Pharmaceutical

Amendment aims to help protect people from dangerous medical devices

morcellator Amendment aims to help protect people from dangerous medical devices“What happened with the power morcellator should never be allowed to happen again, said Rep. Mike Fitzpatrick, who helped push the so-called 21st Century Cures bill through Congress. The bill boosts federal funding for medical research and changes drug approvals, but it also includes an amendment Fitzpatrick says was inspired by recent controversy over power morcellator devices used during some gynecological procedures.

The amendment aims to protect the public from dangerous medical devices by requiring information such as the make and model number of devices used during a procedure or treatment to be included in medical records to help track patient harm.

Power morcellators are surgical tools fitted with a long tube-like blade that shreds uterine fibroids or entire uteruses inside the uterine cavity and removes the tissue through a small incision in the abdomen. The device was favored by many doctors for hysterectomies and myomectomies (uterine fibroid removal) over open surgeries because it was less invasive, left less scar tissue, and offered shorter recovery times.

In recent years, it was discovered that the devices could spread undetected uterine cancer, worsening a woman’s odds of survival. About one in 350 women have a type of uterine cancer known as uterine sarcoma. The disease is difficult to detect before the tissue is removed. Thus, women who undergo power morcellation are essentially playing Russian roulette.

The Food and Drug Administration (FDA) ordered a black box warning be placed on the devices and recommended that the device not be used for hysterectomies or myomectomies for “most women.”

Rep. Michael Burgess, a former gynecologist from Texas, opposed the amendment, saying he never used power morcellators and argued that doctors who used the devices were at fault.

The bill passed in the House, but there is no parallel bill in the Senate. The Wall Street Journal reports Sen. Lamar Alexander is working on getting a similar measure passed by the Senate health and education committee, of which he is chair, which he would then present to the Senate for a vote sometime next year.

Source: WSJ