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    Did FDA safety communication reduce myomectomies?

    COG-SpecialDelivery-Issue_2641.jpg

    study presented at the American Society for Reproductive Medicine 2016 Society Congress indicates that the decline in laparoscopic morcellation following the US Food and Drug Administration (FDA) communication did not increase the number of abdominal myomectomies being performed, however the number of laparoscopic myomectomies were significantly reduced.

    The researchers abstracted data from the American College of Surgeons National Surgical Quality Improvement Program database on women undergoing myomectomy before the FDA communication (April 2013 to December 2013, n = 1823) and those undergoing myomectomy after the FDA communication (April 2014 to December 2014, n = 659). Cases from January 2014 to March 2014 were excluded to allow for changing of practices. CPT coding was used to determine myomectomies along with respective approach and fibroid burden. A generalized linear model was used to model the incidence of myomectomies per quarter.

    Perioperative morbidity, operative time, and surgical approach were compared between those who underwent surgery before and after the FDA communication using chi2 and 2 sample t-tests. Multivariable logistic regression was used to calculate adjusted odds ratio (aOR) with 95% confidence intervals (CIs).

    Related: A containment system for morcellation

    Researchers found that myomectomy rates decreased by 63.9% following the FDA communication (P<0.01). The decrease varied by surgical approach was more pronounced for laparoscopic in comparison to abdominal myomectomies (70.9% vs 56.3%, P<0.001 respectively). Post-FDA communication, myomectomies were more likely to be abdominal (57.1%) than laparoscopic (42.9%), which is the reverse of pre-FDA communication where 47.2% were abdominal and 52.8% were laparoscopic (P<0.001). No change in relative disease burden of myomectomies performed before and after the communication was noted (P=0.28). Myomectomies performed after the communication showed an increased risk of sepsis (aOR 4.11; 95% CI 1.15, 14.61) following adjustment for myoma burden, but the absolute rates for both groups were <1%. There were no significant changes noted in operative time or other perioperative morbidity.

    The researchers concluded that the FDA safety communication on power morcellation did have an impact on the practice of myomectomy. They stated that the findings will be expanded once the 2015 data are available.

    NEXT: Are children of chronically ill mothers at increased risk of heart disease?

    Miranda Hester
    Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

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