Bayer Pharmaceuticals and Washington University are facing injury allegations in a lawsuit regarding the Mirena intrauterine device.
A woman has raised alarm over injuries she claims she suffered from the Mirena IUD during a research experiment conducted at the St. Louis, Missouri, university called “Contraceptive CHOICE.”
Contraceptive CHOICE has been praised by various advocacy groups for its purpose — the project was meant to promote birth control to girls and young women in impoverished areas who often do not have health insurance and provide free contraceptives to 7,500 to 10,000 women over a four-year period.
As part of the project, these women were provided their choice of birth control at no cost, for the past three years. This included several forms of contraceptives: diaphragms, condoms, intrauterine devices (IUDs), and birth control pills.
This project is considered a success of the Washington University School of Medicine, as the statistics show fewer pregnancies and abortions. An additional study was conducted and found that this project did not increase the risk of dangerous sexual behavior.
Unfortunately, the project has brought medical injuries to 27-year-old Delancy, as she chose to use the Mirena IUD as part of the project. Delancy alleges that in direct result of the device, she suffered multiple injuries, which required two heart surgeries and left her in a chronic condition.
According to the Mirena lawsuit, Delancy states at the time she accepted the birth control, she did not know it was for a scientific study, and felt as though they bribed her to accept the device with the promise of free birth control and gift cards.
The Missouri woman stated that she had been recruited to join the experiment during a routine doctors visit during the pregnancy of her third child. She agreed to join and had started using the Mirena IUD immediately following the birth, which is considered an “off-label use,” since Bayer does not recommending inserting the Mirena until four to six weeks after delivery.
Delancy claims that the Mirena was inserted as soon as she discharged the placenta after delivering her baby. Days later, she developed endocarditis, a chronic heart condition, which resulted in the need for the two cardiac surgeries.
Delancy is suing Washington University School of Medicine for her injuries, claiming they did not properly warn her of the risks, and did not seem to be concerned about the possible side effects. The college has denied all the allegations, and insists that their highest priority is on the safety and rights of the participants. Delancy’s lawsuit includes several members of the medical review board who were supervising this study.
Bayer had initially been named in the Mirena injury lawsuit but had managed to escape litigation due to the fact that the company had published literature on the product’s side effects. Allegedly, the researchers ignored this research as they distributed the Mirena IUD to participants. It was also discovered that the defendant had asked Bayer for their support in this experiment, but the company refused as the products were being used for off-label purposes.
In a written statement, Washington University said it denies all allegations of the lawsuit, and will fight with its own legal representation. The medical school insists that each participant had gone through a rigorous consent process, which included explaining the risks and benefits, meaning that none of the participants were not aware of the risks, the researchers claim.
Mirena Side Effects
The Mirena IUD was first approved by the U.S. Food and Drug Administration in December 2000, and is manufactured by Bayer Pharmaceuticals. It has over two million prescribers in the United States alone.
It is a small t-shaped device, made of biologically safe plastic that can be inserted into the body. It is directly implanted into the uterus, and releases a small dose of leveonorgestrel, directly into the bloodstream to prevent ovulation and sperm-to-egg fertilization.
File a Mirena IUD Class Action Lawsuit Claim
If you or a loved one was the victim of a Mirena IUD injury, you have legal options. Please visit the Mirena IUD Injury Class Action Lawsuit Investigation. There, you can submit a claim for a free legal review and if it qualifies for legal action, a seasoned Mirena IUD lawyer will contact you for a free, no-obligation consultation. You will be guided through the litigation process at no out-of-pocket expenses or hidden fees. The Mirena injury attorneys working this investigation do not get paid until you do.
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