Laparoscopic Power Morcellators
What is a power morcellator?
Laparoscopic power morcellators are medical devices used during minimally invasive surgical procedures to treat uterine fibroids, also known as leiomyomas. During the procedure, the fibroid tissue or the uterus is fragmented into small pieces for easy removal from the woman’s body. Women who underwent hysterectomy (removal of the uterus) or myomectomy (removal of fibroids) through a minimally invasive surgical technique may have opted to do so because of the benefit of a shorter post-operative recovery period.
What does the FDA say about the issue?
Current FDA data estimates that 1 in 350 women undergoing a hysterectomy or myomectomy for treatment of fibroids is later diagnosed with a previously unsuspected uterine sarcoma (cancer), including leiomyosarcoma. According to the FDA, THERE IS NO RELIABLE METHOD TO PREDICT OR TEST WHETHER A WOMAN WITH FIBROIDS MAY ALSO HAVE UTERINE SARCOMA.
The problems and risks associated with use of laparoscopic power morcellator to perform hysterectomy (removal of the uterus) or myomectomy (removal of fibroids), is the unknown cancerous cells are spread within the woman’s pelvis and abdomen and significantly worsens the woman’s chance of long term survival.
The FDA now warns against the use of morcellator devices on the majority of women undergoing treatment of fibroids. The FDA has also issued a new set of guidelines and recommendations for physicians to follow when treating women with fibroids, and has issued a new boxed warning label for the devices to inform doctors and patients:
“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.”
Because of the FDA warning, women and their families are bringing lawsuits for compensation against the manufacturers of these medical devices. If you have been diagnosed with endometrial stromal sarcoma, leiomyosarcoma or any other uterine cancer following a hysterectomy or fibroid removal (myomectomy), contact lawyer Michael P. Fleming for a free consultation.