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Risks & Complications

All surgical procedures are associated with some risk.

Talk to your surgeon prior to surgery about possible risks and complications.

Some of the possible adverse reactions may include (transient) inflammatory foreign body reaction, seroma formation, infection potentiation, adhesion formation, fistula formation and extrusion when certain mesh products are used in hernia repair. Use of some mesh devices in contaminated or infected wounds can lead to: fistula formation and/or rejection of the mesh, or to infection that may require removal of mesh.

Mesh devices are generally not used in patients with the potential for growth or tissue expansion (such as infants or children or women who may become pregnant) as the mesh will not stretch significantly as the patient grows.

The PROCEEDTM Surgical Mesh device has a unique component that should not be used in the presence of uncontrolled and/or active bleeding as fibrinous exudates may increase the chance of adhesion formation.

Specific risks and complications are possible, when FlexHD® Acellular Hydrated Dermis is implanted. Use of FlexHD® in patients exhibiting autoimmune connective tissue disease is not recommended - specific or nonspecific immune response to some component of the graft. Possible adverse effects of using human skin include but are not limited to: local or systemic infection, dehiscence and/or necrosis due to poor revascularization, specific or nonspecific immune response to some component of the graft.

Extensive medical screening procedures have been used in the selection of all tissue donors for MTF. Transmission of infectious diseases such as HIV or hepatitis, as well as a theoretical risk of the Creutzfeldt-Jakob (CJD) agent, may occur in spite of careful donor selection and serological testing.