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Johnson & Johnson has requested that doctors around the world cease use and return laparoscopic power morcellator devices manufactured by the pharmaceutical giant’s Ethicon division. The devices are used to cut large masses of tissue, such as uterine fibroids, for removal during minimally invasive hysterectomy, myomectomy, and other procedures.
“Because of this 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,” the company wrote in a letter. The company also said the move is not a recall because, according to Ethicon, the morcellators function as designed.
Johnson & Johnson already suspended worldwide sales of the devices in April after the FDA discouraged use of the devices due to their potential to distribute malignant and benign tissue throughout a patient’s body, potentially upstaging undetected cancers and causing other negative outcomes. Several hospitals, such as Massachusetts General and Brigham & Women’s, both in Boston, have already stopped using the devices, but they remain in use throughout the United States.
Approximately 1 in 350 women who undergoes a hysterectomy or myomectomy has an undiagnosed uterine sarcoma, a type of cancer that is notoriously difficult to detect because of its similarity to benign fibroids. If a sarcoma is morcellated during the procedure, the cancerous tissue can be spread to other parts of the patient’s body. This can potentially upstage the cancer and substantially worsen patient outcomes. Even benign tissue, when spread throughout the body in this manner, can have serious side effects.
A July 10-11 FDA panel on the matter stopped short of recalling the devices but advocated for stronger warnings and better patient education. The FDA did not rule out the possibility of an outright ban of the devices. Meanwhile, cases brought against Ethicon by patients who say they were harmed by power morcellators are in their early stages.
If you have been diagnosed with a uterine sarcoma after a surgery involving a power morcellator, or had fibroids or uterine tissue removed from other organs after such a surgery, request a free case review to help you assess your legal options.