It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2007 and mesh was implanted due to stress urinary incontinence, pelvic prolapse, and abnormal uterine bleeding.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.
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(b)(4).It was reported that the patient underwent a gynecological procedure and mesh was implanted along with d&c, diagnostic hysteroscopy, thermachoice endometrial ablation, diagnostic cystoscopy due to sui and abnormal uterine bleeding.It was reported that following insertion the patient experienced pain, infection, recurrence, bleeding, dyspareunia, neuromuscular problems, bloating and hematoma.It was reported that patient underwent mesh revision/removal.No additional information was provided.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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