Indian River Medical Center, among other hospitals in the country, has stopped using a minimally invasive method to remove growths from the uterus after the government warned that the procedure can spread cancer cells.
In the procedure, called laparoscopic power morcellation, electronic surgical devices are used to shred non-cancerous fibroids, which are then removed through a small incision. It had become a widely accepted alternative to traditional surgery requiring a larger incision.
Doctors have known of the risk that the procedure could inadvertently scatter cells from undetected cancerous tumors to other parts of the body. But the chances of that happening are greater than had been thought, the Food and Drug Administration said in discouraging use of the method until more is known.
Not long after the FDA’s announcement in April, Johnson & Johnson suspended sales of the devices pending more study. “Everyone is looking at the issue and studying it,” said Dr. James Presley, OB/GYN in Vero Beach.
He said the method still has a future, but safer methodology will be needed. “Stopping its use in all patients went beyond the recommendations from the FDA,” he said. “The FDA issued no restriction in the use of power mocellation in patients without uterine fibroids.”
In an emailed statement, Dr. Charles W. Mackett III, senior vice president and chief medical officer at the center, said the hospital stopped using the devices in early May, after the FDA warning and patient-safety alerts. “IRMC joined many major hospitals and hospital systems throughout the U.S. who suspended use of these devices,” he said, noting sales of them have also been suspended.
It was reported recently that a much higher number of women than previously thought have undetected cancer in the fibroids, and that grinding the growths can inadvertently disperse cancerous material in the abdomen.
The procedure has been used to remove the noncancerous growths themselves or the entire uterus. Power morcellation requires special training to use safely. Only a few Vero Beach practitioners are credentialed to perform it.
Fibroids, fairly common in women, are often left alone if they do not cause pain, bleeding or interference with fertility. For cases where they must be dealt with, electronic uterine procedures were developed as a less invasive alternative to traditional surgery, in which the uterus or fibroids are removed through the vagina or a large incision in the abdomen. It’s believed to result in faster recovery as well as smaller scars.
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, the FDA’s director for medical devices.
“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.”
A number of additional treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hysterectomy and myomectomy, and laparoscopic hysterectomy and myomectomy without morcellation, as well as other non-surgical options. In a myomectomy, used for women who may want to get pregnant, fibroids are removed while the uterus is not.
The FDA will convene a public meeting of the Obstetrics and Gynecological Medical Devices Panel to discuss information related to laparoscopic power morcellation. “Input from clinical and scientific experts will help provide valuable information and perspectives to clarify the proper clinical role for these devices,” said Maisel.
“We anticipate the discussion will include whether a boxed warning related to the risk of cancer spread should be added to the product labeling for laparoscopic power morcellators to ensure patients and healthcare professionals are adequately informed of the risks.”
The FDA estimates that 1 in 350 U.S. women who undergo fibroid procedures each year has a form of cancer called uterine sarcoma.
The agency did not give estimates for the number of cancers affected by the problem, but at least 50,000 U.S. women undergo the procedure each year for hysterectomy.
Fibroids can cause bowel and bladder problems as well as pain and bleeding, especially among women in their late 30s and their 40s. Fibroids are responsible for at least 240,000 hysterectomies a year, the FDA estimates.
Hysterectomies are recommended for many reasons in women. These include pelvic pain, painful periods, cancer or pre-cancer of the cervix, uterus, fallopian tubes and ovaries, and for uterine fibroids that have become symptomatic.
“We all agree with suspending its use for uterine fibroids, but completely stopping it’s use went beyond the FDA recommendations, and will impact women having minimally invasive gynecologic surgery for other reasons,” Presley said.
