Johnson & Johnson told doctors in 2014 not to use power morcellators, which have been found to spread certain types of uterine cancer. Sales of J&J’s laparoscopic power morcellators were halted in 2014 after FDA issued a warning statement. FDA warned that morcellators used for hysterectomy and fibroid removal surgeries could spread sarcoma in some patients, lowering survival chances.
Morcellators spread Cancer, Studies show
Studies from the FDA as well as from researchers at Columbia University determined that approximately 1 in 350 women suffer undiagnosed cancer when undergoing fibroid surgery. The risk for women requiring hysterectomy operations is roughly 1 in 368.
These findings prompted J&J to urge those who had purchased a power morcellator to discontinue its use and return it immediately. According to a Wall Street Journal story, Johnson & Johnson initially defended its morcellators, but now says the risk of the morcellator’s spreading cancer outweighs potential benefits of its use. Morcellator sales account for a tiny fraction of J&J’s huge business, but J&J holds nearly 75% of the U.S. marketshare for laparoscopic power morcellators.
What is Power Morcellation?
Laparoscopic power morcellation is used for fibroid treatment. The morcellator device divides uterine tissue into smaller pieces which can then be removed through a small abdomen incision typically made during a laparoscopic procedure. Before morcellators hit the market, morcellation was performed using a machine that required the surgeon to squeeze the handle, or else to manipulate a scalpel to create small specimens that could be removed from the abdominal cavity. The first power morcellator unit was launched in the U.S. in 1993.
FDA Warning on Laparoscopic Morcellation
In April 2014, the FDA issued a warning which recommended surgeons avoid using morcellators during hysterectomy or myomectomy operations due to the risk that the devices may spread cancerous uterine tissue to other parts of the body.
William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said:
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients. 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 hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”