In April the FDA issued a warning about the dangers of using the power morcellator surgical instrument for removal of fibroid tumors and for hysterectomies. As I noted in a previous article, over half a million women undergo hysterectomies every year.
Now Johnson and Johnson, the largest maker of these devices, is suspending worldwide sales, promotion and distribution of its morcellators. The use of these devices makes it easier to perform non-invasive operations but has been linked to an increased risk of a very rare but deadly cancer. The growing evidence of the link between the cancer and use of the power morcellator led the FDA to issue the warning in mid-April of this year.
Johnson and Johnson has followed the FDA warning with this statement, “We believe that suspending the commercialization of these products until their role is better understood and redefined by the medical community is the appropriate course of action at this time,”
The halt in sales does not prevent doctors from continuing to perform the laparoscopic surgeries using existing devices. While the FDA investigation is underway, the American College of Obstetricians and Gynecologists (ACOG) is doing its own review concerning the use of the power morcellator and will be issuing guidelines soon. In the meantime, several hospitals, including the Cleveland Clinic and The University of Pennsylvania Health System, have suspended the use of the morcellator until the FDA guidelines are announced.
According to a New York Times article, Johnson & Johnson is not planning a product removal at this point, noting that the FDA has indicated power morcellation might still be the best option for some patients. For now, caution and a thorough conversation with your doctor are imperative if removal of fibroid tumors or a complete hysterectomy is being discussed.
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