Following a warning from the FDA, certain types of morcellators have been blamed for spreading previously undetected cancer.

A morcellator is a surgical device used to cut and remove tissue. There are basically two types of morcellators: laparoscopic and hysteroscopic.

Hysteroscopic morcellators incorporate a trap or bag that contains the tissue removed.

Of the two types of morcellators, hysteroscopic models have not generated the same controversy that laparoscopic models have.

Laparoscopic morcellators are used during laparoscopic surgery to cut larger masses of tissue into pieces small enough to be removed through the small incisions used in that type of surgery.

Using a morcellator for laparoscopic surgery allowed the patient to get the usual benefits that laparoscopic surgery has over open abdominal surgery.

Generally, laparoscopic procedures involve less tissue damage, and as a result they require less recovery time. They also tend to create less of a risk of infection.

For a few years, power morcellators saw frequent use in gynecological surgeries like hysterectomy and fibroid removal.

But according to an FDA warning from 2014, women who underwent these surgeries faced a particular risk of developing aggravated cancer.

FDA Warns About Morcellator Cancer

The FDA issued its warning in April 2014 and updated it the next November.

According to these communications, about 1 in 350 women undergoing surgery for uterine fibroids have a uterine sarcoma that goes undetected prior to surgery.

The FDA says there is no reliable way to detect these cancers prior to surgery.

For those reasons, the FDA warned against the use of power morcellators for fibroid surgery in all but a few cases.

The agency says morcellation should be avoided in patients who are peri- or post-menopausal or who are candidates for en bloc tissue removal.

The FDA also directed manufacturers to include a boxed warning in the labeling for their morcellators that addresses the possibility of spreading cancerous tissue.

The Risk of Morcellator Cancer

It’s believed that in the course of using a power morcellator to cut up the tissue that needs to be removed, bits of this undetected cancerous tissue are cut loose and scattered elsewhere near the surgical site.

This cancerous tissue can migrate elsewhere in the abdomen and begin to thrive, potentially forming multiple cancerous growths throughout the abdomen.

Cancer that is spread across a broader area like this can be much more difficult to treat effectively. This effect can significantly lower a patient’s odds of survival.

Types of Morcellators Subject to Recall

The FDA’s warning did not include a mandate for a recall of these devices. However, after the warning went out, manufacturer Johnson & Johnson halted morcellator sales and later issued a recall of three different types of morcellators.

The recalled morcellators were the Gynecare Morcellex, the Morcellex Sigma, and the Gynecare X-Tract.

All three models were products of J&J’s Ethicon subsidiary. Prior to the recall, J&J had been a leader in sales of power morcellators.

In a letter to care providers, J&J stated that it remains confident its morcellators perform as intended.

However, the risk-benefit profile for the use of morcellators in hysterectomy and fibroid surgery remains uncertain, the company said.