Months after the U.S. Food and Drug Administration (FDA) warned a medical device could spread deadly uterine cancer, many doctors and hospitals are still using it.
The power morcellator made by Johnson & Johnson (J&J) was removed from the market after the FDA warned it could spread undetected uterine cancers.
A report in the Wall Street Journal says some gynecologists are still using morcellators to remove fibroids from the uterus, despite the FDA warning and J&J recall.
In a small number of patients the fibroids actually mask a hidden sarcoma. The morcellator grinds the fibroids, as it’s designed to do, and in the process can also spread an undetected cancer, increasing a patient’s risk between one in 300 to one in 1,000, reports the WSJ.
Who is continuing to use the morcellator?
Atlanta Gynecologist Michael Randell says he has never seen a case of spreading the uterine cancer called leimyosarcoma. He still uses the power morcellator but sometimes put a bag around the tool to hopefully collect stray bits of tissue.
Dr. Jeffrey Thurston, a Dallas gynecologist, believes the risks have been overblown and the FDA should not interfere with patient care. Dr. Robert Graebe, from Monmouth Medical Center in New Jersey, at first disagreed with the FDA but now thinks the medical device should be proven safe before it is put back into use.
ACOG (American College of Obstetricians and Gynecologists) says many doctors defend the use of the morcellator with more patient informed consent.
While the Johnson & Johnson morcellator is off the shelf, a competitor Richard Wolf GmbH, is picking up the slack.
Read the story in the Wall Street Journal and download a free eBook Deadly Medicine about the medical doctor who was diagnosed with advanced cancer after her morcellating procedure.