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Transvaginal Mesh Complications

Pelvic Organ Prolapse

Approximately one in three women over the age of 60 will experience pelvic organ prolapse, which occurs when the weakness or damage to the pelvic floor muscles and connective tissue causes one or more of the pelvic organs to sag into or through the vaginal opening. Pelvic organ prolapse occurs when the supporting structures of the pelvis give way, allowing organs such as the bladder, uterus, or rectum to sag or bulge into the vagina.

Pelvic organ prolapse repair surgery can be performed through either the abdomen or the vagina with transvaginal mesh. To be specific, the common types of repair surgery include abdominal sacrocolpopexy, in which the surgeon attaches the prolapsed organ to nearby ligaments or bones; vaginal colpocleisis, in which the surgeon removes excess tissue and closes off the vagina; and transvaginal placement of a surgical mesh, which reinforcing stitches or a synthetic mesh to support the prolapsed pelvic organs.

While these options are all available, unfortunately the transvaginal mesh procedure has become increasingly popular in recent years. The Transvaginal mesh material is a type of synthetic netting that is implanted through the vagina in order to provide support for the prolapsed organs.

And although transvaginal placement of a surgical mesh is associated with a greater risk for POP mesh complications than other surgical options, there is no indication that it offers any greater clinical benefit for women electing to undergo pelvic organ prolapse repair surgery. On July 13, 2011, the FDA issued a warning that patients undergoing pelvic organ prolapse repair with a transvaginal mesh may be at a greater risk for mesh complications than women pursuing other surgical treatments. Women should discuss all surgical options with their doctor prior to electing to undergo pelvic organ prolapse repair surgery so that they can make an informed decision about which type of surgery is best for them. Because the manufacturers of transvaginal meshes failed to warn patients and doctors about this increased risk, women suffering mesh complications may be able to file a claim seeking compensation for medical bills, pain and suffering and other damages.

The Transvaginal Mesh Complications

There are a number of complications associated with the use of transvaginal meshes to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). One such complication is erosion of the mesh. This can occur when the mesh becomes embedded in the surrounding tissues, causing inflammation and pain. In some cases, the mesh may even perforate the vaginal wall or other organs.

Infection is another potential complication of transvaginal mesh surgery. This can occur when bacteria from the vagina or other sources contaminate the mesh, causing an infection to develop. Infections may be localized, affecting only the area around the mesh, or they may be more widespread. Treatment for a transvaginal mesh infection may include antibiotics, surgical removal of the infected tissue, or, in severe cases, removal of the entire mesh. These complications can be serious and potentially life-threatening. As such, it is important to be aware of them before undergoing transvaginal mesh surgery.

Among the vaginal mesh complications reported by women who underwent pelvic organ prolapse repair surgery with a transvaginal mesh, including mesh erosion, infection, and bleeding. Other complications include pain during sex, urinary problems, contraction or shortening of the vagina, discomfort, vaginal scarring, and bowel, bladder, and blood vessel perforation.

While sometimes complications can be treated with medication or additional surgeries, others can be more serious and may require long-term care with painful side effects. In some cases, the vaginal mesh will need to be removed in order to relieve the symptoms.

FDA Alerts the Public

In 2008, the FDA released a safety communication which announced that they had received over 1000 reports of complications associated with transvaginal mesh in the past three years. The FDA claimed that the placement of surgical mesh to treat POP and stress urinary incontinence can result in a number of serious complications, including organ damage, infection, and pelvic pain.

Since the release of the safety communication, the number of mesh complications reported to the FDA has increased exponentially; from 2008 to 2010, FDA received over 1500 reports of mesh complications from pelvic organ prolapse surgery alone. This is five times as many reports as they had received between 2005 to 2007. The FDA’s stance on transvaginal mesh complications is clear: these meshes are dangerous and should not be used in any surgical procedure.

In 2019, the FDA ordered mesh manufacturers to stop selling devices for transvaginal repair of pelvic organ prolapse in the United States. The FDA’s decision was based on a review of available evidence, which showed that the risks of surgical mesh placed transvaginally to treat POP outweigh the benefits. The FDA will continue to monitor the safety of these devices in women who have already received transvaginal mesh for POP repair. The FDA’s decision is correct, as transvaginal mesh is a dangerous and unnecessary medical device. Given the risks and lack of efficacy, it is clear that transvaginal mesh should never have been used for treatment. The FDA’s decision will protect women from unnecessary harm and should be lauded as a victory for patient safety.

In Brief

Transvaginal mesh surgery to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) has been linked to a number of serious complications, including infection, pain, and organ perforation. It is important for women who have undergone pelvic organ prolapse repair surgery with transvaginal mesh to be aware of potential complications that may arise. In 2019, the FDA ordered mesh manufacturers to stop selling devices for transvaginal repair of pelvic organ prolapse in the United States due to the risks associated with using these meshes. Women who have already received transvaginal mesh for POP repair should consult with their doctor if they experience any of the reported complications. 

If you or someone you love has received corrective surgery for transvaginal mesh complications or is having to live with the complications, legal redress and significant settlements are a very realistic possibility. You are invited to complete the settlement forms and submit an application for review by a leading transvaginal mesh lawyer.