ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

Additional Manufacturer Narrative

IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EXTRUSION, INFECTION, URINARY PROBLEMS AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2009 DUE TO EROSION. IT WAS REPORTED THAT THE PATIENT UNDERWENT VAGINAL MESH EXCISION WITH ENTEROCELE REPAIR W/ BIOLOGIC GRAFT ON (B)(6) 2011 DUE TO SEVERE VAGINAL PAIN. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT PELVIC ORGAN PROLAPSE AND CYSTOCELE ON (B)(6) 2009 AND MESH WAS USED. THE SUTURES WERE UTILIZED AND REPORTEDLY ERODED POST-OPERATIVELY. THE PATIENT EXPERIENCED PAIN, INFLAMMATION, INFECTION, DISSOLVING AND EROSION OF THE MESH AND SUTURES, URINARY AND BOWEL PROBLEMS, DYSPAREUNIA, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES INCLUDING A MESH REVISION SURGERY ON (B)(6) 2009. THE PATIENT HAD A MESH EXPLANTATION SURGERY ON (B)(6) 2011 DUE TO EROSION. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

Additional Manufacturer Narrative

(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-02283 AND MEDWATCH 2210968-2013-02284. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

Additional Manufacturer Narrative

DIABETES MELLITUS