Guest guest Posted October 8, 2004 Report Share Posted October 8, 2004 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/ Quote Link to comment Share on other sites More sharing options...
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