It was reported that the patient underwent a gynecological procedure and mesh was implanted along with concurrent hysterectomy, bso anda&p repair.It was reported that following insertion the patient experienced pain, recurrence, infections, pain during intercourse, mesh extrusion, bleeding, vaginal scarring, bowel problems, and neuromuscular problems.It was reported that patient underwent mesh revision/removal on (b)(6) 2008 as per doctor¿s recommendation due to injuries, conditions and/or symptoms she experienced.(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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