Another woman has come forward concerning serious injuries associated with the Mirena® intrauterine device (IUD) manufactured and marketed by Bayer Healthcare Pharmaceuticals, Inc.
National law firm, Parker Waichman LLP, filed a lawsuit on behalf of the Utah woman who alleges that the Mirena® IUD perforated her uterus and that Bayer failed to warn about the risks. The lawsuit was filed on February 14, 2013 in the Superior Court of New Jersey Law Division, Morris County (Docket No. MRS L-0433-13). Bayer has been named as the defendant.
The woman was implanted with the Mirena® IUD in January 2011, according to the lawsuit, which alleges that she tolerated the procedure well and that there was no reason to suspect that the Mirena® IUD had perforated her uterus. The woman went to her physician on February 7, 2011 for a follow-up visit and he confirmed that the strings were visible and that the device was in its proper place.
One month later, on March 28, 2011, the woman’s physician could no longer see the Mirena’s® strings and a transvaginal ultrasound was performed. The device could not be located in the uterus and an X-ray revealed that the Mirena® IUD was in her pelvis overlying the sacrum. That April, the plaintiff had to undergo a laparoscopic surgical procedure to retrieve and remove the Mirena® IUD, which was embedded in her omentum.
The lawsuit also alleges that the Mirena® IUD is inherently defective, creates an unreasonable risk of injury to women, that Bayer failed to warn about the risks, and that the plaintiff’s damages are a result Bayer’s negligent and wrongful conduct. The woman is suing for severe and permanent physical injuries, substantial pain and suffering, and economic loss.
In 2009, Bayer was reprimanded by the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) for overstating the benefits—and neglecting to mention the risks—of Mirena® in the company’s “Simple Style” program.
According to the U.S. Food and Drug Administration (FDA), the most serious side effects associated with the Mirena® IUD include:
- Perforation of the uterine wall
- Embedment of the device in the uterine wall
- Intrauterine pregnancy
- Ectopic pregnancy
- Group A streptococcal sepsis
- Pelvic inflammatory disease (PID)
Matthew J. McCauley, Senior Litigation Counsel at Parker Waichman LLP, co-chairs the American Association for Justice (AAJ) Mirena® IUD Litigation Group. The Group is actively involved in exchanging educational materials and medical literature in order to best represent victims.