5 Things to Know About Morcellation
1 Power morcellators helped offer less-invasive surgery

Doctors didn’t need powered morcellators, but they helped. Medical articles occasionally described tennis-elbow-like injuries for doctors wielding older, manual morcellators. In contrast, most powered versions let a tube-shaped motorized blade, inserted through a small hole in the abdomen, to do the work. Training videos show the blade cutting into the tissue, which is pulled up the tube in pieces. Tens of thousands of women had morcellator-aided hysterectomies every year, and proponents said the devices spared them longer incisions and got them back on their feet faster after surgery.

2 They also posed a potential danger that was largely overlooked

Gynecologists saw from the beginning that morcellators can drop bits of tissue. They also knew that what looks like a fibroid can be a hidden cancer, but many doctors say they believed that happened rarely. In some cases, doctors discounted early hints of risk. A study from South Korea in 2011 turned heads at a medical conference by showing how morcellating these tumors, rather than removing them whole, was more likely to spread cancer and worsen survival rates.

3 Years later, the morcellator problem spilled into the public sphere.

The issue went mainstream in December 2013 with the well-publicized case involving Amy Reed, a then-40-year-old anesthesiologist. Boston’s Brigham and Women’s Hospital said that, by using a power morcellator, it inadvertently worsened the cancer of Dr. Reed, who joined her doctor husband in calling attention to the problem. In court filings, the hospital, which is being sued by Dr. Reed, has denied wrongdoing.

In April 2014, the FDA surprised the medical community by advising doctors not to use power morcellators. The agency said 1 in 350 women undergoing the surgery actually have a cancerous tumor that looks like a fibroid and can’t be reliably detected before surgery. Johnson & Johnson, the largest manufacturer, suspended global sales and then withdrew its device from the market that July. In November 2014, the FDA called for manufacturers to place a “black-box” warning, the FDA’s strongest, on the device.

4 Warnings led to shift in surgeries on women

The FDA didn’t ban the device; it said it wanted to leave a window open for the small number of women for whom the tool’s benefit may outweigh its risks. Still, the agency said any woman who does undergo the procedure should be warned that morcellation could spread unsuspected cancer.

In the new landscape, U.S. gynecologists have changed the way they perform hysterectomies now that they no longer can readily use morcellators, according to hospitals and studies.

While some surgeons remain dismayed about new limits imposed on the device, other doctors have said concerns that its loss would lead to major problems didn’t materialize. Instead, doctors say they turned to alternatives. The doctors are often choosing a “mini-laparotomy,” in which the uterus is removed through a small incision above the pubic bone. The incision is typically between 1 1/2 inches and 3 inches, versus roughly 1/2-inch to 3/4-inch incisions in procedures using the morcellator.

Meanwhile, the American Congress of Obstetricians and Gynecologists recommends vaginal hysterectomies, when feasible, as having the best outcomes and fewest complications.

5 Scrutiny of the device is still under way

The controversy has moved to Washington and into the courts. Based on a request from Congress, the U.S. Government Accountability Office is investigating why the device was marketed for two decades before the FDA warned it can spread uterine cancer.

In a statement on Friday, the FDA said its “primary concern is the safety and well-being of patients.” The FDA said it “was notified by the GAO of its investigation and plans to fully cooperate with the review.”

Though device applications and other records show the FDA knew early on that morcellators could spread dangerous cells, the agency said the magnitude of the risk wasn’t realized until the issue came into the spotlight in late 2013.

Meanwhile, dozens of other women have come forward, with many filing lawsuits. Some of these cases are being settled by J&J.

J&J said in a statement to The Wall Street Journal last year that its morcellators “have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue.”
  • DR AJITH RAVINDRAN Thank you, sir for this article. I was interested in this topic after reading about Dr.Reed last year. Probably, like many aids in surgical/medical practice the pros and cons of using this instrument should be fully discussed with the individual patient.
  • Dr Sharmistha Ganguly Thank sir for a nice review.. is it so difficult to diagnose malignancy related to fibroid preoperatively?? A good radiologist can very well givs us the clue to the diagnosis like RI and PI low in cases of malignancy or preinvasive stage.. high flow in diastole... moreover when tissue needs morcellation , it has to be voluminous else colpotomy would suffice..in such a huge fibroid we can definitely raise high index of suspicion preoperatively and avoid morcellation if investigated properly.. MRI will add to the preoperative diagnosis..