Major complications associated with xenograft biologic mesh implantation in abdominal wall reconstruction
Karem C Harth1, Michael J Rosen
1University Hospitals Case Medical Center, Case Western Reserve School of Medicine, Cleveland, OH, USA.
Background:
There is limited research for xenograft biologic mesh performance in the setting of infection despite widespread use and significant associated costs.
Design:
The authors retrospectively reviewed an FDA database for reported xenograft adverse events (AEs). All meshes were used in the setting of abdominal wall reconstruction from 1997 to 2008.
Results:
The authors identified 150 AEs. Permacol and Collamend comprised 75% (n = 112) of reported cases. Main AEs included acute mechanical failure (42%; n = 63), mesh disintegration (32%; n = 48), and poor mesh integration (13%; n = 20); 80% of cases were described as infected, and nearly 90% of AEs required reoperation.
Conclusions:
Major complications are reported to the FDA for xenograft biologic meshes. Cross-linked meshes had the most AE reports to the FDA. The intrinsic properties of meshes and how they relate to infection-related outcomes are poorly understood. The findings from this FDA database review point toward a need to carefully evaluate these products.
Insights
Xenograft biologic mesh complications are frequently reported to the FDA, especially with cross-linked meshes. Further research is needed to understand mesh properties and infection outcomes in abdominal wall reconstruction.
Area of Science:
- Biomaterials Science
- Surgical Innovation
- Medical Device Safety
Background:
- Limited research exists on xenograft biologic mesh performance during infection.
- Xenograft meshes are widely used in abdominal wall reconstruction, incurring significant costs.
- Understanding mesh behavior in infected environments is crucial for patient safety.
Purpose of the Study:
- To analyze adverse events (AEs) reported to the FDA concerning xenograft biologic meshes.
- To identify common complications and contributing factors for mesh failure.
- To evaluate the safety and efficacy of xenograft meshes in abdominal wall reconstruction.
Main Methods:
- Retrospective review of FDA database for xenograft mesh adverse events.
- Analysis of meshes used in abdominal wall reconstruction between 1997 and 2008.
- Categorization of adverse events and associated mesh types.
Main Results:
- 150 adverse events were identified, with Permacol and Collamend accounting for 75%.
- Primary complications included mechanical failure (42%), disintegration (32%), and poor integration (13%).
- 80% of cases involved infection, and nearly 90% required reoperation.
Conclusions:
- Xenograft biologic meshes, particularly cross-linked types, are associated with major complications reported to the FDA.
- The relationship between mesh properties and infection outcomes remains poorly understood.
- A careful evaluation of these medical devices is warranted based on FDA adverse event data.
Related Concept Videos
01:24Healing II: Complications
01:26Aneurysm III: Interprofessional Care