Woman Sues Bayer Over Mirena® IUD, Alleges Device Caused Organ Perforation

National law firm, Parker Waichman LLP, just filed a lawsuit on behalf of a woman who was implanted with a Mirena® IUD. The lawsuit alleges that the Mirena® IUD caused substantial injuries in the Florida woman, that the Mirena® IUD birth control device migrated from its intended position and perforated the uterus, and that the device caused the woman physical and emotional damages. The woman underwent surgery to remove the contraceptive device.

The lawsuit names Bayer Healthcare Pharmaceuticals, the manufacturer of the Mirena® IUD, as a defendant and was filed on November 5, 2012 in the Superior Court of New Jersey Law Division, Morris County (Civil Action No. MRSL-2723-12).

According to the complaint, the woman received the Mirena® IUD in 2008. By July 2010, she suffered from pelvic pain; the strings attached to the device were unable to be located and the IUD could not be found though an ultrasound. This forced the woman to have to undergo laparoscopic surgery in December 2010 to remove the Mirena® IUD. The lawsuit also alleges a number of damages on behalf of the woman, including severe and permanent physical injuries, pain and suffering, and economic losses in the form of medical expenses and lost wages.

The Mirena® IUD is a long-term form of birth control that is constructed of plastic, attached to two strings, and is inserted into the uterus for up to five years. While implanted, the IUD releases the synthetic hormone, levonorgestrel.

The lawsuit states that Bayer admits it is unsure exactly how Mirena® works to prevent pregnancy and alleges that Bayer has not warned about the spontaneous migration of the IUD. The device’s label only warns that the Mirena® IUD may migrate if the uterus is perforated during insertion.

The plaintiff’s experience contradicts this notion, given that she had no symptoms of migration until two years after the device was implanted. According to the complaint, she well tolerated the initial procedure and neither she nor her doctor had any reason to suspect that her uterus was perforated until she began experiencing pelvic pain much later.

Bayer has been scrutinized in the past over the way it which it has marketed the Mirena® IUD. In 2009, the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) determined that certain claims made by the company’s “Simple Style Program,” which marketed Mirena® to “busy moms,” were unsubstantiated. The agency said that, among other things, the program also failed to mention side effects such as weight gain, acne, and breast tenderness. The DDMAC also disregarded the notion that Mirena® IUD does not require any type of regular routine follow-up.

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