Implant Switch Uplifts S. Fla.


By Robert Plotkin
The Miami Herald, October 25, 2003

A federal panel's recommendation to lift the ban on silicone breast Implants bodes well for South Florida's plastic surgeons.

For Katina Hudson cosmetic surgery was the answer to her dissatisfaction with the way her B-cup breasts fit her clothes.

But the Pompano Beach resident soon grew unhappy with the D-cup saline breast implants she'd obtained in 1998.

"You were able to see the saline bag," Hudson, 31, said, "I couldn't bend over without someone seeing the sack, the ripples. My husband wasn't happy at all. He could feel the sack." Sometime soon, women everywhere - including those residing in the cosmetic-surgery kingdom called South Florida - may have another choice: silicone.

Last week, after more than a decade of controversy stemming from allegations that silicone implants could prove harmful if they leaked, an advisory panel for the U.S. Food and Drug Administration recommended lifting an 11-year ban on the silicone sacks.

While a final ruling by the FDA may be months away, industry watchers anticipate that, like many fashion accessories, breast implants will soon to retro, circa pre-1992, the year the ban was put in place.

On the day the FDA panel's decision came down, stock for one of the biggest breast-implant manufacturers, the Santa Barbara, Calif. -based Inamed (IMDC), shot up nearly 23 percent, to $84.31. (It closed Friday at $81.90.)

It's not that the silicone ban has in any way tempered the U.S. breast-augmentation business; roughly 237,000 women receive breast implants each year in the United States - a fivefold increase since 1992, according to the American Society of Plastic Surgeons. But doctors believe that having silicone as an option will lure new customers or repeat ones who say consistency of a silicone implant is much more lifelike than the saltwater-filled ones Hudson first received.

Three years ago, Hudson joined the approximately 25,000 women who have used a loophole in the FDA ban to replace their saline implants with silicone ones.

Under a "compassionate use" exception, the FDA allowed plastic surgeons to use silicone implants on women who were receiving reconstructive surgery, including replacement of existing breast implants.

CHRONIC WOES
Many of those women became part of an FDA investigation into complaints, including one from the non-profit consumer-advocacy group Public Citizen's, that ruptured silicone implants were causing chronic ailments.

Even after last week's decision, made after the FDA panel had reviewed several studies, Public Citizen's health research director, Dr. Sydney Wolf, still believes that silicone implants can cause problems.

"When saline ruptures, it is just saltwater; when silicone comes out, the body is highly reactive," said Wolf, an internist. "The benefit is that the silicone gel feels more natural - but that comes at a significant price.

"Inamed acknowledges that 4 percent of its silicone implants rupture within three years. "Some people say the 10 year rupture rate is 3 to 5 percent, and some say it is over 50 percent," said JoAnn Kuhne, the senior director of clinical and regulatory affairs at Inamed, adding that even if silicone were to leak into the body and travel through the lymphatic system, it would be safe.

"The wealth of information shows that silicone is non-toxic and totally bio compatible," she said. "It is in syringes; diabetics get a tiny does of silicone with each injection. There is silicone in dialysis equipment."

Hudson said that she'd been concerned that silicone might be unsafe but that, as she sat in the Aventura waiting room of Dr. Leonard Hochstein with her husband and read the copies of implant medical studies, she became intrigued.

Her decision, she said, was final once she'd visited the home of one of Hochstein's patients and the woman removed her shirt and bra and showed Hudson her new breasts. "I asked her to bend over, to see if there were any ripples, like {with} my saline implants," Hudson said, "She moved into different positions, she did everything for me." Then she said, "No, you have to see how they feel. So I felt her breasts, and they felt like natural breasts."

Hochstein said 60 of the 200 women on whom he performed breast implantation last year chose silicone and agreed to participate in the studies.

NOT INEXPENSIVE
But he predicted that saline-implants sales would not go by the wayside. Silicone implants currently cost $1,000 more.

"Many of the women who are getting breast augmentations are 19 to 22-years old," he said. "The 19-to-22 year olds plan years in advance. They have in mind that they need $1,000 to $5,000, and they save and save and save, and that extra thousand dollars makes a big difference."

For Tara Franchina, 31, of Pompano Beach, the $1,000 price difference proved the deciding factor.

"I know that silicone feels better and is much more natural and softer," Franchina said last week. "If it was $200 more, I would have gotten the silicone, but $1,000 more is too much. I am not a connoisseur of implants. Big boobs are big boobs to me."



About the Author

Article courtesy of Dr. Leonard Hochstein of Miami and Aventura FL, who offers extensive experience in Breast Augmentation, Breast Implants, and Breast Enhancement surgery!

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