The FDA said today that it plans to convene an advisory panel to evaluate the use power morcellators in gynecological procedures after the devices, used to remove uterine tissue, were linked with the spread of cancer.
The federal watchdog agency in April asked doctors to avoid laparoscopic power morcellation, a procedure in which the uterus or uterine fibroids are broken up into smaller pieces prior to removal. The increasingly popular procedure allows surgeons remove tissue through small incisions rather than through open surgery, but the FDA warned that it may also allow undetected cancers to spread.
The warning prompted Johnson & Johnson (NYSE:JNJ) to suspend sales of its Ethicon subsidiary’s power morcellators later that month. Now the FDA’s Obstetrics and Gynecology Devices panel is scheduled to meet July 10-11 to "discuss the safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy," the agency said.
"FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data. The committee will make recommendations regarding the appropriate use, premarket testing, labeling, and other risk mitigations (including the use of containment bags) for these devices," according to the FDA.
The panel will also consider whether the devices are properly classified and "assist FDA in determining the appropriate level of regulatory control necessary for this device type, including discussion of class II (special controls) or reclassification to class III (subject to premarket approval application (PMA))," the agency said.