Risks and Considerations

Considerations Prior to Surgical Repair

If you are considering surgery for stress urinary incontinence your physician may ask you questions about your medical history, to ensure you are a candidate for this type of procedure. Some of these contraindications, warnings/potential complications, and post procedural events associated with surgery for stress urinary incontinence are listed below as a reference for you. You should consult your physician for a complete understanding of this information to determine whether this procedure is right for you.

Intended Use / Indications for Use

The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Contraindications

A mesh implant is contraindicated in the following patients:

  • Pregnant patients, patients with the potential for future growth or patients who 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 / Potential Complications

The risks and benefits of performing a suburethral sling procedure in the following should be carefully considered:

  • Patients with untreated coagulopathies or who are being treated with either anticoagulants or antiplatelet agents.
  • Patients with hypertonic bladders or vesico ureteral reflux.
  • Patients with blood coagulation disorder.
  • Patients with compromised immune system or any other conditions that would compromise healing.
  • Take special care in cases of bladder prolapse because of anatomical distortion. If the patient requires a cystocele repair, it should be done prior to the suburethral sling placement.
  • Vaginal and urinary tract infection should be treated prior to implantation.
  • This product is intended for use only by clinicians with adequate training and experience in treatment of female stress urinary incontinence (SUI).

The following complications have been reported due to suburethral sling placement, 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, scarring, scar contracture, 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, ongoing pain (pelvic, vaginal, groin, dyspareunia), infection, detrusor instability, complete failure of the procedure resulting in incontinence and mild to moderate incontinence due to incomplete urethral support or overactive bladder.
  • In addition to the above listed potential complications, allergic reaction, abscess, bruising, bleeding (vaginal, hematoma formation), vaginal discharge, dehiscence of vaginal incision, nerve damage, edema and erythema at the wound site, have been reported due to suburethal sling procedure.
  • It has also been reported that orthostatic symptoms, fatigue and shortness of breath may occur due to the potential development of bleeding, including occult bleeding.*
 

Post Procedure

  • Should dysuria, bleeding or other problems occur, contact your physician immediately.
  • In the event that infection presents post procedure, the entire mesh may have to be removed or revised.
  • Like all foreign bodies, the mesh may potentiate an existing infection reaction or sepsis.
  • Tissue responses to the implant could include: local irritation at the wound site, vaginal erosion or exposure through the urethra or other surrounding tissue, migration of the device from the desired location, fistula formation, foreign body reaction, and inflammation. The occurrence of these responses may require removal or revision of the mesh.
  • 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/exposure, device migration, complete failure of the procedure resulting in incontinence due to incomplete support or overactive bladder.

*For Obtryx™ Transobturator Mid-Urethral Sling System procedure only

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician trained in use of surgical mesh for repair of stress urinary incontinence. Refer to package insert provided with the product for complete Instructions for Use, Contraindications, Potential Adverse Effect, Warnings and Precautions prior to using this product.

Individuals depicted are models and included for illustrative purposes only.

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