FDA Recommends Black Box Warnings for Power Morcellators

The FDA is recommending that manufacturers of power morcellators – surgical tools used during a procedure known as morcellation – add three warnings, including a black box warning, to their products’ packaging.

Earlier this year, the FDA issued a safety alert about the use of morcellation during hysterectomies (removal of the uterus) and myomectomies (removal of uterine fibroids) after finding that 1 in 350 women undergoing these procedures had unsuspected, highly cancerous tumors known as sarcomas in their uterine tissue. According to the FDA, morcellators could essentially “spray” these unsuspected cancer cells throughout the body, causing the patient’s disease to worsen.

On Monday, the FDA issued an Immediately in Effect (IIE) guidance{: target="_blank"} that suggested power morcellator manufacturers add a black box warning and two contraindication warnings to their products to better inform doctors and patients about the risk of spreading cancer cells during morcellation.

The new black box warning the FDA is recommending reads:

“WARNING: 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.”

Furthermore, the agency recommended that morcellators include warnings that the tools are contraindicated (should not be used) for:

• Gynecologic surgery in which the tissue to be morcellated is known or suspected to be malignant
• Removal of uterine tissue containing suspected fibroids in patients who are:
  • Peri- or post-menopausal, or
  • Candidates for en bloc (removing tissue intact) tissue removal, for example, through the vagina or via a mini-laparotomy incision

In its IIE guidance, the FDA said that these recommendations were prompted by input from the agency’s panel on Obstetrics and Gynecology Devices, as well as public commentary the agency received during a public meeting in July when it discussed ways to mitigate cancer risks associated with morcellation.