Power Morcellation Gets Government Attention

The case of laparoscopic power morcellators is especially disturbing, because a widely used device turned out out to be especially dangerous.

Qmed Staff

Laparoscopic power morcellators, used for 24 years in the U.S. to slice up tissue during laparoscopic hysterectomies and myomectomies, can also potentially spread cancer in women, it turns out.

How did that happen? Even members of the U.S. Congress are asking the question, with morcellators featured in a House Committee on Energy & Commerce hearing this year involving FDA's Jeffrey Shuren (see below). The U.S. Government Accountability Office has also agreed to investigate FDA's handling of laparoscopic power morcellators, The Wall Street Journal reported early this year.

Last year, FDA released a safety communication discouraging the use of the devices because of the possibility that they could inadvertently spread cancer during fibroid removal. Johnson & Johnson's Ethicon subsidiary, the largest manufacturer of the device, also pulled its morcellators from the market last year. Pulled morcellator models included the Gynecare Morcellex tissue morcellator, Morcellex Sigma tissue morcellator, and the Gynecare X-tract tissue morcellator.

FDA's decision to recommend against using the device has been met with pushback from some gynecologists arguing that the procedure is a superior option to major surgery via an abdominal incision for many patients. Other gynecologists believe, however, that the risk of spreading hidden cancer is far greater than the 1 in 1000 risk that was initially assumed -- perhaps being as great as 1 in 276.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz. Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker

Image is of the Gynecare Morcellex Tissue Morcellator, as previously shown on Ethicon's website.