Study: Risk Of Hidden Cancer In Gynecologic Surgery Higher Than Previously Thought

Undetected cancer among women undergoing a type of minimally invasive hysterectomy or fibroid removal surgery is more common than previously thought, a new study finds. Researchers at Boston Medical Center report that the risk of such hidden cancer is about 1 in 352 women.

The upshot: these women may have had the undetected cancer spread within their bodies inadvertently through a technique that has fallen out of favor called “power morcellation,” which was typically used in these types of surgeries. The technique involves cutting the woman’s uterus or fibroids into small pieces to make them easier to remove during the less invasive laparoscopic procedure.

The new findings (which looked at the cases of more than 19,000 women) support a 2014 estimate by the U.S. Food and Drug Administration that approximately 1 in 350 women undergoing this type of surgery face the risk of hidden cancer. But earlier conventional wisdom was that the risk of undetected cancer for women undergoing this kind of surgery was closer to 1 in nearly 5,000 or more.

“The take-home message of the study is that the true risk of an undetected cancer at the time of gynecologic surgery for what was assumed to be benign disease is about 1 in 352 women,” says Dr. Rebecca Perkins, a practicing gynecologist at BMC and lead author of the new study.

This kind of minimally invasive surgery had “increased greatly” over the past decade, researchers report, because the procedures involved less pain and shorter recoveries, among other benefits.

But power morcellation came under public and regulatory scrutiny a few years ago (in large part due to excellent reporting by Jennifer Levitz at The Wall Street Journal). In 2014, the FDA issued a series of warnings against the use of laparoscopic power morcellators in the majority of women undergoing these types of gynecologic surgeries because of the risk of spreading unsuspected cancer.

At that time, regulators estimated the risk of hidden cancer this way:

Based on an FDA analysis of currently available data, we estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma.

If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood.

Continue reading

WSJ: Women At Risk, Doctors Split On Procedure Linked To Rare Cancer

Here’s another excellent Wall Street Journal report on the controversial procedure known as “morcellation.”  Reporter Jennifer Levitz notes that even after the FDA issued a warning on the practice (which involves a “laparoscopic power morcellator” that allows for less invasive surgery to remove fibroids by slicing them up, but can also potentially spread a rare type of cancer through the body) doctors are split on how to proceed.

According to the report:

The FDA said women undergoing surgery for what look like benign fibroids actually have a 1 in 350 risk of hosting an undetected cancer called a uterine sarcoma. Morcellating these tumors can spread cancerous tissue internally and significantly worsen the odds of long-term survival, the agency said.

So what are women to do when the medical community itself is divided? From the WSJ:

(wikimedia commons)

(wikimedia commons)

A number of doctors believe the FDA overreached, and think the cancer risk is so small that gynecologists can go an entire career without seeing a case. Others call the advisory a necessary precaution.

Hospitals and private practices are taking an array of approaches. The University of Pittsburgh Medical Center system, which has more than 50 obstetrics and gynecology practices, opted to continue using the device.

The medical system changed its informed-consent forms to include wording on cancer risk and told doctors to discuss the risk with patients. But Allen Hogge, chairman of obstetrics, gynecology and reproductive sciences there, questioned the data behind the FDA’s estimate. The FDA began looking at the issue after media reports late last year about a prominent Boston doctor who discovered she had sarcoma after morcellation.

“I think this is mostly public relations and not science,” Dr. Hogge said. In response, the FDA said it conducted a rigorous analysis of published literature.

The common practice of morcellation, which is often used for hysterectomies, came under fire when Dr. Hooman Noorchashm, a cardiothoracic surgeon at Brigham and Women’s Hospital and his wife, Dr. Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center launched a publicity campaign aimed at stopping the procedure, Continue reading