Monday, February 05, 2007

With ban over, silicone is back for implants and women want it

FDA-approved models for breast augmentation are proving popular.
By Ann Wlazelek Of The Morning Call
Fourteen years after health scares prompted lawsuits and a government ban, silicone breast implants are making a noticeable comeback on the cosmetic surgery market.

Fears of leaks, lupus and rheumatoid arthritis dissipated in November when independent researchers found no link and the U.S. Food and Drug Administration approved newer models made with a thicker lining and spill-proof gel.
Since then, area plastic surgeons say more than a dozen patients have asked for silicone instead of salt-water-filled saline implants. And the nationwide demand for breast-enhancing surgery continues to grow.

''Some are asking for the new Gummy bear implants,'' said Lehigh Valley plastic surgeon John Altobelli, a longtime silicone advocate who said the consistency of the new implants resembles that of the confection.

''Yes, they are definitely asking,'' said Dr. Jaime Bastidas, who works at Easton Hospital in Wilson. ''It's not that saline [implants] are bad, but gel implants do have a more natural feel. For some women that's important: how they feel, not just how they look.''

One of those women is a 32-year-old nurse who works in Allentown and asked that her name be withheld for privacy. For her, fear wasn't a factor in choosing silicone.

''They feel more natural and they look better,'' she said. ''I'm not worried about the risks...Obviously they must have worked out the bugs or they wouldn't be back on the market.''

Altobelli, her surgeon, said he never doubted the safety of silicone implants, even in the 1980s and 1990s, when class-action suits were brought against Dow Corning, the leading manufacturer, and nine women had filed complaints against him.

''One by one all were dropped,'' he said of his suits. Not settled, he clarified, ''dropped.''

Dr. Ed Salgado, chief of plastic surgery at St. Luke's Hospital-Fountain Hill, said he was an early proponent of saline implants but also considers silicone safe, largely because the FDA had permitted their continued use in breast reconstruction.

''A healthy 40-year-old could not use them but some poor lady getting chemotherapy for breast cancer who doesn't know her future can,'' Salgado observed. ''It made me think it is defensible to use'' silicone implants.

It's too soon, three months after the ban was lifted, to say whether the demand for silicone nationwide will surpass saline again, says the American Society for Aesthetic Plastic Surgery.

However, interest in breast enlargement surgery, a procedure called augmentation, has not waned in the eight years on record. Augmentation remained the second-most common cosmetic surgery procedure (after liposuction) last year, society data shows. And the number of augmentations ballooned 260 percent, from 101,176 in 1997 to 364,610 in 2005.

But now that options have been restored for women who want larger breasts, surgeons said there is more to consider than ''the feel'' when choosing silicone or saline.

First, a woman must be 22 or older — the age at which breasts have fully developed — to receive silicone implants in augmentation surgery. She also must agree to be followed in studies for up to 10 years. Those are the new FDA restrictions.

Even though several panels of experts, including the Institute of Medicine, found no evidence that silicone implants caused autoimmune or other major diseases, none of the studies predicted the rupture rate or long-term effects past 10 years.

''The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices,'' the FDA's approval statement said, based on the fact that diseases studied were no more common among women with implants than women without.

Silicone implants cost more, about $825 to $875, or twice as much as saline implants, surgeons note. That's important because most women pay the full price, which can run $7,000 or more for the operating room, surgeon, staff and equipment. Insurers don't consider breast enhancement a covered service.

Saline is less dense than the silicone gel, so the clear pouch it comes in can sometimes pucker or ripple in ways that don't look natural and can be seen under the skin.

To compensate, Dr. Edward Guarino said he slightly overinflates implants with saline. And to compensate for the body's tendency to build a scar-tissue capsule around saline implants, Guarino instructs his patients to massage their breasts starting the third day after surgery to prevent the condition.