New FDA safety communication highlights why power morcellators should not be used in hysterectomies

morc2Sept. 8, 2016 – San Diego, CA Some of the tests physicians rely on to screen for ovarian cancer in women may not be accurate enough to use, the Food and Drug Administration said Wednesday, highlighting an important reason why power morcellators should not be used during gynecological surgeries.

In a safety communication released Sept. 7, the federal agency said currently available ovarian screening tests may not be sensitive enough to “reliably screen for ovarian cancer without a high number of inaccurate results” and recommends against using them.

The agency said it worries women and their doctors will make treatment decisions based on these inaccurate results. It is especially concerned for women who are at an increased risk for ovarian cancer, including those with a family history or who have already gone through menopause, because of the chance of false negatives with the screening tests.

Women who have ovarian cancer may receive false-negative test results indicating no cancer is present, which could cause them to delay treatment or not seek treatment at all, the agency said.

Other women may not have ovarian cancer but receive false-positive test results which indicate cancer is present, leading them to seek additional testing or even surgery that are both costly and unnecessary.

The FDA said in its Sept. 7 safety warning:

“… available data do not demonstrate that currently available ovarian cancer screening tests are accurate and reliable in screening asymptomatic women for early ovarian cancer.  … Using unproven ovarian cancer screening tests also may be harmful for women with increased risk for developing ovarian cancer. For instance, these women and their doctors may not take appropriate actions to reduce their future risk if they rely on a result that shows no cancer currently present. Yet, this group of women is still at high risk of developing ovarian cancer later based on their gene mutation and/or family history. The FDA believes that women at high risk for developing ovarian cancer should not use any currently offered test that claims to screen for ovarian cancer.”

This recommendation underscores why power morcellators should not be used during hysterectomies and other gynecological surgeries and why their use in these procedures is estimated to have decreased nearly 80% since 2014.

Power morcellators are used to grind up the uterus and other reproductive organs during minimally invasive surgeries, such as hysterectomies and myomectomies, to make the organs easier to remove. Their use came under fire in recent years after numerous studies suggested the devices were spreading undetected cancers throughout women’s abdomens.

In 2014, the FDA issued a safety communication discouraging their use to remove the uterus or uterine fibroids because of the risk of spreading undetected uterine cancer. Much like screening tests for ovarian cancer, there are currently no reliable methods for testing whether or not a woman with fibroids has uterine cancer.

About 1 in 350 women who undergo a hysterectomy or myomectomy will have undetected uterine sarcoma, a type of uterine cancer. There is a risk of spreading that unsuspected cancer throughout a woman’s abdomen when using a power morcellator, “significantly worsening [her] long-term survival,” the agency wrote in its 2014 release.

Multiple reports in scientific literature have also linked the use of power morcellators to the spread of undetected ovarian cancer in women, as one 2014 study published in the journal Obstetrics and Gynecology indicates.

Ovarian cancer is the fifth leading cause of cancer-related death in women in the United States. The National Cancer Institute estimates more than 22,000 women will be diagnosed with the potentially deadly disease in 2016 alone.

Fortunately for the thousands of women who undergo hysterectomies and other gynecological procedures each year, the FDA’s 2014 safety communication has resulted in an estimated 80% reduction in use of power morcellation during these procedures, as indicated by a study published last month in JAMA.

Without reliable tests to screen for early gynecological cancers — as the FDA’s numerous safety communications have indicated — the dramatic decrease in use of these devices in some minimally invasive surgeries should be seen as a victory for women and women’s health.