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  • Feds want to question new J&J CEO in Risperdal fraud case
    In a motion filed as part of a fraud case against Johnson & Johnson, the federal government alleges that new company CEO Alex Gorsky “was actively involved in matters at issue in this case,” Forbes reports. Government prosecutors charge that Johnson & Johnson paid kickbacks to Omnicare, ...
  • Top Johnson & Johnson officials try to reassure shareholders
    During Johnson & Johnson’s annual meeting, outgoing CEO Bill Weldon and successor Alex Gorsky both tried to reassure shareholders that the company is getting its act together, the Washington Post reports. According to the Washington Post, shareholders were “upset over the health giant’s ba...
  • Article says FDA approval process is flawed
    In a recent article titled “Four Medical Implants that Escaped FDA Scrutiny,” Scientific American takes a critical look at a U.S. Food and Drug Administration approval process that allows dangerous medical devices to be sold in the United States. The article states that the rate of recalls, faul...
  • FDA issues guidelines for medical devices
    The U.S. Food and Drug Administration has issued what the agency is describing as a “first-of-a-kind guidance” to help medical device manufacturers get through the review process for new devices. The FDA is issuing the document, titled “Factors To Consider When Making Benefit-Risk Determinatio...
  • Group says legislation ignores FDA loophole
    According to a news release by the Consumers Union, a Senate committee is scheduled to discuss legislation that would fail to correct a loophole allowing dangerous medical devices to make it onto the market. The Consumers Union is the policy and advocacy arm of Consumer Reports. On April 25, the Sen...
  • FDA defends medical device approval process
    An internal document from the U.S. Food and Drug Administration defends the agency’s rejection of European standards for approving medical devices, according to a report in the Minneapolis-St. Paul Star Tribune. The FDA document amounts to the agency’s defense of its own practices, and describes...
  • Doctor: No advantage to dangerous implant
    In testimony before the U.S. Food and Drug Administration, Dr. Michael Carome called for a ban on all vaginal mesh products, on the grounds that they have no advantages over other forms of treatment, yet cause a host of severe health problems. Mesh implants are used to treat urinary incontinence and...
  • J&J reports profit increase, despite troubles
    Johnson & Johnson reports that its first-quarter profits increased by 12.5 percent, Bloomberg reports. That increase came despite the company’s problems with nearly 30 recalls for a number of nonprescription and prescription medicines, as well as medical devices. That 12.5-percent increase cam...
  • New J&J CEO involved in previous recall
    A Newark Star-Ledger profile of Alex Gorsky, the new CEO of Johnson & Johnson, describes him as “the go-to man” during the company’s 1998 recall of Hismanal, an antihistamine that proved to have dangerous cardiovascular side effects. Gorsky has succeeded previous chief executive officer Wi...
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