It was reported, by the patient, that they underwent a gynecological procedure in 2007 and mesh was implanted.The patient states that the mesh did not repair the pelvic floor, caused major incontinence issues, vaginal bleeding, and further prolapse.The patient underwent an unspecified number of additional procedures to repair the pelvic floor, repair the bladder and remove exposed mesh which she reports were unsuccessful.No additional information was provided.
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(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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