Based on the target audiences of the two morcellation warnings issued by the U.S. Food and Drug Administration, it appears that the federal agency expects the issue of safety regarding power morcellator use to extend beyond what it initially anticipated.

The first power morcellator warning from the FDA came in April 2014. At that time, the agency made a statement that “Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

The original caution was issued to medical professionals in the following fields: Obstetrics/Gynecology, Internal Medicine, Pathology, Nursing and Oncology.

However, by September 2014 the U.S. Food and Drug Administration appeared to “upgrade” their warning by releasing the following statement: “The FDA is warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids.”

This warning was released to medical professionals in Obstetrics/Gynecological Surgery and most importantly, added General Surgery.

General Surgery applies to any procedure that involves the abdomen including the stomach, pancreas, small bladder, gall bladder and liver. On average, there are more than six million general surgeries in the U.S. each year, more than 12 times the amount of hysterectomies.

Currently, nearly half a million hysterectomies are performed annually with 11 percent of them using a power morcellator. Even though it appears that is a small number, it actually means that thousands of women may be placed at risk of spreading undetected uterine cancer.

Power Morcellator Risks

A power morcellator is a medical tool used during laparoscopic surgery in order to shorten a patient’s post-operative recovery time. Compared to traditional abdominal hysterectomies, use of the device provides a less invasive procedure for patients.

However, researchers have discovered that morcellation use can cause unsuspected cancer tissues to spread quickly throughout the abdomen.

The FDA estimates that one in 350 women who use morcellation during a hysterectomy or myomectomy procedure are eventually diagnosed with uterine sarcoma.

Since there is no real way to detect if uterine cancer exists prior to having surgery, this has made the power morcellator a serious health risk.

Due to these recent findings, and because of the high cancer risk, some of the largest health insurance companies in the U.S. including Cigna, Aetna and UnitedHealth Group Inc., are choosing not to cover the use of a power morcellator in procedures.

Morcellation Cancer Lawsuits

The number of power morcellator lawsuits being filed continues to grow. Currently there are two dozen lawsuits pending in the federal court. In general, a morcellation lawsuit claims that manufacturers did not adequately test the medical tool before they were used for surgical procedures.

Some plaintiffs allege that power morcellator makers were aware of the cancer risks linked to the device but downplayed any health concerns.

One of the leading power morcellator manufacturers, Johnson & Johnson, has already decided to stop selling the medical tool until its link to spreading cancer is better understood. Johnson & Johnson is not the only maker of power morcellators and since a full recall has not been ordered, other companies will continue to manufacture the device.