(RxWiki News) Earlier this year, Johnson & Johnson stopped selling a certain surgical device because it poses a risk of spreading a dangerous cancer in women. Now, the company is taking it one step further and asking doctors to return the device.
In April, the US Food and Drug Administration (FDA) warned against the use of devices known as laparoscopic power morcellators, which are used as part of a procedure to remove growths in a woman's uterus called fibroids. In most cases, uterine fibroids are not cancerous. However, in select cases, they can be.
The FDA warning about morcellators came after researchers found that morcellation could spread uterine sarcomas — a type of uterine cancer — to other parts of the body.
Johnson & Johnson halted sales of the morcellators after the FDA told doctors not to use the devices. Now, The Wall Street Journal reports that Johnson & Johnson will ask doctors around the world to return the devices that have already been sold.
"Discuss the risks and benefits of uterine fibroid treatment with your OB-GYN."
According to the FDA, about 1 in 350 women undergoing hysterectomy (surgical removal of the uterus) or myomectomy (removal of uterine fibroids that leaves uterus intact) has uterine sarcoma. It is these women who concern the FDA when it comes to morcellation.
"The FDA's primary concern as we consider the continued use of these devices is the safety and well-being of patients," said William Maisel, MD, MPH, chief scientist at the FDA's Center for Devices and Radiological Health, in an FDA press statement in April. "There is no reliable way to determine if a uterine fibroid is cancerous prior to removal.
"Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterctomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals."