A new study has provided additional evidence to support the Food and Drug Administration’s warnings regarding laparoscopic power morcellators used in hysterectomies.
A Columbia University study that was published on July 22 in the Journal of the American Medical Association, found that approximately 1 out of every 370 women who have hysterectomies using a power morcellator have undetected uterine cancer.
Laparoscopic power morcellators are used in hysterectomies and in surgery to remove fibroids. Use of power morcellators in these surgeries has been discouraged by the FDA.
Power morcellators “mince” tissue inside the body allowing the tissue to be removed through small incisions. If the woman has undiagnosed uterine cancer, morcellation can cause cancerous cells to spread to other parts of the body. Women with undiagnosed uterine leiomyosarcoma are at greatest risk. There are numerous reports of women being diagnosed with Stage 4 ULMS within weeks of power morcellator use.
At a hearing held by the FDA recently, many gynecologists and physicians argued that the benefits of the minimally invasive power morcellator procedure outweighed the risks. Dr. Jason Wright, lead author of the Columbia University study and chief of the gynecologic oncology division at Columbia University College of Physicians and Surgeons said that the Columbia study is “an answer to some of those criticisms and might mitigate the concerns of those who disagree with the FDA figures.”
“With the FDA figures, they used older studies that just looked at pathology reports for women who underwent hysterectomies – this is a study of recent patients, and also these are numbers specific to women who actually underwent an electric power morcellation,” Wright said.
The Columbia University study used a large insurance database to identify over 36,000 women who had hysterectomy performed using a power morcellator between 2006 and 2012. Undetected uterine cancer was present in 99 of these women – 1 out of every 368.
Doctors who are in favor of continued power morcellator use have argued that the risk of undetected cancer is low for younger women, making power morcellation a safe alternative. However, the Columbia University study found that 32 percent of the women who were found to have undetected uterine cancer were younger than 50 years of age.
The Ohio Power Morcellator Injury Attorneys at Clark, Perdue & List are investigating claims for personal injury and wrongful death arising from cancer spread by power morcellation. If you or a loved one has been diagnosed with uterine cancer following a surgical procedure using power morcellation, call Clark, Perdue & List.