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A U.S. lawmaker is calling on the Obama administration to include a review of morcellator cancer risks as part of its ambitious “Cancer Moonshot” initiative.
In a letter sent last week to Vice President Joe Biden, Pennsylvania Congressman Mike Fitzpatrick urged the administration to include medical device reviews and monitoring as part of the Cancer Moonshot initiative.
The request comes after concerns emerged in recent years about a risk of undiagnosed cancer being spread by medical devices used during minimally invasive laparoscopic hysterectomy and uterine fibroid report.
Known as power morcellators, the devices are designed to allow the surgeon to cut up and remove the fibroid or uterus through a small incision in the abdomen. Although morcellators were rapidly adopted by hospitals nationwide after they became available, they have now been largely abandoned by the medical community since it was discovered that they pose an unreasonable risk of upstaging hidden cancers that are contained within the uterus. This may disseminate the contained cancer throughout the body, greatly reducing life-expectancy and overall quality of life for women.
“While it is critically important we support the development of innovative new devices and drugs to treat cancer, it is just as important to take this opportunity to implement meaningful reforms to make medical devices safe,” Fitzpatrick wrote. “Unfortunately, for decades, a medical device known as a laparoscopic power morcellator proved tragically unsafe, spread cancer throughout the body of those it was designed to help, and led to the death of hundreds, if not thousands, of women.”
Although laparoscopic procedures reduce the risk of infections and shorten recovery time, the FDA has estimated that about 1 in 350 women who undergo hysterectomy or myomectomy for uterine fibroid removal may have unsuspected uterine sarcoma. Morcellators may pose a serious and potentially life-threatening risk of these women, advancing leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers to an advanced stage that is difficult to treat and life-threatening.
The Cancer Moonshot program was announced in January, during President Barack Obama’s State of the Union address. The goal is to combine the knowledge and skills of the medical industry, federal regulators and scientists to look for new cures and treatments for cancer. The name is a reference to the program NASA launched to put a man on the moon.
Rep. Fitzpatrick wrote that by including medical device review and monitoring into the program, it could prevent thousands of unnecessary cases of advanced stage cancer, helping to achieve the program’s goals.
In December, Rep. Fitzpatrick urged the FDA to conduct a criminal investigation into how certain hospitals, like Brigham and Women’s Hospital, Rochester General Hospital, and the University of Rochester Medical Center, used laparoscopic power morcellators and whether they adequately warned women about the potential risks.
The agency responded in late March, acknowledging his request, but saying that they could not reveal whether there was a criminal investigation currently proceeding against those, or any other, medical facilities.
Morcellator Cancer Lawsuits
The letters come amid a growing number of laparoscopic hysterectomy cancer lawsuits being pursued against Ethicon, Karl Storz and other manufacturers of power morcellators, alleging that women and the medical community were not adequately warned about the potential risks associated with electing the minimally invasive procedure.
The litigation emerged after the FDA first highlighted concerns about the link between uterine morcellation and cancer in early 2014.
After concluding that there is no way to make the devices safe for women, Johnson & Johson’s Ethicon unit issued a morcellator recall in July 2014, and announced that they would no longer manufacturer or sell the devices. The company controlled about three quarters of the power morcellator market. A number of other manufacturers still sell the devices despite the FDA warnings.
Since October 2015, all Ethicon morcellator lawsuits filed throughout the federal court system have been consolidated as part of a federal MDL, or multidistrict litigation, which is centralized before U.S. District Judge Kathryn H. Vratil in the District of Kansas. Settlements have already been reached in a large number of cases.