Word: fda
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Dates: during 1990-1999
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Last week an expert medical panel appointed by the FDA did its best to close out the debate. The panel declared that allegations of safety risks are inconclusive at best and recommended that the implants remain on the market. However, because so much uncertainty remains, the experts urged doctors to use the devices only for reconstruction after surgery; tight restrictions were placed on using them for breast augmentation. That would exclude up to 80% of women who have historically received the implants. The recommendations are subject to approval by FDA Commissioner David Kessler, who typically follows the advice...
...million women who already have implants ought to check their breasts regularly for any change in shape or texture that might indicate rupture, the panel advised. Torn sacs should be removed immediately. In the meantime, the FDA and Dow Corning are planning intensive safety studies to resolve lingering doubts. Unfortunately, preliminary data will not be available for two to three years. That is a long wait for assurances that should have been part of the package years...
...large degree, Dow made a virtue of necessity. The FDA had threatened to make the documents public anyway, and some of the most damaging information had already leaked to the press. Still, the firm's moves last week reflected a new public relations savvy, if not a heightened corporate conscience. First it stopped the hemorrhaging of bad news by putting out all the documents at once. A few hours later, it announced the bold management changes...
...Corning's new chairman, Keith McKennon, a veteran of Dow Chemical's Agent Orange and dioxin crises, promised to cooperate with the FDA and hinted that the company might even help women who wanted their implants removed and could not afford the surgery. But Dow Corning's problems are not over. Last week a congressional committee asked for a criminal investigation into the firm's handling of implants. Among the evidence: a 1980 memo from a Dow Corning salesman complaining that the company's decision to put "a questionable lot of mammaries on the market . . . has to rank right...
...FDA has been irresponsible. They've had jurisdiction since 1976 and they've been dragging their feet," said Dr. Nicholas E. O'Connor, a plastic surgeon at Brigham and Women's Hospital. "They're not releasing information on how risky it is, and they haven't said what [doctors] should...