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Currently, the only FDA-approved drug for ischemic stroke victims is tissue plasminogen activator (tPA), which is also given to patients who have suffered a heart attack...
...Waltons" to other film and television work, became progressively sicker with lupus-like symptoms after she'd had her implants for about five years, she says. "I immediately began to feel better after I got them out," she says. McDonough, now a filmmaker, will speak at the FDA meeting and also shoot it for a project she's working on about implants...
...market is booming: about 240,000 women had implants last year to enlarge their breasts, a sixfold increase over 1992. That?s in spite of the fact that women must be told before getting them that saline implants can rupture and deflate suddenly, requiring immediate surgery. When the FDA conducted its first safety review of saline implants in 2000, it ruled they could continue to be marketed "despite relatively high complications and failure rates...
...women who want implants, as well as most plastic surgeons, tend to prefer the more natural look and feel of silicone. They are immensely popular in Europe, points out Inamed executive JoAnn Kuhne. Which is only one reason why it may be an uphill climb for opponents: The FDA says that contrary to popular belief, its approval of a medical device is a risk-benefit analysis to determine whether it?s reasonable to let consumers make their own decisions- not a certification that it is absolutely safe...
...first time the feds have recovered funds to cover the cost of treating implant injuries. A year ago, several agenceis were awarded $10 million as part of the Dow Corning bankruptcy settlement- and also received $100,000 from Inamed, the same company that is the subject of the October FDA meeting. An FDA spokeswoman had no comment on the Medicare lawsuits...