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    FDA’s morcellation safety communication and hysterectomy trends

    In the 8 months immediately following the US Food and Drug Administration (FDA)’s statement discouraging use of power morcellation during hysterectomy, practice patterns changed, according to a new study by University of Michigan Researchers. The retrospective analysis showed that rates of laparoscopic and vaginal hysterectomy increased, as did non-transfusion complications and 30-day hospital admissions.

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    The data are from a cohort of patients who underwent hysterectomy for benign indications in the Michigan Surgical Quality Collaborative from January 2013 to December 2014. Rates of hysterectomy (abdominal, laparoscopic, and vaginal), rates of major postoperative complications, and 30-day hospital readmissions and reoperations were compared before and after the FDA’s April 17, 2014 safety communication. Major complications included blood transfusions, vaginal cuff infection, deep and organ space surgical site infection (SSI), sepsis, pulmonary embolism, cardiac arrest, respiratory failure, and death. The median episode cost related to readmissions was calculated using Michigan Value Collaborative data.

    During the reviewed period, 18,299 hysterectomies were performed. Of them, 2753 were excluded due to non-benign indications including cancer, cervical dysplasia, or endometrial hyperplasia and 174 due to missing covariate data. Compared to the 15 months before the safety communication, in the 8 months following the FDA statement, use of laparoscopic hysterectomies decreased by 4.1% (P=0.005), while abdominal and vaginal procedures increased by 1.7%  (P=0.112) and 2.4% (P=0.012), respectively.

    Major surgical complications, excluding blood transfusions, significantly increased, from 2.2% to 2.8% (P=0.015). Rates of hospital readmission within 30 days also increased from 3.4% to 4.2% (P=0.025). No significant changes were seen in rates of reoperations or for all major surgical complications. The median risk-adjusted total episode cost for readmissions was $5847 (interquartile range $5478-$10,389).

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    Judith M. Orvos, ELS
    Judith M. Orvos, ELS, is a a BELS-certified medical writer and editor and an editorial consultant for Contemporary OB/GYN.
    Miranda Hester
    Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.
    Marian Freedman
    Marian Freedman is a freelance writer.

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      Which is faster to do? Morcellating a 1 KG uterus or just taking it out abdominally? The latter, of course. So why would surgeons want to use a morcellator, taking extra time and do an LSH instead? Because they want to have more options for patients! Because they want to work hard so the patient doesn't have to (@ recovery). We are the true #PatientAdvocate!


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