The House of Representatives passed a bill earlier this month that would create a more stringent system for monitoring the safety of certain medical devices, such as laparoscopic power morcellators, by ensuring that make and model numbers are recorded and correlated with patient outcomes.
According to a statement from the office of Rep. Mike Fitzpatrick (R-PA), who authored the amendment adding the provision to the so-called “21st-Century Cures” bill, such identifiers “are not incorporated into all electronic health records, which makes it difficult to fully achieve … benefits to patient safety.”
There has been quite a bit of controversy lately over gynecological use of morcellators, which are used to cut up uterine growths such as fibroids (the average uterus has between six and seven fibroids) so that the tissue can be removed through very small incisions. These minimally invasive procedures, usually done as part of hysterectomies, were done by the tens of thousands until the FDA warned last year that women who undergo them have a 1 in 350 chance of having undetected uterine sarcoma, a type of cancer that can be spread and worsened when morcellators are used.
That warning is consistent with a University of Michigan study published earlier this year in the journal Obstetrics and Gynecology, which found that 1 in 368 women undergoing a hysterectomy to treat fibroids had sarcoma that could be spread by the use of a morcellator.
One high-profile wrongful death case involving morcellator use was recently settled out of court, and more lawsuits arising from similar situations are still being filed. The FDA now recommends that the devices not be used, but stops short of banning them outright.
Fitzpatrick, himself a cancer survivor, says that while the provision was created to address the morcellator issue, he also hopes it will create a more robust dialogue surrounding the issue of regulating and tracking medical devices in general.
“What happened with the power morcellator should never be allowed to happen again,” Fitzpatrick said at a hearing before a vote was taken on the bill.