A controversial medical device used in hysterectomies and myomectomies is being recalled by Johnson & Johnson’s Ethicon Endo-Surgery unit following FDA warnings that the product could spread cancerous tissues. The company’s Morcelex, a device known as a morcellator, is the first such device to be withdrawn by its manufacturer.
While the recall comes from the manufacturer, and not the FDA, the agency is said to be considering several options for the future of morcellators, including a possible ban or further regulation of the devices.
The FDA first sounded a warning about morcellation earlier this year, noting that certain women faced an increased risk of late-stage cancer following the procedure. The agency noted that one in every 350 women treated for fibroids could also have uterine sarcomas (cancer), in which case morcellation – slicing up the fibroids or uterine tissue for easier removal – actually poses a significant risk of spreading unsuspected cancer cells. While the recall comes from the manufacturer, and not the FDA, the agency is said to be considering several options for the future of morcellators, including a possible ban or further regulation of the devices.
Ethicon has already suspended the sale and promotion of its morcellation devices and hasn’t distributed them since April. The company, however, decided stronger action was needed following a meeting with the FDA While the Morcelex seems to be effective at removing benign fibroids, the risk of spreading cancer seems to outweigh the device’s benefits.
Is This An Official Recall?
While Ethicon has asked doctors to return all Morcelex devices, this is not an official FDA-backed recall. The reason for this is simple: the device is not actually defective or dangerous – it’s simply ill-suited for the task at hand. Doctors need to be able to distinguish between benign and cancerous areas of the uterus when removing fibroids, and, as a procedure, morcellation seems to lack the required precision. When uterine tissue is cut into small pieces to be removed via abdominal incisions, cancerous tissue may also be exposed. The risk of exposing this tissue is considered too great for the procedure to continue, and so Ethicon has asked doctors to stop using its Morcelex device.
Will This Make it More Difficult To Have a Hysterectomy or Fibroid Removal Surgery?
Not at all. Only 11 percent of the 500,000 hysterectomies performed every year are done using power morcellation and laparoscopic surgery. The FDA is keeping an open mind on power morcellation, noting that in certain cases it may still be the best option. According to the agency:
“A number of additional treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, and laparoscopic hysterectomy and myomectomy without morcellation, as well as other non-surgical options.”
Morcellation devices manufactured by companies other than Johnson & Johnson may also remain in use, though the FDA has “instructed manufacturers of power morcellators used during laparoscopic hysterectomy and myomectomy to review their current product labeling for accurate risk information for patients and health care professionals.”
Will Johnson & Johnson Face Lawsuits Over This?
They will - and, in fact, they already are. A lawsuit was filed in May by a woman in New York who was diagnosed with cancer after undergoing a hysterectomy with a morcellator. Ethicon is accused of failing to carry out sufficient testing and research about the risks of its Morcelex device. Other lawsuits are expected to follow, and Ethicon have indicated that they will fight these suits, claiming that morcellation devices “have always included cautions in their instructions for use … about the potential spread of malignant, or suspected malignant, tissue.” If the lawsuits move forward, it will be up to a judge to decide on the merits of each case.