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 suburethral sling implant is contraindicated in the following patients:
- Pregnant patients, patients with potential for future growth or patients that are considering future pregnancies.
- Any patients 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 limitations or infections that would compromise healing.
Warnings
Contents supplied STERILE using 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 re-use, re-process or re-sterilize. Re-use, re-processing or re-sterilization 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. Re-use, re-processing or re-sterilization 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 complications that have been reported due to suburethral sling placement include, 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.
Cautions
- The procedure should be performed with very careful attention to avoid laceration of any vessels, nerves, bladder and bowel.
- Retropubic bleeding can occur. Check carefully before releasing patient from the hospital.
- Cystoscopy must be performed to confirm bladder integrity.
- Do not remove the protective plastic sleeve covering mesh implant until proper position has been confirmed.
- 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 4 weeks. 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.
