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Study Links Power Morcellation with Hysterectomy Complications

doctor counseling womanOver the past year, news reports have brought attention to cancer risks that are increased by power morcellation with hysterectomy procedures. But gaining less attention is the risk that the procedure may spread other benign, but still life-disrupting, uterine diseases.

Earlier this year, Obstetrics & Gynecology Journal published a report of three case studies of non-cancerous morcellator complications that women suffered after undergoing power morcellation and concluded that open power morcellator uterine procedures may be associated with clinically significant spread of disease.

Morcellation with hysterectomy risks

The FDA approved the first power morcellator device in 1995 for use in laparoscopic, or keyhole, surgeries. The devices have gained popularity over the years as more patients have sought less invasive surgical options. The morcellator works by blasting apart tissues to be removed through a tiny incision, omitting the need for openings big enough for surgeons to manually remove larger sections of tissue.

It is estimated that more than 200,000 women per year have undergone uterine surgery with morcellation devices. The device has been used to simplify both hysterectomy and myomectomy procedures. However, the FDA warned earlier this year that approximately one out of every 350 women has an undetectable, and therefore undiagnosed cancer that can be spread by the morcellation procedure.

Complications include spread of cancerous and benign cells

As the power morcellator breaks apart tissues to be removed, it disperses particles, including cancer cells and other diseased tissues that may be present, throughout the abdomen and pelvis. In cases of severe forms of cancer like metastic leiomyosarcoma, this spread can accelerate the cancer’s growth and greatly decrease the chance of survival.

The focus of campaigns to ban the use of power mocellators in uterine procedures has focused on its role in accelerating cancer. The Obstetrics and Gynecology report, however, highlights the problem of benign but still serious conditions. It focused on three women who each underwent a minimally invasive hysterectomy by power morcellation and afterward returned with serious complications that required multi-organ resections to correct. In one case, the patient developed multiple tumors that required the removal of several organs. The other patients developed bowel obstruction and abdominal adhesions, both of which required surgical resection to repair.

FDA warned against uterine morcellator surgeries

Given the growing connection between uterine morcellation procedures and serious complications, many groups have begun lobbying for a power morcellator ban. Earlier this year, the FDA issued a warning about the risk of spreading aggressive uterine cancers and took the dramatic step of requiring a black box warning on the device to that effect. In the wake of the warning, many insurance companies pulled coverage for morcellator procedures for fibroid removal or hysterectomy.

A number of manufacturers have produced morcellator devices but the largest by far has been Johnson & Johnson’s Ethicon division, which produced more than ¾ of the devices in the market. But in light of the risks with morcellation procedure, Ethicon announced a voluntary recall of the device in September 2014. Other manufacturers have refused to follow suit. Victims of complications from power morcellators, however, are lining up to sue the manufacturers and more are expected to join their ranks in the near future.

 


  1. Obstetrics & Gynecology, Surgical Cytoreduction for Disseminated Benign Disease After Open Power Uterine Morcellation, http://journals.lww.com/greenjournal/Abstract/publishahead/Surgical_Cytoreduction_for_Disseminated_Benign.99247.aspx

  2. Health.com, FDA Adds ‘Boxed Warning’ to Devices Used to Remove Uterine Fibroids, http://news.health.com/2014/11/24/fda-adds-boxed-warning-to-devices-used-to-remove-uterine-fibroids/