Due to rising concerns about the risk of uterine cancer being spread by power morcellators used in laparoscopic hysterectomy and myomectomy fibroid removal procedures, the FDA’s Obstetrics and Gynecology Devices Advisory Committee met on July 10 and 11 to produce recommendations for their use.

The FDA estimates that among women undergoing hysterectomy or myomectomy for fibroid removal, 1 in 352 have an unsuspected uterine sarcoma (cancer in the muscle and supporting tissues of the uterus) and 1 in 498 have the even deadlier leiomyosarcoma, a rare cancerous tumor often found in the uterus or abdomen.

This rate is higher than previously quoted, and prompted the FDA to issue a safety communication warning on April 17, 2014, discouraging the use of laparoscopic power morcellators in women with symptoms of uterine fibroids due to the risk of rupturing the sarcoma and spreading cancer throughout the uterus and abdomen.

At the meeting, the FDA advisory panel discussed recommendations for distinguishing leiomyomas from leiomyosarcomas, additional training for physicians using morcellators, and a potential black box warning for these devices. The panel stopped short, however, of banning morcellators or enacting a recall.

Earlier this summer, Johnson & Johnson issued a voluntary recall of its power morcellators, stating it was the next step in its April announcement that it is getting out of the morcellation business.

“We believe Ethicon morcellation devices perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators, but the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain,” the company said in a letter to medical providers.

Overview of Morcellator Cancer Concern

The popularity of morcellators has been increasing throughout the years because these devices have been advertised to be less invasive and require less hospital recovery time after the procedures. These devices work by cutting a small incision in the abdomen, where the uterine fibroids are then removed in small parts. Most commonly, morcellators are used for various gynecological procedures including:

• Myomectomy (removal of fibroids)
• Hysterectomy (removal of the uterus)
• Oophorectomy (removal of the ovaries)
• Salpingectomy (removal of fallopian tubes)

However, each of these procedures carries the risk of spreading uterine sarcoma because the uterine fibroid is disturbed during the procedure. Unfortunately, once the sarcoma is ruptured the cancer spreads rapidly through the body, often limiting treatment options at the time of diagnosis.

Following the FDA warnings, many hospitals announced that they would cease using morcellator devices until an established method of handling the device as safely as possible is announced. Additionally, manufacturing companies have started pulling out of the powered morcellator device market, such as Johnson & Johnson and their Ethicon subsidiary.

As the public became aware of this, women and their families have started filing morcellator cancer lawsuits against manufacturing companies, stating they had put them in danger through negligence. Many of the plaintiffs allege that their uterine cancer cases were directly caused by their morcellator devices, and never would have used them if they had known about the risk of spreading cancer.