Pa Patient Saf Advis 2014 Dec;11(4):167.
Letter to the Editor: Uterine Power Morcellation—What Are the Risks?
Obstetrics and Gynecology
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Are you able to provide information about the risk of spread of unsuspected malignancies by the use of power morcellation in gynecological surgery? There are reported instances of cancers which have been found in pathologic examination of morcellated specimens.

Thank you.

J. L. Ginsburg, MD, MMM, CPE
Vice President Medical Affairs
Evangelical Community Hospital

Editor’s Note

Thank you for your inquiry regarding the risk of spreading unsuspected malignancies by use of power morcellation in gynecologic surgery. This procedure received national attention this past year. In April 2014, the US Food and Drug Administration (FDA) issued a safety communication stating, “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”1

In July 2014, FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee held a two-day conference to provide advice and recommendations to FDA,2 and Wright et al. identified a prevalence of 27 uterine cancers per 10,000 women who underwent morcellation.3 Johnson and Johnson had already stopped the sale of its laparoscopic power morcellators in April 2014,4 and in July 2014, it withdrew its power morcellators from the market worldwide.5  In November 2014, FDA released an immediately-in-effect guidance document recommending that manufacturers of laparoscopic power morcellators include a boxed warning and two contraindications in their product labeling.6

While there are published cases of this issue in the literature, the Pennsylvania Patient Safety Authority analysts were unable to locate any events reported through the Pennsylvania Patient Safety Reporting System (PA-PSRS) that addressed the use of power morcellation or a morcellator in gynecologic surgeries. The time interval between the use of power morcellation in gynecologic surgery and the evidence of the spread of uterine cancer makes it unlikely that this type of event would be captured in PA-PSRS.

Notes

  1. US Food and Drug Administration. Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication [online]. 2014 Apr 17 [cited 2014 Oct 1]. http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm
  2. US Food and Drug Administration. July 10-11, 2014: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee meeting announcement [online]. 2014 Jul 8 [cited 2014 Oct 1]. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm400221.htm
  3. Wright JD, Tergas AI, Burke WM, et al. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation [online]. JAMA 2014 Jul 22 [cited 2014 Oct 1].
    http://jama.jamanetwork.com/article.aspx?articleid=1890400
  4. Reuters. J&J suspends sale of device used in fibroid surgery [online]. 2014 Apr 30 [cited 2014 Oct 21]. http://www.reuters.com/article/2014/04/30/us-johnson-johnson-device-idUSK BN0DG06G20140430
  5. American Recall Center. Alert (7/31/2014): Johnson and Johnson withdraws power morcellators from worldwide markets [online]. 2014 Jul 31 [cited 2014 Oct 21]. http://www.recallcenter.com/power-morcellator
  6. US Food and Drug Administration. Immediately in effect guidance document: product labeling for laparoscopic power morcellators [online]. 2014 Nov 25 [cited 2014 Dec 3]. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM424123.pdf

 

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