Bravo Dr. Zuckerman! Silicone, saline choice still confusing

[Guest guest]

EXCERPT:

"Getting silicone breast implants (without the

MRIs to detect ruptures) has greater risks than sky diving," says

Zuckerman, president of the nonprofit research and education

organization.

"The thing that's so dangerous about silicone

breast implants is that things can seem absolutely fine. But in time,

they can break inside the body and might leak," she says. "We don't

actually know what those (leakage) risks are. But, we do know that

two-thirds of the time, you can't detect a rupture (without an MRI)."

Because there's no way to enforce FDA

recommendations, she believes most women won't follow through, either

because they can't afford it or because they don't think there's

anything wrong.

"Right now, I think the biggest issue for women

making a decision about silicone breast implants is 'Can I afford an

additional $10,000 to $20,000 (for MRIs and possible replacement

surgeries) over the next few years?' " Zuckerman says.

The FDA will continue its review of the

silicone implants, requiring the manufacturers to study their effects

on 43,000 women for 10 years after surgery.

http://www.signonsandiego.com/news/health/20061226-9999-1c26saline1.htmlBy R.J. Ignelzi UNION-TRIBUNE STAFF WRITER December 26, 2006 After 14 years, women who want to surgically add more curves to their figures again have a choice: saline or silicone.

However, those who opt for the newly approved

silicone breast implants may find their choice is padded in confusion,

frustration and added costs.

Last month, the Food and Drug Administration

lifted its ban on silicone gel implants, dismissing concerns about

harmful effects from leaks as unsupported by extensive testing. But the

agency, along with manufacturers of the implants, urged women to

undergo a special magnetic resonance imaging (MRI) every couple of

years "over a woman's lifetime" to detect ruptures. The series of MRIs

could cost women $10,000 in the first 10 years, on top of the costs of

the original cosmetic surgery, usually $5,000 to $8,000.

If any break in the implant's seal is detected,

"the implant should be removed and replaced, if needed," the FDA says

and tells women to expect at least one additional surgery to remove or

replace faulty implants. No such recommendations are made for saline

breast implants.

Because breast augmentation is a cosmetic

procedure, medical insurance does not pay for the original surgery,

testing or repeat surgeries.

"What was a relatively inexpensive way for a

young lady to feel better about herself can now become very expensive,"

says Dr. Bodor, chief of plastic surgery at the VA Medical

Center in San Diego and an assistant professor of plastic surgery at

the University of California San Diego School of Medicine.

Breast augmentation is one of the top three

cosmetic surgeries for women. Nearly 300,000 women got breast implants

in 2005 in the United States, according to the American Society of

Plastic Surgeons.

The FDA had banned silicone gel implants for

cosmetic use in 1992, amid worries that the devices were rupturing and

the leaking silicone caused or contributed to autoimmune disorders,

including lupus, multiple sclerosis and rheumatoid arthritis. The

silicone gel moratorium never applied, however, to women getting

reconstructive surgery after cancer.

For the past 14 years, most women who wanted

breast enhancement used implants filled with saline, which is less

popular than silicone because it doesn't look and feel as much like

natural breast tissue.

The FDA doesn't recommend regular testing to

detect leaks in the saline implants because if one breaks, a woman

knows it. A leak in a saline implant causes it to noticeably deflate as

the salt water is absorbed into the body. The broken implant is then

surgically removed and a new one inserted.

When a silicone gel implant breaks, nobody may

know. Called a "silent rupture," it can go unnoticed, because the

cohesive gel usually stays within the capsule of scar tissue that forms

around the implant. The fear is that the gel may migrate to other parts

of the chest or underarm area. Only a special breast coil MRI can

adequately detect small breaks or tears in the implant.

Despite rupture risks, some plastic surgeons have never had concerns about the safety of silicone implants.

"I never doubted that silicone was a problem. I

personally did around 125 pairs of silicone implants a year for eight

years (before the 1992 ban), and never saw any problems that had to do

with cancer or immune or arthritis problems," says Dr. Roark,

plastic surgeon at the La Jolla Cosmetic Surgery Centre.

Dr. Ross Rudolph, a Scripps Clinic plastic

surgeon, says the concern over silicone implants "never made a lot of

sense to me." He notes that silicone was considered safe enough to be

used for reconstructive surgery, and that the outer envelope of saline

implants is made out of silicone.

"A lot of the negative press (about silicone

implants) wasn't really fed by science. It was fed more by fear," Bodor

says. "I think most doctors will probably recommend what the FDA

recommends ... but I think it's best to base this surveillance on a

less dogmatic and a more individualized program."

Some plastic surgeons, however, aren't convinced that the MRIs are necessary.

"As a matter of practicality, I won't push

anyone to get MRIs. There's no science in that. It's simply an

outgrowth of the restrictions of the FDA," Roark says. "Why do we have

to do this now after 40 years of augmentations? I am certain that is

just a political maneuver. The only reason someone would do MRIs

without any medical indication is (because of) fear."

Some consumer health groups like the National

Research Center for Women and Families in Washington, D.C., warn that

not following the FDA's MRI recommendation could be dangerous.

"Getting silicone breast implants (without the

MRIs to detect ruptures) has greater risks than sky diving," says

Zuckerman, president of the nonprofit research and education

organization.

"The thing that's so dangerous about silicone

breast implants is that things can seem absolutely fine. But in time,

they can break inside the body and might leak," she says. "We don't

actually know what those (leakage) risks are. But, we do know that

two-thirds of the time, you can't detect a rupture (without an MRI)."

Because there's no way to enforce FDA

recommendations, she believes most women won't follow through, either

because they can't afford it or because they don't think there's

anything wrong.

"Right now, I think the biggest issue for women

making a decision about silicone breast implants is 'Can I afford an

additional $10,000 to $20,000 (for MRIs and possible replacement

surgeries) over the next few years?' " Zuckerman says.

The FDA will continue its review of the

silicone implants, requiring the manufacturers to study their effects

on 43,000 women for 10 years after surgery.~~~~~~~~

www.BreastImplantInfo.org (Dr. Zuckerman's site)

www.BreastImplantAwareness.org/Holidays2006.html