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ParaGard Intrauterine Contraceptive Devices Recalled

Posted on in Birth Control

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 Newland & Newland, LLP today.

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