Ethicon, the largest manufacturer of power morcellators issued a voluntary worldwide market withdrawal of its Gynecare Morcellex, Morcellex Sigma and Gynecare X-Tract product lines following a statement issued by the FDA discouraging morcellator use due to serious medical concerns in April of 2014. The Johnson and Johnson company refuses to call the withdrawal a recall and asserts that the devices work exactly as intended. The statement by the FDA sites concerns that include the spread of cancerous tissue and the formation of fibroids among other serious medical complications and conditions that have been found to result from morcellator use.
Uterine Sarcoma Concerns
Uterine sarcoma is a form of cancer that is difficult to screen prior to laparoscopic procedures. The use of power morcellators can spread malignant tissue and advance the course of multiple forms of uterine cancer, making treatment more difficult and rendering prognoses less optimistic. When the cancer is detected in stage one, there is a five year survival rate of almost two thirds of patients but the spread of malignant tissue through morcellator use can advance undiagnosed uterine cancers to stage three— which carries a survival rate of only fifteen percent. This is the primary concern cited in the FDA statement but not the only complication that may arise from power morcellator use.
Recall vs Withdrawal
It is important to note that while Ethicon and the other major manufacturers of these devices have ceased marketing and distribution that the devices are still being used in hospitals across the country. Several hospitals have opted to no longer perform procedures that involve morcellator use and at least one major insurance carrier no longer covers such surgeries but the majority of hospitals are still allowed to use power morcellators sold prior to the market withdrawal. Johnson and Johnson is refusing to recall the devices because it claims that the devices are not defective and work properly.
The hesitation to pull these devices from operating rooms across the country will ultimately result in more injuries and deaths related to complications caused by their use. The FDA has convened an advisory committee and ordered a review of product labeling in order to more clearly warn practitioners and patients of risks and potential complications. In addition, doctors are now required to have patients sign consent forms that acknowledge they have been informed of the risks of morcellator use prior to undergoing procedures which involve them. While the FDA has not banned the use of power morcellators, it has not ruled out a ban in the future.
If you or a loved one has been injured or passed away due to complications brought on my morcellator use, contact us today for a free consultation with a lawyer. We will be happy to answer your questions, review the details of your case and let you know more about your rights and legal options. All of our attorneys work on a contingency basis, which means we will never require payment from any of our clients unless we are able to collect compensation on their behalf.