The patient¿s attorney alleged a deficiency against the device.
The product was used for therapeutic treatment of an incisional hernia and umbilical hernia.
It was reported that after the inlay implant, the patient experienced infection, purulent material, abscess, phlegmon, inflammation, adhesions, granulation tissue, foreign body reaction, drainage, granuloma, and recurrence.
Post-operative patient treatment included removal of mesh, excision of phlegmon, lysis of adhesions, small bowel resection, hernia repair with sutures, debridement, granuloma with cauterized with silver nitrate, antibiotics, and hernia repair with mesh.
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