Complications of Transvaginal Mesh Kit in the Treatment of Vaginal Prolapse

transvaginal mesh kit vaginal prolapse

When the vaginal vault (the upper part of the vagina) collapses and protrudes into the vaginal canal, this condition is known as vaginal prolapse.

Vaginal prolapse treatment options are condition specific. In many instances, medical attention is unnecessary. Your doctor may recommend pelvic floor muscle strengthening exercises for mild situations (such as kegel eggs, pictured above). Your doctor may use a vaginal pessary to support your weakened vaginal wall. Colposuspension is a minimally invasive surgical treatment in which the vaginal wall is linked to a stable ligament in the pelvis and may be helpful in the most severe situations.

The vaginal wall may be strengthened with mesh implanted by a surgeon. In some cases, a larger incision is made in the stomach, whereas in others, many smaller incisions are made. In either case, the urogynecologic surgical mesh implants may be inserted.

When the transvaginal mesh kit is inserted vaginally to correct pelvic organ prolapse, complications might arise. These issues include vaginal mesh protrusion, mesh exposure, pelvic pain, mesh erosion, and sexual discomfort. Some women have even undergone transvaginal mesh removal due to mesh-related complications.

Effectiveness of Self-cut vs. Mesh-Kit Titanium-Coated Polypropylene Mesh for Transvaginal Treatment

Self-cut mesh is as safe and effective as commercial precut mesh when treating pelvic organ prolapse after surgery. Surgical mesh implantation, either self-cut titanium-coated polypropylene mesh or precut commercial mesh kits, was randomly allocated to 336 women with severe pelvic organ prolapse (mean age 63.3 years).

At 12 months, the composite transvaginal mesh surgery success rate for both groups was 95.9% for the self-cut mesh group and 87.4% for the mesh-kit group; these rates were not statistically different. Vaginal bulge symptoms, retreatment for pelvic organ prolapse and stress urinary incontinence, and vaginal prolapse at or below the hymen were considered unsuccessful outcomes.

Some women with severe pelvic organ prolapse may benefit from self-cut mesh treatments during transvaginal placement. However, in 2019, the US Food and Drug Administration mandated that all transvaginal mesh kits be pulled from the market.

Transvaginal Mesh Kit: What Women Should Know

In pelvic mesh surgery, the surgical mesh is inserted vaginally instead of abdominally. While the surgery has been linked to significant and often disabling consequences for thousands of women, abdominal mesh surgery is generally considered a safer alternative.

The FDA issued a safety communication on transvaginal mesh implants in 2008, highlighting the risks involved. The FDA’s concerns and warnings persisted, and on January 4, 2016, the agency reclassified vaginal mesh surgery for the treatment of POP from moderate risk to high risk. Surgical mesh implants were reclassified as unsafe after they had previously been used in the bodies of hundreds of thousands of women.

Although the FDA classed surgical mesh used to repair POP as Class III high-risk devices on January 4, 2016, there have been no recalls of this product yet (update: ProteGen Sling was recalled in the late 90’s). The FDA’s highest risk classification for medical devices is Class III. 

Women who have used mesh are suing the manufacturers in the thousands. These patients have endured severe and sometimes devastating injuries, persistent agony, and, in many instances, repeated operations to cure the damage / remove the vaginal mesh implant and avoid additional harm, with different degrees of success.

The FDA warns that the hazards of transvaginal mesh may not be worth the potential advantages and urges a return to previous techniques for treating POP and SUI wherever possible. The Food and Drug Administration urges clinicians to realize POP may be effectively treated without transvaginal synthetic mesh. In addition, patients need to know whether their physicians are using mesh. Finally, patients must proactively ask questions about the need for other treatment options for prolapse.

Efficacy and safety of transvaginal mesh kits in the treatment of prolapse of the vaginal apex

According to research, the safety and effectiveness of vaginal mesh kits used in the surgical treatment of apical vaginal prolapse are not yet recognized. Excluded were reports of mesh usage for incontinence, fistula repair, or vaginal apex support that focused only on the anterior or posterior compartments.

Pelvic mesh kits have a high success rate on objective measures when used to repair apical vaginal prolapse. However, because of poor data quality and short follow-up, a rising percentage of women need surgical intervention for problems associated with mesh. More studies must be done on the effects of these interventions on the symptoms and quality of life of women who undergo them.

FDA ban on transvaginal mesh: What does it mean for women facing pelvic organ prolapse?

The FDA’s April 2019 restriction on surgical mesh devices for pelvic organ prolapse left many confused about what to use to treat pelvic organ prolapse.

Although the FDA has banned surgical mesh for pelvic organ prolapse repair, effective surgical methods for treating POP and stress urinary incontinence are still not subject to the same risks.

Some examples of other surgical procedures are:

Stress urine incontinence has been treated with bladder or vaginal slings since the 1990s, and they are still the gold standard. The sling, which may be made of synthetic mesh or human tissue, wraps around the urethra like a hammock and keeps it closed. It is an excellent choice for women concerned about “leaking,” it is inserted via a tiny incision in the vagina. Most female urology doctors and urogynecologists recommend bladder and vaginal mesh slings; the FDA has not banned them.

During abdominal or laparoscopic/robotic prolapse correction, the surgeon makes five tiny incisions in the patient’s belly and inserts a mesh or tissue-based strip to reposition the pelvic organs or damaged tissue. The FDA has determined that the mesh and its implantation into the body are safe and do not pose any serious risks.

When repairing a prolapse transvaginally utilizing the patient’s tissue, healthcare providers can lift the prolapsed organs and restore the pelvic organ support without resorting to invasive surgery.

FDA Orders Mesh Manufacturers to Stop Selling Devices for Transvaginal Mesh Kit Repair of Pelvic Organ Prolapse

Manufacturers of most surgical mesh used to treat pelvic floor disorders (Boston Scientific Uphold Lite, Boston Scientific Xenform, Coloplast Direct Fix Anterior) were told by the FDA on April 16, 2019, that they must immediately cease sales and distribution of their products while the agency reviews their premarket approval (PMA) applications.

Pelvic mesh for pelvic organ prolapse was reclassified by the FDA in 2016 from class II (low risk) to class III (high risk), and the agency found that the manufacturers, Boston Scientific and Coloplast, did not meet the premarket standard of reasonable assurance of safety and effectiveness.

Mesh Types, Manufacturers, and Brands

The following are the most common surgical mesh manufacturers and products:

  • Boston Scientific – Advantage, Advantage Fit, Obtryx, Lynx Pinnacle, Prefyx, Uphold American Solyx
  • Medical Systems – Elevate, Apogee, BioArc, Monarc, IN-Fast, MiniArc, Perigee, Sparc
  • Coloplast Corp. – Restorelle Smartmesh, Novasilk Synthetic Flat Mesh, Exair Mesh, , Aris, Minitape SlingTransobturator (TOT) Sling, Omnisure Sling, T-Sling with Centrasorb, Supris Suprapubic Sling, T-Sling with Centrasorb
  • C.R. BardInc. Pelvisoft, Pelvicol, Pelvilace, Pelvitex, Perfix Plug. Align, Avaulta Plus BioSynthetic Support System.
  • Ethicon, Inc. (Johnson & Johnson) – Prolift M, Gynemesh, TVT Retropubic System, Gynemesh PS, Prolift, TVT Abbrevo, TVT Secur – Uretex Prosima TVT, TVT-O, TVT Exact.

What Can Woman Do To Take Action on These Manufacturers?

If you have any difficulties or symptoms, such as prolonged bleeding or discharge from the vagina, discomfort in the pelvis, groin, or during intercourse, you should contact your doctor. Notifying your doctor that you have surgical mesh is essential if you need further surgery or medical intervention.

Additionally, it is critical to understand your legal rights and choices if a surgical mesh implant has harmed you. A transvaginal mesh lawyer may assist you in obtaining the restitution you are due for the injury you have incurred.

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