According to allegations raised in a recently filed product liability lawsuit, design problems with the Paragard IUD make the birth control implant prone to break during removal surgery, resulting in serious and potentially permanent injuries.
The complaint (PDF) was filed by Carley Tredway earlier this month in the U.S. District Court for the Middle District of Florida, indicating the manufacturers Teva Pharmaceuticals, and CooperSurgical, Inc. failed to adequately warn users and the medical community about this propensity to break during explant.
ParaGard is a copper IUD birth control implant, involving a T-shaped plastic frame wrapped with copper wire coils, which are designed to produce an inflammatory reaction in the uterus that is toxic to sperm and prevents pregnancy. The birth control device is supposed to remain in place for up to 10 years, but is intended to be removable and allow women to conceive after it is explanted.
According to the lawsuit, Tredway, of Florida, was implanted with a ParaGard in 2008. However, when she went to have the device removed in September 2018, one of the arms broke off in her body and was left behind in the uterus. As a result of the Paragard failure, Tredway had to undergo a hysteroscopy in October 2018, to have the broken arm of the IUD surgically removed from her uterus.
The lawsuit notes that the FDA has received more than 1,600 reports of ParaGard implants breaking since 2010, with more than 700 of those cases classified as serious health problems.
“Defendants knew or should have known that ParaGard IUD can and does cause serious harm to individuals who use it, due to the risk of the ParaGard IUD’s arm breaking upon removal,” the lawsuit states. “Defendants knew of these risks from the trials they performed, their post-marketing experience and complaints, third party studies, and their own analysis of these studies, but took no action to adequately warn or remedy the defects and instead concealed, suppressed and failed to disclose or fix this danger.”
Tredway’s claim is one of a growing number Paragard IUD lawsuits filed in recent months, involving similar allegations of problems during removal surgery.