No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, adhesions, bowel obstruction, inflammation, fistula and underwent surgical intervention.The instructions-for-use supplied with the device lists adhesions, inflammation and fistula as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided, a supplemental emdr will be submitted.Not returned.
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Attorney alleges that the patient underwent surgery for implant of a non-bard/davol mesh in the abdomen to repair an abdominal hernia.On or about (b)(6) 2016, the patient underwent a recurrent hernia repair and a marlex mesh (bard flat mesh), was implanted during this repair.The patient underwent removal surgery on or about (b)(6) 2020.It is alleged that the patient experienced and continues to experience severe and chronic pain, inflammation, adhesions to bowel, bowel blockage, dense adhesions, serosal tears from the adhesiolysis, fistula, and surgery to remove the mesh.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, permanent impairment, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the device was defective.
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