Did FDA safety communication reduce myomectomies?

November 9, 2016

A study looks at whether myomectomies were also impacted by the FDA safety communication. Also, chronically ill mothers may be more likely to give birth to children with heart disease. Plus: Can antenatal steroids reduce mortality in extreme prematurity?

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?


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

Women who have congenital heart defects or type 2 diabetes may be at higher risk of having babies with severe congenital heart disease and infants born to women with many other chronic diseases may be at high risk of a mild form of heart disease, according to a study published in the Canadian Medical Association Journal.

Researchers in Taiwan looked at 1,387,650 live births from 2004 to 2010. Chronic disease in the mothers and mild or severe forms of congenital heart disease were identified using Taiwanese National Health Insurance medical claims. Multivariable logistic regression analysis was used to examine associations between specific types of congenital heart disease and various chronic diseases.

The researchers found that the overall prevalence of congenital heart disease in children was higher among those born to women who had certain chronic diseases such as diabetes mellitus type 1 (adjusted odds ratio [OR] 2.32, 95% confidence interval [CI] 1.66-3.25), diabetes mellitus type 2 (adjusted OR 2.85, 95% CI 2.60-3.12), hypertension (adjusted OR 1.87, 95% CI 1.69-2.07), congenital heart defects (adjusted OR 3.05, 95% CI 2.45-3.80), anemia (adjusted OR 1.31, 95% CI 1.25-1.38), connective tissue disorders (adjusted OR 1.39, 95% CI 1.19-1.62), epilepsy (adjusted OR 1.37, 95% CI 1.08-1.74) and mood disorders (adjusted OR 1.25, 95% CI 1.11-1.41) than those who didn’t have chronic disease. Mild forms of congenital heart disease had a similar pattern. Congenital heart disease was more prevalent among babies born to mothers with congenital heart defects or type 2 diabetes but not with other maternal chronic diseases.

More: What you need to know about cardiovascular disease in pregnancy

The researchers concluded that many chronic diseases in mothers can increase the risk of mild congenital heart disease, with type 2 diabetes and congenital heart defects increasing the risk of severe congenital heart disease. They believe that preconception counseling and careful monitoring of mothers with chronic disease during pregnancy would be helpful.

NEXT: Can antenatal steroids reduce mortality in extreme prematurity?


Can antenatal steroids reduce mortality in extreme prematurity?

A large study funded by the National Institutes of Health showed support for the administration of antenatal steroids (ANS) for extremely premature babies according to a report published in JAMA Pediatrics.

Participants in the observational cohort study were extremely premature babies (birth weight range, 401-1000 g; gestational age, 22-27 weeks) who were delivered at participating centers of the National Institute of Child Health and Human Development Neonatal Research Network between January 2006 and December 2011. The main outcome was rates of death or neurodevelopmental impairment at 18 to 22 months’ correct age. The definition of neurodevelopmental impairment was presence of any of the following: moderate to severe cerebral palsy, a cognitive score less than 85 on the Bayley Scales of Infant and Toddler Development III, blindness, or deafness.

Next: Patient refuses cerclage, medication; delivers early

In the no ANS group were 848 babies; 1581 babies were in the partial ANS group; and 3692 were in the complete ANS group. In the no ANS group the mean (SD) birth weight was 725 (169) g and the mean (SD) gestational age was 24.5 (1.4) weeks. In the partial ANS group, the birth weight was 760 (173) g and the gestational age was 24.9 (2) weeks. In the complete ANS group, the birth weight was 753 (170) g and the gestational age was 25.1 (1.1) weeks.

Of the 6121 infants, 4284 (40.0%) survived to the 18- to 22-month follow up and data were available for 3892 of them. Among the 3 groups, there were significant differences in mortality rates between the no ANS group (43,1%), partial ANS group (29.6%), and complete ANS group (25.2%); severe intracranial hemorrhage among survivors in the no ANS group (23.3%), partial ANS (19.1%), and complete ANS (11.7%); death or necrotizing enterocolitis in the no ANS group (48.1%), partial ANS (37.1%), and complete ANS (32.5%); and death or bronchopulmonary dysplasia in the no ANS group (74.9%), partial ANS (68.9%), and complete ANS (65.5%). Death or neurodevelopmental impairment occurred in 68.1% of the no ANS group, 54.4% of the partial ANS group, and 48.1% of the complete ANS group. When compared to no ANS course, complete (odds ratio, 0.63; 95% CI, 0.53-0.76) and partial (odds ratio, 0.77; 95% CI, 0.63-0.95) courses were linked to lower rates of death or neurodevelopmental impairment following logistic regression analysis.

The researchers concluded that ANS exposure showed a dose-dependent protective effect against death or neurodevelopmental impairment in babies who are extremely premature. They state that these results support prompt administration of ANS with expectation of completing the course before delivery.