If you have been diagnosed with stress urinary incontinence (SUI), you are not alone. SUI is a common and treatable condition.
- Many women suffer from some type of urinary incontinence
- SUI is caused by weakening of the pelvic muscles that support the bladder and urethra, the thin tube that releases urine from the body.
- With SUI, everyday exertion activity or movements like laughing, sneezing or exercising put stress on the bladder – causing urine to leak out involuntarily.
Talk with your doctor about the various options that exist to manage SUI. These include treatments such as behavioral therapy, Kegel exercises, biofeedback and electrical stimulation devices. If these non-surgical approaches are not right for you, you may be a candidate for incontinence surgery to treat SUI.
If you suffer from another type of incontinence, such as urge or mixed incontinence, click here to learn about other treatment options.
Incontinence Surgery for SUI
SUI is the most common type of urinary incontinence and can be the cause of some very embarrassing situations. You may be surprised to learn there are treatments that could reduce urine leakage or stop it altogether, so you can get back to doing the things you enjoy most.
If non-surgical approaches to treating SUI are not right for you, you may be a candidate for incontinence surgery. While there are a variety of surgical techniques that have been used over the years, the current standard of care is to use a Tension-free Vaginal Tape (TVT) sling procedure.
- Tension-free Vaginal Tape (TVT) Sling Procedure: usually performed as an outpatient procedure, in which the surgeon places a thin piece of flexible, permanent synthetic mesh under the urethra, like a sling (commonly called “suburethral sling” or “mid-urethral sling”). For some patients, an in-patient procedure may be required.
- “Tension-free” means that there is no tension between the sling and urethra under normal circumstances. Tension is only generated to close off the urethra (and help prevent leakage) when intra-abdominal pressure increases such as with a laugh, cough, or sneeze. Additionally, the synthetic mesh does not require sutures (“stitches”) to secure it in place.
- Minimally invasive procedure that requires an incision in the vagina and two small incisions in the lower abdomen or inner thigh
- Performed under local, regional or general anesthesia
- Learn about types of TVT sling procedures
Less common surgical methods for SUI are:
- Conventional Sling Procedure: A sling is placed under the “bladder neck”, the area of thickened muscle where the bladder connects to the urethra, the tube that carries urine from the bladder.
The material of the sling may be synthetic mesh or possibly from human or animal tissue. Stitches will be needed in your abdomen to secure the sling to the pelvic tissue versus the “tension-free” approach.
- Bladder Neck Suspension Surgery: Your surgeon uses stitches (instead of a sling) to lift up and secure the tissues. An abdominal incision is required, so recovery may take several weeks.
GYNECARE TVT™ Family of Products Essential Product Information
The GYNECARE TVT™ Tension-free Support for Incontinence, GYNECARE TVT EXACT® Continence System and GYNECARE TVT™ with Abdominal Guides Tension-free Support for Incontinence, are intended to be used in women as pubourethral slings for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
GYNECARE TVT™ Obturator System Tension-free Support for Incontinence and GYNECARE TVT ABBREVO® Continence System are intended to be used in women as suburethral slings for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
- As with any suspension surgery, these procedures should not be performed in pregnant patients.
- Additionally, because the PROLENE Polypropylene Mesh will not stretch significantly, it should not be performed in patients with future growth potential including women with plans for future pregnancy.
WARNINGS & PRECAUTIONS
- Do not use the GYNECARE TVT Family of Products in patients who are on anti-coagulation therapy.
- Do not use the GYNECARE TVT Family of Products in patients who have a urinary tract infection.
- Bleeding or infection may occur post-operatively.
- Transient leg pain lasting 24-48 hours may occur and can usually be managed with mild analgesics after a GYNECARE TVT Obturator System or GYNECARE TVT ABBREVO System procedure.
- Since no clinical information is available about pregnancy following sub-urethral sling procedure with the GYNECARE TVT Family of Products, the patient should be counseled that future pregnancy may negate the effects of the surgical procedure and the patient may again become incontinent.
- Since no clinical information is available about vaginal delivery following sub-urethral sling procedure with the GYNECARE TVT Family of Products, in case of pregnancy, delivery via cesarean section should be considered.
- Post-operatively, refrain from heavy lifting and/or exercise (e.g. cycling, jogging) for at least three to four weeks and to refrain from intercourse for one month. The patients can usually return to other normal activity after one or two weeks.
- Contact your surgeon immediately if there is burning sensation during urination, unusual bleeding, problems voiding or other problems.
Physicians should use their surgical experience and judgment to determine if PROLENE Mesh is appropriate for certain patients. Patient-specific factors may impair wound healing, which may increase the likelihood of adverse reactions.
- Punctures or lacerations or injury of vessels, nerves, structures or organs, including the bladder, urethra, or bowel, may occur and may require surgical repair.
- Improper placement of the GYNECARE TVT Family of Products devices may result in incomplete or no relief from urinary incontinence or may cause temporary or permanent urinary tract obstruction.
- Transitory local irritation at the wound site may occur.
- As with any implant, a foreign body response may occur. This response could result in extrusion, erosion, exposure, fistula formation and/or inflammation.
- Mesh extrusion, exposure, or erosion into the vagina or other structures or organs.
- As with all surgical procedures, there is a risk of infection. As with all foreign bodies, PROLENE Mesh may potentiate an existing infection.
- Acute and/or chronic pain
- Voiding dysfunction
- Pain with intercourse which, in some patients may not resolve.
- Neuromuscular problems, including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area may occur
- Recurrence of incontinence
- Bleeding including hemorrhage or hematoma.
- One or more revision surgeries may be necessary to treat these adverse reactions.
- PROLENE Mesh is a permanent implant that integrates into the tissue. In cases in which the PROLENE Mesh needs to be removed in part or whole, significant dissection may be required.
OTHER ADVERSE REACTIONS
- Urge incontinence
- Urinary frequency
- Urinary retention
- Adhesion formation
- Atypical vaginal discharge
- Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse
Consult your doctor to discuss the potential benefits and risks of your treatment options and whether PROLENE mesh is appropriate for you.
For more information, please call 1-877-Ethicon and ask to speak with a nurse.