Word: fda
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Dates: during 1990-1999
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Kessler's decision is based on evidence -- some of it still sealed under court order -- that has come to light since the FDA last reviewed safety information in November. At that time, an advisory committee recommended that the implants be left on the market. But studies released in the course of recent legal proceedings against Dow Corning Wright, the largest U.S. implant manufacturer, suggest that the company may have known about safety problems for years and kept them under wraps. Kessler said he has also received a number of case reports from rheumatologists linking the device to autoimmune disorders...
...despite similar accounts from hundreds of women, scientists have yet to prove conclusively that implants are responsible for their woes. Critics of last week's FDA ruling, including many doctors, contend that the agency may have needlessly raised women's fears before convincing evidence was in. Cole feels that despite the court order, Kessler should have released the new information to the medical community before calling the moratorium. "We're getting hundreds of calls from women who want to know what this new information is, what it means," he said, adding that some women may avoid getting suspicious breast lumps...
...Calif., had implants inserted three years ago after a double mastectomy for breast cancer. Now she says, "I'm frightened. At this point, emotionally, I don't know how I could take another operation." Cindy Pearson, of the National Women's Health Network in Washington, has been pushing the FDA to act on this issue since 1983, and she is livid: "They've allowed over half a million women to get into this horrible quandary because they didn't order long-term studies earlier. If this were heart valves, or anything used by both sexes, the FDA wouldn't have...
...RECONSTITUTED FDA...
...Food and Drug Administration was a federal backwater best known for being slow to approve potentially life-saving drugs. The agency gained some respect in 1991 as new commissioner David Kessler took aim at the food industry, insisting that nutritional claims on labels be based on scientific fact. The FDA seized brand-name products like Procter & Gamble's Citrus Hill Fresh Choice orange juice that failed to meet strict standards...