New Studies Confirm Morcellator Hysterectomy Risks

The power morcellator is a small surgical tool commonly employed in routine gynecological procedures such as fibroid tumor removal (myomectomy) and hysterectomies. Used in laparoscopic or key-hole surgeries, the instrument enables surgeons to break down tissue, allowing for easy extraction and a faster recovery. Recent studies on power morcellation during gynecological surgery, however, have shed light on the hidden dangers posed by the spread of aggressive sarcoma (cancer), which is disseminated by the tool’s rotating blades.

University of Michigan researchers published their findings on morcellator risks last week, the results of which were strikingly similar to those found by the FDA. Of the 2,575 participants who had fibroid removal surgery, one in 368 had undiagnosed uterine cancer that could be exacerbated with power morcellation during surgery.

Myomectomies and morcellator hysterectomy risks

Myomectomies are not always performed with the assistance of power morcellators, although many gynecologists do rely on the devices. The researchers of the study, which was published in the medical journal Obstetrics & Gynecology, caution that women should be aware of “the possibility of a poorer prognosis should an unidentified malignancy be morcellated,” since there does not exist a reliable test to diagnose uterine sarcoma before surgery.

In late 2014, the FDA warned against the use of morcellators in myomectomies and hysterectomies in the vast majority of patients, but particularly those who were peri or post-menopausal, due to evidence that the tool could spread undetected cancerous cells. Though the agency stopped short of banning the device, the warning spurred many hospitals to stop using the tools altogether. Johnson & Johnson, which once held the lion’s share of the morcellator market, has stopped selling the instruments in what they labeled a voluntary recall.

Another study published in the Journal of the American Medical Association Oncology found that women who undergo hysterectomies with morcellation face a higher cancer risk than those who have only fibroids removed. The authors conceded that a morcellator-assisted fibroid tumor removal surgery “should be approached with caution” in women over 50, since risks of uterine sarcoma increases with age.

AAGL morcellator endorsement

As controversy and litigation involving power morcellators and cancer intensifies, the Wall Street Journal reports how device manufacturers continue to influence the medical industry. Just one month after the FDA morcellator warning came out, the American Association of Gynecologic Laparoscopists (AAGL) issued its own report that seemingly endorsed the instrument, stating that the morcellator “remains safe when performed by experienced, high-volume surgeons.”

The WSJ learned that Arnold Advincula, Columbia University Medical Center’s chief of gynecological surgery and who joined the AAGL board, had been paid some $50,000 in speaking and consulting fees by Blue Endo, which makes morcellators.

Advincula’s contribution to the influential medical society report violated numerous conflict-of-interest policies, according to former AAGP president Ceana Nezhat. This latest revelation may spark further investigation into the hazards of these medical devices, which have been the topic of numerous morcellation lawsuits alleging that manufacturers and doctors failed to warn of the cancer-spreading risks.

Resources Resources