The U.S. Food and Drug Administration (FDA) gave power morcellators the strictest safety warning possible on Monday, stating that the device can spread cancer in the majority of women who have cancerous uterine fibroids.
The “black box” warning means that the FDA is strongly recommending power morcellators not be used in laparoscopic hysterectomies to remove potentially cancerous fibroids. Furthermore, doctors and patients are advised to discuss alternate methods for fibroid removal without morcellation devices. Short of a complete ban, the black box warning is the strongest caution the FDA issues.
While morcellators had previously been deemed safe and thousands of women were undergoing power morcellation procedures, the FDA has clearly decided that the risks of undergoing surgery with a power morcellator far outweigh the benefits.
The Nov. 24th announcement strengthens the FDA’s initial concerns about the device. In April, the agency said that 1 in 350 women has hidden sarcomas that are found in later testing. Through the morcellation process, those potentially cancerous cells are pulverized, and may spread existing cancer to new areas of the abdomen.
It is unlikely that physicians would construe the FDA’s warning as anything but extreme caution against the use of power morcellators. The agency does not regulate the actions of doctors and physicians, but those who choose to continue to use morcellators may be exposing themselves to serious legal liability.
If you or a loved one underwent surgery with a power morcellator only to discover that your cancer spread, you could be eligible for compensation.
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