Practice patterns and postoperative complications before and after US Food and Drug Administration safety communication on power morcellation

Abstract

In April 2014, the US Food and Drug Administration (FDA) published its first safety communication discouraging "the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids." Due to the concern of worsening outcomes for patients with occult uterine malignancy, specifically uterine leiomyosarcoma, the FDA recommended a significant change to existing surgical planning, patient consent, and surgical technique in the United States. We sought to report temporal trends in surgical approach to hysterectomy and postoperative complications before and after the April 17, 2014, FDA safety communication concerning the use of power morcellation during myomectomy or hysterectomy. A retrospective cohort study was performed with patients undergoing hysterectomy for benign indications in the Michigan Surgical Quality Collaborative from Jan. 1, 2013, through Dec. 31, 2014. The rates of abdominal, laparoscopic, and vaginal hysterectomy, as well as the rates of major postoperative complications and 30-day hospital readmissions and reoperations, were compared before and after April 17, 2014, the date of the original FDA safety communication. Major postoperative complications included blood transfusions, vaginal cuff infection, vaginal cuff dehiscence, ureteral obstruction, vesicovaginal fistula, deep and organ space surgical site infection, acute renal failure, respiratory failure, sepsis, pulmonary embolism, deep vein thrombosis requiring therapy, cerebral vascular accident, cardiac arrest, and death. We calculated the median episode cost related to hysterectomy readmissions using Michigan Value Collaborative data. Analyses were performed using robust multivariable multinomial and logistic regression models. There were 18,299 hysterectomies available for analysis during the study period. In all, 2753 cases were excluded due to an indication for cancer, cervical dysplasia, or endometrial hyperplasia, and 174 cases were excluded due to missing covariate data. Compared to the 15 months preceding the FDA safety communication, in the 8 months afterward, utilization of laparoscopic hysterectomies decreased by 4.1% (P= .005) and both abdominal and vaginal hysterectomies increased (1.7%, P= .112 and 2.4%, P= .012, respectively). Major surgical complications not including blood transfusions significantly increased after the date of the FDA safety communication, from 2.2-2.8% (P= .015), and the rate of hospital readmission within 30 days also increased from 3.4-4.2% (P= .025). The rate of all major surgical complications or hospital reoperations did not change significantly after the date of the FDAcommunication (P= .177 and P= .593, respectively). The median risk-adjusted total episode cost for readmissions was $5847 (interquartile range $5478-10,389). Following the April 2014 FDA safety communication regarding power morcellation, utilization of minimally invasive hysterectomy decreased, and major surgical, nontransfusion complications and 30-day hospital readmissions increased.