By Elizabeth Akincilar-Rummer
In May 2015 a Delaware jury ordered Boston Scientific, a medical device company, to pay a woman $100 million for pain complications following vaginal mesh placement for treatment of pelvic organ prolapse. A few months prior to that a Texas woman was awarded $73 million for similar complications. Some think that these cases are just the tip of the iceberg because many more similar cases are pending. Many companies like Johnson & Johnson have pulled some of their mesh products from the market altogether, whereas others continue to offer them.
The Offender: Mesh
Utilization of graft, traditionally a piece of living tissue that is transplanted surgically, has been used in pelvic floor reconstruction for over a century. In the beginning, grafts used in surgery to treat incontinence and prolapse were associated with a fair amount of complications. Things started to change when general surgeons began using synthetic grafts, or mesh, for hernia repairs and began getting much better outcomes. It wasn’t long before pelvic surgeons recognized the opportunity to improve their surgical outcomes and began using similar mesh products for pelvic floor conditions.
Fast forward to 1998 when the tension-free vaginal tape (TVT) mid-urethral synthetic (MUS) sling was introduced. This was a serious game changer for pelvic surgeons. Not only did it become the current gold standard for treatment of stress urinary incontinence (SUI), but it paved the way for the US FDA approval of transvaginal mesh prolapse repair. In 2010 approximately 210,000 synthetic slings were placed in the USA.2 Success rates were estimated at 51-99% for retropubic (behind the pubic bone) and transobturator (TOT) slings4-6.
Because of the success of the MUS slings, medical device marketing teams recognized a HUGE opportunity. It has been estimated that the prevalence of pelvic organ prolapse in women over 60 was 41.1%!1 Surgery for prolapse is performed twice as commonly as for continence surgery. That’s like 30 million potential patients!!! As you can imagine, transvaginal mesh ‘kits’ started coming out of the woodwork. CHA-CHING!!!!! In 2010 approximately 75,000 women underwent transvaginal mesh placement for POP.2
Unfortunately, using mesh in surgeries for both incontinence and pelvic organ prolapse had some serious repercussions.
One study reviewed the complication rates for mid-urethral synthetic (MUS) slings for urinary incontinence between 1995 and 2007, and reported 4.3 – 75.1% for retropubic slings, and 10.5 -31.3% for transobturator (TOT) MUS. The retropubic approach had a higher occurrence for bladder injury versus the TOT approach which reported more groin pain. However, pelvic pain and pain with intercourse has been reported in up to 24% following MUS slings. Another major concern after MUS surgery is urinary function. Some women report severe difficulty or inability to urinate or urinary frequency after MUS surgery. Overall, voiding dysfunction rates are estimated to be between 2.8 and 38% following a retropubic sling and 0-15.6% with the TOT approach7.
Early on, the results of transvaginal mesh looked promising for the treatment of pelvic organ prolapse (POP) in a few short-term studies. They were introduced to reduce recurrence as well as improve durability. Many companies began to market ‘mesh kits’ to simplify their placement transvaginally. However, serious complications started to emerge. Now it’s thought that the studies were not rigorous enough and many of the complications surfaced after the duration of the trial protocols.
The complications included mesh extrusion, also called erosion or exposure, as well as infection and pain. Mesh extrusion is when the mesh is exposed within the vaginal canal. The Society of Obstetrics and Gynecology of Canada reported a mesh erosion rate of 5-19%. Another study from the Society of Gynecologic Surgeons reported an erosion rate of synthetic mesh to be 10.3%. The symptoms of mesh erosion include vaginal discharge, vaginal pain, pain with intercourse, or pain experienced by the sexual partner. Pain with intercourse, or dyspareunia, has been reported at rates of up to 38% following transvaginal mesh placement8. Mesh actually causing infectious complications is relatively rare.
The Contributing Factors
It is unclear exactly what the contributing factors are of these devastating complications. Some ideas include poor surgical technique, deficient training, infection, patient factors, or an inherent defect of the synthetic material. In addition, there are still lots of unanswered questions regarding vaginal tissue, the aging process and how the mesh affects the vaginal wall healing and inflammatory responses. Other potential risk factors include concomitant hysterectomy, advanced patient age, smoking and diabetes mellitus.
What actually leads to the pain after mesh placement is likely multifactorial. It is thought to be a combination of nerve or muscle damage/entrapment and/or tension on the vagina or surrounding structures as a result of retraction (shortening) of the mesh, scarring, or chronic inflammatory response to the mesh.
The FDA’s response
Some of these complications were found to be irreversible and debilitating which lead to two FDA notifications in 2008 and 2011. In 2008 the FDA released a Public Health Notification in response to the complications related to surgical mesh. In 2011 the FDA Safety Communication stated that the complications ‘are NOT rare’ and the ‘transvaginally placed mesh in POP repairs does NOT conclusively improve clinical outcomes over traditional non-mesh repairs’. Their aim was to educate the public and healthcare providers about mesh and provide recommendations for informed decision-making. In fact, the FDA published a list of questions patients were encouraged to ask their surgeons prior to undergoing vaginal mesh placement as well as recommendations following surgery. Here’s a few examples of the pre and post mesh placement questions recommended by the FDA. You can find the complete list of the recommended questions here.
Recommended preoperative questions:
- Why do you think I am a good candidate for surgical mesh?
- What are the pros and cons of mesh in my particular case?
- How likely is it that my repair could be successfully performed without surgical mesh?
- If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
- What can I expect to feel after surgery and for how long?
- If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
Recommendations for postoperative care:
- Notify healthcare provider if you have any of the following:
- Persistent vaginal bleeding or discharge
- Pelvic or groin pain
- Pain with sex
- Post-operative pelvic floor physical therapy
- Many women with pelvic organ prolapse can benefit from pelvic floor physical therapy to improve their musculoskeletal function, decrease certain pains, and help restore normal bladder, bowel, and sexual function. Often times, pre and post-operative physical therapy is not offer to patients and it should be. Click here for more information.
For complications with a MUS sling in some women, either complete or partial removal of the sling is the only effective treatment. Removing the sling can be challenging for the surgeon and the extent of tissue damage is often unknown. Other possible treatment strategies include pelvic floor physical therapy, pain medications, and nerve blocks.
In women experiencing vaginal mesh exposure, treatment options include observation, use of topical estrogen or antiseptics, systemic or topical antibiotics, office-based trimming of the extruded material, and partial mesh excision or total mesh excision. Medical management alone with antibiotics, antiseptics and topical estrogen yield low success rates. Office-based mesh excision can be challenging due to limited visualization and discomfort for the patient. A more formal mesh excision, often a total excision, is preferred.
One study looked at 481 patients who underwent vaginal mesh revision. After mesh excision/revision surgery, 73% reported an improvement in pain, 19% experienced no change in pain, and 8% reported an increase in pain. Patients with prior chronic pelvic pain were significantly less likely to experience improvement in pain symptoms.3
Mesh excision has possible complications of its own. If the mesh was placed closer to the front of the vagina, excising it can injure the bladder or urethra. If the mesh was placed towards the back of the vagina, removing it could cause damage to the bowel.
The Mesh Hunter
Gynecologist and pelvic surgeon, Mark Conway, MD, commonly surgically excises vaginal mesh for women experiencing pelvic pain. During a brief interview, he gave us his two cents on mesh. Full disclosure, he has served as a plaintiff’s expert witness on mesh liability cases.
How do you determine who is a good candidate for surgical mesh removal?
Essentially, any patient with mesh that has pain is a potential candidate for surgical excision. However, an examination is essential. Upon vaginal exam, if palpation of the mesh causes pain, especially if it reproduces the pain the patient is complaining of, that is a good indicator that removing it would likely decrease or eliminate the pain.
How many surgical mesh removals have you performed?
What are the greatest challenges in surgically removing mesh?
It is easier to remove a completely intact mesh versus one that has been previously surgically revised. The transobturator mesh is more difficult to remove because the material is much more difficult to get to. Also concerning the TOT mesh, it can be very difficult to locate in the groin. Another challenge is removing mesh that goes through the sacrospinous ligament, as is used in some repairs for pelvic organ prolapse. Lastly, mesh can get fibrotic and adherent, essentially stuck, to the bladder, urethra and bowel, which can be challenging to remove.
What are the greatest risks involved in mesh excision?
Bleeding can be a risk because the area is so vascular. Also wound infection and damage to the urethra, bladder and/or bowel are also risks.
How often have your patients already undergone a surgical mesh removal before consulting you?
80% of the patients that come to see me have already undergone at least one surgical mesh revision, and often they are on their 3rd or 4th procedure. In fact, patients are often told that their mesh had already been removed or can’t be removed any further, yet I am almost always able to find and remove additional mesh.
Do you utilize mesh in SUI and/or POP treatment?
I do not utilize transvaginal mesh for POP. I only perform a laparoscopic approach. I don’t place midurethral slings, but I will refer patients to a urologist to have it done.
Although surgeons and clinicians are recommended to report mesh and device complications, adverse events are underreported and the reporting process can be time consuming and is completely voluntary. Until a national registry exists, recognition of device-associated complications will be further delayed and not reported in the literature, thus exposing even more patients to these risks. Until then, I encourage women to do their homework before considering a mesh placement procedure. Find a surgeon who has performed many of these procedures and utilize the FDA’s recommended list of questions before you commit to surgery.
- Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women’s Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002;186(6):1160–1166
- US Food and DRug Administration (2011) FDA safety communication: update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse 13 May 2013.
- Danford JM et al. Postoperative pain outcomes after transvaginal mesh revision. Int Urogynecol J (2015) 26:65-69.
- Serati M, Ghezzi F, Cattoni E, et al. Tension-free vaginal tape for the treatment of urodynamic stress incontinence: efficacy and adverse effects at 10-year follow up. Eur Urol 2012;61(5):939-46 17.
- Ward K, Hilton P; Group UaITT. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol 2004;190:324-31 •• First randomized controlled trial between TVT and Burch colposuspension. .
- Ogah J, Cody J, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev 2009;4:CD006375 19. B
- Kasturi S, Hale DS. “J” cut of sling for postoperative voiding dysfunction following synthetic midurethral slings. Int Urogynecol J 2011;22(8):933-6
- Bako A, Dhar R. Review of synthetic mesh-related complications in pelvic floor reconstructive surgery. Int Urogynecol J Pelvic Floor Dysfunct 2009;20(1):103-11