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5 2 O U T P AT I E N T S U R G E R Y M A G A Z I N E O N L I N E | J U N E 2 0 1 4 ally issuing judgments about complicated clinical matters that are fueled by public perception rather than research-supported conclusions. Many will remember the agency's ban on silicone breast implants despite a dearth of clinical evidence. The tidal wave of ensuing litigation sent a chill through the entire country's medical community, and it took the FDA over 15 years to reverse its decision. We expected something, but we were surprised by the forcefulness of this advisory. Instead of a reasoned suggestion that physicians responsibly warn patients about the small but real dangers involved with morcellators, the FDA chose to make a sweeping recommendation that has the potential to increase the morbidity and mortality for hundreds of thousands of women about to undergo hysterectomies. It's true that in extremely rare instances —most studies suggest about 1 in 1,000 cases — leiomyomatas (benign uterine fibroids) have leiomyosar- comas hidden within them. Sarcomas are extremely aggressive cancers that tend to spread quickly to distant locations through blood and lymphat- ics, rather than spreading contiguously. Unfortunately, unless a sarcoma is found serendipitously when it is little more than microscopic and in an intact hysterectomy specimen, the disease is lethal. In other words, once a sarcoma is diagnosable, it is almost always too late for any surgical inter- vention to improve the dismal prognosis. The hypothesis that morcellators, when used on a uterus that contains a sarcoma, will (a) spread the tumor and (b) negatively impact the progno- sis, is largely unfounded by any controlled prospective research. While it has been suggested this might be the case, it is largely speculative. Furthermore, the FDA advisory states that the incidence of sarcoma is 1 in 350, which many feel to be nearly 3 times the actual rate. Banning a pro- cedure that we've all seen to be extremely beneficial for thousands and thousands of patients simply does not seem like the best course of action. G Y N E C O L O G Y © 2014 Olympus America Inc. Trademark or Registered Trademark of Olympus or its affiliate entities in the U.S. and/or other countries of the world. All patents apply. OAIENE0613AD11270 The World's ONLY Articulating HD 3D Video System The World's ONLY Universal Platforms Deliver Innovative, Cost-Effective Solutions Fully-Integrated Ultrasonic and Advanced Bipolar Technology For More Information contact your local Olympus representative at 800.848.9024 or visit www.medical.olympusamerica.com OSE_1406_part2_Layout 1 6/13/14 11:40 AM Page 52