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, inflammation and recurrence.
The instructions-for-use supplied with the device lists adhesions, inflammation and recurrence as possible complications.
A review of the manufacturing records was performed for the subject lot 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) 2011, the patient underwent a surgery for the repair of left lower abdominal hernia with implant of a non-bard/davol mesh and a bard/davol ventrio mesh.
On or about (b)(6) 2012, the patient underwent revision surgery of both mesh products.
Attorney alleges that the patient experienced and/or continues to experience severe and chronic pain, inflammation, swelling in the lymphatic nodules in the lower abdomen, adhesions, recurrence, and mesh detachment as a result of their implantation with the mesh products.
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 also alleged that the device was defective.
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