FDA officials met with Guidant Corporation representatives because of a company defibrillator that malfunctioned in 26 cases, including one in which a college student died.
The New York Times reports that "the meeting followed the disclosure that Guidant had not informed doctors for three years about a design flaw in the implantable defibrillator." The device is a heart shocker implanted to bring a poorly-beating heart back to functional rhythm.
The Times reports: "Guidant sent out an advisory to doctors nationwide about the device and recommended that it not be removed because of the electrical problem. Guidant said it believed that a substitute device would not perform better ... and that the implant procedure posed risks."
Editor's note: amidst all the discussion about drug safety, consumers should not lose sight of the questions about device safety, and about the number of problems that are only recognized once a product is approved and in widespread use.
Posted by schwitz at May 25, 2005 09:37 AM | TrackBackNot only did Guidant not disclose; also, a doctor with ties to the company solicited support in attacking the "biased" and "shoddily reported" Times article. "In the interest of creating headlines and another NYT scoop," the doctor charged, the Times "has likely caused harm to innocent people." See "Heart Trouble" at http://urielw.com/guidant.htm .
Posted by: Uriel at June 14, 2005 10:47 PMGuidant Defibrillator Recall Information
Posted by: Danny at July 5, 2005 11:09 AM