Laparoscopic Power Morcellators Used to Treat Uterine Fibroids Could Spread Cancer

Laproscopic power morcellators are electric medical devices used during different types of laparoscopic surgeries.  A set of spinning blades is used to cut tissue. Power morcellation is used in surgeries to treat unterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy).  Morcellation refers to the division of tissue into smaller pieces or fragments, which is useful during laparoscopic surgeries to allow the removal of tissue through small incision sites.  The CDC estimates that 600,000 hysterectomies are performed annually in the United States, most frequently to treat uterine fibroids.

In a news release posted on April 4, 2014, the FDA estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of uterine fibroids is found to have an unsuspected uterine sarcoma, which is a type of cancer. In most cases, physicians do not have a reliable way to identify patients with uterine sarcoma.  A peer reviewed study published by Michael A. Seidman, et al. in November 2012 entitled, “Peritoneal Dissemination Complicating Morcellation of Uterine Mesenchymal Neoplasms” reviewed 1091 cases of uterine morcellation performed from 2005 to 2010 at Brigham & Women’s Hospital in Boston, and concluded that “uterine morcellation carries a risk of disseminating unexpected malignancy with apparent associated increase in mortality (i.e., death) much higher than appreciated currently.” This means that the morcellator cuts up and disperses cancerous tissue throughout the abdomen. The inability to tell whether a patient has uterine sarcomas combined with the risk that the power morcellation procedure will spread cancerous material within the pelvis and abdomen should be very disconcerting to women uterine fibroids. Indeed, the FDA recognized in April that power morcellation in women with uterine sarcoma risks “significantly worsening the patient’s liklihood of long-term survival.”

In an  April 17 2014 Safety Communication, the FDA warned against the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.  The same  day, The American Congress of Obstetricians and Gynecologists (ACOG) released a statement acknowledging the FDA safety communication and promising to evaluate the incidence of uterine sarcomas.  On May 9, 2014, ACOG issued a Special Report entitled, “Power Morcellation and Occult Malignancy in Gynecologic Surgery.”

Here is ACOG’s May 9, 2014 conclusion:

… there are no sufficiently large population-based series to provide an accurate rate of preoperatively undiagnosed uterine sarcoma in patients undergoing hysterectomy. Given the relative rarity of uterine sarcomas in this context, it would take a considerably large cohort (approximately 100,000) to have much narrower confidence intervals and , therefore, a more precise risk estimate.  As a result, a national prospective morcellation surgery registry is needed to acquire an adequate volume of consistent and reliable data.  ACOG encourages the FDA to call for the establishment of such a registry.

To be clear, ACOG responded to the FDA’s warning that power morcellation risks spreading devastating cancer throughout a women’s abdomen and pelvis by suggesting that the FDA “call for the establishment of” a registry of power morcellation surgeries and get back to ACOG when the registry has 100,000 cases which have been evaluated by whomever establishes the registry.  In the meantime, what happens to the women with unknown uterine sarcomas who undergo laparoscopic power morcellation to treat uterine fibroids?  On behalf of my wife and daughter, I wish the organization that advises OBs and GYNs would recommend to its members that they heed the FDA warning and use an alternative treatment.  At the very least, shouldn’t ACOG tell its members to share the FDA warning with their patients? NOW

The FDA’s April 17 Safety Communication  led the leading manufacturer of power morcellators to respond by halting sales of the devices.

Some major hospitals around the nation have placed a moratorium on further use of power morcellators until the FDA issues a decision pending the upcoming Advisory Committee meeting that will convene to evaluate the devices on July 10-11th.

Related:

• Uterine issues leading to the use of power morcellators
• Patients Should Know: Power Morcellation to Treat Uterine Fibroids May Spread Cancer