Essure and the risks of reoperation

October 21, 2015

A new study examines the risk:benefit of the Essure device. And, does anti-osteoporosis medication in the wake of a fragility fracture reduce the risk of a future fracture? Plus: What role do high maternal blood glucose levels play in her child's future cardiovascular health?

As the Food and Drug Administration continues to weigh the risk:benefit profile of Essure, a report published in BMJ is adding new data on outcomes with the device. Results of the population-based cohort study show that rates of unintended pregnancy are similar for hysteroscopic and laparoscopic sterilization but that Essure is associated with a 10-fold higher likelihood of reoperation.

Recommended: FDA declares Essure safety a top priority

Researchers from Cornell University analyzed data on more than 50,000 patients who underwent hysterscopic or laparoscopic sterilization between 2005 and 2013 in New York. The main outcomes examined were safety events occurring within 30 days of and unintended pregnancies or reoperations within 1 year after the procedures. A mixed model, which took into account hospital clustering, was used to compare the outcomes, after adjustment for patient characteristics and other confounders.

During the study period, 8048 women were sterilized using the Essure device and 44,278 underwent laparoscopic sterilization. Over that time, utilization of hysteroscopic sterilization increased and utilization of laparoscopic sterilization decreased.

Overall, women in whom the Essure device was used tended to be older than those sterilized laparoscopically. They were also more like to have a history of pelvic inflammatory disease (10.3% vs 7.2%, P<0.01), major abdominal surgery (9.4% vs 7.9%, P<0.01), and cesarean delivery (23.2% vs 15.4%, P<0.01).

When compared with laparoscopic sterilization, Essure was not associated with a higher risk of unintended pregnancy after a year (odds ratio 0.84 [95% CI 0.63 to 1.12]). It was, however, associated with a substantially increased risk of reoperation (odds ratio 10.16 [7.47 to 13.81]).

“With an estimated 600,000 sterilization procedures performed in the US every year,” the authors said, “the device-based hysteroscopic sterilization has a major public health impact, and comparative safety and effectiveness of sterilizations are important for decision making by patients and physicians. A registry based study is warranted to further understand the failure events after device use and improve the safety and efficacy of sterilization procedures.”

NEXT: Does anti-osteoporosis medication lower post-fracture risk?


Anti-osteoporosis medication lowers post-fracture risk

Using anti-osteoporosis therapy to treat patients in the years immediately after a fragility fracture can significantly decrease the risk of subsequent fracture, according to the results of a population-based study. For every 27 patients who take the medication within 3 years post-fracture, 1 patient will be spared a subsequent fracture.

More: Guidelines may miss osteoporosis in women at risk

Published in The Journal of Bone & Joint Surgery, the report by researchers from the University of Chicago is an analysis of a large population-based sample, taken from the Truven Health Marketscan databases. De-identified, integrated, person-specific data on claims from 2003 to 2012 were studied.

The population included 31,069 individuals aged ≥50 years who had sustained a fracture of the wrist, proximal part of the humerus, hip or vertebra and had 3 years of continuous enrollment following fracture. The researchers stratified the subjects into two groups-those who took anti-osteoporotic therapy and those who did not-and followed them for 3 years. Only 10.6% of the target population were treated with anti-osteoporosis therapy and they tended to be older and female.

Overall, the 3-year subsequent fracture rate was 7.5% for the group that had taken anti-osteoporosis medication versus 9.7% in the group that had not received the treatment. For the group who had taken anti-osteoporosis medication, the unadjusted odds ratios for subsequent fracture showed risk reductions of 33%, 48%, 28%, 20%, and 25% after an index wrist fracture, index proximal humeral fracture, index hip fracture, index vertebral fracture, and after all fractures combined, respectively.

After adjustment for age and sex, the researchers found that the group that received treatment had risks that were 50% lower after an index fracture, 52% lower after an index proximal humeral fracture, 34%  lower after an index hip fracture, 43% lower after an index vertebral fracture, and 40% lower after all fractures combined. The number needed to treat to prevent a subsequent fragility fracture was 28 after an index wrist fracture, 20 after an index proximal humeral fracture, 26 after an index hip fracture, 25 after than index vertebral fracture, and 27 after all fractures combined.

Treatment with anti-osteoporotic therapy after a fragility fracture, the authors concluded, leads to a 40% decrease in the 3-year risk of subsequent fracture, when adjusted for age and sex.

NEXT: Impact of non-diabetic high glucose levels on future heart health of the baby


Glucose levels in pregnancy and heart defects

Even when blood glucose during pregnancy is below the cutoff for diabetes, women with elevated levels may be at greater risk of delivering babies with congenital heart defects, according to results of a case control study in JAMA Pediatrics.

Next: Pregnancy and future CVD risk

Researchers assessed a population-based cohort of 277 pregnant women from southern and central California who were carrying infants with tetralogy of Fallot (TOF) (n = 55), dextrotransposition of the great arteries (dTGA) (n =42), or healthy infants without congenital heart disease (CHD) (n = 180). Serum samples were collected from 2003 to 2007 and the analysis was conducted from March 2015 to July 2015.

When compared to those for controls, serum glucose values were elevated in samples from women whose offspring had TOF (P = .01, Wilcoxon rank sum test). No such elevation was seen, however, in maternal samples for offspring with dTGA when compared to controls (P = .18, Wilcoxon rank sum test).

Serum glucose values were higher in the maternal samples for offspring with TOF (median 97.0 mg/dL) than in controls (median 91.5 mg/dL, P=.01) but the same was not true of maternal samples for offspring with dTGA versus controls (P=.18) Serum insulin levels were significantly different between controls (median 18.8 µIU/mL) and maternal samples for offspring with dTGA (median 13.1µIU/mL; P=.048) but not with TOF (median 14.8 µIU/mL; P=.35). Compared with maternal blood glucose levels in infants without cardiac malformations, maternal blood glucose levels in models with including insulin were strongly associated with odds of TOF (adjusted OR 7.54; 95% CI 2.3-24.69) but not with dTGA (adjusted OR 1.16; 95% CI 0.28-4.79)

The investigators concluded that glucose is a continuous variable to odds of specific cardiac malformations. They also urged further investigation into the risks created by insulin signaling and glucose metabolism during early pregnancy.