A new study released for the 2015 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) links Mirena exposure to the development of IIH (idiopathic intracranial hypertension) also known as pseudotumor celebri (PTC).
Mirena is a type of long-acting, reversible hormonal intrauterine device (IUD) manufactured by Bayer Pharmaceuticals. An IUD is a small, flexible device that is implanted into the uterus for birth control purposes. Mirena uses levonorgesterel, a progestin birth control hormone, to slowly release a small amount into the uterus over time. Because Mirena releases hormones directly into the uterus, a lower level is release than with oral contraceptive birth control pills.
Mirena is one of only two levonorgestrel-releasing intrauterine systems (LNG-IUS) currently available in the U.S. The other is Skyla, a lower dose LNG-IUS that is recommended for women who have not had children. Mirena is recommended to women who have had at least one child, and is more than 99 percent effective in controlling pregnancy for up to 5 years, at which time it must be replaced.
Both Mirena and Skyla are distributed and marketed by Bayer. Mirena was first approved by the U.S. Food and Drug Administration in 2000, and in 2009, Bayer obtained a new indication for Mirena: treatment of heavy menstrual bleeding in women already using an IUD. Skyla was only recently approved in 2013. Neither product’s label alerts patients or their doctors about the risk of developing PTC/IIH.
What is PTC/IIH?
Pseudotumor celebri/intracranial hypertension is present in the brain when cerebrospinal fluid is not absorbed properly, leading to an increase in pressure. The condition is named pseudotumor celebri because its symptoms mimic a brain tumor, although no tumor is actually present.
PTC is common in women of childbearing age, particularly those who are overweight or those who have experienced sudden weight gain. Because Mirena is only prescribed to women of childbearing age, it is even more critical that patients be made aware of the potential increased risk of developing PTC through Mirena exposure.
Globally, the IUD is the most popular form of reversible birth control, with an estimated 150 million users. Mirena must be inserted by a medical provider and typically costs approximately $800. Although the device is very effective at preventing pregnancy, many women experience dangerous, life-threatening side effects in addition to PTC/IIH, including perforation of the uterus, pelvic inflammatory disease, and ectopic pregnancy.
A partner with Childers, Schlueter & Smith, LLC,, Brandon Smith has devoted his practice to pharmaceutical litigation, mass torts, products liability and serious personal injury. A frequent guest speaker at legal seminars all over the country—Brandon is focused on helping injured victims nationwide, however possible. Named a SuperLawyer in 2017, he has also been called out as one of 10 Best Attorneys For Georgia by the American Institute Of Personal Injury Attorneys.