Despite the publication of a study that confirms an earlier government assessment that the use of laparoscopic power morcellators—devices used in minimally invasive uterine procedures—is risky, some gynecologists continue to use them. A number of health insurers, meanwhile, are no longer paying for morcellation, citing patient safety risks.
The Food and Drug Administration (FDA) in April issued a safety communication for power morcellation, noting that if the procedure “is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis.”
The FDA said that it discourages the use of power morcellation for certain procedures and estimated that 1 in 350 women undergoing a hysterectomy (removal of the uterus) or myomectomy (removal of uterine fibers) has unsuspected uterine sarcoma.
FDA's estimate of hidden sarcomas was corroborated in July by a JAMA study that found 1 in 368 women have undetected cancer that could be inadvertently spread by morcellation. Previous estimates of undetected sarcoma ranged from 1 in 500 to 1 in 10,000. Jason Wright of Columbia University led the study and said that it “might mitigate the concerns of those who disagree with the FDA figures,” reports the Advisory Board Company.
Some Doctors Continue to Use Tool, Others More Wary
Not all members of the medical community agree with the FDA's assessment of morcellators. According to a Wall Street Journal report, doctors such as Jeffrey Thurston say the government should keep out of doctor-patient relationships. “It is none of their business,” said Thurston, a Dallas gynecologist who disputes the 1 in 350 undetected sarcoma figure cited by the FDA and tells patients that “we don't think those numbers are correct.”
While the FDA has yet to ban morcellators, some doctors are erring on the side of caution. Monmouth Medical Center's Robert Graebe told the Journal that, “People want to fight back, but it's not putting patients' safety first. It's not worth playing Russian roulette with the patient.”
Insurers Nationwide Stopping Payment for Morcellator Procedures
As the Pittsburgh Business Times reports, UPMC Health Plan, Highmark Inc., Blue Cross Blue Shield of Massachusetts, Harvard Pilgrim and Fallon Health are among the insurance companies no longer providing payment for gynecological procedures that use a morcellator.
Vice President of Medical Affairs at UPMC said that reimbursement was being discontinued to “protect patient safety,” while UPMC spokeswoman Gloria Kreps called the policy decision “an appropriate and prudent course of action.”
UPMC and Highmark's decision to halt morcellator payments came two days after major morcellator manufacturer Johnson & Johnson voluntarily recalled its morcellators, made by J&J subsidiary Ethicon.
Get a Free Power Morcellator Injury Case Review
The defective medical device attorneys at Andrus Wagstaff PC are currently assessing the viability of personal injury claims stemming from power morcellation procedures. If you or a loved one developed cancer of the abdomen or pelvis following a laparoscopic hysterectomy or myomectomy, contact us for a no-cost case evaluation.