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 subsequent surgical intervention.The instructions-for-use supplied with the device lists hernia recurrence, adhesions, and inflammation 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, on or about (b)(6) 2016, the patient underwent repair of an abdominal hernia and was implanted with a non-bard/davol mesh.On or about (b)(6) 2017, the patient underwent revision of the non- bard/davol mesh for the repair of an abdominal hernia and was implanted with a bard/davol ventrio mesh patch during this repair.On or about (b)(6) 2019, the patient underwent removal of the mesh products.The patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, significant adhesions, recurrence and surgery to remove the mesh.Attorney also alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is further alleged that the device was defective.
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