FDA Discourages Laparoscopic Power Morcellation in Hysterectomy, Myomectomy
The FDA is discouraging the use of laparoscopic power morcellation for the removal of the uterus or uterine fibroids in women based on a recent analysis of currently available data.
Approximately 1 in 350 women undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's likelihood of long-term survival.
Based on currently available information, the FDA recommends that health care professionals:
- Be aware that the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.
- Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.
- Carefully consider all the available treatment options for women with symptomatic uterine fibroids and discuss the benefits and risks of all treatments with patients.
After carefully weighing the risks and benefits of the procedure, if a health care professional nonetheless determines that laparoscopic power morcellation is the best therapeutic option for his or her patient, the health care professional should:
- Inform patients that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.
- Be aware that some clinicians and medical institutions now advocate using a specimen “bag” during morcellation in an attempt to contain the uterine tissue and minimize the risk of cancer spread in the abdomen and pelvis.
The FDA has instructed manufacturers of power morcellators used during laparoscopic hysterectomy and myomectomy to review their current product labeling for accurate risk information for patients and health care professionals.
For more information call (855) 543-3784 or visit the FDA Safety Alert Page.