The Food and Drug Administration (FDA) issued a news release on April 17 that discouraged laparoscopic power morcellation in removing fibroids, non-cancerous tumors that develop from the muscle layers of the uterus.
The FDA said that the procedure, which involves dividing uterine tissue into smaller fragments so it can be easily removed through an incision in the abdomen, can spread undetected cancer around the abdomen posing risks to the patient.
Following FDA's warning, healthcare company Johnson & Johnson (J&J), the largest maker of the device used for fibroid surgery, announced on Thursday that it has halted the sale, distribution and promotion of its power morcellators worldwide.
The company, however, said that it is not removing the product permanently as the FDA acknowledged that power morcellation may still remain the best option for some patients. Sale of the device will be temporarily suspended though as the company awaits clarification from regulators and the medical community regarding morcellation and fibroid treatment.
"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 said.
The FDA said that it plans to conduct an advisory committee meeting this summer to discuss matters regarding laparoscopic power morcellation. FDA's Center for Devices and Radiological Health chief scientist William Maisel said that the discussions may tackle the necessity for including warning on labels of power morcellators.
"We anticipate the discussion will include whether a boxed warning related to the risk of cancer spread should be added to the product labeling for laparoscopic power morcellators to ensure patients and health care professionals are adequately informed of the risks," Maisel said.
J&J, however, said that its Ethicon morcellation devices, which it had been selling since 1988, have long included cautions about the potential risks of spreading malignant tissues.
Fibroids are the most prevalent type of benign tumors in women. While most uterine fibroids do not cause problems, they can grow and cause other symptoms that include painful sexual intercourse and painful menstruation. Besides laparoscopic power morcellation, other options for treating fibroids include traditional surgical hysterectomy and myomectomy, laparoscopic hysterectomy and nonsurgical options.
