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Following the deaths of several women from involving use of power morcellators, a Pennsylvania congressman is asking federal health regulators to investigate whether some hospitals violated regulations by failing to report the problems.
In a a letter sent to George Karavetsos, head of the FDA Office of Criminal Investigations on December 18, Representative Mike Fitzpatrick requested that the agency investigate Brigham and Women’s Hospital, Rochester General Hospital, and University of Rochester Medical Center. The letter indicates that the hospitals did not report when women died of advanced stage cancer that was likely spread by the use of power morcellators during laparoscopic hysterectomies and myomectomies for uterine fibroid removal.
The Pennsylvania Republican is asking the FDA to investigate whether the hospitals violated their legal reporting obligations by not reporting the deaths, as serious questions continue to remain unanswered about how federal regulators failed to identify the potential cancer risks from morcellation for years after the devices were introduced.
Power morcellators became increasingly popular over the past decade, providing doctors a way of cutting up and removing the uterus or uterine fibroids through a minimally invasive, laparoscopic procedure. While these procedures reduce recovery time and the risk of infections or other complications, morcellators have been largely abandoned within the medical community since it was discovered last year that they pose an unreasonable risk for women with hidden cancers, which doctors are unable to detect before the procedure.
“For over 2 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,” the letter states. “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 [sic] as intended, it is likely many women’s lives could have been spared from the horrific consequences of morcellation.”
FDA estimates suggest that about one out of every 350 women undergoing surgery for symptomatic uterine fibroids may actually have undiagnosed or unsuspected sarcoma contained within the uterus, leading the agency to first warn about the morcellation cancer risks in April 2014.
While the agency has allowed laparoscopic morcellators to remain on the market, with much stronger warnings about the potential risks, many hospitals have announced that they will no longer perform hysterectomy or myomectomy procedures with morcellation, indicating that there is no way to justify the risk.
Power morcellator cancer concerns first came to public awareness in late 2013, when Dr. Hooman Noorchashm launched a campaign to halt their use after his wife, Dr. Amy Reed, was diagnosed with leiomyosarcoma following a morcellation procedure. The couple has since moved from Boston to Fitzpatrick’s district in Pennsylvania, where he has taken up their cause.
In August, Fitzpatrick was one of about a dozen lawmakers who sent a letter to the Government Accountability Office (GAO) calling for an investigation into the FDA’s approval and oversight process for power morcellators. That investigation is currently underway.
As more families learn about the link between the devices and uterine cancers diagnosed in recent years, a growing number of morcellation cancer lawsuits are being filed against manufacturers of the devices, alleging that they failed to adequately warn women or the medical community about the risks associated with the minimally invasive procedures.
If consumers and the medical community had been provided accurate and complete information about the potential risk that morcellators may disseminate aggressive cancers throughout the body, plaintiffs allege that they would have elected to undergo alternative procedures for removal of uterine fibroids.
Amid a mounting number of cases filed throughout the federal court system against Johnson & Johnson’s Ethicon subsidiary, which was previously the leading manufacturer of the medical devices, the U.S. Judicial Panel on Multidistrict Litigation established consolidated federal proceedings the litigation in October.
All product liability lawusits filed over the spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers following use of an Ethicon morcellator are centralized before U.S. District Judge Kathryn H. Vratil in the District of Kansas, as part of a federal MDL, or multidistrict litigation.