 2004. A third company, Brazil-based Silimed, is also preparing to seek U.S. approval to sell its gummy bear implants, but its trials are not as far along as the others, says Steven Teitelbaum, a Santa Monica plastic surgeon who is part of the trials for all three companies.

As the nickname suggests, gummy bear implants are made from a thick, flexible gel, which is contained within a layer of plastic. The gel is made of silicone, but the consistency is such that it can't easily leak into the body if the implant's outer layer cracks.

That potential for leakage is one of the FDA's most serious concerns about current models of silicone implants. The FDA banned them for years while it evaluated women's complaints that leaking implants had ruined their health.

The first cohesive gel implant was Style 410, developed in 1993 by Inamed Corp. of Santa Barbara, which is now part of Allergan.

But the early 1990s was a lousy time for silicone implants, at least in this country, because the FDA was in the process of banning them.

That ban was lifted last year when the FDA decided that leaking silicone from ruptured implants probably does not cause disease.

But the FDA required Allergan and Mentor to continue studying silicone leakage for 10 years, and to watch for health problems such as chronic pain. The FDA also warned people with silicone implants to get regular MRI scans to check for leaks.

Because of the U.S. controversy over implants in the 1990s, Style 410 was introduced in Europe.

"It was well-received and still is very popular there," Las Vegas plastic surgeon Samir Pancholi told cosmetic medicine professionals in a conference last spring.

He called cohesive gel implants "as close as we have to the ideal implant."

Plastic surgeons cite these advantages:

Minimal problems with folding and wrinkling, which can affect other types of implants.

Fewer incidents of a painful condition where the body builds up a capsule of hard tissue around the implant, said Teitelbaum, who has implanted "gummy bear" models in about 500 patients in the past six years.

Less chance of problems from a ruptured implant. "You can pretty much cut it in half and not worry about any silicone migration," Pancholi said.

Leaking isn't a deciding factor for most breast-implant patients, says Dr. Donald Altman, chief of plastic surgery at Irvine Regional Hospital and Medical Center.

If a silicone implant needs to be replaced, most patients will replace it with an identical one, he says.

Surgeons cite some disadvantages of gummy bear implants:

They are slightly more rigid than current silicone implants. "It's not rock-hard, but it is a little bit firmer," Pancholi said. That makes them inappropriate for women with lax breasts, Teitelbaum said.

Surgeons must make a larger incision to insert them into the breast. And because cohesive gel implants are less flexible than other varieties, the cut must be at least 5 centimeters. In contrast, a silicone implant on the market today requires a 4- or 5-centimeter incision. Saline implants, which are inserted empty and then filled with a syringe, need only a 3-centimeter incision.

Gummy bear implants are expected to cost more than current models, although prices haven't been announced.

Contact the writer: cstewart@ocregister.com or 714-796-7841

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