J&J Withdraws Morcellators From Market Amid Safety Concerns
By Jof Enriquez,
Follow me on Twitter @jofenriq
Johnson & Johnson’s (J&J) subsidiary Ethicon is pulling power morcellators used for uterine surgeries from the global market due to concerns that the devices could inadvertently spread cancer during procedures.
“Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk,” company spokesperson Matthew Johnson told Bloomberg.
The move came roughly three months after the company decided to suspend the marketing of the devices in response to a safety communication notice from the U.S. FDA.
As reported in a previous Med Device Online article, J&J in April had halted the worldwide sale, distribution, and promotion of its full lineup of power morcellators marketed as the Gynecare X-Tract, the Gynecare Morcellex, and the Morcellex Sigma.
The FDA’s notice cited clinical data that indicated that the use of fibroid clipping tools “poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.”
At least one critic told the New York Times that J&J’s swift decision on pulling the controversial devices from the market was uncharacteristic of the world’s largest medical device company.
“The company has had a rather abysmal track record on the public health front of ethical breaches in the last few years, so this is good that they’re doing this,” Diana Zuckerman, president of the National Center for Health Research, a public health advocacy group, told the NYT. “At least it goes back to an earlier time when the company was seen as doing the right thing.”
The ongoing debate over the safety of power morcellators – tube-shaped devices inserted through tiny holes in the abdomen to remove fibroids – has rankled patients and doctors alike.
The Wall Street Journal cited a recent study by Columbia University which found that “1 in 368 women undergoing hysterectomies have a hidden uterine cancer that could be spread by a morcellator,” and that the “device has the potential to spread more types of uterine cancer in a woman's body than previously thought.”
Meanwhile, some gynecologist groups have been saying that the devices used for minimally-invasive, laparoscopic surgeries help women avoid open surgeries, which are associated with more complications and longer recoveries, the WSJ reported.