MAUDE Database Audit Shows Inaccurate Representation of Mesh-Related Adverse Events and Trends

Shuddhadeb Ray, MD, Kyle C Ward, DO, Christopher D Barrett, MD, Kevin P Costello, Corey R Deeken, PhD, Sara Baalman, MA, Margaret M Frisella, RN, Brent D Matthews, MD. Washington University School of Medicine.

INTRODUCTION: The objective of this study was to illustrate the limitations of the Manufacturer and User Facility Device Experience (MAUDE) database and evaluate the consistency of reports of mesh-related adverse events for abdominal wall hernia repair. The MAUDE database contains medical device reports submitted to the Food and Drug Administration by voluntary reporters including patients, attorneys, manufacturers and device user facilities including hospitals, limiting the accuracy of the filed reports. The MAUDE database allows the user to search by specific medical devices to view reports of device malfunction that have caused death or serious injury. The use of mesh for abdominal wall hernia repair is pervasive and all mesh has the potential to fail or have associated complications. There is currently no other centralized national tracking system for surgical mesh-related adverse events, and this database has been utilized to make claims regarding trends in complications of using hernia mesh materials.

METHODS AND PROCEDURES: A retrospective analysis was conducted at our institution, a high-volume tertiary academic surgical center in St. Louis, Missouri. Patients treated with mesh abdominal wall hernia repair during a seven-year period (2004-2011) were identified and medical records were reviewed. Date of surgery, age, BMI, sex, ASA score, location of hernia, number of previous surgeries, number of previous hernia repairs, defect size, mesh size, mesh type, operating time, hernia recurrence, mesh-related adverse events, and date of last follow-up appointment were recorded. The MAUDE database was queried for mesh-related adverse events in the same time period using date of operation and type of mesh used during the operation. The mesh-related adverse events identified at our institution were cross-referenced to the compiled MAUDE data by the date of surgery and type of mesh, with matches confirmed with review of operative reports. Statistical significance (p<0.05) was determined using the chi-square test.

RESULTS: Patients (n = 2298) with a mean age of 55 ± 13 years underwent hernia repair with mesh: incisional (n = 1961), umbilical (n = 307), epigastric (n = 47), spigelian (n = 9), and lumbar (n = 2) hernia. Mesh-related adverse events were considered central mesh failure (n = 7), suture retention failure (n = 4), mesh fragmentation (n = 3), premature degradation (n = 5), and erosions/adhesions requiring bowel resection (n = 35). All mesh-related adverse events (n = 54) occurred after incisional hernia repair. Mesh-related adverse events were higher for recurrent hernias (p = 0.016), open repairs (p = 0.013), and contaminated cases (p = 0.032). No mesh-related adverse events at the surgical institution were identified within the MAUDE database after audit of all applicable reports (n = 4135).

CONCLUSIONS: The MAUDE Database does not provide an accurate representation of mesh-related adverse events or trends. There is a need for a national centralized system to more consistently and accurately track mesh-related adverse events.

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