It’s been nearly two years since the U.S. Food and Drug Administration (FDA) issued a safety communication discouraging the use of laparoscopic power morcellator use during a laparoscopic hysterectomy or myomectomy to remove fibroids.

The devices, once used in many gynecologic laparoscopic surgeries, involve inserting a tiny instrument with a rotating blade into incisions in the abdomen.

Once inserted, it operates like a food processor to break up a fibroid-filled uterus (or just the fibroids) into tiny pieces. Power morcellator use allows removal of this tissue through small laparoscopic incisions.

In April 2014, the FDA warned that grinding up fibroids or the uterus could send bits of tissue into the abdominal or pelvic cavity, where they can lodge and grow, and cause pain, bleeding and infection.

In November 2014, the FDA took its warning a step further. It cautioned that the devices should not be used on most women.

It also recommended – but didn’t require – that manufacturers of laparoscopic power morcellators update the safety statements on their labels, including a black box warning, the FDA’s most serious one.

Another recommendation was that women undergoing the procedure sign detailed consent forms highlighting the risk of cancer spread. The agency stopped short of enforcing an outright ban.

After this FDA-issued warning, power morcellator use declined significantly. However, according to a recent study, the risk of cancer thought to be associated with power morcellator use has not.

The new study looked only at changes in the rates of hysterectomies since the FDA warning was announced.

Hysterectomies can be used as a treatment for a number of conditions including fibroids, vaginal bleeding, vaginal prolapse and pelvic pain, according to lead researcher Dr. Jason Wright.

Dr Wright is an associate professor of obstetrics and gynecology at the Columbia University College of Physicians and Surgeons in New York.

According to the report published in the Aug. 23 issue of the Journal of the American Medical Association (JAMA), Wright and colleagues collected data on more than 200,000 women who had a hysterectomy. Among these women, 58 percent had a minimally invasive procedure, the study showed.

In 2013, nearly 14 percent of minimally invasive hysterectomies were done using power morcellation. By 2015, power morcellator use had dropped to 3 percent, the researchers found.

“The striking thing about this study is that even with all the media attention and the uptake of guidance and the scrutiny — and certainly, physicians are being more careful about who they choose to perform this procedure in — some women who underwent morcellation still developed cancer”, Dr. Wright noted.

“I don’t think there is any patient that you can say with certainty that there is no cancer risk,” he added. “However, prior studies have shown us that younger women generally have a lower risk of cancer, and that’s probably the group of women that is safest to consider morcellation in.”

FDA Warns About Power Morcellator Use

The FDA estimates that about one in 350 women who require hysterectomy or myomectomy surgery for uterine fibroids have undiagnosed uterine sarcoma.

If morcellators are used on these patients, there is a risk they will spread cancerous tissue to other parts of the body.

According the FDA warning, “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellator use for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”

Since the FDA warnings, numerous hospitals have banned the use of the devices and several health insurers now either refuse to cover procedures using the device or require tighter controls on power morcellator use.

Were You Diagnosed With Cancer After Power Morcellation Surgery?

If you or a loved one underwent a laparoscopic gynecological surgery for morcellation of fibroids and thereafter developed uterus, pelvis or abdomen cancer, you need to protect your rights and speak to an experienced morcellator cancer attorney as soon as possible.

You may be entitled to a significant award for pain and suffering and other damages caused by the spread of undetected sarcoma due to power morcellator use. Contact an experienced attorney for your free, no obligation consultation.