Call Us: 864-286-1520
Carolina Continence Center
FDA Recommended Q&A
The FDA has issued a warning about mesh usage in vaginal surgeries. For more information, please click here.
Are you planning to use mesh in my surgery?
We have routinely been using mesh in our pelvic reconstructive procedures since 2006 and have achieved very favorable results. Many studies comparing mesh to non-mesh repairs have demonstrated lower recurrence rates when mesh is utilized. The FDA review of these studies acknowledges the anatomical benefit of mesh use, but unfortunately “dismisses” it because measurement scales of “quality of life” were no different. The fact is that these studies are not long term (only one year), and our many years of experience tell us that patients with anatomical failure (the prolapsed is recurring) will eventually suffer symptoms and quality of life deterioration. If we are planning to use mesh we ALWAYS discuss the benefits as well as risks with you. Remember, the use of mesh is our recommendation only; it will only be used with your informed consent.
Why do you think I am a good candidate for surgical mesh?
Most all patients are good candidates. Historical data has shown that over 30% of patients undergo repeat surgery for pelvic organ prolapse. This is very similar to surgical data on hernias. Surgeons have found that the addition of mesh has significantly reduced the need for subsequent surgeries by almost 75%. It would seem logical that pelvic organ prolapse could be considered a hernia, but in the pelvis, and the addition of mesh a logical addition to these surgical procedure. The thinking is that patients that have weak or compromised tissue such as older patients, tobacco users, patients with known collagen deficiencies, large prolapses, and those who have undergone prior reconstructive surgery are especially good patients for mesh placement. Our research has shown that the only relatively “not good” candidates are those who have had prior pelvic surgery utilizing any permanent material (suture or mesh) and now have chronic pelvic pain.
Why is surgical mesh being chosen for my repair?
Mesh placement is being recommended for your repair in order to improve the durability of your surgery (by decreasing the risk of prolapse recurrence). Several studies have demonstrated a superior anatomical repair when mesh is used vs. when it is not used.
What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
For a non-surgical option you could use an intra-vaginal support device called a ‘pessary’. The other surgical alternatives include suture repair of your tissue which carry a higher failure rate, or trans-abdominal delivery of the mesh to the pelvis which requires general anesthesia and longer surgical time. Transabdominal placement also exposes patients to additional peri-operative complications such as bowel injury or obstruction, more post-operative pain and longer recovery time. In our hands, there is no difference in the risk of vaginal mesh exposure when mesh is placed either through the transvaginal or abdominal approach.
What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
Many studies consistently demonstrate a 30-40% failure rate in anatomical correction of prolapse when no mesh is involved in the repair. The benefit (pro) of using mesh is to lower the failure rate to approximately 10%. The “cons” of using mesh are the risks associated with its use, namely exposure of the material into the vaginal cavity, and pain during intercourse. These occur in only 2-3% of our patients. These complications can be treated and resolved in most all patients with office based interventions.
Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
Your sexual partner should not be able to feel the mesh during intimacy as the mesh lies deep behind the vaginal wall. Newer material properties of the mesh construct such as light weight and increased elasticity have contributed to the material being essentially undetectable by your partner or even your gynecologist. If there is an exposure of the mesh, however, your partner could feel a “scratchy sensation” with penetration. This happens in only 2-3% of the cases when our surgeons have performed the mesh placement. These exposures also tend to be small and easily repaired, often in the office, or as an outpatient in an ambulatory surgery center.
If surgical mesh is to be used, how often have you implanted this particular product?
The Physicians at the CarolinaContinenceCenter have implanted thousands of mono-filament, knitted, macropourous. polypropylene meshes over the past five years.
What results have your other patients had with this product?
In order for us to feel confident about counseling our patients on the success we have using vaginal mesh, we have done extensive research on transvaginal mesh and continue to monitor our patients long term after they have had the mesh implanted.
We have performed this surgery in over 2,000 patients in our practice and a great majority of these patients are in various study bases. Some of the patients had mesh implanted over five years ago. The most common risks of mesh placement include exposure of mesh material, and/or pain with intercourse. Our patient databases reflect that when we perform the surgery less than 2% of our patients have developed any of these complications. In fact, over 90 % of our patients have reported that are very satisfied with the results, they would recommend the surgery to a friend or family member and most importantly when asked “looking back if you had to do it all over would you have the surgery again?” Over 90 % stated they would.
What can I expect to feel after surgery and for how long?
You can expect to “feel” immediate relief from pressure-like discomfort within your lower pelvis or vagina, the resolution of fullness or any protrusion of vaginal tissue you may have had prior to your surgery. Also we anticipate you will experience improvement in function of your lower urinary tract (voiding and/or urinary control) as well as your rectum (with defecation) depending on the type and location of your prolapse preoperatively. We have long term (from 2008) studies confirming lasting durability for most patients.
Which specific side effects should I report to you after the surgery?
As we discuss with all patients peri-operatively and in our pre-op instruction booklet, we ask all patient to notify us if after surgery you have any fever or bleeding more than a menstrual period. Symptoms in the future we would also want you to report would be vaginal discharge, spotting, pain or irritative symptoms you or partner may experience during intercourse.
What if the mesh surgery doesn’t correct my problem?
If the surgery doesn’t “correct” your symptoms, we will continue to evaluate as to “why”. Functional improvement in the lower urinary tract or rectum does not always spontaneously occur after anatomical correction (surgery)of prolapse. Occasional additional medical or behavioral therapies will be necessary in addition to the corrective surgery for your prolapsed condition. Unfortunately these interventions rarely ever significantly help without first surgically correcting the prolapse.
If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
We are the most experienced surgeons in mesh surgery for pelvic organ prolapse in the region, if not the nation. We will treat any complications you may have. We do care for women referred to us from other institutions with mesh complications. We have a greater than 90% success rate in resolving complications.
If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
We occasionally have to “revise” a surgical mesh by either releasing the tension or excising a small exposed area. We have never had to “remove’ a mesh that we have placed. We do have the experience to remove mesh, as we have done so in patients referred to us by other physicians.
If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?
Yes, we routinely provide the product information to all patients at the time of consent for surgery.