FDA Warning on Hysterectomy Procedure Raises Awareness of Cancer Risk

by Searcy Denney Scarola Barnhart & Shipley
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A cancer risk surrounding a technologically advanced and minimally invasive surgery for removing the uterus has prompted the Food and Drug Administration to issue a warning discouraging the medical procedure.

The procedure, laparoscopic power morcellation, can spread malignant tissue – if any is present in the patient – beyond the uterus and throughout the pelvic region, endangering her lifespan.

Leiomyosarcoma, pictured here, is a risk of power morcellation. Leiomyosarcoma, pictured here, is a risk of power morcellation.

“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” Dr. William Maisel, of the agency’s Center for Devices and Radiological Health, said of the power morcellator. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal.”

An FDA analysis concludes an estimated one in 350 women who have hysterectomies (removal of the uterus) or myomectomies (removal of fibroids on the uterus) possess a type of uterine cancer.

“Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals,” Maisel said.

Power morcellators enable laparoscopic surgeons to break apart the uterus into tiny bits so the tissue can pass through a narrow port via a small incision in the abdomen. The problem arises when the tiny bits of tissue escape the port and spread into the body.

“Given the enhanced growth potential of uterine tumor cells, the postoperative growth of nodules of tissue generated by morcellation is a worrisome possibility,” an article in OBG Management reads.

Temple University in Philadelphia was one of the first hospitals to have placed tighter restrictions on power morcellation, with the head of the institute’s Department of Obstetrics, Gynecology and Reproductive Science saying the surgery should be limited to rare instances and done with an abundance of caution.

This image shows calcified fibroids. Courtesy of James Heilman, M.D. This image shows calcified fibroids. Courtesy of James Heilman, M.D.

Brigham and Women’s Hospital in Boston also is scrutinizing the procedure and questioning its viability.

“Electromechanical morcellation has enabled gynecologists to offer patients a minimally invasive approach for specimen extraction for over two decades,” Dr. Jon Einarsson, a gynecologist at the institute, told Contemporary OB / GYN. “However, morcellation in its current form has drawbacks that have been highlighted by recent events. I believe that in the next few years, open electromechanical morcellation will be a thing of the past.”

The FDA has issued the following recommendations for women considering the procedure:

  • Consult your doctor about the risks of power morcellation and how they could affect you.
  • Discuss different options for a hysterectomy or a myomectomy, as several are available for treating your medical condition.
  • If your doctor recommends the laparoscopic procedure, have him or her give you a detailed explanation and reason.
  • For women who already have undergone the procedure, it is recommended they follow up with their doctors even if no cancer was detected in the tissue that was removed.
  • For women who are experiencing recurring symptoms – or new ones – they should make a medical appointment as soon as possible.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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