No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including hernia recurrence, infection, fistula and subsequent surgical intervention for mesh removal.The instructions-for-use (ifu) supplied with the device lists fistula, adhesions and recurrence of hernia as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis." should additional information be provided, a supplemental emdr will be submitted.Not returned.
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Attorney alleges that on (b)(6) 2007, the patient underwent incisional hernia repair surgery and was implanted with a bard/davol composix mesh.It is alleged that he patient suffered the development of abdominal pain, enterocutaneous fistula, evidence of post surgical change within the hernia sac related to prior mesh repair, at least two skin defects within the anterior abdominal wall overlaying the large ventral hernia, increasing distention, recurrent abdominal wall hernia with a draining sinus and an underlying mesh infection, mild cellulitis surrounding the skin openings.It is also alleged that on or about (b)(6) 2009, the patient underwent a revision surgery for laparotomy, resection of enterocutaneous fistula with a small bowel resection, removal of the foreign body, hernia mesh device, lysis of adhesions, repair of massive ventral hernia and bilateral rectus advancement flaps.It is alleged that the patient has suffered injuries, losses and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences.Attorney alleges that the patient experienced severe pain and suffering, including chronic pain.It is also alleged the patient was treated with a course of hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics and rest.Attorney alleges that the patient will require further invasive repair surgery, physiotherapy, rehabilitation and will continue to require other forms of medical care.It is also alleged that the device was defective.
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