Rep. Mike Fitzpatrick (R-Pa.) wants the FDA to open a criminal investigation of several deaths associated with laparoscopic power morcellators used during surgeries to remove ostensibly benign uterine tumors.
The morcellators, which use a cutting tip to shred and remove uterine tissue, have been implicated in the spread of a lethal cancer that can masquerade undetected as benign fibroids.
The FDA in April 2014 issued a warning about the devices, later convening a special advisory panel to evaluate their continued use in the surgical suite. The watchdog agency estimates that about 0.3% of women undergoing hysterectomy or fibroid surgery are found to have undetected uterine sarcomas, including the deadly leiomyosarcoma.
In November 2014, the FDA ordered so-called “black box” warnings for the labels on morcellators, advising doctors that the devices, until recently a mainstay of gynecological surgery, be avoided in nearly all fibroid-removal procedures.
Fitzpatrick, citing FDA regulations requiring hospitals and medical device companies to report any incidents that “reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility,” asked the agency’s Office of Criminal Investigations to open a probe into deaths at Boston’s Brigham & Women’s Hospital, Rochester General Hospital and the University of Rochester Medical Center involving morcellators made by Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon. That company recalled its morcellators in July 2014, after pulling them from the market in April of that year.
“For the over 2 decades since the power morcellator was 1st 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. The FDA stated in a response letter to my office dated Nov. 12, 2015, that ‘[p]rior to late 2013, FDA did not receive any adverse reports related to the spread or upstaging of unsuspected cancer through morcellation of uterine tissue,'” Fitzpatrick wrote.
“In fact, the 1st 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,” he wrote in the Dec. 18 letter.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.