Copper intrauterine device (T 380A copper IUD) · CooperSurgical, Inc. (a subsidiary of The Cooper Companies; acquired Paragard from Teva Pharmaceuticals in 2017, with Teva entities remaining as co-defendants) · updated June 2026
Thousands of women have sued the makers of the Paragard copper IUD, alleging the device can break apart during removal and leave fragments in the body that may require surgery to retrieve. The cases are consolidated in federal multidistrict litigation, In re: Paragard IUD Products Liability Litigation, MDL No. 2974, in the U.S. District Court for the Northern District of Georgia, where court records indicate roughly 4,071 lawsuits were pending as of June 1, 2026. These are allegations that remain unproven; the first bellwether trial ended in a defense verdict, and no court has established that Paragard causes the alleged injuries.
This page is general information about ongoing litigation and FDA safety actions — not medical or legal advice, and not a statement that Paragard caused any injury. Allegations described here are claims that have not been proven in court. Always consult a licensed professional.
Plaintiffs allege that the Paragard copper IUD is prone to breaking or fracturing during removal, leaving plastic or copper fragments embedded in the uterus or migrating to other organs, and that retrieving these pieces can require additional surgeries up to and including hysterectomy. They allege the device was defectively designed and that the manufacturers failed to adequately warn patients and physicians about the risk of breakage on removal despite allegedly being aware of adverse-event reports. These are unproven allegations. The defendants deny wrongdoing, and the jury in the first bellwether trial (Braxton v. Teva) returned a defense verdict, rejecting the failure-to-warn and design-defect claims. No court has established that Paragard causes the alleged injuries, and nothing here is legal or medical advice.
The FDA has issued no recall and no boxed warning for Paragard, which has been marketed since its initial U.S. approval in 1984. The FDA has, however, made prescribing-information changes. A September 2019 label revision added breakage language under Warnings and Precautions, Section 5.5 (Embedment), stating that "Breakage of an embedded Paragard during non-surgical removal has been reported." Following an FDA safety review of intrauterine-system breakage (drawing on FAERS adverse-event data for the approved IUDs, a review the FDA has said it began in 2021), the agency approved a June 2024 label update adding device-breakage adverse-reaction information and embedment/removal guidance (for example, assessing for embedment and perforation, and using imaging such as X-ray if removal cannot be accomplished with gentle pulling). As of mid-2026, the FDA has not issued a formal public safety communication or a recall specific to Paragard breakage, and it did not require a "Dear Doctor" letter for the 2024 label change.
In re: Paragard IUD Products Liability Litigation, MDL No. 2974, before Judge Leigh Martin May in the U.S. District Court for the Northern District of Georgia. According to a plaintiff-side litigation tracker, roughly 4,071 lawsuits were pending in the MDL as of June 1, 2026 (up from about 3,982 in early April 2026); thousands of cases have been filed in total. Named defendants include Teva Pharmaceuticals USA, Teva Women's Health, The Cooper Companies, and CooperSurgical. The first bellwether trial (Braxton v. Teva) ended in a defense verdict in February 2026, and an interlocutory appeal on a warning/preemption question was granted in 2026, which may stay or affect remaining cases. A second bellwether (Robere) has been scheduled to proceed later in 2026. No global settlement had been announced as of mid-2026.