Pre-treatment with Mifepristone before Mirena insertion helps optimize the bleeding pattern

Pretreatment with low dose Mifepristone significantly improves the bleeding pattern following the insertion of the levonorgestrel-releasing intrauterine system with a 52 mg reservoir (LNG-IUS 52 mg, Mirena®) report the results of randomized control trial published in Journal of Human Reproduction.

The LNG-IUS is one of the most cost-effective contraceptive method currently available, but many women discontinue its use because of irregular bleeding/spotting during the initial three months following its placement. It is estimated that about 25–62% of women experience irregular vaginal bleeding during the first 3-6 months causing them to discontinue the contraceptive.

With continued use after 3-6 months, the irregular bleeding and spotting are reduced, and more than half the women experience amenorrhea at the end of 1 year.

The Swedish researchers recruited 68 eligible women attending the Karolinska University Hospital from November 2009-2013 for this prospective, randomized, double-blind, placebo-controlled trial (European Union Clinical Trials Register–2009-009014-40). Fifty-eight women met the eligibility criteria and were randomized to receive 50 mg mifepristone as single oral dose or placebo for two months before and three days following the insertion of LNG-IUS.

The LNG-IUS insertion was timed at the end of two 28 days menstrual cycle. All women were asked to systemically note the daily bleeding and spotting (B/S) or adverse effects for two months of mifepristone treatment and six months following the insertion of LNG-IUS.

The study participants underwent routine physical and gynecological examination, required laboratory tests including pelvic ultrasound, tests for chlamydia infection, breast biopsy, endometrial biopsy and pap test at baseline and during follow-up.

After statistical analysis, researchers noted significant lower B/S in the mifepristone group (−17.8% points, P < 0.001) in the first month following the LNG-IUS insertion. However, no significant difference was observed in both groups in the subsequent months.

This European study is the first study investigating the effect of prophylactic use of progesterone receptor modulators to reduce the B/S associated with post-LNG-IUS insertion. Other studies have investigated mifepristone for therapeutic purposes.

Based on the study results, researchers are optimistic that other modified treatment protocols of mifepristone with different duration and dose could be explored in further studies. Studies could also be planned with other progesterone receptor modulators to address the issue of B/S immediately after LNG-IUS insertion.

Full Text

Ob/Gyn Updated Facebook page

News from ACOG 2017: Obese Women face higher risks of Hormonal IUD expulsion.

http://www.healthtalktanzania.com

Women with a BMI of 40 or more have 3.06 times higher odds of expulsion of levonorgestrel IUD as compared with women who are overweight, obese or have a BMI less than 35 according to a study presented at the at the ACOG 2017.

Lynne Saito-Tom, MD and her colleague from University of Hawaii at Manoa, Honolulu, conducted this retrospective cohort study at Kaiser Permanente-Hawaii between January 2009 and December 2010.

The study was also published in May issue of Journal of Obstetrics and Gynecology.

The researchers recruited 1,071 eligible patients, of whom nearly one third were obese with nearly 8% had a BMI more than 35. The main independent variable was BMI at the time of insertion and the dependent variables include successful IUD insertion, difficult IUD insertion, 12-month continuation, and complications related to the LNG-IUD.

No differences were observed across different BMI groups for insertion (P = .59) or acceptance of IUD for 1 year (P = .69)

Patients with BMI 40 and more faced higher rates of complications (24%) as compared to obese (13%) , overweight or class 1 obesity counterparts (10%).

The study did not have sufficient women enrolled to explore the reasons of higher expulsion but the researchers did think that it may be related to difficult insertion in very obese women and also menorrhagia experienced by these women.

This is the first known study to evaluate LNG-IUD use by BMI in diverse Hawaiian population of Asian and Pacific Islander women. 

Larger studies are needed to stratify the expulsion and complications according to class of obesity.

Meanwhile, the researchers advocate that the study findings should not discourage physician from educating women about the benefits of IUDs.

“While the expulsion rate was higher than seen generally, it is still an effective method for most obese women. That’s much more beneficial than discouraging patients,” said the lead researcher Dr. Saito-Tom.  

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]

---

[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