A federal panel’s recommendation to lift the ban on silicone
breast Implants bodes well for 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 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 – 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, 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.