On Monday, the U.S. Food and Drug Administration issued a warning against the use laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.
This strengthens a warning that was previously issued in April.
These devices are long and slender and have sharp, tissue-eating cutters on the end. The force of the blade entering and grinding into the uterus can cause cancerous tissue to expel out to other areas.
For women who are cancer-free, this risk wouldn’t apply. However, the FDA estimates that approximately 1 in 350 women who are undergoing a hysterectomy or myomectomy for fibroids are found to have an unsuspected uterine sarcoma. Thus, laparoscopic power morcellation presents a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.
One manufacturer, Johnson and Johnson, had already issued a worldwide recall through its subsidiary, Ethicon, of the device and asked doctors to stop using it in April.
“The FDA’s primary concern is the safety and well-being of patients, and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” said William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, in a news release. “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”
The warning informs health care providers and patients that:
- Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
The two contraindications advise of the following:
- Laparoscopic power morcellators are contraindicated (should not be used) for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or candidates for en bloc tissue removal (removing tissue intact) through the vagina or mini-laparotomy incision. (These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)
- Laparoscopic power morcellators are contraindicated (should not be used) in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.
The FDA has stopped short of banning the device outright, and many manufacturers are involved in legal suits.
S.C. Rhyne is a blogger and novelist in New York City. Follow the author on Twitter @ReporterandGirl, http://Facebook.com/TheReporterandTheGirl and visit her website at http://www.SCRhyne.com
