FDA Calls for Black Box Warning for Power Morcellators
Chris Welsh, Esq.
The FDA now demands a ‘Black Box Warning’ for power morcellators, a device used in performing hysterectomies and to remove fibroid tumors. The warning is the most serious that the agency issues. The warning for power morcellators will state the following:
“Uterine tissue may contain 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.”
Reportedly, the device has been available for two decades to break up tissue into tiny fragments, but experts are concerned that the fragments will spur cancer growth in patients. Last year, the device faced widespread concern with growing reports of cancer and cancer-risk in women treated with it (usatoday.com).
Doctors perform nearly 600,000 hysterectomies each year. It is estimated that morcellation is used in approximately 11-12% of those procedures. If you or a loved one has had a uterine laparoscopy or hysterectomy, or is considering one, talk to your doctor about your options and risks. If your procedure included morcellation, seek medical attention immediately. You may also want to consider legal options.
Learn more at drugwatch.com.