On November 24, 2014, the Food & Drug Administration made another significant step in improving the safety of women. The FDA issued its latest safety alert relating to the widespread use of power morcellators. A power morcellator is a medical device that is used during a number of gynecological surgeries – the removal of the uterus or fibroids, including laparoscopic supracervical hysterectomy (LSH), robot-assisted hysterectomy, laparoscopic myomectomy (uterine fibroid removal), and other minimally-invasive fibroid surgeries. The first FDA safety alert released about the power morcellator devices was issued in April of 2014 regarding the risk of spreading cancer cells during the procedure which grinds up uterine tissue or fibroid growths. Use of power morcellator devices has been linked to an increased risk of leiomyosarcoma, a rare uterine cancer, which can spread throughout the pelvis, bladder, lungs, and other parts of the body.
The November of 2014 safety alert recommends that the manufacturers of the devices enhance their product warning labels to provide stronger warnings about the risks of the spreading of cancer cells with the use of power morcellators. The FDA’s alert notes that this is a “significant public health issue” and that the safety instructions for use of power morcellators will carry a “black box” warning label in the future, which is the strongest warning label utilized for drug and medical devices regulated by the FDA. The new guidance from the FDA indicates the future warning labels for power morcellator devices will carry substantially the following warnings for patients and their doctors:
“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 new labeling requirements from the FDA also mandate the inclusion of several contraindications, which are essentially guidelines as to particular patients or pre-existing conditions which may make use of the medical device inappropriate. These new contraindications include avoiding use of power morcellators to remove uterine tissue and suspected fibroids in women who face a greater risk of uterine cancer, including those who are peri-menopausal or post-menopausal (which is a large percentage of the women who undergo hysterectomies and surgeries for the removal of fibroids). A new contraindication will also be required to warn about avoiding use of the device in women who have known or suspected cancer.
A panel of scientists, physicians, and industry representatives was convened in July of 2014 to provide advice to the FDA about the continued use of power morcellators on patients, and this latest safety alert and anticipated changes to the warning labels for the devices were issued following the recommendations of that panel. It is disappointing that the panel and/or the FDA did not advocate for complete suspension of the use of the devices, although it is quite common for the FDA to choose enhanced warnings over a product recall. That being said, in light of the serious safety issues, it is doubtful that most patients would knowingly choose to undergo a hysterectomy or surgery to remove a fibroid and consent to the use of a power morcellator, as the risks of developing an aggressive, widely-disseminated uterine cancer appear to far outweigh the benefits of a quicker procedure with smaller incisions that is arguably made possible with use of a power morcellator device. One can only hope that patients in the future are educated about the potential risks of use of the power morcellator devices so that they can make truly informed decisions prior to surgery or, better yet, that surgeons just stop using the devices completely, so that future patients will not be unknowingly subjected to this cancer risk.
The lawyers of Searcy Denney Scarola Barnhart & Shipley, P.A. have been representing patients injured by dangerous medical devices and drugs for decades. Please contact us if you desire more information about power morcellator devices and the individual product liability lawsuits being filed on behalf of patients who have developed aggressive uterine cancer as a result of the use of a power morcellator device.