The patient¿s attorney alleged a deficiency against the device.
The product was used for therapeutic treatment of a bilateral inguinal hernia.
It was reported that after the implant, the patient experienced abscess, infected mesh, purulent material, mesh erosion, mesh not attached/free floating, scarring, obliteration of the normal planes, spermatic cord involved, mesh migration, adhesions, open wound, sinus drainage, staphylococcus aureus, bleeding, nonviable subcutaneous tissue, inflammation, scar tissue, and infection.
Post-operative patient treatment included incision/drainage of abscess, removal of mesh, purulent material expressed, lavage with saline and betadine, wound debridement, wound was irrigated, fascial defect was loosely reapproximated at the site of the plug with sutures, wound vac, open wound was then copiously irrigated, elliptical incision and subcutaneous dissection, skin/nonviable subcutaneous tissue/some external oblique fascia was excised, bleeding controlled with ligatures of silk, hemostasis was achieved with electrocautery, lysis of adhesions, portions of mesh were left behind due to be too densely adhered and scarred to remove, and sharp excisional debridement of skin/subcutaneous tissue.
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