Rep. Mike Fitzpatrick is asking the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations to find out why Johnson & Johnson unit Ethicon did not report to the agency concerns that its gynecological tool used to perform hysterectomies and myomectomies (uterine fibroid removal) could cause the spread of uterine cancer, worsening the odds of survival.
Power morcellators are surgical tools fitted with a tube-like blade that shreds uterine fibroids or entire uteruses inside the uterine cavity and removes them through a small incision in the abdomen. In April 2015, the FDA warned that the procedure could spread undiagnosed uterine cancer, known as uterine sarcoma, making the disease more difficult to treat. In November 2015, the agency followed up by placing a black box warning on the device and urging doctors not to use morcellation on “most women” due to the risk of cancer spread.
Fitzpatrick is also asking that investigators question why Brigham and Women’s Hospital in Boston, Rochester General Hospital, and the University of Rochester (New York) Medical Center did not report patient deaths that were linked to power morcellation. Medical facilities are required to report a suspected medical device-related death to the FDA within 10 days after it is determined that a device may have caused or contributed to the serious injury or death of a patient.
Likewise, medical device manufacturers are required to report any deaths or serious injuries suspected to be linked to their devices within 30 days. Fitzgerald says that since neither the hospitals where the deceased patients underwent power morcellation nor manufacturers of the device reported any serious injuries or deaths, the current reporting regulations may be ineffective.
The first report the FDA received about cancer spread concerns with power morcellators was from a family member whose wife had disseminated uterine cancer suspected to have been caused by power morcellation. “Had the regulations worked as intended, it is likely many women’s lives could have been spared from the horrific consequences of morcellation,” Fitzpatrick said.
In 2006, a Pennsylvania pathologist notified Ethicon that about one in 300 women who underwent hysterectomies using power morcellators were later diagnosed with a type of uterine cancer known as uterine sarcoma. However, Ethicon never reported the information to the FDA.
Source: Bloomberg BNA
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