ParfumGigi@aol.com

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.

FDA-approved models for breast augmentation are proving popular.

By Ann Wlazelek Of The Morning Call

Breast enlargement surgery takes about the same amount of time whether the implant is saline or silicone, and patients are generally sent home the same day. But saline implant patients might heal a bit faster because their implants can be placed through a smaller incision than those containing silicone gel.

That's because saline implants arrive as empty pouches. Surgeons roll and fold the pouches into a smaller size that can easily fit through a small incision. The doctors then inflate them once they are in place.

Silicone, especially in its new gel form, cannot be folded or rolled. So the incision must be about an inch larger to accommodate the full size of the pouch.

During the nurse's operation Jan. 25, Altobelli made about a 3-inch curved incision directly under each breast, where a natural fold might occur. After creating a pocket under each pectoral muscle, he used a finger to gently push each lubricated implant through the opening and into place. The result was natural-looking: The edges of the pouches were not visible.

Guarino, who prefers saline, said he can achieve the same look without incisions on the breasts, by entering through the armpit and inserting the implant under the breast muscle. The technique cannot be done with gel-filled implants.

He also finds that saline affords him and his patients a bit more flexibility for adjusting breast size. Most women are not even, Guarino said. One breast is slightly larger or smaller than the other. With saline, surgeons can add more to one implant, less to another to make the breasts more symmetrical.

Because silicone implants come already filled, their size cannot be adjusted, he said.

Guarino acknowledges that his preference for saline probably persuades most of his patients to make that choice. At Sacred Heart Hospital in Allentown, where he operates, 99 percent of the augmentations he performs involve saline implants.

Salgado said he's been happy with saline implants but now offers silicone gel as an option for women who are slender or who want a big increase in breast size.

''Silicone minimized the inevitable rippling when there's not a lot of fat covering the implants,'' he explained.

Salgado said having to explain the reasons silicone was off the market for so long puts him on the defensive. But truth be told, he added, ''There was nothing wrong with silicone from the very start.''

Dr. Robert X. Murphy said he prefers to give patients information on benefits and risks and let them decide. The plastic surgeon at LVH acknowledges he is not as ''pro silicone'' as some of his colleagues but still has no concerns about implant health risks.

''When Dow was sued and went bankrupt, a couple of bad corporate decisions made them look really bad,'' Murphy said. ''That's why silicone was pulled for cosmetic cases but never for reconstructions. It's a superior product for breast replacement.''

One woman, who used online information to weigh the pros and cons of silicone implants, said she found the FDA's stance so ''gray'' that she chose saline instead.

''They said there's no proof [silicone] causes disease yet women who get them must be followed for 10 years,'' said the 24-year-old from Whitehall Township, who also requested anonymity for privacy reasons. ''I really did want them but I worried that every time I'd get a pain I'd be wondering if it was the silicone.

''I don't regret that I got the saline,'' she added. ''I regret that I let the gray stuff scare me.''

Irma Rivera Gonzalez, an Allentown woman who is still fighting for compensation on a 1994 claim that her ruptured silicone implant led her to get lupus, said she would not choose silicone if given the choice again.

''I don't believe it,'' the 52-year-old said of the science that ruled silicone safe. The saline implant replacements she received in 1995 were better, she said.

Still, the nurse who chose silicone for her augmentation said she's thrilled with her decision and the result. ''I'm small, 110 pounds. I was disgusted with never having clothes that fit,'' she said. ''Now, I look a hell of a lot different. I'm thrilled.''

Surgeons say regardless of the reasons, the fact that women have a choice again is a good thing.