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According to allegations raised in a recently filed product liability lawsuit, a Georgia woman indicates her doctors experienced problems removing Paragard birth control, when the copper IUD fractured and broke inside her body, leaving small pieces missing which pose a continuing health risk.
Heather Spence filed the complaint (PDF) in the U.S. District Court for the Northern District of Georgia on September 3, indicating Teva Pharmaceuticals, The Cooper Companies, Inc., and Coopersurgical, Inc. sold a reversible birth control implant prone to break at the arms when it is removed.
ParaGard is a copper intrauterine device (IUD) intended for long-term birth control up to 10 years, which is intended to be removable and allow women to conceive after it is explanted.
The implant involves a T-shaped plastic frame, wrapped with copper wire coils designed to produce an inflammatory reaction in the uterus toxic to sperm, preventing pregnancy. However, hundreds of women have experienced painful and debilitating Paragard removal problems when the device fractured during explant procedures, often resulting in the need for a hysterectomy or other invasive surgery to retrieve the IUD.
According to the lawsuit, Spence had a ParaGard IUD implanted in 2011. However, when she went to have it removed in June 2020, both Paragard IUD “arms” broke off inside of her uterus. Attempts to remove the debris using ultrasound as a guide failed, and the ParaGard arms remain inside of Spence’s body, and will require she undergo additional medical procedures.
“Prior to her procedures, Plaintiff and her doctors were provided with no warning from the Defendants of the risk of ParaGard IUD failure and injury, nor were Plaintiff and her doctors provided with adequate warning of the risk of removal of ParaGard IUD,” the lawsuit notes. “This information was known or knowable to the Defendants.”
Spence’s lawsuit presents claims of negligence, defective design, defective manufacturing, failure to warn, common law fraud, negligent misrepresentation, breach of warranty, gross negligence, and violation of state consumer protection laws. She seeks both compensatory and punitive damages.
The case joins a growing number of Paragard IUD lawsuits filed in recent months, each involving similar allegations of problems during removal surgery.