Theodoros & Rooth, P.C.

FDA Discourages Use of Common Laparoscopic Surgery Method

The U.S. Food and Drug Administration (FDA) discourages the use of power morcellation for the treatment of uterine fibroids or as a means of hysterectomy.

Uterine fibroids, called leiomyomata, are common. The National Institutes of Health (NIH) reports most American women develop fibroids at some time in their lives. A popular method of removing fibroids, called morcellation, is under fire for causing life-threatening complications to women with undiagnosed fibroid malignancies.

Morcellation is a technique that involves inserting a power tool through a small laparoscopic incision in the abdomen. Once in place, the surgeon uses the power morcellator to cut and reduce tissue into pieces small enough to remove through the incision. Morcellation is less invasive than other forms of fibroid removal and hysterectomy, and generally results in a shorter recovery period.

According to a FDA news release, the agency now considers power morcellation a danger for the following reasons:

  • When uterine tissue is churned by the morcellator blade, it results in the spraying of tissue within the abdominal cavity.
  • The FDA reports one in 350 women may have previously undetected uterine sarcoma, or cancer.
  • For women with underlying cancer, power morcellation may spread cancer throughout the abdomen, greatly increasing the risk of death.
  • Uterine morcellation could nick, cut, or tear other veins or organs in the abdomen.

Following the FDA news release in April of this year, the American College of Obstetricians and Gynecologists (ACOG) released a report detailing the benefits of morcellation but noting the need for careful evaluation and consent prior to the procedure.

Discouragement by the FDA is a strong deterrent for morcellation. Be sure you understand the risk if your doctor recommends morcellation. And seek skilled legal guidance if you suffer serious injury as a result.