The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after the implant, the patient experienced mesh deformation, abscess, adhesions, infection, recurrence, mesh migration, cellulitis, bacterial infection, granuloma, ulcer, granulation tissue, inflammation, fibrosis, foreign body reaction, (b)(6), pain, nausea, nonhealing wound, abdominal pain, purulent material, erythema, skin warmth, failure of mesh, fibrinous reactive tissue, respiratory failure, draining wound, disrupted mesh, and meshoma/ balling.Post-operative patient treatment included revision surgery, hernia repair with new mesh, admission to hospital, antibiotics, lysis of adhesions, removal of hernia sac, reduction of hernia contents, debridement of skin/ subcutaneous tissue/ muscle/ muscle fascia, abdominal wall component separation, placement of drains, closure of rectus fascia, debridement/ resection of skin/ subcutaneous stitch granuloma, fibrinous reactive tissue dissected, medication, and removal of mesh.
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