Hysterectomy is the most commonly performed major gynecologic surgery in the United States. Over 400,000 hysterectomies are performed annually in the United States and it is estimated that 1 in 3 women will have had a hysterectomy by age 60 years. Of the benign hysterectomies performed in the United States, 68% are done for the primary indication of abnormal uterine bleeding (AUB), uterine leiomyomata, and endometriosis. The American Congress of Obstetricians and Gynecologists (ACOG) supports the use of alternatives to hysterectomy.
Over the past decade, there has been a substantial decline in the number of hysterectomies performed annually in the United States. Wright et al analyzed annual inpatient hysterectomy rates in the United States and found a 36.4% decrease in number of hysterectomies performed in 2010 (433,621) as compared to 2002 (681,234). One explanation for these results is an increase in utilization of uterine-sparing alternatives to hysterectomy. However, despite the decrease in numbers of hysterectomies in the United States, appropriateness of hysterectomy is still an area of concern. In 1 study of 497 hysterectomies in California, 76% of those done for endometriosis, AUB or chronic pelvic pain failed to meet ACOG criteria.
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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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