Paragard IUD Lawsuit Lawsuit

“Analysis of the FDA's MAUDE adverse event database reveals thousands of reports describing Paragard IUD arm fracture during attempted office-based removal. Reports submitted by gynecologists, ob-gyn residents, and healthcare facilities across the United States describe the same failure pattern: clinician applies standard traction to the Paragard strings during removal, encounters resistance, and one or both T-frame arms fracture at or near the junction with the vertical stem. Clinicians report that fractured fragments are not always immediately visible or retrievable in the office setting, requiring referral for hysteroscopic procedures under anesthesia. The report volume in the MAUDE database accelerated noticeably after 2017 — the year of CooperSurgical's acquisition — a pattern that MDL 2974 plaintiffs allege reflects post-acquisition manufacturing changes that adversely affected frame integrity.”

“Multiple peer-reviewed studies published in ob-gyn literature have documented Paragard arm fracture during removal as a recognized clinical complication occurring at rates that increase with device duration of use and are not attributable solely to clinician error. A study published in the Journal of Minimally Invasive Gynecology examined a cohort of patients undergoing Paragard removal and documented arm fracture in a clinically significant proportion of cases, particularly among patients who had carried the device for seven or more years. The studies found no correlation between clinician experience level and fracture rate, contradicting the manufacturer's implicit suggestion that fracture was a technique-dependent event. Researchers noted that the polyethylene frame material, combined with the barium sulfate filler, creates a composite that undergoes progressive embrittlement under uterine environmental conditions, making fracture a foreseeable material science outcome rather than a random or operator-dependent event.”

“Discovery proceedings in MDL 2974 have targeted CooperSurgical's internal quality complaint management system, which tracks fracture-related customer and clinician complaints separate from the MAUDE public database. Internal complaint records are typically more granular than MAUDE reports — they include lot number data, manufacturing date ranges, facility codes, and complaint investigation conclusions that can link fracture events to specific production periods. Plaintiffs allege that these records will show an increase in fracture complaints in post-2017 production lots consistent with manufacturing process changes made after the Teva acquisition, and that CooperSurgical's quality engineering team conducted internal complaint trend analyses that identified the fracture pattern without triggering corrective actions or labeling updates.”

“The FDA's 2020 mandated update to Paragard's prescribing information required for the first time that the label explicitly state: that the Paragard IUD may break during removal, that pieces may remain in the uterus or be carried to other locations if complete removal is not possible, and that healthcare providers should consider imaging to assist with removal in cases of difficulty. The FDA-CooperSurgical correspondence underlying the labeling update — including any FDA Warning Letters, 510(k) supplement requirements, or post-market surveillance study orders — is sought in MDL 2974 discovery as evidence of the regulatory communications that preceded the label change. The updated label became effective in 2020, more than 35 years after Paragard entered the U.S. market and years after the MAUDE database had accumulated thousands of fracture-related adverse event reports.”