Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.
In an Immediately in Effect (IIE) guidance, the FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications. The IIE guidance allows the FDA to issue its recommendations expeditiously to help address a significant public health issue.
“The FDA’s primary concern is the safety and well-being of patients and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”
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Linda Interlichia arrived alone at her family’s Cape Cod vacation home a half-mile from the beach last fall. Her routine there had been unchanged for years: She opened the doors to let the breeze flow in from the marsh and sat on the deck in the afternoon, sipping a glass of Chardonnay.
The second night, ease gave way to dread. Heavy pelvic bleeding left her faint, and the next morning, she drove herself to the emergency room.
It was, she confided to her husband, Frank, among the most frightening episodes in her life. The hemorrhaging under control, she returned home to Rochester, N.Y., and saw her doctor the same week.
To Mrs. Interlichia’s relief, her gynecologist, Wendy Dwyer, linked the bleeding to benign uterine growths, she said, and offered an enticing solution, a brochure extolling a robot-assisted hysterectomy through tiny incisions.
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Since the 1990s, thousands of women have undertaken a surgical procedure that may have risked their lives. After Dr. Amy Reed had surgery to remove uterine fibroids, involving a procedure known as power morcellation, she learned that it had worsened her prognosis by spreading a cancer she and her doctors didn’t know she had. Dr. Reed became a vocal critic of power morcellators and the doctors who used them, dividing the medical community. Now doctors and companies are waiting for more-permanent guidance from the FDA. This story, drawn from ongoing coverage in The Wall Street Journal, is a gripping human-interest account of public trust and the fallibility of modern medicine.
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Deadly Medicine: A Common Surgery for Women and the Cancer It Leaves Behind