A young woman from St. Louis, Missouri has filed a Mirena lawsuit that raises troubling questions about a clinical trail conducted by the Washington University School of Medicine. The trial was designed to test an off-label use of the Mirena IUD which is specifically contraindicated in the prescribing information for the device. However the plaintiff in this lawsuit claims that the school’s researchers never informed her of those facts.
“I don’t feel like they were informative about it,” the mother of three young children told the Associated Press. “If I knew it was a clinical trial or research, I wouldn’t have joined. I basically feel like they bribed me with free birth control and gift cards.”
According to her complaint, the plaintiff was enrolled in the school’s “Contraceptive CHOICE” program, which sought to provide free contraceptives to 7,500 to 10,000 women over a four-year period. The Associated Press reports that the school also launched a clinical trial in October 2012 to determine whether insertion of Mirena immediately after delivery would result in greater use of the contraceptive than if insertion occurred four to eight weeks after delivery. According to the trial protocols, some 200 women between the ages of 14 and 45 would be enrolled in the study, with half receiving Mirena right after giving birth. The remaining subjects were implanted with the IUD during the four to eight week period specified by the product’s label.
It should be noted that Bayer Healthcare Pharmaceuticals, the manufacturer of the Mirena IUD, specifically recommends that the device NOT be implanted right after birth, as the uterus is prone to infection in the weeks immediately following delivery. Bayer did not participate in the University of Washington’s clinical trial, and is not named in the complaint.
The plaintiff at the center of this Mirena lawsuit was among the women who were implanted with the IUD following birth, immediately upon the discharge of the placenta. The complaint states that within days of its insertion, she developed a heart condition called endocarditis, which can be caused by a bacterial infection. She has since undergone two heart valve surgeries and will need to take a blood thinner to prevent heart attacks and strokes.
“Research has to be done, but I question the wisdom of people participating in off-label medical experiments without being fully apprised of the risks,” her attorney told the Associated Press.
Incidentally, the clinical trail at the center of the lawsuit was completed in December 2012, but its results have yet to be published.
While Bayer is not a party to this lawsuit, the company is named in more than 1,000 lawsuits filed on behalf of women who allegedly suffered serious Mirena complications due to spontaneous migration of the IUD. Spontaneous migration occurs when the IUD moves from its proper position in the uterus long after it was correctly implanted by a healthcare provider. According to Mirena IUD lawsuits, Bayer provides no warnings about this risk, and only states that migration can occur if the uterus is perforated when the IUD is inserted.
Mirena complications related to spontaneous device migration include uterine perforations, infections, adhesions and scarring, and other injuries that can permanently affect a woman’s reproductive health, the lawsuits claim.