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Silicone uptake: Cosmetic surgeons embracing silicone gel — mostly

Article-Silicone uptake: Cosmetic surgeons embracing silicone gel — mostly

NATIONAL REPORT Experts weighing in on the advantages of silicone gel versus saline implants offer equivocating observations. Some say silicone gel breast implants represent a welcome option for informed patients, while others question whether manufacturers have adequately studied silicone's potential risks. Experts also point out that saline isn't going away; some patients will continue to prefer it over silicone.

In November, the Food and Drug Administration (FDA) approved the marketing of silicone gel-filled breast implants made by Allergan Medical (formerly Inamed) and Mentor for breast reconstruction in women of all ages and for breast augmentation in women ages 22 and older.

An FDA press release states, "Now that the products have been determined to be safe and effective, the FDA will continue to monitor them." The FDA is requiring manufacturers to study 40,000 women for 10 years post-implantation (and to continue core studies for 10 years). At the same time, the products' labeling emphasizes risks including rupture and the need for MRIs starting three years after implantation and every two years thereafter.

DIVERGING OPINIONS All but one cosmetic surgeon contacted by Cosmetic Surgery Times applaud the FDA's announcement.

Dr. Rosenberg
The decision "hasn't convinced me the implants are safe. I was comfortable with that based on review of the literature in the last 15 years," says Michael Rosenberg, M.D., a cosmetic surgeon in private practice in Mount Kisco, N.Y. "The FDA's decision has allowed me to have an upfront discussion with my patients and let them choose what's best for them," adds Dr. Rosenberg, who began using silicone for breast augmentation in late November.

Availability was never intended to mean silicone gel implants will suit all patients, he adds. Rather, Dr. Rosenberg says that the availability of silicone implants "empowers women to make well-educated choices and keeps the decision between patient and physician."

Dr. Berman
LONG OVERDUE DECISION Although the MRI requirement "sounds a little excessive," according to Mark Berman, M.D., F.A.C.S., a Santa Monica, Calif.-based cosmetic surgeon in private practice, he says the FDA's decision is long overdue.

"Silicone implants are much more natural, and women tend to like them better," he says. Some women have "gotten it in their heads that silicone is somehow dangerous, so they prefer saline. But in all honesty, if a silicone implant were to rupture, the woman would still preserve her breast mound" while awaiting repairs, whereas the body resorbs saline, adds Dr. Berman.

Nevertheless, some sources are approaching silicone implants with great caution.

"Will I now change to all silicone implants? Absolutely not," says Rod J. Rohrich, M.D., professor and chairman, department of plastic surgery, University of Texas Southwestern Medical Center, Dallas.

Dr. Rohrich
Dr. Rohrich says he'll offer silicone implants only to patients with no breast tissue who have failed other implants. And he'll tell them that, with silicone, "The incision is much larger," and the incidence of implant hardening is significantly higher — five percent for saline, 20 percent to 30 percent for silicone. He adds that, although both silicone and saline implants last 13 to 15 years, "one doesn't know" when silicone implants have ruptured.

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