Rep. Mike Fitzpatrick is urging the U.S. Food and Drug Administration (FDA) to launch a criminal probe into the deaths of women who have undergone gynecological surgeries using power morcellator devices.
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 them through a small incision in the abdomen.
In April, the FDA issued a warning that power morcellation for hysterectomies and myomectomies can spread undetected uterine cancer, worsening the odds of survival. In November, the FDA ordered black box warnings be placed on the devices and urged doctors not to use power morcellators on most women due to the risk of cancer spread.
In August, Rep. Fitzpatrick helped push through Congress the so-called 21 Century Cures Bill to boost federal funding for medical research and change drug approvals. It also included an amendment that was inspired by the recent controversy over the safety of power morcellators.
“What happened with the power morcellator should never be allowed to happen again,” he said.
Rep. Fitzpatrick asked the FDA’s Office of Criminal Investigations to investigate deaths at Boston’s Brigham & Women’s Hospital, Rochester General Hospital and the University of Rochester Medical Center linked to power morcellators made by Johnson & Johnson subsidiary Ethicon.
“For the over two decades since the power morcellator was first cleared for use on patients, the FDA’s Medical Device Reporting regulations failed to catch the severe dangers posed to women’s health by morcellation,” Fitzpatrick wrote in the Dec. 18 filing. “In fact, the first time the FDA received a report of death or serious injury was neither from a user facility nor a device manufacturer. It was from a physician citing the case of a family member who has a disseminated cancer that was suspected to have resulted from a procedure in which a power morcellator was used. It should not have taken a family devastated by this device to raise the issue to the FDA. Had the regulations works as intended, it is likely many women’s lives could have been spared from the horrific consequences of morcellation.”
Rep. Fitzpatrick is proving to be an advocate for women’s health issues. Also in November, he introduced legislation to ban the permanent birth control implant Essure after numerous complaints from women who claim to have been harmed by the device.
Essure consists of two nickel alloy coils that are implanted in each of the fallopian tubes where they work with the body to create a barrier that prevents the sperm from reaching the egg. Essure is the only FDA-approved non-surgical permanent birth control device.
Since its approval in 2002, Essure has been linked to serious complications including allergic reactions, infections, and chronic pain. The devices have also been found to migrate and perforate the fallopian tubes or uterine wall, or embed in other organs. Often, hysterectomies or other surgical intervention is required to remove the device.