Transvaginal Mesh and Mesh Complications

Dr. Ashford’s answers to the FDA's recommended "questions to ask your surgeon about transvaginal mesh surgery" dated July 13, 2011. Most patients with prolapse can be treated without surgery or have surgery without mesh products. However when mesh is indicated, it can be extremely helpful for the long-term success of a repair.

Are you planning to use mesh in my surgery?

I am planning to correct your prolapse and to provide optimum symptom relief. How you and I decide to do this will be based upon your concerns, desires, anatomic defects, and symptoms. I am able to correct prolapse with or without the use of mesh. Each surgical option comes with its own set of risks and benefits. Mesh is no different. It has benefits and risks. With that said, below are answers to questions specifically for women in whom a mesh repair would be best.

Why do you think I am a good candidate for surgical mesh?

Many women are good candidates for surgical mesh. Women who have weak or compromised tissue such as older patients, tobacco users, women with known collagen deficiencies, large prolapses, and those who have undergone prior reconstructive surgery that has failed are especially good patients for mesh placement. Research has shown that relatively “poor” candidates for mesh are those who have had prior pelvic surgery utilizing any permanent material (suture or mesh) and now have chronic pelvic pain.

I have been using mesh in my pelvic reconstructive procedures to repair pelvic organ prolapse (prolapse of bladder, rectum, uterus and vaginal cuff) since 2001 and have achieved very favorable results. There are many ways to repair pelvic organ prolapse. There are options to repair without the use of mesh, with mesh in the vagina or with mesh without going through the vagina. I believe that in the patient suffering from a falling uterus, bladder or rectum there is a procedure that addresses her medical problem and comfort level with mesh materials. My goal is not to force any particular procedure but rather to get you better. With that said, many studies comparing mesh to non-mesh repairs have demonstrated lower recurrence rates when mesh is utilized.This has been my experience as well. After more than 10 years of using mesh in select patients I am convinced that the benefits of mesh far exceed the potential risks. I have seen many satisfied and happy patients as a result of these procedures. This is precisely why I’ve used mesh in select patients for 10 years. We will discuss all options mesh and without mesh. I will discuss the benefits as well as risks with you for all the procedural options. Together we will plan a procedure with the goal of solving or relieving your symptoms. If mesh is utilized it will never be used without your informed consent.

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 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?

Non surgical options would include aggressive physical therapy to improve the pelvic floor musculature. This is not expected to cure your prolapse but may improve your symptoms. The use of a synthetic device called a pessary can be utilized. This device is placed in the vagina in the office and does not involve surgery. The pessary does not cure the prolapse but rather holds it up for you. We clean the pessary at regular intervals. The other surgical alternatives include transvaginal suture (or “traditional”) repair of your own native tissue, a biologic graft augmented repair using human cadaveric fascia lata or dermis. Trans-abdominal sacrocolpopexy (which may be laparoscopic) placement is another good option.

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?

The answer to this question, will obviously by nature of the question, change from patient to patient. I will address this more specifically to your situation upon your visit to the office. However to speak in general terms, studies consistently demonstrate a 30-40% failure rate in anatomical correction of prolapse when a traditional native tissue suture repair is performed and no mesh is involved. This experience has been confirmed by other pelvic floor surgeons. The benefit (“pros”) of using mesh is to lower the failure rate to less than 10%. The “cons” of using mesh are the risks associated with its use, namely exposure of the material into the vaginal cavity called an erosion (approximately 1-5% of the time) and pain during intercourse (2-3% of patients). These complications can be treated and resolved in most all patients with office based or outpatient surgery interventions or vaginal wall physical therapy. A complication of not using mesh and performing a traditional suture repair of your own tissue is a 30-40% failure rate requiring another more difficult (because of scar tissue from the first failed surgery) prolapse surgery and pelvic reconstruction.

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 (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 might feel a “scratchy sensation” with penetration. This happens in only 3% of the cases when I 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. In addition, a small percentage (2-3%) of women experience mesh contracture over time and can have vaginal pain and pain with intercourse. Mesh contracture often responds to vaginal wall physical therapy and local injections of pain medication. If these treatments fail, an outpatient surgery to release and possibly remove the area of the contracted mesh may need to be performed.

If surgical mesh is to be used, how often have you implanted this particular product?

I have implanted hundreds polypropylene meshes since 2001.

What results have your other patients had with this product?

I have been using implanted transvaginal mesh in various forms over that past 10 years. The most common risks of mesh placement include exposure of mesh material called erosion (about 3% of the time to date in my practice), and/or pain with intercourse (in about 2-3% of patients). Although complications can occur with any surgery, the overwhelming majority of my patients have reported that they are very satisfied with the results.

What can I expect to feel after surgery and for how long?

You can expect to “feel” 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. I also 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 pre-operatively. This will vary from patient to patient.

Which specific side effects should I report to you after the surgery?

Please notify me with fever or bleeding more than a menstrual period. Pain that is not relieved by medications, difficulty with urination or defecation should be reported. Other symptoms in the future I would want you to report would be vaginal discharge, spotting, pain or irritative symptoms you or your 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 you to determine “why”. Functional improvement in the lower urinary tract or rectum does not always occur after anatomical correction of prolapse (surgery). Occasionally, 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?

I am one of the most experienced surgeons in mesh surgery for pelvic organ prolapse in the region. I will treat any complications you may have. I do care for women referred to me from other doctors with mesh 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?

I occasionally have to “revise” a surgical mesh by either releasing the tension or excising a small exposed area. I have never had to “remove’ an entire mesh that I have placed. Having to remove an entire mesh would increase the chances of recurrent prolapse.

If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?

Yes, I will provide the product information to all patients at the time of consultation and/or consent for surgery.