In April this year, healthcare company Johnson & Johnson announced that it will stop the sale and distribution of its power morcellators after the Food and Drug Administration (FDA) discouraged its use for hysterectomy, or the removal of the uterus, and myomectomy, the removal of uterine fibroids, as the use of the device could spread undetected cancer.
Johnson & Johnson, however, said it is merely suspending the commercialization of the surgical device while awaiting update from the medical community. Findings of the study "Uterine Pathology in Women Undergoing Minimally Invasive Hysterectomy Using Morcellation" which was published in the Journal of the American Medical Association on July 22, however, appear to have helped prompt the company to finally recall its hysterectomy power morcellators.
On Wednesday, the company said that will ask doctors to return the power morcellators it has manufactured. It also plans to reach out to customers to ask them to return the morcellators they have purchased following a company decision for a worldwide withdrawal of all its morcellation devices that still remain in the market.
Johnson & Johnson's Ethicon unit, which makes the controversial device, said that it is pulling out the power morcellators from the market because the risks and benefits of using the device in hysterectomies and myomectomies remain uncertain.
"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 spokesman Matthew Johnson said.
The FDA said that of the 350 women undergoing surgery using morcellators, one may have a type of cancer that can spread beyond the uterus and this spread of malignant cells to other parts of the body could have a significant impact on a woman's chances for survival.
"There is no reliable way to determine if a uterine fibroid is cancerous prior to removal," William Maisel, from the FDA's Center for Devices and Radiological Health said. "Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals."
Results of the JAMA study strengthened this contention as the findings showed that 27 in every 10,000 women undergoing hysterectomy had cancerous tumors that can spread to other parts of the body by morcellation.