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    Breast Implants: The Controversy Continues


    The majority of the controversy over implants has surrounded those filled with silicone. But both saline and silicone-filled implants have a silicone shell. The theory goes that if the saline implants leak, deflate, or rupture, which they often do, they would release only salt water and not silicone into the body.

    Thus, saline-filled implants were allowed by the FDA to remain, on the condition that the manufacturers prove their safety at some point in the future. That point comes now with the advisory committee meetings this week. No matter what's in the shell, it's undisputed that implants can pose risks for the woman in the vicinity of the implant. In a previous interview with WebMD, Leroy Young, MD, a professor of surgery at Washington University in St. Louis, spoke about the likelihood that implants will eventually rupture. "I tell most of my patients that their implants probably will have to be replaced over the next 10 years," he says.

    That brings up additional risks that always accompany surgery, such as anesthesia complications, infection, abnormal bleeding, or clotting, whether for the first surgery or a follow-up operation. According to the FDA, implants of all types can also cause what's called "capsular contracture," which is the hardening of the breast due to scar tissue around the implant. The result can be temporary or permanent change or loss of sensation in the nipple or breast tissue, formation of calcium deposits in surrounding tissue, shifting of the implants, or interference with mammograms.

    So whatever the FDA decides about saline implants, an element of risk will always be associated with them. In a letter the agency sent to the chairman of the Commerce Committee, which oversees the FDA, a 1997 study in The New England Journal of Medicine was cited that found infections occurred in 2.5% of women undergoing implants. "Other local complications include rupture, pain, ... and disfigurement, all of which may lead to medical interventions and repeat surgeries," the letter stated.

    And don't expect silicone-filled implants to fall off the front page. Many women reportedly say they're more satisfied with them than the saline devices. And in that same letter citing implant complications, the FDA stated there's a need for silicone gel-filled implants, at least for reconstruction following breast cancer surgery. "Saline-filled breast implants and new breast surgical techniques are not adequate for all women," the letter stated. "There continues to be a public health need for silicone gel-filled breast implants."

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