Power Morcellators Get Toughest FDA Black Box Warning For Cancer Risk
The FDA has issued a warning that power morcellators can spread cancer, and now recommends against the tool’s use in most hysterectomies (removal of the uterus) or myomectomy (fibroid removal). Power morcellators are a laparoscopic tool that surgeons use to chop uterine tissue into small pieces. The device makes the surgery less complicated, and patients recover more quickly than from conventional surgery. Problems arise, however, when morcellators are used on patients with unsuspected cancer, as the device sprays cancerous tissue throughout the uterus, spreading the disease.
The FDA’s “black box warning” is the strongest possible warning issued by the FDA. Generally a black box warning would be issued only after a long comment period, but the high risk of cancer spread from the morcellation procedure (estimated at 1 in 350 patients) prompted the FDA to use its regulatory power to recommend that manufacturers of laparoscopic power morcellators include this warning on the product label immediately:
- 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 recommended labeling goes on to advise that morcellation should not be used in peri– or post-menopausal women who are candidates for en bloc (removing tissue intact) vaginal or mini-laparotic incision, and women in whom cancer is suspected.
Many patients and doctors had hoped that the FDA would ban the use of the morcellator outright, given the grave consequences of cancer spread. This warning still allows morcellator use so long as the doctor communicates the FDA warning to the patient.
Johnson & Johnson’s Ethicon unit suspended sales of its laparoscopic power morcellation tool from the market this spring after the FDA issued guidance advising against their use. J&J completely withdrew the tool in August. Several health insurers have also announced that they will no longer cover the procedure. However, other companies still have morcellators on the market and the procedure is still performed by surgeons.
A woman who has been diagnosed with uterine cancer after undergoing power morcellation may have a legal claim. If you developed cancer after undergoing hysterectomy or myomectomy with a power morcellator and are seeking legal advice, please call Attorney Marilyn McGoldrick at 888-341-1405 or tell us your story online here. Like all legal claims, there are short time limits. Call now for a confidential, free consultation.