N
Patient 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT # IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. THIS PRODUCT IS INTENDED FOR USE ONLY BY PHYSICIANS TRAINED IN THE SURGICAL PROCEDURES AND TECHNIQUES REQUIRED FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE AND THE IMPLANTATION OF NONABSORBABLE MESHES. THE PHYSICIAN IS ADVISED TO CONSULT THE MEDICAL LITERATURE REGARDING TECHNIQUES, COMPLICATIONS, AND HAZARDS ASSOCIATED WITH THE INTENDED PROCEDURES. DESCRIPTION: THE ALIGN? RETROPUBIC/SUPRAPUBIC/RETROPUBIC-SUPRAPUBIC (R/S/RS) URETHRAL SUPPORT SYSTEM (ALIGN? URETHRAL SUPPORT SYSTEM) IS A SUBURETHRAL SLING DEVICE INTENDED FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE. THE SYSTEM CONSISTS OF STAINLESS STEEL INTRODUCERS AND A POLYPROPYLENE MESH SLING IMPLANT ENCASED IN A PROTECTIVE SHEATH WITH GREEN GUIDE TUBES AT EACH END OF THE SHEATH. CONNECTORS ARE ATTACHED TO THE DISTAL ENDS OF THE GUIDE TUBES, AND ARE DESIGNED TO ATTACH TO THE TIP PORTION OF THE INTRODUCER NEEDLES. THE DEVICE IS TERMINALLY STERILIZED BY ETHYLENE OXIDE. INDICATIONS FOR USE: THE ALIGN? URETHRAL SUPPORT SYSTEM IS INDICATED FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE RESULTING FROM URETHRAL HYPERMOBILITY AND/OR INTRINSIC SPHINCTER DEFICIENCY. CONTRAINDICATIONS: THE ALIGN? URETHRAL SUPPORT SYSTEM IS CONTRAINDICATED FOR PATIENTS EXPERIENCING ANY OF THE FOLLOWING CONDITIONS: PREGNANCY, URINARY TRACT INFECTION, ANTICOAGULANT THERAPY, AND/OR INFECTION IN THE OPERATIVE FIELD. WARNINGS: - THE IMPLANT PROCEDURE AND THE INSTRUMENTATION ASSOCIATED WITH THE SURGICAL PLACEMENT OF THE ALIGN? URETHRAL SUPPORT SYSTEM CARRY AN INHERENT RISK OF INFECTION AND BLEEDING, AS DO SIMILAR UROLOGICAL PROCEDURES. THE USE OF SURGICAL STAPLES, CLIPS, SCREWS, OR OTHER NON-SUTURE ATTACHMENT MECHANISMS NOT SUPPLIED WITH THE ALIGN? URETHRAL SUPPORT SYSTEM CAN DAMAGE THE IMPLANT. - AFTER USE, THE PRODUCT AND ITS PACKAGING SHOULD BE TREATED AS A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE, AND FEDERAL LAWS AND REGULATIONS. PRECAUTIONS: THE USUAL PRECAUTIONS ASSOCIATED WITH UROLOGICAL PROCEDURES SHOULD BE FOLLOWED: - BASED ON PHYSICIAN EXPERIENCE AND TRAINING, A THOROUGH ASSESSMENT OF EACH PATIENT SHOULD BE MADE TO DETERMINE THEIR SUITABILITY FOR THE IMPLANT PROCEDURE. ADDITIONAL CONSIDERATION SHOULD BE GIVEN TO USE OF THE IMPLANT IN PATIENTS WITH A COMPROMISED IMMUNE SYSTEM, ANY CONDITION THAT WOULD COMPROMISE HEALING, OR ANY PATIENT WITH A HISTORY OF PRIOR ABDOMINAL OR PELVIC SURGERIES. CONSIDERATION SHOULD ALSO BE GIVEN TO THE ABILITY OF THE PATIENT TO TOLERATE THE SURGICAL PROCEDURE. - ACCEPTED SURGICAL PRACTICE AND PRECAUTIONS MUST BE FOLLOWED FOR THE MANAGEMENT OF CONTAMINATED OR INFECTED WOUND SITES, WHEN THE ALIGN? URETHRAL SUPPORT SYSTEM IS USED. - POSTOPERATIVE BLEEDING MAY OCCUR IN SOME PATIENTS AND MUST BE CONTROLLED PRIOR TO PATIENT RELEASE. - THE IMPLANT PROCEDURE REQUIRES DILIGENT ATTENTION TO ANATOMICAL STRUCTURES AND CARE TO AVOID PUNCTURE OF LARGE VESSELS, NERVES, BLADDER, BOWEL, URETHRA AND ANY VISCERA, DURING INTRODUCER PASSAGE. - CYSTOSCOPY SHOULD BE PERFORMED TO CONFIRM BLADDER INTEGRITY OR RECOGNIZE A BLADDER PERFORATION. - DUE TO ANATOMICAL DISTORTION THAT CAN BE CAUSED BY PELVIC ORGAN PROLAPSE, IF THE PATIENT REQUIRES CYSTOCELE REPAIR, IT SHOULD BE PERFORMED PRIOR TO THE IMPLANTATION OF THE SUB-URETHRAL SLING. - PROPER PLACEMENT OF THE SLING IMPLANT AT MID-URETHRA REQUIRES THAT IT LIE FLAT WITH MINIMAL OR NO TENSION UNDER THE URETHRA. - THE ALIGN? URETHRAL SUPPORT SYSTEM IS INTENDED AS A SINGLE-USE DEVICE. DO NOT RE-STERILIZE ANY PORTION OF THE ALIGN? URETHRAL SUPPORT SYSTEM. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/ OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. - PATIENTS SHOULD BE ADVISED THAT PREGNANCY FOLLOWING A MESH SLING IMPLANT PROCEDURE MAY NEGATIVELY AFFECT THE SUCCESS OF THE PREVIOUS IMPLANT PROCEDURE AND INCONTINENCE MAY RECUR. - THE SAFETY AND EFFECTIVENESS OF THE ALIGN? URETHRAL SUPPORT SYSTEM IMPLANT PROCEDURE HAS NOT BEEN ESTABLISHED FOR THE TREATMENT OF STRESS URINARY INCONTINENCE IN MALES OR CHILDREN UNDER THE AGE OF 18. - CHECK THE INTEGRITY OF THE PACKAGING BEFORE USE. DO NOT USE THE ALIGN? URETHRAL SUPPORT SYSTEM IF THE PACKAGING IS OPENED OR DAMAGED. - AS FOR ANY IMPLANTABLE MATERIAL, IT IS RECOMMENDED TO OPEN THE PACKAGE AT THE TIME OF IMPLANTATION. - POST-OPERATIVELY THE PATIENT SHOULD BE ADVISED TO REFRAIN FROM HEAVY LIFTING, EXERCISE (E.G. CYCLING, JOGGING) AND/OR INTERCOURSE UNTIL THE PHYSICIAN DETERMINES IT IS SUITABLE FOR THE PATIENT TO RETURN TO NORMAL ACTIVITIES. ADVERSE EVENTS: COM...