As the polarized debate regarding the safety and desirability of power morcellation in minimally invasive hysterectomies continues to rage, Johnson & Johnson, easily the largest manufacturer of laparoscopic morcellators, has announced that it's withdrawing the device from the market.
Under the glare of ongoing government scrutiny, the company's Ethicon division, which sells the devices, suspended sales of new morcellators in April, immediately after the FDA issued an advisory recommending that morcellator use be suspended or severely restricted. The company went much further this week, announcing that it will ask customers to return the devices.
The FDA held hearings on the safety of power morcellation this summer, and some believe the practice may eventually be banned entirely.
The issue gained prominence when a Harvard anesthesiologist and medical professor underwent the procedure last fall, unaware that her uterus contained a hidden sarcoma. Morcellation, which breaks the uterus into small pieces so it can be extracted through the incision site, spread and upstaged her cancer. Since then, she and her husband, also a Harvard professor, have led a campaign to end the practice.
While there's no question that morcellation can spread cancer in women with undetected or undiagnosed cancer, there's no clear consensus on the percentage of women at risk. In its advisory, the FDA estimated that the risk is about 1 in 350. Johnson & Johnson's decision this week follows closely on the heels of a study published in the Journal of the American Medical Association (JAMA), which found that among 36,470 women who underwent morcellation between 2006 and 2012, 99 had uterine cancer — or 1 of every 368.
But the FDA's estimates have been called into question, and some experts say the significance of the new study is being widely misunderstood and/or misquoted — indeed, a Wall Street Journal story says it shows that "1 in 368 women have a hidden (emphasis added) uterine cancer that could be spread by a morcellator."
Jason D. Wright, MD, director of gynecologic oncology at the Columbia University Medical Center in N.Y., and the lead author of the study, tells Outpatient Surgery Magazine that what the study found were cases of uterine cancers that were undetected, but not necessarily hidden, before morcellation occurred.
The distinction is significant because the morcellation controversy has largely centered on the dangers of hidden sarcomas, which are nearly impossible to detect. Elizabeth Pritts, MD, director of the Wisconsin Fertility Institute argues that the significance of the JAMA study is misunderstood because uterine sarcoma accounts for only 2% to 4% of all uterine cancer cases. Dr. Pritts, who testified before the FDA, says she and colleagues will soon publish a paper that puts the risk of hidden sarcoma at about 1 in 6,400.
Dr. Wright acknowledges that the percentage of uterine cancer patients with hidden sarcomas is much smaller than the percentage of uterine cancer patients on the whole, but estimates that it is "probably over 10 or 20%."
He adds, however, that "other uterine cancers may be asymptomatic or not detected. What we found was cancer that wasn't detected pre-operatively, whether it was asymptomatic or for some other reason. If the physicians had known, they wouldn't have morcellated."
Jeffrey Thurston, MD, of the Texas Health Women's Specialty Surgery Center of Dallas, says the decision by Johnson & Johnson is "at best, disappointing," and ultimately the result of the FDA's "falling prey to politics and Harvard's seemingly endless unmerited influence."
Dr. Thurston and others maintain that the percentage of women at risk from the procedure is much smaller than the FDA's assertion of 1 in 350, and that banning or restricting power morcellators would do more harm than good, because hidden sarcomas are so rare and so lethal (regardless of whether they're spread by morcellation), and because alternative open procedures are associated with much higher rates of morbidity and mortality.
Dr. Wright agrees that "there are probably women who derive a benefit" from morcellation, and that it's associated with "lower complication rates and quicker recoveries," especially for younger women. "Advanced age was one of the strongest factors for having the risks outweigh the benefits," he says. "For younger women, it may still be a reasonable option. But there's very little objective data to guide the debate. We need to quantify the risk."
The decision by Johnson & Johnson may make the risk harder to quantify.