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, recurrence, adhesions, inflammation and surgical intervention.
The instructions-for-use supplied with the device lists 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 the patient underwent a ventral hernia repair on or about (b)(6) 2011 and a bard/davol ventralight st mesh was implanted.
On or about (b)(6) 2012, the patient underwent revision of the ventralight st mesh and a non-bard/davol mesh was implanted to repair a recurrent ventral hernia.
On or about (b)(6) 2014, the patient underwent removal of the mesh products.
It is alleged that the patient experienced and/or continues to experience severe and chronic pain/discomfort, pain and suffering, nausea, chills, inflammation, dense adhesions, mesh migration, recurrence, and surgery to remove mesh.
Attorney 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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