How the Paragard IUD Fractures and Injures Women During Removal
The Paragard T380A is a copper intrauterine device marketed as a hormone-free, long-term contraceptive. Unlike hormonal IUDs, Paragard relies on copper wire coiled around a T-shaped polyethylene frame to prevent pregnancy. While designed for up to ten years of continuous use, a significant number of Paragard devices fracture at the arms during removal — leaving plastic and copper fragments inside the uterus, fallopian tubes, and surrounding tissue that require additional surgical procedures to extract.
Arm Fracture During Removal — Brittle Polyethylene
The horizontal arms of the Paragard T-frame are made of polyethylene embedded with barium sulfate, a radiopaque filler that allows X-ray visualization. Over time — and in some cases within months — the polyethylene becomes brittle and loses its structural integrity. When a clinician applies the traction force necessary for removal, one or both arms snap off rather than bending inward as the device was designed to do, leaving fragments inside the uterine cavity or cervical canal.
Copper Wire Breakage and Fragment Retention
Fine copper wire coiled around the Paragard frame can break free from the frame during removal, particularly when the polyethylene arm fractures and alters the mechanical load on the coil. Broken copper wire segments are small enough to migrate into tissue folds, the uterine cornua, or through the fallopian tube ostia, making complete surgical retrieval difficult and sometimes requiring hysteroscopy or laparoscopy.
Device Embedment in the Uterine Wall
In some patients, the Paragard device becomes partially or fully embedded in the myometrium — the muscular wall of the uterus — through a process called myometrial penetration or intramural embedding. Embedded devices cannot be removed by standard office-based traction and require hysteroscopic or surgical extraction. Attempts to remove an embedded device without imaging confirmation of its position risk uterine perforation.
Retained Fragments Requiring Surgical Intervention
When Paragard arm fractures occur, the retained fragments do not remain stationary. Uterine contractions, patient movement, and the body's inflammatory response can displace fragments toward the cervix, into the myometrium, or through the uterine wall into the peritoneal cavity. Retrieval of retained fragments typically requires hysteroscopic surgery under anesthesia; fragments that have migrated outside the uterus may require laparoscopic or open abdominal surgery.
Uterine Perforation and Fallopian Tube Damage Causing Infertility
Attempted removal of a fractured or embedded Paragard — particularly when the location of retained fragments is not confirmed by imaging before the procedure — carries significant risk of uterine perforation. Perforating instruments or migrating fragments can damage the fallopian tubes, ovaries, and adjacent structures. Tubal damage from Paragard-related perforation or retained copper fragments is a recognized cause of pelvic inflammatory disease, ectopic pregnancy, and permanent infertility in affected women.
- Material Degradation Over Extended Use: Polyethylene exposed to the uterine environment undergoes slow oxidative degradation. The barium sulfate filler incorporated into Paragard's arms creates stress concentration points within the polymer matrix that accelerate crack propagation under the mechanical load of removal. Devices used for longer periods — particularly those approaching or exceeding ten years — show higher fracture rates, but fractures have been documented in devices removed well before the labeled use period expired.
- Inadequate Warnings to Clinicians and Patients: Paragard's prescribing information historically did not prominently warn clinicians that arm fracture during removal was a documented risk or describe the appropriate steps — including imaging before removal — to take when encountering resistance during removal. Clinicians unaware of the fracture risk may apply additional force when resistance is felt, increasing the probability that a partially fractured arm will complete its break.
- Post-Acquisition Manufacturing and Design Changes: Paragard was acquired by CooperSurgical from Teva Pharmaceuticals in 2017. Plaintiffs allege that manufacturing process changes following the acquisition may have affected the material properties of the polyethylene frame, and that post-acquisition quality control failed to identify increased fracture rates in the new production lots. Internal complaint data from the post-acquisition period is central to ongoing litigation discovery.
- Absence of Pre-Removal Imaging Protocol: Unlike other long-term contraceptive devices, Paragard has no standard clinical protocol requiring ultrasound or X-ray imaging to confirm device position, integrity, and the absence of embedment before initiating removal. This protocol gap means clinicians routinely attempt traction removal without knowledge of whether the device is properly positioned, embedded, or already partially fractured — increasing the probability of retained fragment injuries.
- The FDA MAUDE adverse event database contains thousands of reports describing Paragard IUD arm fracture during attempted removal, making it one of the most frequently reported IUD complications in the database
- Peer-reviewed clinical literature has documented Paragard fracture during removal as a recognized complication with rates that increase with duration of use
- The FDA issued a labeling update in 2020 requiring Paragard's prescribing information to include warnings that the device may break during removal, and that fragments may be left inside the patient
- MDL 2974 in the Northern District of Georgia consolidates thousands of federal Paragard fracture cases before Judge Leigh May
The Paragard litigation centers on the claim that CooperSurgical and Teva Pharmaceuticals knew or should have known that the polyethylene T-frame was susceptible to fracture during removal — a foreseeable failure mode given the material properties of the frame and the documented adverse events in the FDA reporting system. Plaintiffs allege both design defect (the frame material was inadequate for the mechanical demands of removal) and failure to warn (clinicians and patients were not given adequate information about fracture risk or guidance to prevent it). The injuries caused — retained fragments, additional surgeries, uterine perforation, and infertility — are severe and well-documented in medical records.