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Laparoscopic power morcellators are devices used in different types of minimally invasive surgeries, such as procedures to remove uterine fibroids. The U.S. Food and Drug Administration (FDA) has warned that morcellators pose a risk of spreading unsuspected cancerous tissue, such as sarcomas, beyond the uterus, when used for a hysterectomy or myomectomy.
In a recent study published in the American Journal of Obstetrics and Gynecology entitled Prevalence of Unexpected Leiomyosarcoma at Myomectomy: A Descriptive Study, the researchers note that the use of morcellation may not be harmful in all cases. The FDA notes this may happen in one out of every 498 procedures.
The researchers searched the databases of their center to find the number of myomectomies performed at laparoscopy or laparotomy during the 15 year period from January 1999 to December 2013. The team reviewed pathology reports and crosschecked them with those of their gynecologic oncology service. Their goal was to determine the frequency of leiomyosarcomas and tumors with atypical features that were not discovered preoperatively. Myomectomies were performed in 2,356 women, laparoscopy in 1,388 cases and laparotomy in 968 cases. During the period of 2008 to 2013, only one-third of patients underwent myomectomy at laparotomy and all fibroids removed endoscopically were morcellated.
The researchers concluded that the risk of unexpected leiomyosarcoma was less than 1/2,000. The proportion of unexpected tumors was less than 1/1,000, which was much lower than the amount indicated by the FDA. However, it is important to note that the FDA estimate was mainly centered on hysterectomy series, where the risk of occult leiomyosarcoma should be greater, as women are typically older than those undergoing myomectomy. Additionally, the occurrence of unexpected leiomyosarcoma during myomectomy is very low in young women, according to the research team.
They concluded that if power morcellation was banned, the major downfall would be having to impose a substantial additional morbidity in women undergoing an open procedure, as opposed to a minimally invasive one.
American Journal of Obstetrics and Gynecology, Prevalence of Unexpected Leiomyosarcoma at Myomectomy: A Descriptive Study http://www.ajog.org/article/S0002-9378(15)01206-5/pdf
U.S. Food and Drug Administration, UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm
For Further Information
More on the U.S. laparoscopy device market can be found in the report published by iData entitled U.S. Market for Laparoscopic Devices – 2015. This report covers the U.S. and includes the following market segments: laparoscope market, access device market, hand instrument market, insufflation device market, suction-irrigation device market, direct energy market, ultrasonic device market, closure device market, gastric band market, powered morcellator market, and female sterilization device market.
The global series on the “Laparoscopic Device Market” covers 16 countries including the U.S. and 15 Countries in Europe. The full reports provide a comprehensive analysis including units sold, procedure numbers nationally and by State in the U.S., market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment.
About Procedure Tracker
Additional procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by country, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.
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