(b)(4).It was reported that the patient underwent a gynecological procedure on (b)(6) 2007 and tvt-secur was implanted.It was reported that following insertion the patient experienced pelvic pain, vaginal mesh erosion, dyspareunia, urgency, incontinence, urinary frequency, uti, nocturia, interstitial cystitis, irritative bladder, and overactive bladder.It was reported that patient underwent cystocele mesh revision on (b)(6) 2013 by dr.(b)(6) at (b)(6).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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