FDA Reiterates Warning Against Power Morcellation for Fibroids
Agency says use of device has declined since first warning in 2014.
Evidence continues to show that the use of laparoscopic power morcellators, which are utilized in minimally invasive hysterectomies and for removal of fibroids, is dangerous because it may potentially spread cancer, the FDA said.
In a new white paper (pdf), the FDA stated that medical evidence continues to show that women treated with power morcellation have higher rates of cancer that has spread and worse clinical outcomes compared to women whose cancer is treated with manual morcellation or without the procedure.
“While minimally invasive surgery conveys several advantages over open surgery for women with fibroids including reduced recovery time and rate of wound infection, the use of [power morcellation] during these surgeries poses a risk due to unsuspected uterine sarcoma. The FDA continues to caution against the use of [power morcellation] in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”
The FDA first warned about the dangers of power morcellators in a 2014 safety communication (pdf). Since that time, the agency says their use has declined.