Should a Morcellator be used for uterine fibroids or hysterectomies?
A morcellator is a tool used to chop up tissue inside the body in order to remove it through a small incision. The FDA issued a safety communication in April warning women undergoing surgery for laparoscopic power morcellation for the removal of the uterus or uterine fibroids in women. The agency said, “Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”
The FDA plans to have a hearing this summer on the morcellator efficacy. The next meeting of the Obstetrics and Gynecology Devices Panel is July 10-11, 2014. They will address the morcellator issue at this meeting which is open to the public.
Even though the device is designed to suck up the shredded tissue like a vacuum cleaner, it is still possible for the device to spread tiny particles into the abdomen. The rationale for using a morcellator allows for removal of tissue through a smaller incision, making surgery less severe, less dangerous and requires a less time to recover. This is logical if the tissue you grind up is not cancerous. But at this time, there is not a way to determine if the tissue is cancerous before removal.
This medical ethics conundrum has recently been highlighted by the case of Dr. Amy Reed who developed advanced cancer after a hysterectomy involving morcellation. She and her husband, Dr. Hooman Noorchashm, are on a mission to change the practice of using morcellation. They have posted a change.org petition urging gynecologist to “Stop Morcellating the Uterus in Minimally Invasive and Robot Assisted Hysterectomy and Myomectomy.” They ask that the American Congress of Obstetricians and Gynecologists and the American Board of Obstetrics and Gynecology to change their use of morcellation as a “standard of care” for these procedures.
So far, they have collected about 9500 signatures. Anyone can show their support by going to their petition. They have also posted links to press coverage and information about morcellation.
The American Congress of Obstetricians and Gynecologists published a Special Report this month (May, 2014) on the use of power morcellators. The report notes that non-invasive surgery is safer. And abdominal hysterectomies are three times the risk of mortality than laparoscopic (non-invasive) hysterectomies. But it also asks the FDA to recommend that a national registry on these procedures be established so additional data can be analyzed. According to the FDA, there is currently no reliable method for predicting whether uterine fibroids are cancerous.
Has the FDA taken appropriate action? Some doctors have said they don’t believe the statistics warrant such a warning. According to the Wall Street Journal article, “a number of doctors believe the FDA overreached” because the risk of cancer is minimal. But other doctors feel the FDA’s safety warning is appropriate. However, the FDA warning is nonbinding so no mandatory action is required from medical professionals.
What percentage of these procedures that result in spreading cancerous and deadly tissue would be considered acceptable or even ethical to physicians and patients? Allen Hogge, chairman of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh Medical Center system, questioned the agency’s data, saying that the reports were “mostly public relations and not science,” according to the WSJ. Duke University Health System also opted to continue use of the power morcellator after obtaining patient consent.
A similar debate has emerged over C-section deliveries. In this case, some doctors argue for the use of this invasive surgery compared to a vaginal delivery. Women who experience long labor times are encouraged and, in some cases, pressured to have a C-section. Consumer Reports recently investigated C-sections and concluded that they “drive up costs and increase risks for mothers and babies.”
Informed Consent and a Bag
The American Congress of Obstetricians and Gynecologists recommends using a bag on the morecellator to capture tissue that is not sucked up by the morcellator. They also recommend that the patient be given informed consent- an explanation of risks associated with morcellation.
Brigham, Temple and Massachusetts General now require doctors to inform their patients about the risk of morcellation spreading cancer. Some gynecologists have opted to cease using a morcellator.
Hopefully soon the FDA and the medical community will be persistent about examining the use of morcellators and come up with better statistics and information about alternatives. And current and future doctors will be properly trained in other options.