Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH A SOLYX SINGLE INCISION SLING SYSTEM FOR HER STRESS URINARY INCONTINENCE DURING A PROCEDURE ON (B)(6) 2011. ACCORDING TO THE PATIENT, HER URINE LEAKAGE WAS NOT COMPLETELY ELIMINATED, AND SHE BEGAN EXPERIENCING DYSPAREUNIA SHORTLY AFTER THE IMPLANTATION PROCEDURE, WHICH VARIED FROM SEVERE STABBING TO DULL ACHING. IN ADDITION, HER PARTNER REPORTEDLY COULD FEEL THE SLING DURING INTERCOURSE AND EXPERIENCED PAIN AND SCRATCHING. THE PATIENT FOLLOWED UP WITH THE PHYSICIAN ON MULTIPLE OCCASIONS, AND THE PHYSICIAN WAS REPORTEDLY ABLE TO "RECREATE" THE PAIN AND SCRATCHING SENSATIONS, BUT NOTED THERE WAS NO EXPOSURE, PROTRUSION, OR EROSION OF ANY KIND. THE PATIENT WAS PRESCRIBED HYDROCODONE (15 TABLETS) FOR HER PAIN. SHE CONTINUED TO EXPERIENCE CONSISTENT DYSPAREUNIA AND GENERAL DISCOMFORT FOLLOWING INTERCOURSE. REPORTEDLY, THE PHYSICIAN DOES NOT KNOW THE CAUSE OF HER COMPLICATIONS. ON (B)(6) 2013, THE PATIENT UNDERWENT A TOTAL MESH EXPLANTATION BY THE IMPLANTING PHYSICIAN. THE PROCEDURE WAS COMPLETED WITH NO ISSUES AND THE MESH WAS COMPLETELY REMOVED. POST-EXPLANTATION, THE PATIENT REPORTEDLY STILL HAS PAIN AND GENERAL DISCOMFORT, AND WAS PRESCRIBED ANOTHER ROUND OF HYDROCODONE (30 TABLETS). ALL OTHER INFORMATION IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.