FDA Issues Updated Safety Communication For the Use of Power Morcellator Tools in Fibroid Removal Surgery
January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.
Throughout 2014, there have been significant developments by the FDA advising about the use of power morcellator tools in laparoscopic procedures. Power morcellator tools are used by surgeons to cut tissue by dividing the tissue into smaller fragments. However, recent studies have demonstrated that the use of these tools may increase the risk of spreading a type of cancer called uterine sarcoma. There is growing concern that the cancerous tissue can spread into a woman’s abdomen and pelvis cavities, and eventually, throughout the body.
The survival rate of this cancer drops dramatically when uterine sarcoma has spread. The FDA now estimates that 1 in 350 women undergoing a hysterectomy or myomectomy procedure has been found to have an unsuspected uterine sarcoma. Accordingly, on November 24, 2014 the FDA issued an updated safety communication with the following language:
If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood.
Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.
Disclaimer: This blog post is not legal advice and does not create an attorney-client relationship. You should contact an attorney for the most accurate and up-to-date information.