Power Morcellators Attracting Media Attention, FDA Scrutiny

Surgical Rounds®September 2014

Minimally-invasive procedures that rely on morcellators are attractive to women because of the associated shorter recovery time. However, the FDA recently warned about the dangers of these tools.

Gynecologists and surgeons use power morcellators during minimally invasive hysterectomies and fibroid removals to shred tissue, facilitating its removal through a small abdominal incision. Minimally-invasive procedures that rely on morcellators are attractive to women because of the associated shorter recovery time.

However, on April 17, 2014, the US Food and Drug Administration (FDA) warned that power morcellators have the potential to spread undetected uterine sarcomas into a woman's peritoneal cavity. The FDA notes that approximately 1 in 350 women with fibroids actually have undiagnosed uterine sarcoma.

The Journal of the American Medical Association published a study (N = 232,882) discussing this risk in July 2014. Conducted by a team of physicians from Columbia University College of Physicians and Surgeons, the study found that uterine cancers occurred in 27 out of 10, 000 women undergoing morcellation. Other malignancies and precancerous abnormalities were also detected.

Shortly after this study was released, Johnson & Johnson's Ethicon Inc. recalled 3 power morcellator devices, stating that the risks and benefits associated with uterine morcellation were unclear. Ethicon Inc. is the nation’s largest manufacturer of morcellators.

As would be expected with controversial issues, several studies and opinion pieces have been published in recent months. The August 2014 issue of Obstetrical and Gynecological Survey includes a comprehensive review of morcellation, including its history, various iterations, and recommendations for counseling patients.

A rudimentary morcellator was first used in 1973 and was refined in the 1990s. Morcellation’s primary risks include damage to adjacent structures, blood loss, and increased operative time. The authors indicate that these complications are quite rare.

The review addresses cancer dissemination directly, explaining that leiomyosarcoma, a rare smooth muscle malignancy, is of concern (as the FDA noted) because it is highly aggressive. The authors review the proper surgical technique that minimizes risk, and urge careful patient counseling. They also advise physicians to stay abreast of this rapidly-changing topic.

On Aug. 1, one of the nation's largest Blue Cross and Blue Shield insurance providers, Pennsylvania-based Highmark Inc., announced it is discontinuing coverage for uterine morcellation as of September 1, 2014. Cleveland Clinic made a similar announcement earlier this year.

The American Congress of Obstetricians and Gynecologists and the AAGL, a group that advocates minimally invasive surgery, argued that a ban would deny women minimally invasive treatment that reduces the risks associated with open surgery. It is important to note that the risks are somewhat elevated for particularly for obese patients.

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