Journal of minimally invasive gynecology · 2026
Characterizing MAUDE Reports for Xenform Bovine Dermal Matrix in Transvaginal Pelvic Organ Prolapse Repair: A Mixed-Methods Descriptive Analysis.
СтатьяНазвание и аннотация: Перевод в очереди
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Corn Megan, Elliott Christopher S, Sokol Eric R
Аннотация
STUDY OBJECTIVE: Following the 2019 Food and Drug Administration (FDA) order to cease sales of transvaginal pelvic organ prolapse (POP) repair devices, questions persist regarding adverse event attribution for biologic grafts. We aimed to characterize FDA Manufacturer and User Facility Device Experience (MAUDE) reports referencing Xenform for transvaginal POP repair and contextualize findings with prospective clinical evidence and FDA postmarket ("522") data.
DESIGN: Mixed-methods descriptive study combining systematic MAUDE database review with narrative review of prospective clinical evidence and FDA regulatory summaries.
SETTING: FDA MAUDE publicly available surveillance database.
PATIENTS: MAUDE reports referencing Xenform submitted between January 2010 and December 2025.
INTERVENTIONS: Xenform bovine dermal matrix for transvaginal POP repair.
MEASUREMENTS AND MAIN RESULTS: Attorney submissions comprised 81.7% of reports (n = 1209); 80.8% (n = 1196) lacked sufficient clinical detail. Only 16 reports (1.1%) were classified as high-likelihood device-related events, including postoperative abscess requiring graft explant (n = 3), pelvic pain requiring reoperation (n = 6), and vaginal suture-line separation (n = 7).
CONCLUSION: Few MAUDE narratives contained sufficient detail to implicate Xenform in a device-attributed adverse event. Report volume peaked in 2013 coincident with FDA regulatory activity and mesh litigation, suggesting Xenform reporting patterns may have reflected the broader medicolegal context rather than a material-specific safety signal. The absence of detailed reporting is not evidence of safety, but reflects structural limitations of passive surveillance. Available evidence supports material-class trade-offs rather than a risk profile equivalent to synthetic mesh. The withdrawal has narrowed surgical options for patients with recurrent or complex POP. Prospective, long-term data on biologic graft safety remain a priority to inform future regulatory evaluation.
DESIGN: Mixed-methods descriptive study combining systematic MAUDE database review with narrative review of prospective clinical evidence and FDA regulatory summaries.
SETTING: FDA MAUDE publicly available surveillance database.
PATIENTS: MAUDE reports referencing Xenform submitted between January 2010 and December 2025.
INTERVENTIONS: Xenform bovine dermal matrix for transvaginal POP repair.
MEASUREMENTS AND MAIN RESULTS: Attorney submissions comprised 81.7% of reports (n = 1209); 80.8% (n = 1196) lacked sufficient clinical detail. Only 16 reports (1.1%) were classified as high-likelihood device-related events, including postoperative abscess requiring graft explant (n = 3), pelvic pain requiring reoperation (n = 6), and vaginal suture-line separation (n = 7).
CONCLUSION: Few MAUDE narratives contained sufficient detail to implicate Xenform in a device-attributed adverse event. Report volume peaked in 2013 coincident with FDA regulatory activity and mesh litigation, suggesting Xenform reporting patterns may have reflected the broader medicolegal context rather than a material-specific safety signal. The absence of detailed reporting is not evidence of safety, but reflects structural limitations of passive surveillance. Available evidence supports material-class trade-offs rather than a risk profile equivalent to synthetic mesh. The withdrawal has narrowed surgical options for patients with recurrent or complex POP. Prospective, long-term data on biologic graft safety remain a priority to inform future regulatory evaluation.