Mirena Adverse Events are Making Headlines Again

Recent news coverage has highlighted the many side effects reported for Mirena contraceptives, largely focusing on a rare neurological condition called pseudotumor cerebri. The name literally means "false tumor," which accurately describes the disorder also known as idiopathic intracranial hypertension (IIH). Patients with IIH experience headaches, ringing of the ears and brief episodes of blindness that can seem like they are caused by a brain tumor.

Though IIH has garnered significant media attention of late, the U.S. Food and Drug Administration (FDA) has received less than 700 reports of this condition in the nearly 20 years Mirena has been on the market, making it one of the least frequently reported Mirena adverse events. Despite the fact that almost 80% of Mirena-IIH reports have been made in the last two years, the link between the two has been dismissed by medical experts and judges alike, though some have advocated for further study on the matter.

Patients Still Report Common Mirena Side Effects

The FDA's Adverse Events Reporting System (FAERS) currently shows over 95,000 reports of adverse events associated with the Mirena contraceptive, some of which have lead to lawsuit settlements over device migration and perforation issues. The majority of those lawsuits were settled in April 2018, and additional filings are not expected as the product label has been updated to include the side effects in question.

Interestingly, FAERS data indicates that Mirena adverse event reports peaked at over 15,000 in 2011 and appeared to be slowly but steadily declining until 2017 when they jumped by nearly 30%. According to official FDA documents, the Mirena device did not undergo any material changes in 2016 or 2017 that might explain the increase in side effect reports. In fact, the types of side effects reported remained virtually unchanged from previous years.

Most Common Mirena Adverse Events Reported in 2017

  • Device Expulsion or Dislocation
  • Device Breakage or Embedment
  • Pelvic Pain
  • Bleeding
  • Depression
  • Anxiety
  • Loss of Sex Drive

With no device changes to blame and 2018 carrying the fewest reported Mirena adverse events since 2010, some other factor must explain the 2017 spike.

Trump's Election Followed by Increased Usage of Intrauterine Devices Like Mirena

According to data compiled by athenahealth, Donald Trump's election may have caused a 19% increase in intrauterine device doctor's appointments between October and December 2016. Athenahealth researchers noted this as the first time in five years that IUD procedures and follow-ups increased in both November and December.

Some news outlets reported women rushing to get IUDs after the 2016 election out of fear. Donald Trump had promised to repeal the Affordable Care Act, which would have left many women struggling to afford birth control. In an effort to avoid that struggle, some women chose to quickly switch to a long-term method of birth control, like Mirena.

FAERS data shows that device expulsion was by far the most commonly reported Mirena-associated adverse event in 2017, and clinical studies show device expulsion typically occurs within six months of placement. If the IUD rush fell largely in the months between the election and inauguration, the increase in adverse events may in fact be attributable to nothing more than increased usage of Mirena contraceptives.

Increased Device Usage May Lead to More Mirena Lawsuits

The Mirena birth control device has been the subject of countless lawsuits since long before Donald Trump's election. While we cannot pinpoint the percentage of Mirena IUDs within the athenahealth database, Bayer has estimated that it is the most-prescribed IUD in the United States, making it likely to account for a substantial portion of the increase in IUD prescriptions. If the increase in adverse events in 2017 is any indication, Bayer may have only their own success to blame if they face even more Mirena lawsuits in the future.

Authored by Katy Moncivais, Ph.D.Medical Editor
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Katy Moncivais holds a Ph.D. in Biomedical Engineering from The University of Texas at Austin. She’s an experienced Regenerative Medicine Consultant with a demonstrated history of working in the hospital & healthcare industry. Skilled in adult stem cells, medical devices, biomechanics, bacterial and mammalian cell culture, and regenerative medicine, she provides guidance on an array of topics affecting consumers. In her role at ConsumerSafety.org, Dr. Moncivais works alongside the writing and research staff to help deliver fact-based news stories to consumers. Her unique professional history alongside her rigorous educational background allows her to contribute to a variety of consumer-focused topics with a fresh perspective. In addition, Dr. Moncivais reviews portions of medically driven content to ensure scientific accuracy.
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