Not for the first time, another emerging lawsuit alleges that the Mirena® intrauterine device (IUD) perforated and migrated outside of a woman’s uterus. The woman alleges the Mirena® IUD migration caused her substantial injury and damage and necessitated surgery. The national law firm, Parker Waichman LLP, filed the lawsuit on behalf of a Missouri woman.
According to the lawsuit, the Mirena® IUD perforated through and migrated outside of the woman’s uterus, forcing her to undergo laparoscopic surgery to remove the device. The lawsuit was filed on November 30th in the Superior Court of New Jersey Law Division, Morris County (Docket No. MRSL-2928-12). Bayer Healthcare Pharmaceuticals has been named as the defendant.
The Mirena® IUD was approved in 2000 as a form of long-term contraception. The small, T-shaped plastic device is attached to two strings and is inserted into the uterus by a healthcare professional. While inserted, the Mirena® IUD slowly releases the hormone levonorgestrel; Mirena® is left inside the uterus for up to five years.
According to the lawsuit, Bayer, the maker of the Mirena® IUD says it is not exactly sure how the device works to prevent pregnancy. The lawsuit also notes that the defendants only warn about the risk of uterine perforation when the device is first inserted, and does not mention the risk of spontaneous migration.
According to the complaint, the woman received the Mirena® IUD in 2009. At that time, she appeared to well tolerate the procedure and there was little evidence to suggest that the device had perforated her uterus. In December 2010, however, she presented to the emergency room, where an ultrasound showed that Mirena® was no longer inside her uterus. Surgery was required to remove the device from her body.
The lawsuit alleges that, as a direct result of the Bayer’s negligent and wrongful actions, the woman suffered from severe and permanent physical injuries, substantial pain and suffering, and economic loss due to medical expenses and lost wages.
The complaint also states that Bayer has a history regarding the deceptive marketing of Mirena® and that Bayer was contacted in 2009 by the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) over its “Simple Style” program, which featured live presentations to promote Mirena®. The DDMAC warned Bayer for failing to mention the risks of Mirena® while making unsubstantiated claims about its benefits; among other things, the presenters told women that Mirena® would help increase libido and help them “look and feel great.” The script also stated that the device did not require any type of monthly routine.
The DDMAC dismissed all of these claims as false, and warned Bayer against making misleading statements about Mirena® in the future.