Morcellation May Cause Cancer to Spread During Fibroid Removal, Hysterectomies

The FDA is discouraging the use of morcellation during hysterectomies and myomectomies. The agency made this announcement after discovering that a higher-than-expected number of women undergoing these surgeries were unaware that they had highly malignant, cancerous tumors known as sarcomas in their uterine tissue. According to the FDA, the use of morcellation on these patients may cause the cancer to spread, significantly worsening their prognoses. Since the FDA’s announcement, several manufacturers were hit with lawsuits claiming they did not properly warn doctors or patients about the risks associated with their surgical tools.

FDA Discourages Use of Morcellation, Recommends Black Box Warning Due to Cancer Risk

In April 2014, the FDA published a safety communication about the risks of using morcellators in hysterectomies and myomectomies after finding that sarcomas are more prevalent than it previously thought. In 2012, the Wall Street Journal reported that doctors believe only between three and seven per 100,000 women have these cancerous tumors in their uterine tissue; however, the FDA’s analysis found that this number was actually much higher, with approximately 1 in 350 women reported to have unsuspected uterine sarcomas.

The FDA said that if morcellation is used to remove a cancerous tumor, the cancer may spread to other areas of the body, including the abdomen or pelvis, and put patients at risk for serious, potentially deadly forms of cancer. Since there is no reliable way for doctors to determine whether a fibroid is cancerous prior to removal, the agency announced it was discouraging the use of morcellators in hysterectomies and myomectomies to help reduce this risk.

Then, in November 2014, the FDA recommended that morcellator manufacturers add three warnings to their products’ packaging. First, the FDA recommended a black box warning that urges doctors to discuss the possibility of spreading unsuspected sarcomas during morcellation. Second, the agency recommended two contraindication warnings that suggest the procedure should not be used for:

• Removal of tissue that is known or suspected to contain malignancies


• Removal of tissue containing suspected fibroids in the following patients:
  • Peri- or post-menopausal patients
  
  
  • Candidates for en bloc (intact) tissue removal through the vagina or other incisions

Have Any Morcellator Manufacturers Issued Recalls?

Yes. In July 2014, Johnson & Johnson’s Ethicon division – the largest producer of morcellators – announced it was issuing a worldwide recall for its Morcelex device. The announcement came just two weeks after the FDA’s panel on obstetrics and gynecological medical devices held a public meeting and discussed ways to mitigate the risks associated with these surgical tools. Following the meeting, Ethicon reportedly told doctors that the company believed a recall was necessary because “it is not clear that the benefits of the device outweigh its risks.”

No other manufacturers have issued recalls for their products and more than two dozen morcellators remain on the market today.

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