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, hernia recurrence, adhesions, inflammation and revision surgery.The instructions-for-use (ifu) supplied with the device lists hernia recurrence, adhesions, pain 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 on or about (b)(6) 2012, the patient underwent repair of a left lower quadrant hernia during which a bard/davol ventralex mesh was implanted.It is alleged that on or about (b)(6) 2014, the patient underwent an additional left lower quadrant hernia surgery during which a non-bard/davol physiomesh was implanted.It is alleged that on or about (b)(6) 2017, the patient underwent revision surgery.Attorney alleged that the patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, recurrence, adhesions, and adhesions to the mesh.The ventralex mesh caused serious injury and had to be surgically removed via invasive surgery and necessitated additional invasive surgery to repair the hernia.It is also alleged that the patient has suffered and will continue to suffer physical pain and suffering, as well as mental anguish, permanent and severe scarring and disfigurement and had emotional distress, sustained severe and permanent pain, suffering, disability and impairment.Attorney also alleges past, present, and future damages, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by the patient and permanent impairment.It is also alleged that the device was defective.
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