 The top U.S. health regulator warned Monday that a common surgical tool shouldn’t be used on most women during hysterectomies, a decision that caps nearly a year of debate and is expected to sharply curtail a procedure that the agency said can spread hidden cancer. The Food and Drug Administration used its authority to call for an immediate “black box” warning for laparoscopic power morcellators, the strongest caution the agency issues. Typically, such warnings on product labels undergo a lengthy comment period before being completed, lawyers for device makers said. “We believe that in the vast majority of women, the procedure should not be performed,” said William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. The move strengthens guidance the FDA issued in April and draws tight boundaries around use of a device that divided gynecologists and alarmed women. Morcellators were being used in thousands of minimally-invasive procedures every year to remove growths known as fibroids. While fibroids are benign, they can be hard to distinguish from a dangerous form of cancer called uterine sarcoma, which can’t be reliably detected before surgery. Morcellators, which typically use a fast-spinning... |
