The patient¿s attorney alleged a deficiency against the device.
The product was used for laparoscopic therapeutic treatment of a incisional epigastric hernia.
It was reported that after the implant, the patient experienced distended small bowel, adhesions, hernia recurrence, seroma, infection, hematoma, mesh erosion into viscera, abscess, pain, swelling, drainage, discomfort, fluid collection, blood loss, cloudy fluid, fever, fibrous and adipose tissue, vascular congestions, inflammation, foreign body giant cell reaction, granulation tissue changes, multinucleated giant cells, and open wound.
Post-operative patient treatment included small bowel resection, lysis of adhesions, hernia repair with new mesh, drainage of seroma, exploration of surgical wound and abdominal wall, debridement, revision surgery, mesh removal, feeding jejunostomy, fluid aspirated, antibiotics, capsule dissected and excised down to mesh, evacuation of hematoma, wound packed, wound irrigated, and wound vac.
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