Reported in F.D.A. Deal Would Relax Rules on Reporting Medical Device Problems. (The New York Times, 7/11/2017)
But consumer advocates point to recent problems where initial reports of device malfunctions did not involve any injuries, but later evidence — sometimes additional devices showing flaws or reports indicating patients were harmed — began to surface. They pointed to cardiac defibrillators that ran out of batteries; the power morcellator, designed for laparoscopic surgery to remove uterine fibroids, which spread cancer through patients’ bodies; a type of breast implant that is linked to a rare cancer; and the superbug-bearing duodenoscope, whose design flaws made it virtually impossible to disinfect.
Wall Street Journal graphic found at The Ultimate Guide To Understanding Your Legal Options As A Victim of Uterine Cancer Accelerated By Power Morcellation Surgery. (Greenberg and Bederman LLC)
Power morcellator overview. (Recall Report)