Paragard is an intrauterine contraceptive device “IUD” marketed as a hormone free long-acting reversible contraceptive. The device is inserted by a medical professional, often during an office visit. The T-shaped Paragard device is made of plastic and wrapped in copper along the stem and portions of both arms. Attached to the end of the stem are white strings designed to be used to remove the device after approximately 10 years of use.
Since 2006, the FDA has received complaints of complications from more than 32,000 women or their physicians about Paragard. Many women had their device migrate, become embedded in their uterus or come out on its own. Hundreds of those complaints include reports of the device breaking and, in many cases, causing pain and additional procedures to remove any remaining piece of their Paragard device.
Though Paragard has been approved by the FDA for use in the United States for decades, since 2005 the manufacturers have not adequately warned women or their doctors about the device’s potential to break during removal.
Complications from failure to remove all of the device include:
- Irregular menstruation
- High-risk pregnancy
- Hysterectomy (to remove the remaining piece or pieces)
Originally manufactured by FEI for Ortho-McNeil Pharmaceutical, Paragard was acquired by Teva Pharmaceuticals in 2008. It was purchased by The Cooper Companies and CooperSurgical in 2017 and is still available to women as a contraceptive option.
Johnson Law Group has a history of successfully defending the rights of women injured by contraceptive devices. If you experienced issues with the removal of your Paragard IUD, contact us for a free consultation to determine whether you may have a viable claim.