Fact or Fiction:

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GRAND ROUNDS – NOV 2022
Mirena Causes
Brain Tumours
 Characterized by: increased intracranial pressure that
predominantly affects young, obese women of
reproductive age

What is - pathogenesis is not fully elucidated

idiopathic
intracranial Symptoms:

hypertension? - headache

- visual loss (from papilledema and optic nerve damage)

- pulsatile tinnitus

- back and neck pain

Study Objective
QUANTIFY RISK OF INTRACRANIAL HYPERTENSION WITH
INTRAUTERINE LEVONORGESTREL DEVICE (MIRENA)
Methods
Epidemiologic study, using:

1) quantify a reporting OR for ICH and Mirena from the US FDA AE Reporting System (FAERS)

2) retrospective cohort study using IMS LifeLink Database comparing risk of two OCP ethinyl estradiol
(EE) with Mirena

Bayesian sensitivity analysis to account for BMI

Methods
FAERS database – captures 5 million reported adverse events.

Used terms: benign intracranial hypertension, idiopathic intracranial hypertension, cerebal edema, ICH,
papilledema. Date range: 1 Jan 2004 – 30 Sept 2013.

Specified prior distributions for prevalence (10-20/100000) and OR with Mirena (1.5-2.5) and then
combined these with ICH events in FAERS database using Bayesian framework to estimate new ROR

- this allows incorporation of data from existing knowledge plus real data to estimate an ROR
BMI confounder
- BMI associated with IIH

- clinicians may be more likely to Rx IUD for higher BMI

- used Bayesian sensitivity analysis to incorporate different magnitudes of BMI and its effect on crude OR
for ICH
Levonorgestrel
- second generation progestin available in both oral and intrauterine formulation

- intrauterine known as Mirena

- systemic absorption with intrauterine delivery thought to be lower than oral, however some studies show
similar rates of adverse events to oral formulation
Results
Results
Conclusion
- higher than expected number of reports of ICH with Mirena in FAERS database

- then found similar risk of ICH with Mirena compared to EE-norgestimate (Tri Cyclen)

- recommended further investigation into ICH and EE-norethindrone (Loestrin)

Limitations
- FAERS database only records adverse events

- aggregate data and no information about other covariates

- ICH is itself a rare disease

- BSA method assumes logistic regression model based on binomial distribution, but the relationship may
follow other types of models
Biologic Plausibility?
- levonorgestrel shown to bind heavily to sex hormone binding protein system (SHBG) and to lesser extent
albumin

- forms stable, long lived complex with SHBG from which it dissociates slowly

- studies shown that after continuous use of IUD, that serum concentration of levonorgestrel is variable and
may be comparable to those with oral formulations

- Ewies, 2009 - “plausible that LNG-IUS has same effect as 1-2 Noregeston tablets daily on continuous
basis”
Endometrial
ablation is effective
birth control
What is endometrial ablation?
- minimally invasive surgical procedure