Johnson & Johnson‘s (NYSE:JNJ) and its Ethicon subsidiary suspended sales of laparoscopic power morcellators, used in fibroid removal surgery, following FDA warnings that they may unwittingly help spread undetected cancers.
The company stopped short of issuing a recall, telling customers that federal healthcare regulators continue to view morcellation as an important option for some patients. Ethicon noted that the devices have always carried a label warning of the "potential spread of malignant tissue," according to a letter obtained by Reuters.
FDA medtech regulators issued a formal warning earlier this month advising doctors to avoid using 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.,
Since there’s no way to know whether a fibroid is cancerous prior to removal, breaking up the tissue may allow pieces to escape and spread an undetected cancer outside the uterus.