Prescriptive Information
Indications The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.
Contraindications
The Mesh Assembly is contraindicated in the following patients:
Pregnant patients, patients with potential for future growth or patients that are considering future pregnancies. Any patient with soft tissue pathology into which the implant is to be placed. Patients with any pathology which would compromise implant placement. Patients with any pathology such as blood supply limitation or infection that would compromise healing. Warnings
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
Potential Adverse Effects
The following complications that have been reported due to suburethral sling placement includes, but are not limited to:
As with all implants, local irritation at the wound site and/or a foreign body response may occur. Tissue responses to the implant could include vaginal extrusion, erosion through the urethra or other surrounding tissue, migration of the device from the desired location, fistula formation and inflammation. The occurrence of these responses may require removal of the entire mesh. Like all foreign bodies, the mesh may potentiate an existing infection. Excess tension may cause temporary or permanent lower urinary tract obstruction and retention. Known risks of surgical procedures for the treatment of incontinence include pain, infection, erosion, device migration, complete failure of the procedure resulting in incontinence and mild to moderate incontinence due to incomplete support or overactive bladder. In addition to the above listed potential complications, allergic reaction, fistula, abscess, detrusor instability, pelvic and vaginal pain, dysparenia, vaginal bleeding, vaginal discharge, dehiscence of vaginal incision, edema, and erythema at the wound site, have been reported due to suburethral sling procedures. It has also been reported that groin pain, orthostatic symptoms, fatigue and shortness of breath may occur due to the potential development of hematoma in the obturator foramen. Cautions
Standard surgical practices should be followed for the suburethral sling procedure as well as for the management of contaminated or infected wounds. The procedure should be performed with very careful attention to avoid laceration of any vessels, nerves, bladder and bowel. Do not remove the protective plastic sleeve covering mesh implant until proper position has been confirmed. Ensure the mesh is placed with appropriate tension under the mid-urethra. Use of this device should be done with the understanding that subsequent infection may require removal of the mesh. Patients should be counseled to refrain from heavy lifting, exercise, and intercourse for a minimum of four weeks after the procedure. Physician should determine when it is suitable for each patient to return to normal activities. Should dysuria, bleeding or other problems occur, the patient should be instructed to contact the physician immediately. Do not use any mechanical means of contact with the mesh (such as clips, staples, etc.) within the urethral support region of the mesh as mechanical damage to the mesh may occur. Avoid excessive tension on the mesh during handling.
