New breast implants claim break resistance
by Patricia Anstett - Detroit Free Press - 20 July 2004
A new generation of breast implants, available in Europe but limited to small studies in the United States, promises to be more resistant to rupture, say doctors involved with studies of the new devices.
Cohesive gel breast implants are made with a solid type of silicone. It has the consistency of a soft cheese, whereas silicone gel is more liquid. Cohesive gel implants have been used in Europe since 1993, but they're limited to use by about 50 U.S. physicians through clinical studies.
"It's much softer than saline implants and looks more natural; our patients are very happy with it," says Dr. Eti Gursel, chief of the plastic surgery division at Harper University Hospital, Detroit.
Unlike current silicone breast implants, which use devices within a separate silicone shell, cohesive gel implants have an integrated design that blends the shell with the implant to reduce the risk of rupture of the devices, says Dan Cohen, vice president for global government affairs for Inamed Corp., a Santa Barbara, Calif., implant manufacturer.
The more solid gel also allows the company to provide more shapes and styles, he says.
Doctors in Sweden and Denmark have implanted 3,700 cohesive gel devices since 1995, with only one instance of identified rupture, Cohen says.
Inamed hopes to present information from the studies later this year to the federal Food and Drug Administration. It is seeking approval to sell the devices, Cohen said.
Saline implants -- devices filled with saltwater in a silicone shell -- have been the main type of implant used in breast augmentation and reconstruction since 1992. That year, the FDA restricted silicone gel breast implants to research studies, citing concerns about rupture and other problems.
Earlier this year, the FDA rejected Inamed's bid to return silicone gel breast implants to the market. The company expects to respond later this month to the FDA with information the agency requested, Cohen says.
Dr. Dennis Hammond, a Grand Rapids plastic surgeon, has implanted the cohesive devices in more than 50 patients, also with good results, he says. He reported his findings at the recent annual meeting of the American Society for Aesthetic Plastic Surgery.
Previous gel implants were prone to rupture and leak, Gursel and Hammond say. "You almost can push through the implant and touch finger-to-finger," Hammond says.
Ruptures would occur when wrinkles formed in the implant, creating a weak spot in the implant shell. "The new implant doesn't wrinkle and the gel is so thick it resists rupture," Hammond says.
Saline implants, the primary kind used in breast augmentation and reconstruction surgery since the FDA ruling in 1992, "give a more rounded look, not a teardrop shape," Hammond says.
They also are more prone to wrinkle in thinner women, he says. A disadvantage is that the firmer implants may be costlier and may not provide "the perfect projection" to the breast, Hammond says.
Most doctors are taking a wait-and-see attitude toward the new gel implants. "Up to now, I haven't seen any credibile multi-center data or any studies on their safety features, only reports of individual small experiences," says Dr. Mary McGrath, a plastic surgeon at the University of California, San Francisco.
Whether the more solid type of silicone will avoid problems remains to be seen, implant critics say.
Diana Zuckerman, president of the National Center for Policy Research for Women & Families, a Washington D.C., resource organization, says questions remain about the new implants, including whether the gel will liquefy several years after surgery. Until answers are provided, "a woman is taking a risk with a product that's new and hasn't been tested for a long time," she says.
