Power morcellators have been used in hysterectomies and myomectomies — the removal of uterine fibroids — for two decades. Morcellation is used to break uterine tissue into tiny fragments for removal.
In April 2014, the U.S. Food and Drug Administration (FDA) issued a warning discouraging doctors from using laparoscopic power morcellators due to the risk of spreading undiagnosed cancer cells. Shortly after the FDA’s warning, Johnson & Johnson (J&J) suspended sales of its power morcellators. Three months later, J&J announced it would withdraw its morcellators from the market worldwide.
Awareness of morcellation cancer risks spread in December 2013 after the Wall Street Journal reported the story of Amy Reed, a Boston anesthesiologist diagnosed with Stage 4 leiomyosarcoma after a morcellation hysterectomy. Amy had undetected Stage 1 cancer that spread during the morcellation procedure.
The risk of morcellators upstaging cancer may be news to the public, but it is not news to some doctors who have debated the safety and effectiveness of the device for years.
During a 2011 gynecology conference, Bobbie Gostout, Mayo Clinic’s chair of obstetrics and gynecology, expressed concern over the safety of morcellation. “I don’t think there is an acceptable safe morcellator,” Gostout said.
A Pennsylvania doctor attempted to alert J&J of the dangers of morcellation in 2006, but the company dismissed his complaints, the Pittsburgh Business Times reported. Another article published in The Wall Street Journal suggests that data on morcellation and cancer dates as far back as 2003. This suggests that for at least 10 years, someone knew that morcellation could be dangerous, but patients were not warned. Now, many of them are paying the ultimate price.