Related Experiment Video
Updated: Aug 5, 2026
Transvaginal Mesh Insertion in the Ovine Model
Published on: July 27, 2017
Characterizing MAUDE Reports for Xenform Bovine Dermal Matrix in Transvaginal Pelvic Organ Prolapse Repair: A
Megan Corn1, Christopher S Elliott2, Eric R Sokol1
1Department of Obstetrics & Gynecology (Drs. Corn and Sokol), Stanford University, Palo Alto, California.
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.
Insights
Few adverse events were linked to Xenform biologic grafts in pelvic organ prolapse repair, suggesting reporting may reflect litigation rather than safety issues. More data is needed on biologic graft safety.
Area of Science:
- Urogynecology and reconstructive pelvic surgery
- Biomaterials and medical device safety
- Regulatory science and postmarket surveillance
Background:
- Transvaginal pelvic organ prolapse (POP) repair devices faced a sales ban in 2019.
- Questions remain about attributing adverse events to biologic grafts used in POP repair.
- Xenform, a bovine dermal matrix, was used for transvaginal POP repair.
Purpose of the Study:
- To analyze FDA MAUDE reports for Xenform used in transvaginal POP repair.
- To contextualize MAUDE findings with clinical evidence and FDA postmarket data.
- To assess the safety profile and reporting patterns of Xenform.
Main Methods:
- Mixed-methods descriptive study.
- Systematic review of FDA MAUDE database (2010-2025).
- Narrative review of prospective clinical evidence and FDA regulatory summaries.
Main Results:
- Most MAUDE reports (81.7%) were from attorneys and lacked clinical detail.
- Only 1.1% of reports (16 cases) were high-likelihood device-related events.
- Reported events included abscess, pelvic pain, and suture-line separation.
Conclusions:
- Limited MAUDE data implicated Xenform in specific adverse events.
- Reporting patterns correlated with regulatory activity and litigation, not necessarily material safety.
- Biologic grafts may offer material-class trade-offs compared to synthetic mesh, but long-term safety data is crucial.
