Tags: fda | hysterectomy | device | cancer

FDA: Hysterectomy, Myomectomy Device Could Spread Undetected Cancer

By Clyde Hughes   |   Friday, 18 Apr 2014 07:37 AM

The FDA issued a warning Thursday to doctors that a common procedure performed during a routine hysterectomy or myomectomy could possibly spread undetected uterine cancer.

The procedure for myomectomy, which is the removal of the uterine fibroids, or for a hysterectomy, which is the removal of the uterus, involves a treatment called laparoscopic power morcellation. That treatment utilizes a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen, according to the FDA. 

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One in 350 women who are undergoing a hysterectomy or a myomectomy has an unsuspected type of uterine cancer called uterine sarcoma, which could spread to the abdomen and pelvis through the laparoscopic power morcellation procedure. 

The spreading of the cancer to the abdomen and pelvis "significantly" worsens the patient's chances of long-term survival, the FDA warned.

"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, deputy director at the administration's Center for Devices and Radiological Health, said in a statement.

"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 morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their healthcare professionals," he added.

Dr. Hooman Noorchashm, a surgeon at Brigham and Women’s Hospital in Boston, told ABC News that the FDA announcement was a "major step forward." His wife, Dr. Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center in Boston, underwent the procedure last fall and undetected cancer cells spread through her abdomen.

Doctors diagnosed Reed with a stage IV cancer, leiomyosarcoma, days later.

"The major accomplishment is going to be 10 years from now when Amy is cancer-free," Noorchashm told ABC News. "What helped her was the sheer magnitude of the truth here . . . I just didn't stop. I've been generating somewhere between three to 10 emails a day since November."

The couple started a petition on Change.org calling for doctors to stop performing laparoscopic power morcellation. It had more than 8,100 signatures as of Friday morning.

The FDA said it would call a meeting of the Obstetrics and Gynecological Medical Devices panel to discuss alternative options for the procedure.

"Input from clinical and scientific experts will help provide valuable information and perspectives to clarify the proper clinical role for these devices," Maisel said in the FDA statement.

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