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ALTERNATIVE TO SILICONE MAY CARRY RISKS/SALINE IMPLANTS

Date: Fri, 25 Feb 2000 09:11:29 -0600

From: icemaidenz@...

IMPLANTS@...

Saline Implants: Safer Choice?

http://www.ABCNEWS.com

When the U.S. Food and Drug Administration banned the use of silicone

implants for cosmetic surgery six years ago, saline implants remained

available, gradually gaining acceptance as the safer alternative. An

estimated 120,000 women this year have received them.

The number of breast implant operations has more than tripled since

the silicone scare of the early 1990s. That's because of the growing

popularity of saline implants — pouches of common salt water that can

be inflated right in the operating room.

But even these implants have had problems. Valves can leak and the

implants have to be removed. That can mean more surgery, more scar

tissue and thousands of dollars more in expense.

The Mentor Corp. is a major supplier of saline implants. Work has

begun on a national class-action lawsuit expected to allege that the

company made defective " leaf valves, " and a separate fraud suit

charges the company did not reveal the extent of the problem.

Valves No Longer Made

_____________________

Executives at Mentor declined to be interviewed. They did say any

suits against the company are without merit, and that the valve

problems were related to certain " surgical and sterilization

techniques " used by doctors.

But a University of Toronto study of failed saline implants,

published last year in the Canadian Journal of Plastic Surgery,

showed that the leaf valves could leak even without those techniques.

Today, the company said there might be other, unknown ways that

doctors can affect the implants. Although Mentor insists its leaf

valve implants were safe, they stopped making them three years ago.

The FDA has cited Mentor for violations in the way it makes its

saline implants. The company has agreed to correct its manufacturing

problems by the end of this month.

What Happens After a Leak?

But there is a second issue, totally apart from this one company.

What happens when any saline implant leaks or ruptures?

In 1992, health authorities reassured women that when that occurs,

what's released is basic salt water, easily absorbed by the body. But

surprising new research at Washington University in St. Louis

suggests that salt water is not always so safe. It can be a breeding

ground for harmful microorganisms.

A look at some saline implants removed from Canadian women suggests

just how contaminated they can become. According to Dr. Leroy Young

of Washington University, if these bacteria were released into the

body, " there would be risk of an infection which would manifest

itself as increase in size of the breast, fever, redness, pain, those

kind of things. "

Mentor says reported infection rates from saline implants are low.

But, says Zuckerman of the National Women's Health Network, " I

don't think anybody knows how often this happens when there are no

studies and no data. Nobody knows. "

That poses a basic dilemma for women — whether there's enough

reliable evidence regarding the safety and effectiveness of saline

breast implants.

Second Opinion columnist and ABCNEWS producer Regush

produced this report.

Sent via Deja.com http://www.deja.com/

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