About 200,000 inpatient surgical operations are done annually in the United States for pelvic organ prolapse (POP), making it one of the most prevalent reasons for women to undergo pelvic reconstructive surgery and some pelvic mesh removal surgery.
There has been a rise in synthetic mesh slings and biological mesh use in transvaginal prolapse surgery during the last several years. Pre-packaged mesh delivery systems, sometimes known as “mesh kits,” are now widely accessible on the market.
Many women speak out about the devastating effects of most surgical mesh issues on their quality of life. The FDA released a safety statement in 2011 warning that transvaginal mesh usage may raise the risk of problems without improving women’s quality of life.
Infection, discomfort, urinary issues, vaginal scarring, weakened vaginal walls, and recurrence of prolapse or incontinence were listed as the most common consequences in the FDA statement. The Food and Drug Administration also noted that erosion may occur when the mesh separates from the weakened vaginal wall and spreads into the surrounding tissue and organs. When erosion causes the exposed mesh to protrude from the vagina, it is also known as extrusion or mesh exposure.
When used to treat pelvic organ prolapse or treat stress urinary incontinence only, transvaginal prolapse repair is intended to be a long-term solution. However, mesh implants have several mesh complications. Many women need numerous procedures to remove the mesh entirely, and the first pelvic floor disorder operation is often quite invasive.
Can pelvic mesh be removed?
Symptoms experienced by women with transvaginal mesh implants might originate either from the surgical removal process or the mesh itself. Transvaginal mesh removal surgery aims to remove all visible remnants of the mesh and restore any damaged tissue.
If the mesh causes significant difficulties, further surgery is required to fix the initial prolapse or stress incontinence.
The kind of mesh or mesh kit utilized during the first procedure may also affect how much mesh the surgeon may remove.
What are the complications of pelvic mesh removal surgery?
It may be challenging to remove transvaginal mesh surgically, and doing so may raise a woman’s risk of problems or new symptoms. Vaginal mesh removal is a sensitive therapeutic procedure that differs from case to case and woman to woman due to the tissue that grows in and around the transvaginal mesh over time.
Removal and repair of transvaginal mesh implants are types of revision surgery. Manufacturers intended these medical devices to be permanent, making complete mesh removal surgery difficult and frequently more painful than the original mesh surgical treatment.
What is the success rate of mesh removal?
Due to the complexity of corrective surgery, doctors are cautious about recommending alterations. Removing mesh or mesh sling is a laborious, uncomfortable operation. A trained surgeon must remove pieces of tiny mesh that have merged with adjacent organs and tissues. The total disappearance of symptoms cannot be assumed without a surgical procedure.
115 women who underwent revision surgery for issues such as uncomfortable sex, pain, discomfort around their pubic bone, and vaginal erosion were surveyed. They reported their results in the March 2017 edition of the American Journal of Obstetrics & Gynecology. Forty-three women filled out the surveys. Only 51% of the women found the changes to be an improvement.
The health of 233 women who had the mesh removed surgically was examined in a 2015 research published in the International Urogynecology Journal. The research found that 73% of patients experienced pain reduction.
In other cases, the risks associated with removing the mesh prevent most patients and the surgeon from doing so.
What is the nightmare of mesh removal?
Revision surgery depends on the kind of synthetic mesh implanted and the severity of the mesh problem. The number of operations required to remove mesh often depends on the type of mesh employed. Some of the women who have sued mesh manufacturers have had more than ten procedures to get the mesh removed.
Patients still have to cope with pelvic pain, prolapse, or incontinence once the mesh implant is removed. There are times when things are far worse. Inflammatory reactions may persist even after surgeons remove the mesh.
Using grafts or other tissues, surgeons may attempt to repair eroded tissues. After removing the mesh, surgeons may utilize the omentum, a wide flap of tissue that hangs from the stomach, to create repairs, as documented in a case study published in Reviews in Urology.
Transvaginal Mesh: 6 Things Women Should Know
- Female pelvic reconstructive surgery using mesh was developed to treat (SUI) stress urinary incontinence and pelvic organ prolapse, common issues for women following hysterectomy, menopause, and delivery. When a woman’s pelvic muscles become too weak, pelvic organs, including the bladder, rectum, and uterus, may prolapse into the vagina.
- While transvaginal and vaginal mesh procedures were developed to aid women with these pelvic floor disorders, not all are risk-free and dependable.
- Some products caused significant complications such as infection, vaginal tissue erosion, and organ perforation.
- Transvaginal mesh surgery has a greater complication risk than other therapies for pelvic organ prolapse and stress urinary incontinence while being less intrusive and less complicated.
- According to the FDA, over 4,000 transvaginal mesh-related problems had been reported to the agency by 2011. Almost 20,000 lawsuits were brought by women who were hurt by transvaginal mesh kits or after having it implanted and experiencing difficulties.
- Revision surgery is used to fix serious problems, including mesh erosion and organ perforation. Synthetic surgical mesh is notoriously difficult to remove since it was developed to be permanent. The mesh causes serious complications when blood arteries and tissues develop around it, necessitating many surgeries to remove it.
FDA ban on transvaginal mesh: What does it mean for women facing pelvic organ prolapse?
In 1996, the first mesh product, the ProteGen Sling, was approved by the U.S. Food and Drug Administration to treat SUI. About three years later, Boston Scientific issued a recall on the product.
However, the FDA approved several variations on the ProteGen Sling design before it was taken off the market.
After reclassifying surgical mesh for some transvaginal repairs as “high-risk” medical devices, the FDA has issued safety notifications, established advisory groups, and even forced manufacturers to cease selling the product during the last decade.
As a result of adverse effects such as vaginal mesh erosion, organ perforation, and infection, more than 100,000 women have filed claims against the producers of the transvaginal mesh products.
While other mesh producers have stopped making mesh altogether, those companies have issued no recalls.
Effective March 26, 2019, transvaginal placement of surgical mesh devices cannot be used to treat pelvic floor disorders. The FDA reiterated the dangers associated with transvaginal implantation of surgical mesh for treating POP in October 2022.