A New York woman is suing the maker of the ParaGard intrauterine device after part of the IUD broke off in her uterus during removal.
In a legal complaint filed August 31 in New York federal court, Vanesha Johnson alleges that Teva Pharmaceuticals USA marketed its ParaGard IUD as “safe and effective” with fewer side effects than other birth control methods, downplayed the risks and overstated the benefits of ParaGard, and “fraudulently withheld important safety information from health care providers and the public.”
The suit also names the Cooper Companies, which bought the rights to the ParaGard IUD in September 2017, as reported by Law360.
IUDs are long-term contraceptive devices inserted into the uterus, typically consisting of small T-shaped plastic frames. ParaGard is the only non-hormonal IUD of the five brands currently available in the U.S. ParaGard is wrapped in a copper wire which prevents pregnancy by provoking an inflammatory response, and unlike hormonal IUDs, does not release progestin.
According to the legal complaint, the FDA has received more than 1,600 reports of ParaGard breaking since 2010, including more than 700 serious reports. Johnson and her attorney claim that IUD-maker Teva should have known the device was defective following consumer reports of problems with ParaGard and independent research.
Johnson’s ParaGard IUD was inserted in June 2017, but three months later, according to the complaint, an ultrasound showed the device had moved out of place in her uterus. When Johnson’s doctor tried to extract the IUD, one arm broke off inside Johnson’s body. Johnson underwent surgery in September to remove the broken-off piece.
Legal documents note that Johnson’s doctor removed her ParaGard IUD exactly “as instructed” by manufacturer Teva’s removal protocols.
Johnson claims the faulty device and subsequent removal surgery caused a variety of injuries, including “significant bodily and mental injuries, pain and suffering, mental anguish, disfigurement, embarrassment … loss of earnings and earning capacity,” in addition to numerous medical expenses, according to the complaint.
More About ParaGard
The official ParaGard website warns consumers that the device sometimes gets stuck in the uterus, requiring surgical removal, but does not mention a problem with it breaking apart on the page that lists side effects.
In 2019, the FDA issued a cease-and-desist letter to CooperSurgical, a unit of Cooper Companies, over a ParaGard television ad that the agency said violated federal law by making “false or misleading representations about the risks associated with ParaGard.”
ParaGard was first approved by the FDA in 1984.
Manufacturer Teva has dual headquarters in the United States and Israel.
By MedTruth Editors