Dr. Diana Zuckerman on Silicone Breast Implants 5/6/2007

EXCERPT: A national survey by the research center found that breast
MRIs cost about $2,000 each. Insurance companies don't cover them.

"If you're going to approve an implanted device that you know is going
to break, I think that's a problem," Zuckerman said.

"All breast implants break eventually. That's the one thing that
everyone agrees on."

And Zuckerman said she is not convinced that silicone gel that leaks
from implants won't cause health problems.

~~~~~~~~~~~~


Silicone implants make big comeback
Despite controversy, women prefer them

http://www.columbusdispatch.com/disp...1_SG6JSFT.html
Sunday, May 6, 2007 3:43 AM
By Misti Crane

THE COLUMBUS DISPATCH
After a 14-year absence fueled by lawsuits and safety concerns,
silicone breast implants returned late last year and have been met
with enthusiasm in many plastic surgeons' offices.

Women undergoing their first surgeries are choosing the silicone
gel-filled enhancers. Others are swapping out saline implants for
silicone.

Most doctors and patients who prefer silicone say the implant feels
more natural. It also costs about $1,000 to $1,500 more than saline.

Cost is one thing Dr. Christine Sullivan mentions when she tells
patients the possible downside of silicone. The others are the
psychological issues associated with the bad press silicone had for so
many years and how hard it is to detect a ruptured implant.

As many as 90 percent of her patients are choosing silicone now that
it's back, she said. And most of those who've had saline implants are
switching to silicone.

Sullivan works at the Sullivan Centre on Olentangy River Road near
Powell, where she performs about 80 breast augmentations each year.
She said patients' chief frustration with saline implants is that they
break often.

She's comfortable with the safety of silicone.

But some women's health advocates question whether patients really
know what they're getting into, including likely follow-up surgeries
to replace ruptured implants and possible complications.

They say the U.S. Food and Drug Administration should not have
approved silicone implants.

The breast business is big: 329,296 women underwent augmentation
surgery last year in the United States, the American Society of
Plastic Surgeons says. A decade earlier, the figure was 87,704.

When the FDA approved silicone implants in November, the decision came
with a requirement that each of the two manufacturers study about
40,000 women for 10 years.

It also came with a recommendation that women have MRIs every other
year to check for ruptures. When saline implants break, women know
right away. When silicone implants break, women and their doctors
often can't tell.

The response to silicone's return to the market has been relatively
strong but varies from region to region and practice to practice, said
Dr. Richard Greco, a spokesman for the American Society of Plastic
Surgeons.

Greco, who practices in Georgia, is like most other plastic surgeons
who are convinced silicone is safe. They say that there is no proven
scientific link between the implants and problems some women have
attributed to them, including neurological problems and arthritis.

The primary risks with either type are infection, rupture and a
condition called "capsular contracture," in which hard scar tissue
develops around the breast and tightens and squeezes it. Other
potential side effects include breast pain and changes in nipple
sensation.

Neither type of implant is designed to last a lifetime.

In a four-year study by the implant maker Allergan, 41 percent of new
implant patients had a significant complication within four years.
That includes 23 percent who needed another operation to fix the
problem.

In Europe and elsewhere, silicone has been available for years and is
the preferred option for most women.

Dr. Dexter Blome, who practices at the Cosmetic Surgery Center of Ohio
on the Far East Side, said he reviews the ups and downs of each type
of implant.

He said silicone often works best for thin women, who have less tissue
over the top of the implant. That can make ripples in saline implants
more visible.

Dr. Rafael E. Villalobos said he has done three silicone augmentations
in his Bethel Road office. He'll be a bigger advocate of silicone
after the manufacturers have enough women for their studies, he said.
"I think there's still quite a bit of hesitancy" about safety.

Villalobos is convinced silicone is safe but isn't pushing it
strongly. The gel implants are more expensive, require a bigger
incision and come pre-filled, which makes it a little more difficult
to create symmetry in some women, he said.

The first women to have the implants have to be part of the company
research, too, meaning they'll have to participate in surveys, have
blood tests and undergo MRIs, he said. "It's a little bit burdensome."

Diana Zuckerman, president of the nonprofit National Research Center
for Women and Families, said she's particularly concerned that few
women will have the recommended MRIs to look for ruptures.

A national survey by the research center found that breast MRIs cost
about $2,000 each. Insurance companies don't cover them.

"If you're going to approve an implanted device that you know is going
to break, I think that's a problem," Zuckerman said.

"All breast implants break eventually. That's the one thing that
everyone agrees on."

And Zuckerman said she is not convinced that silicone gel that leaks
from implants won't cause health problems.


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www.BreastImplantInfo.org Dr. Zuckerman's Website

www.BreastImplantAwareness.org Humantics Foundation Website