UPDATE: The recall discussed below, which took place in 2014, was for two lots of ParaGard devices that were not known to be fully sterile. The ParaGard IUD has never been subject to a full recall. However, in the years since this recall, many patients have reported issues with the devices, and multiple lawsuits are currently pending against the manufacturer.
The primary issue that has been reported with the ParaGard IUD is the possibility that it will break, usually when being removed from a patient’s uterus. This can leave fragments of the device inside a person’s body, and these fragments may need to be surgically removed to prevent further damage to the uterus or other organs. Since 2013, there have been more than 3,000 reports of device breakage made to the Food and Drug Administration (FDA). Nearly 2,000 of these events were considered serious, and 102 people have been hospitalized or faced life-threatening complications. It is likely that the issue is much more widespread, since there are many more people who have not reported incidents to the government or who are unaware of the risks they may face.
While the FDA has not indicated that it will be conducting investigations into the safety of ParaGard IUDs, some online communities are working together to help people share their experiences and raise awareness of the risks people face. In addition, at least 55 lawsuits have been filed in 20 different states by women who have suffered injuries because of the breakage of these devices. If you have experienced any injuries or health issues related to ParaGard IUDs or other birth control devices, Newland & Newland, LLP can advise you of your legal options and help you take action to recover financial compensation. Contact our Schaumburg personal injury lawyers today at 847-797-8000 to arrange a free consultation.
This April, a batch of ParaGard T 380A Intrauterine Copper Contraceptive devices were recalled due to a lack of assurance of sterility, according to the Food and Drug Administration (FDA). The device’s parent company, TEVA Pharmaceuticals which is based in Pennsylvania, voluntarily recalled the devices from hospitals, clinics, and gynecologists across the country.
The ParaGard is a type of contraceptive device implanted into a woman to prevent unintended pregnancy. According to Drugs.com, its success rate is very high with only 1.5 percent of women, who were correctly using the device, reporting an unplanned pregnancy. The IUD device is only authorized to be placed and removed by healthcare professionals who have experience with such implementations. Medical warnings for ParaGard use include intrauterine pregnancy, ectopic pregnancy, pelvic inflammatory disease, immunocompromise, embedment, perforation, and expulsion.
This is not the first time that ParaGard has come under media scrutiny. Unrelated to the recall, a lawsuit was filed against TEVA in March of 2013 after the device embedded itself into one user’s colon, reportedly causing her severe complications which resulted in mandatory colon surgery.
ParaGard, however, is not the only IUD manufacturer to face a product recall. Mirena, an FDA-approved intrauterine contraceptive system, is another popular IUD device that faced lawsuits for failure to perform as advertised. Mirena has been noted to cause serious complications, including ectopic pregnancy, which is when pregnancy occurs outside the uterus. It has also been noted to cause perforation of the uterine wall, as well as pelvic inflammatory disease (PID).
If you or someone you know in Illinois has been negatively affected by an IUD device, it is encouraged that you report those negative side effects to the FDA at www.fda.gov/medwatch. However, the most important step is to seek the counsel of a medical malpractice attorney. Contact [[title]] today.