Hysterectomy Cancer Risk from Morcellators Examined in Studies, Increases With Age

The findings of two new studies appear to confirm concerns over the cancer risk with hysterectomy morcellation procedures, and also suggest that the risk of aggressive uterine cancers being spread may increase with age. 

In the February issue of the medical journal Obstetrics & Gynecology, researchers from the University of Michigan indicate that 2.7% of women undergoing hysterectomies for what appear to be benign uterine fibroids were actually found to have undiagnosed cancer, including 0.22% who had uterine sarcoma.

In another study, published online by JAMA Oncology on February 19, researchers from Columbia University reported that the prevalence of cancer in women who undergo uterine fibroid removal appears to increase with age.

The findings add to a growing body of research that has highlighted the risk of cancer being spread during hysterectomy or myomectomy procedures involving the use of power morcellators. Researchers warn that women undergoing these procedures may have undiagnosed cancer which could be spread to other organs and metastasize.

Power morcellators are medical devices that have been increasingly used in recent years during laparoscopic hysterectomy and myomectomy procedures, allowing the surgeon to cut up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The tool facilitates a minimally invasive surgery, which reduces recovery time, minimizes scarring and helps avoid many of the risks associated with traditional surgery.

Although morcellators were rapidly adopted throughout the medical community, concerns have emerged over the past year about the risk that the devices may spread undiagnosed cancer contained within the uterus.

Last year, the FDA issued warnings after estimating that about one out of every 350 women who may undergo a laparoscopic hysterectomy with morcellation may have unsuspected sarcoma, which doctors are unable to detect before the surgery.

In the University of Michigan study, researchers performed a data analysis on hysterectomy cases from January 1, 2013 through December 8, 2013, which were reported to the Michigan Surgical Quality Collaborative. They looked at procedures that appeared to involve benign surgical indications, such as uterine fibroids, endometriosis, pelvic pain and abnormal bleeding.

“The incidence of unexpected gynecologic malignancy among hysterectomies performed for benign indications was 2.7% and included ovarian, peritoneal, and fallopian tube cancer, endometrial cancer, uterine sarcoma, metastatic cancer and cervical cancer,” the researchers determined. “No reliable predictors of uterine sarcoma exist and caution is warranted in preoperative planning for hysterectomy.”

However, researchers from Columbia University found lower rates of uterine cancer in women who underwent myomectomy procedures, which involve the removal of uterine fibroids while keeping the uterus intact, hopefully preserving a woman’s ability to have children.

In their study, uterine cancer was found in 1 out of 528 women who underwent myomectomy procedures without the use of power morcellators, and in 1 out of 1,073 who did undergo myomectomy with morcellation. They found that the rate of any pathologic finding, such as cancer, endometrial hyperplasia or questionable tumors, in women who did not get morcellation was 1 in 150 and 1 in 230 for women who did get morcellation.

The researchers said while the risk of uterine cancer for women who got uterine fibroid removal, usually performed in younger women, is rare, but that risk appears to increase with age.

“Electric power morcellation should be used with caution in older women undergoing myomectomy,” the researchers concluded.

Hysterectomy Morcellation Concerns

Concerns about the risk of hysterectomy morcellators spreading cancer began to gain widespread attention within the medical community in April 2014, when the FDA announced that it was investigating the risk and warned doctors to avoid uterine fibroid morcellation due to the risk of unsuspected sarcoma.

An FDA advisory panel was convened over the summer to evaluate the available data on the controversial devices, which resulted in a determination that there is no way to make power morcellators safer. However, the panel was split on whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.

In a widely criticized move, the FDA announced in November that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer and more limited indications for appropriate use of the devices.

Many hospitals have already announced that they will no longer perform a hysterectomy with morcellation, and many experts agree that the vast number of prior procedures performed involving the device are no longer appropriate.

In recent months, a growing number of women and families nationwide have been filing hysterectomy morcellator lawsuits against the manufacturers of these devices, alleging that inadequate warnings have been provided for patients and the medical community for years.

Plaintiffs allege that the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have been avoided if any number of different alternative treatment options available for women with symptomatic uterine fibroids had been used, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.