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New Morcellator Studies

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Power Morcellator Cancer Lawyer

Latest research keeps focus on morcellator’s potential to spread hidden cancer.

Two New Studies Add to Scrutiny of Gynecology Tool

By JENNIFER LEVITZ And JON KAMP
Updated Feb. 19, 2015 2:47 p.m. ET

New research is adding to a debate over a surgical tool called the laparoscopic power morcellator that the Food and Drug Administration has warned against using in a vast majority of cases because of its potential to spread hidden cancer in common gynecological procedures.

The University of Michigan said Thursday that researchers at its health system had found that 1 in 368 women undergoing hysterectomies for uterine growths called fibroids instead had an undetected uterine sarcoma, which could be worsened with a morcellator if doctors use that technique.

Their study, which was published in the journal Obstetrics & Gynecology, found risk numbers similar to those identified by the FDA. The study included 2,575 women undergoing surgery for presumed fibroids at a statewide group of hospitals in 2013.

The authors said patients should be advised of ‘the possibility of a poorer prognosis should an unidentified malignancy be morcellated,’ and noted that there was no reliable way to distinguish a benign fibroid from a uterine sarcoma before surgery. Sawsan As-Sanie, an author of the study and director of minimally invasive gynecologic surgery at the university’s obstetrics and gynecology division, said the study was significant in part because it included a diverse set of patients from 52 hospitals.

The story of a common surgery for women and the cancer it leaves behind

Meanwhile, another new study published online Thursday by the Journal of the American Medical Association Oncology found that women who have only fibroids removed with a power morcellator face a lower risk of undetected cancers than hysterectomy patients. But the study authors also said risk increases with age and that there is continued uncertainty about the device.

The morcellator, which is used to remove fibroid growths or the whole uterus through small incisions, can worsen cancers that go undetected before surgery, the FDA warned in November, calling for strict new language on device packaging. Many hospitals have since banned or curbed morcellator use, and former top manufacturer Johnson & Johnson has left the market.

The FDA stopped short of banning morcellators, saying it was leaving open a narrow band for women for whom the tool’s benefits may still outweigh its risks.

Most of the tens of thousands of morcellation procedures performed before controversy over the device erupted in late 2013 involved hysterectomies. But there is also a market for removing just fibroids in procedures called myomectomies, often in younger women who still want to have children.

Myomectomies are most commonly performed without laparoscopic morcellators, although some gynecologists use the devices. The JAMA Oncology study found that 7.7% of 41,777 myomectomies performed between 2006 and 2012 involved power morcellation.

For those patients on whom morcellators were used, 62% of whom were under age 40, researchers found an overall 1-in-1073 rate of undetected uterine cancer. That rate is more than nine times higher than the 1 in 10,000 rate many doctors quoted patients before the morcellation controversy erupted.

The cancers in Thursday’s JAMA Oncology study included sarcomas, an aggressive kind the FDA focused on, as well as endometrial cancers many gynecologists argue are easier to detect preoperatively.

Younger myomectomy patients are ‘potentially an area where you may still consider morcellation,’ Jason Wright, the lead author of the report and division chief of gynecologic oncology at the Columbia University College of Physicians and Surgeons. But patients should still carefully weigh possible hazards, he said.

‘Some women certainly would not want to take the risk of having a potential cancer disseminated,’ Dr. Wright said.

Study authors also said the myomectomy ‘should be approached with caution’ in women over 50.

Doctors not connected with either study said they were carefully watching emerging research. Kimberly Kho, an assistant professor in Department of Obstetrics & Gynecology at the University of Texas Southwestern Medical Center, said the JAMA Oncology study would help doctors better counsel younger women. She said power morcellators aren’t necessary for minimally invasive myomectomies.

At Temple University Hospital, Enrique Hernandez, the hospital’s top gynecologist, said new studies support Temple’s decision to halt use of morcellators. ‘I think it’s too big a risk,’ he said.

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