Paragard IUD Broken During Removal Lawsuit

How Paragard Breaks During Removal

Paragard removal is designed to be a simple office procedure: a provider grasps the two nylon retrieval strings that hang through the cervix and applies gentle, steady downward traction to slide the T-shaped device out of the uterus. The horizontal arms are designed to fold upward as the device exits the cervical os. The problem — documented in thousands of FDA adverse event reports — is that the plastic arms of the Paragard T380A are prone to fracturing at the junction where they meet the vertical stem. When this happens, one or both arms break off and remain inside the uterine cavity or, in more severe cases, become embedded in or migrate through the uterine wall. The retrieval strings may come out intact while the broken device remains inside, giving both provider and patient a false impression of successful removal.

Why Paragard Arms Break — The Design Argument

Plaintiffs in MDL 2974 allege that Teva Pharmaceuticals knew or should have known that the Paragard T380A's arm design was structurally vulnerable to fracture during routine removal. The polyethylene frame becomes more brittle with age and may bond with endometrial tissue during long-term implantation — particularly in older women or post-menopausal patients whose uterine lining changes in texture and thickness. The arms, which must flex upward during retrieval, lack sufficient flexibility to withstand the traction forces applied in difficult removals. Comparative data shows copper IUD adverse events involve breakage at a rate of 9.6% — nearly six times the 1.7% breakage rate for hormonal IUD devices — suggesting a design-specific vulnerability that Teva failed to adequately address through design modification or enhanced warning.

What Happens After the Device Breaks

When a Paragard arm fractures during removal, the clinical pathway depends on the fragment's position and whether the patient experiences immediate symptoms. If the fragment remains in the uterine cavity, hysteroscopy — a camera-guided intrauterine procedure performed under anesthesia — is typically the first intervention. If the fragment has penetrated the uterine wall (perforation) or migrated into the peritoneal cavity, laparoscopy is required. Migration to the bowel, bladder, or fallopian tubes may require more extensive open abdominal surgery (laparotomy). Each escalation in surgical complexity increases the risk of organ damage, scarring, and permanent impairment of fertility. Women who underwent multiple procedures for fragment retrieval, or whose surgical complications resulted in hysterectomy, have the most significant damages profiles in Paragard litigation.

FDA Data on Paragard Arm Breakage

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database contains more than 54,000 adverse event reports associated with Paragard since the device's 1984 approval. In 2022 alone — the year the FDA issued its safety warning — 1,231 reports specifically described device breakage during removal. The FDA 2022 warning acknowledged that Paragard arms can break during removal and that retained fragments may require surgical retrieval. Critics of Teva and CooperSurgical argue that these reports represented a known, documented risk that should have prompted labeling changes and provider education programs decades before the FDA warning was issued. The litigation central argument — failure to warn — is grounded in this documented gap between the known fracture pattern and the inadequacy of Paragard's prescribing information in communicating fracture risk to providers and patients.

Statute of Limitations — The Breakage Date Rule

A 2025 ruling in MDL 2974 established that the statute of limitations for Paragard claims accrues at the moment of device breakage during the removal procedure. Because the breakage event is typically documented in the provider's notes — or at minimum known to the patient when her provider communicates that the removal was incomplete — the court found that the discovery rule does not delay the start of the limitations period. Women in most states have 2 years from the breakage date to file suit. Some states allow 3 years. If your Paragard broke in 2022 and you are in a 2-year state, your deadline was 2024 — which may have passed. Do not assume that because you have not yet filed in the MDL, you still have time. The statute runs from the removal date, not from any MDL event.