The patient¿s attorney alleged a deficiency against the device.
The product was used for therapeutic treatment of an incisional hernia.
It was reported that after the onlay implant, the patient experienced adhesions, recurrence, abdominal pain, exacerbation, crampy associated with meals, contracted scar tissue, painful left side pannus with panniculitis, inflammation, necrosis, discomfort, pain, and infection.
Post-operative patient treatment included revision surgery with additional implant, reconstruction of midline ventral hernia with left sided muscle flap, direct repair of left incisional hernia, abdominal panniculectomy, explantation of retained abdominal mesh with sutures, complex repair, removal of contracted scar tissue, removal of mesh, dermal/fat graft to abdominal wall, complex repair of abdominal wall skin defect, removal of hernia sac, hernia repaired in a vest over pants style, and lysis of adhesions.
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