Today, the FDA issued a safety communication regarding power morcellators. Specifically, the FDA found that manufacturers of power morcellators must change their labeling to include warnings regarding the increased risk of uterine cancer. The boxed warning states:
“Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”
As we previously reported, the injuries associated with the morcellators include leiomyosarcoma (“LMS”) a serious form of cancer that is often fatal. The FDA previously estimated that 1 in 350 women underling hysterectomy or myomectomy is found to have an unsuspected uterine sarcoma. The Society of Gynecologic Oncology has previously estimated that this number was fewer than 1 woman in every 1000 undergoing a hysterectomy.
Disturbingly, an article published on November 26, 2012 examined 1091 instances of uterine morcellation from 2005 to 2010 and revealed a high rate of unexpected sarcoma after morcellation. The article found that there was a 9-fold higher rate of unexpected sarcoma than what had been advised to patients prior to the procedure.
This warning from the FDA comes after the FDA held an advisory committee meeting in which panel members discussed placing more stringent warnings on the devices. Shortly after the meetings, Johnson & Johnson, one of the manufacturers of the morcellator recalled its devices from the market on July 30, 2014.