• FDA discourages use of laparoscopic uterine power morcellators
  • February 20, 2015
  • Law Firm: Burg Simpson Eldredge Hersh Jardine P.C. - Englewood Office
  • The U.S. Food and Drug Administration is urging physicians to think carefully before recommending laparoscopic uterine power morcellation to their patients, The Associated Press reported. A FDA panel of experts found the procedure used to remove uterine fibroids or perform hysterectomies could spread undetected cancer to other parts of a woman's body.

    According to a safety communication published by the FDA in April, laparoscopic power morcellators break up tissue into smaller fragments to make the removal of the tissue easier through a small incision site. The procedure was developed as an alternative to surgery that required larger incisions, according to the AP.

    However, the FDA has found 1 in 350 women undergoing a hysterectomy or fibroid removal has undiagnosed uterine sarcoma (cancer). By dividing the tissue into smaller parts, there is a risk of the sarcoma cells spreading throughout the woman's abdomen and reducing the likelihood of her long-term survival, the FDA warned.

    Many surgeons use a plastic specimen bag to catch and contain the smaller fragments of tissue, according to the AP. But, there is no evidence the bags reduce the risk of spreading cancerous cells throughout the body, according to Dr. Craig Shriver from Walter Reed Medical Center.

    The FDA is strongly discouraging the use of laparoscopic power morcellators during hysterectomies or fibroid removals because there is no reliable way to detect if fibroids have uterine sarcoma. Physicians should inform patients with fibroids that unexpected cancer could spread due to the procedure and that the specimen bag is an option to attempt to minimize the risk.

    Ultimately, if physicians and patients agree the procedure is the best and safest course of action, the patient should sign a consent waiver stating she understands the risks, the AP reported.