Oral Ketorolac found effective in reducing pain during IUD insertion.

courtesy : tonpetitlook.com

Oral Ketorolac administered 40-60 minutes before Intra Uterine Device(IUD) significantly reduces the pain and discomfort associated with the procedure reports the results of small, randomized trial published recently in Journal of Obstetrics and Gynecology Canada.

Although pain tolerance is different across different population, but many times the prospect of a painful procedure scares patients off from getting an IUD inserted.

Ibuprofen and other pain relievers are not effective and a recent trial with injectable pain killers rated the pain at injection site worse than the procedure itself.

This small randomized trial conducted at community hospital in Columbus, Ohio recruited 72 women over a period of 2 years. Eligible women received Ketorolac 20 mg (n = 35) or a placebo (n = 36) 40-60 minutes before insertion.

Demographics and pain ratings for uterine sounding or tenaculum placements were similar between both the study arms.

The patients rated pain on a scale from 0 to 10. Women in the Ketorolac arm reported significant less pain relief score at the time of insertion (4.2 vs. 5.7, P = 0.031), overall pain (3.6 vs. 4.9, P = 0.047), and pain 10 minutes after the procedure (1.1 vs. 2.5, P = 0.007).

The authors concluded that oral ketorolac is significantly effective in reducing the pain associated with IUD insertion.

A New York Federal Judge rules in favor of Bayer’s Mirena IUD, dismissing 1,300 Lawsuits.

A federal judge has ruled in favor of Bayer against all the 1300 lawsuits filed by women who claimed to have suffered from internal injuries after Mirena was inserted.

It all started in 2011 when a woman filed the first complaint. Since then other have joined in claiming to have uterine perforation, inflammation, organ damage, and a host of other medical complications. Bayer has long marketed the IUD as a “hassle free” birth control for busy, on the go moms.

Bayer was warned by FDA in 2009 to scale down the positive effects of Mirena and also put forth the negative effects. The letter also stated that Mirena’s advertisements are misleading consumers by exaggeration of its abilities and do not display the side effects and risks of the IUD. Mirena was approved by the FDA in 2000, and since than Bayer has spent tens of millions of dollars advertising the IUD directly to the consumers.[1]

By the year 2009, it was so popular among women that nearly 7.5% American women had it implanted by then and have generated billions of dollars in revenue for the manufactures.

The lawsuits against Mirena comes in many forms, and in multiple states across the US. Women have claimed to have uterine perforation, increased risk of neurological damage and painful surgical removal, ovarian cysts, headache, migraines, acne, depression, and mood swings. The most common complaint is device migration , damaging and perforating the internal organs.   A website  TheTruth About Mirena  contains many other side effects and makes a grim reading.  

In the year 2015, Bayer had settled 8,250 cases for $1.7 billion but there are still lawsuits pending in national and state courts across the country. All are individually filed complaints but still a class action lawsuit is not filed yet.

In March 2016, US District Judge Cathy Seibel granted Bayer’s motion to bar the plaintiff’s expert witnesses from testifying in the court about perforation caused by the device. She found that the testimony was not backed by scientific literature and was made up just for the purpose of litigation.

Bayer’s lawyer claimed that perforations might have occurred during insertion, but were only detected later and there is no evidence that Mirena causes uterine perforations.[2]

Without expert witness testimony, no jury could rule in favor or against the IUD. So, on August 1, 2016 she ordered that the verdict should go in favor of Bayer in all 13000 cases.[3]

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[1] https://www.pop.org/content/mirena-iud-becoming-more-popular-and-lawsuits-are-piling

[2] http://www.reuters.com/article/us-bayer-mirena-idUSKCN1082N8

[3] https://www.lifesitenews.com/news/judge-dismisses-complaint-from-1300-women-victims-of-bayer-mirena-iud