New Study Supports FDA’s Concerns Over Power Morcellators
A new study published in late July in The Journal of the American Medical Association (JAMA) found that the frequency of undetected malignant tumors in women undergoing hysterectomies is higher than previously thought. This study lends support to the FDA’s recent safety communication warning consumers about the serious dangers posed by the use of power morcellators in hysterectomies, as these devices have a tendency to spread undetected tumors throughout patients’ bodies. The spreading of malignant tumors can cause a rapid upstaging of cancer, resulting in a fatal form of cancer known as leiomyosarcoma.
The JAMA study, conducted by Columbia University doctors, analyzed a large insurance database containing records of 36,470 women who had power morcellation-aided hysterectomies. Of those, 99 women were found to have previously-undetected uterine cancer, meaning that one in 368 women undergoing the hysterectomy had malignant tumors that could be spread by the morcellation technique. This finding suggests a frequency of undetected cancer in hysterectomy patients that is much higher than previously thought.
It is estimated that power morcellators are used in 55,000 to 75,000 hysterectomies and fibroid removal procedures each year. Power morcellators are manufactured by Ethicon (a subsidiary of Johnson & Johnson), as well as a number of other companies such as Olympus, Karl Storz, and Blue Endo. Due to mounting evidence about the dangers of morcellation, Johnson & Johnson recently halted the sale and distribution of these devices.
If you or someone you know were diagnosed with cancer after undergoing a surgery involving the use of a morcellator, you may have a case. The experienced medical device lawyers at Ashcraft & Gerel will conduct a free and confidential evaluation of your potential claim. Please contact us online or call us at 800-829-7037 to discuss how we may assist you.