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NEW BRUNSWICK, NJ—Healthcare conglomerate, Johnson & Johnson (J&J), is suspending worldwide sales, distribution, and promotion of its laroscopic power morcellators but is not permanently pulling them from the market.
A morcellator is a surgical instrument used for division, or “morcellation,” and removal of large masses of tissues during laparoscopic surgery.
The company said it is suspending the sale of its morecellators until their role in fibroid treatment is better understood by the medical community.
“We believe that suspending the commercialization of these products until their role is better understood and redefined by the medical community is the appropriate course of action at this time,” J&J told customers.
“Ethicon morcellation devices have always included cautions in their instructions for use about the potential spread of malignant tissue.”
On April 17 the US Food and Drug Administration (FDA) issued an advisory warning attempting to dissuade doctors from using laparoscopic power morcellators to remove fibroids because of a risk of an often-hidden cancer.
“The FDA said that when used for hysterectomy or myomectomy for women with uterine fibroids, laparoscopic power morcellators can sometimes disperse occult cancerous tissues beyond the uterus,” wrote Medscape Medical News.
“Accordingly, the agency is discouraging the use of these devices for the 2 procedures and encouraging clinicians and patients to discuss other options for fibroid removal.”
According to the Wall Street Journal, several hospitals have suspended morcellator procedures following the FDA’s advisory. However, the sales stoppage doesn’t prevent doctors from using devices already on hand.
J&J said the step was not a product removal. The FDA maintained that power morcellation may still be the best option for some patients after risk evaluation and informed consent.
“This decision was not made lightly because we are well aware of the significant benefits that these products can offer many women,” J&J stated in a letter to customers.
“Since 1998, Ethicon’s morcellation devices have enabled thousands of patients to have minimally-invasive surgical hysterectomy and myomectomy procedures, instead of more-invasive surgical procedures.”
Hooman Noorchashm, MD, a cardiothoracic surgeon at Brigham and Women’s Hospital, in Boston, Massachusetts, is a critic of morcellation.
He’s against using laparoscopic power morcellators for fibroid removal and started a campaign against morcellation after his wife, anesthesiologist Amy Reed, MD, underwent a hysterectomy with power morcellation in October 2013 for fibroid removal only to discover afterward that she had a uterine leiomyosarcoma.
Dr. Reed learned that the procedure might have spread the cancer through her abdomen, worsening her prognosis
A story in the Wall Street Journal last December about Dr. Reed’s case kicked off a vigorous debate in medical circles about the benefits and risks of morcellation, states Medscape Medical News.
“Why are you leaving these devices on the shelves?” Dr. Noorchashm, told Medscape Medical News. “[Johnson & Johnson] are clearly irresponsible.”
Dr. Noorchashm added that J&J and other manufacturers of morcellators have known about these risks for years.
“We congratulate the FDA for acting, but they clearly could pull these devices off the market, and they haven’t.”