Transvaginal Mesh Slings for Stress Urinary Incontinence

Single-Incision Mini-Arc Transvaginal Mesh Slings for Stress Urinary Incontinence: Understanding the Complications & Differences with Other Sling Types

 

bladder sling complications

 

Stress urinary incontinence (SUI) is a common condition, particularly among women, where one experiences the involuntary leakage of urine during physical activities such as coughing, sneezing, lifting, or exercising. Stress incontinence happens when movement or activity pressures the bladder, causing urine to leak. It can have a significant impact on a person’s quality of life and can make regular household tasks much more difficult. One of the most widely used surgical treatments for SUI is the insertion of a sling to support the urethra. In this blog, we explore the complications associated with single-incision mini-arc slings and compare them with other types of slings, such as mid-urethral slings, both retropubic and transobturator.

 

Understanding Stress Urinary Incontinence (SUI)

SUI occurs when the muscles and tissues surrounding the urethra, the tube that carries urine from the bladder to outside the body, are weakened. The bladder expands as it fills, and this increases the chances of leaking for those with SUI. This condition in women is often a result of childbirth but may also be due to surgery, menopause, or other factors that affect the pelvic floor. Stress incontinence may be alleviated or improved through pelvic floor exercises and lifestyle changes, but surgery is one of the most common forms of addressing the issue. Slings are designed to support the urethra, preventing leakage during physical activities. However, some who undergo sling implant surgery may experience complications afterward. If you had a mesh device implanted and experience pain or complications afterward you should contact an experienced transvaginal mesh attorney like Tom Plouff of Plouff Law Offices, PC, to discuss further.

 

bladder sling complications

 

Types of Slings for SUI

  1. Mid-Urethral Slings (MUS)

Mid-urethral slings (or tape), which are sometimes inaccurately referred to as transvaginal mesh slings, are the most commonly used slings for the surgical treatment of stress urinary incontinence in women. The treatment is an outpatient procedure and is regarded as less invasive. It involves the placement of a synthetic mesh tape under the urethra to support the surrounding muscles and ligaments. The two primary approaches for mid-urethral slings are retropubic and transobturator.

  • Retropubic Slings: These slings, also sometimes inaccurately referred to as transvaginal mesh slings, are inserted through an incision in the vaginal wall and positioned behind the pubic bone. The two ends of the sling are then passed through two small incisions in the lower abdomen. The abdomen is normally stitched closed afterward with sutures. One of the well-known retropubic slings is the Gynecare TVT (Tension-Free Vaginal Tape), made by Ethicon/Johnson & Johnson.
  • Transobturator Slings: These slings, also sometimes inaccurately referred to as transvaginal mesh slings, are inserted through an incision in the vaginal wall and positioned through the obturator foramen, which is part of the pelvic floor. The difference between this method and the previous one is in how your surgeon reaches the urethra to place the tape. The sling is then passed through two small incisions in the inner thigh or groin area to position it correctly. A commonly used transobturator sling is the Gynecare TOT (Transobturator Tape), also designed and sold by Ethicon/Johnson & Johnson.

 

bladder sling complications

 

Pictured above is the Gynecare TVT Sling designed by Ethicon.

 

  1. Single-Incision Mini-Arc Slings (SIMS)

Single-incision mini-arc slings, also sometimes inaccurately referred to as transvaginal mesh slings, are a newer type of sling designed to treat stress urinary incontinence. They were created to be less invasive than the previous two methods, requiring only a single incision in the vaginal wall, with no incisions in the abdomen or thigh. The mini-arc slings are typically anchored to the surrounding tissue. A few well-known single-incision mini-arc slings are the Solyx,  manufactured by Boston Scientific, and the Altis Single-Incision Sling from Coloplast.

 

bladder sling complications

Pictured above is the Coloplast Altis Single Incision Sling.

 

Comparing Single-Incision Mini-Arc Slings with Mid-Urethral Slings at a Glance

When comparing single-incision mini-arc slings with mid-urethral slings (retropubic and transobturator), there are several factors to consider:

  • Invasiveness: Single-incision mini-arc slings are designed to be less invasive, with a single incision in the vaginal wall. This contrasts with retropubic slings, which require incisions in the lower abdomen, and transobturator slings, which require incisions in the inner thigh.
  • Complications: Both types of slings carry risks of complications. While single-incision mini-arc slings may have a lower risk of certain complications due to their less invasive nature, they may also have unique complications, such as sling migration and instability.
  • In November 2022 a study titled, “Management of Post-Operative Urinary Incontinence After Midurethral Sling Explanation for Pelvic or Perineal Pain,” concluded that after a sling revision surgery for chronic pelvic pain, post-operative urinary incontinence may happen in 58.4% of patients but only 40% of the patients with chronic pelvic pain had the revision surgery, and those who did have revision surgery had a low risk of pain recurrence and a high rate of urinary continence.
  • In a 2006 study, “Anatomical Path of the Tension-Free Vaginal Tape: Reassessing Current Teachings,” the authors examined 24 unembalmed cadavers following placement of miduretheral slings and found that in 25% of the cadavers the sling passed lateral to the arcus tendineus and perforated the pubococcygeus muscle and in the remaining 75% the sling passed medial to the arcus tendineus and penetrated the periurethral connective tissue. Depending on the degree of deviation lateral to the arcus tendineus fascia pelvis, the pubococcygeus part of the levator ani muscles was perforated in 25% of the cadavers. Perforation of these muscles may be clinically significant if there is resultant levator spasm and later worse pain or voiding dysfunction.
  • Efficacy: Mid-urethral slings, especially retropubic slings, have a longer track record of success in treating SUI. Single-incision mini arc slings, while promising, may not have the same level of efficacy in terms of long-term success rates.

 

bladder sling complications

See the above 3D model of how the Coloplast Altis device is anchored.

 

Complications Associated with Single-Incision Mini-Arc Slings

Single-incision mini-arc slings were developed to offer a less invasive alternative to mid-urethral slings, with the goal of reducing complications and promoting faster recovery. However, like all surgical procedures, they are not without risks. A March 2022 study titled “Single-Incision Mini-Slings for Stress Urinary Incontinence in Women” published in the New England Journal of Medicine found there was a slightly higher initial success rate reported by patients implanted with mini-arc slings at 79.1% compared to patients with mid-urethral slings reporting success rates at 75.6%. Patients implanted with mini-arc slings resulted in less immediate postoperative pain, a shorter operative time, and a shorter recovery time. However, note that the study further found that women who received the mini-arc slings later experienced dyspareunia (or painful intercourse) significantly more than those with mid-urethral slings. More women who had undergone surgery for mini-arc slings reported mesh exposures and received further surgeries for mesh-related adverse events such as persistent urinary incontinence at higher rates than their counterparts with mid-urethral slings.

Here are some of the complications that have been reported with single-incision mini-arc slings:

  1. Erosion and Mesh Exposure

One of the significant complications with single-incision mini-arc slings is erosion or mesh exposure. This occurs when the synthetic mesh material used in the sling erodes through the vaginal wall or other surrounding tissues, leading to pain, infection, and, sometimes, urinary or vaginal fistulae. A December 2022 study titled “Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT” found that patients implanted with mini-arc slings experienced tape and mesh exposure at higher rates than those who had received other mid-urethral slings. The study further discovered that patients with mini-arc slings also experienced slightly higher levels of groin and thigh pain at 15 months post-operation.

  1. Pain and Discomfort

Patients who have undergone single-incision mini-arc sling surgery have reported chronic pelvic pain, dyspareunia (painful intercourse), sexual impairment, nerve injuries, and pain during urination. Studies have found that dyspareunia was more common in women who underwent surgery for a single-incision mini-arc sling. This pain may be due to improper placement or tension of the sling.

  1. Sling Migration and Instability

In some cases, the single-incision mini-arc sling may migrate or become unstable, resulting in recurrent stress urinary incontinence. This can occur if the sling fails to anchor properly to the surrounding tissue. The migration of slings can sometimes erode through the vaginal wall and cause dyspareunia, painful sex.  These complications often require further surgery to correct.  When someone has needed additional surgery after the implant of transvaginal mesh to deal with complications such as migration or erosion, it would be a good idea to speak with an experienced mesh attorney like Tom Plouff of Plouff Law Offices.

 

bladder sling complications

 

  1. Infection and Hematoma

Surgical procedures such as these involving slings carry the risk of infection and hematoma (a collection of blood outside the blood vessels). This risk is present with all sling types, including single-incision mini-arc slings. Issues like these often result in devastating complications which may occur years after the original procedure.

  1. Urinary Retention and Obstruction

Single-incision mini-arc slings can lead to de novo urinary symptoms such as urinary retention (difficulty urinating), or obstructions like a urethral blockage, requiring catheterization or additional surgery to correct the problem.

  1. Nerve and Vascular Injury

Although rare, nerve and vascular injury can occur during the insertion of single-incision mini-arc slings. This can lead to significant complications, including nerve pain or bleeding. Even in the hands of a skilled surgeon complications such as these could result in life-altering consequences for women who undergo the procedure.

bladder sling complications

 

Conclusion

While some may be helped by single-incision mini-arc slings to treat stress urinary incontinence, eventually, many women suffer life-changing complications. All surgical procedures carry risks; however, these slings have been shown to result in serious complications, including erosion, pain, exposure, infection, and sling migration. It is essential for patients and healthcare providers to carefully consider the benefits and risks of different sling types and to choose the most appropriate treatment based on individual circumstances. Further research and long-term studies are needed to assess the true efficacy and safety of single-incision mini-arc slings in comparison with traditional mid-urethral slings. If you believe you have been harmed by the implanting of a mesh device, you are encouraged to contact an experienced mesh attorney like Tom Plouff in Chicago, IL of Plouff Law Offices, PC, to discuss if you have a potential case and if there is any legal remedy available.

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