The patient¿s attorney alleged a deficiency against the device.
The product was used for therapeutic treatment of a incisional hernia.
It was reported that after the implant, the patient experienced unincorporated mesh, which was opened, and this appeared to be into the peritoneal cavity, infection/infected mesh, indurated tissue beneath it appeared to be a rind over the surface of the bowel, chronic granulation tissue, purulent material, adhesions, draining wound, mesh erosion, fistulous communication to the small bowel, bowel injury, murky fluid, attenuated tissue, foreign bodies in the anterior abdominal wall, large squamous cell cancer, recurrence, densely adhered mass, bowel showed less tendency to eviscerate from the abdominal cavity, abscess, open wound, mesh fragmented, area of fluctuance, chronic serositis, hemorrhage, necrosis, chronic draining tracts, fistula, and fluid collection.
Post-operative patient treatment included revision surgery, excision of extensive dissection of the viscera, free this densely adherent mass from the anterior abdominal wall, adhesiolysis, excision of segment of bowel/fistula, wound vac, excision of mesh, excision of foreign bodies in the anterior abdominal wall, full-thickness excision of skin,/muscle/fascia, takedown of enterocutaneous fistula, small bowel resection with primary anastomosis, partial colectomy with end colostomy, partial omentectomy, excision of large squamous cell cancer, hernia repair with new mesh, abdominal irrigation/debridement, change of vacuum dressings, abdominal washout, incision/drainage of abscess, wound was copiously irrigated/debrided and packed with saline-soaked gauze, placement of drains, admission to hospital, and removal/irrigation of purulent material.
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