Word: surgitek
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...Sharon Snider pointed out that the agency's analysis was not yet complete and that in any case the 4-in-10,000 figure greatly overstated the risk. "We don't know where those numbers came from," she said. Still, the FDA applauded a decision by the implants' manufacturer, Surgitek, a Bristol-Myers Squibb subsidiary, to halt immediately the worldwide distribution of the products until the investigation was completed...
...layer of polyurethane foam, were considered by many surgeons to be the best on the market. The older, smooth-shelled variety tended to cause surrounding tissue to tighten into a fibrous mass, sometimes leaving the breast misshapen and hard to the touch. But the polyurethane foam coating of the Surgitek products prevented this from happening by substantially increasing the surface area of the implant. When the neighboring tissue contracts, it does not become too compact. Surgeons who have used the models -- which came into widespread use only in the past decade -- swear by it, as do many women. Said...
...problem with the polyurethane is that when left in the body it can be attacked by cells in the immune system that zero in on foreign objects, chewing them up and walling them off. Just how much polyurethane is broken down in this way is not yet known, though Surgitek has estimated that 10% to 30% might disappear within eight years of insertion...
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