Mirena IUD Lawsuit Alleges Dangerous Postpartum Insertion of Device
A 27-year old woman has sued Washington University School of Medicine for injuries associated with her Mirena IUD, which was inserted immediately after she gave birth as part of the University’s clinical study. Her lawsuit claims the post-birth Mirena IUD caused her to require two surgeries and medication for life.
Deanna Delancy, of St. Louis, had the Mirena IUD inserted free-of-charge as part of Washington University’s “Contraceptive CHOICE” program, as reported by the St. Louis Post Dispatch. The stated purpose of the program was to promote the Mirena IUD as a preferred birth control method of young women and teens and to reduce the rate of pregnancy and abortion in those groups. Young pregnant women, like Ms. Delancy, were invited to participate in the program in exchange for free contraception after they had their babies. The Mirena IUD is a small T-shaped contraceptive device, which is inserted into the uterus, to automatically prevent pregnancy. It is designed to prevent pregnancy for up to five years after insertion.
Ms. Delancy sued the University medical school claiming that she was not informed that the contraceptive program was part of a clinical trial or research, nor did she know that its purpose was to test the safety of inserting the device immediately after giving birth. The prescribing information for the Mirena IUD, published by its maker Bayer Pharmaceuticals, recommends that the device not be inserted for at least four-to-six weeks after a woman gives birth in order to give the uterus sufficient time to heal from labor, otherwise it is prone to infection. During the University’s CHOICE project, the medical school initiated a study wherein about half of the participants were given the Mirena IUD “off-label” (immediately after child birth, like Ms. Delancy) and the other half were given the device as prescribed (four to eight weeks after delivery).
According to Ms. Delancy’s lawsuit, immediately after she gave birth hospital personnel inserted the Mirena IUD device. Within days, she suffered complications from the device – she developed the heart condition “endocarditis” and experienced paid and sickness. She then had to have two heart surgeries and, as a result, she will require prescription medication to prevent heart problems for the rest of her life. She claims the University failed to warn her about the risks of the Mirena IUD and of the risks involved for participants of the program’s clinical trial in having the device implanted “off-label” earlier than recommended. She also claims the University’s program unfairly “targeted poor people who can’t afford birth control.” The University claims no wrongdoing and has asserted that all participants were told of the risks and benefits of signed consent forms before going into labor.
The University is a proponent of “immediate postpartum insertion” of the Mirena IUD, saying its benefits outweigh the risks, and that the purpose of the program was to “determine whether insertion of the Mirena device immediately after delivery would result in greater use than if insertion occurred four to eight weeks after delivery,” according to the St. Louis Post Dispatch article. As cited by the Post Dispatch article, 53 women were enrolled in the Mirena IUD safety study, which was completed in December 2012.
Women who have experienced problems associated with the Mirena IUD are encouraged to contact the attorneys at Audet and Partners, LLP for a free consultation to discuss their legal options. Call us at (800) 965-1461 or fill out our confidential case inquiry form on the right side of this web page.
Source: Doyle, Jim (2014, March 24); Retrieved from: http://www.stltoday.com/business/local/woman-says-wash-u-research-trial-of-birth-control-gave/article_7225b48e-ab3c-5dd3-a3cf-3e313a7c7300.html