An FDA decision to recall one option in treating a pelvic floor disorder left some women confused. But many others have already filed lawsuits.
In 2019, the regulating agency stopped sales of surgical mesh devices indicated for transvaginal repair of pelvic organ prolapse. In this condition, the pelvic organs fall downward and bulge into the vagina.
The FDA said manufacturers of the recalled surgical mesh devices used for the specific surgery failed to demonstrate the safety and effectiveness of the products.
However, many other similar mesh devices used for other surgeries and other conditions remain on the market.
As a result, thousands of women have filed a transvaginal mesh lawsuit against the manufacturers of these devices. Patients claim that the devices caused serious complications and other adverse effects.
What is Transvaginal Mesh?
Transvaginal mesh is a net-like medical device used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). In POP repair, the device reinforces a weakened vaginal wall. On the other hand, in SUI repair, it supports the urethra or bladder neck.
It is called “transvaginal” mesh because doctors implant the device in a surgical procedure through the vagina.
Transvaginal mesh products are very similar to the surgical mesh originally used to repair hernias. These hernia meshes were approved through the FDA’s 510(k) process, which is a fast-track program that can rush products into the market minus the significant testing and costly studies. All manufacturers had to do is to prove that the device is substantially equal to another device that’s already on the market.
In this case, transvaginal mesh products made hernia mesh devices their point of comparison to get a nod from the FDA. However, these surgical meshes from where transvaginal mesh devices evolved are just as problematic.
Unsurprisingly, transvaginal mesh implants have also caused several complications. They include erosion, organ perforation, and infections, among others.
The Use of Transvaginal Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence
In 1996, the FDA approved the first pelvic mesh for stress urinary incontinence (SUI). Meanwhile, in 2002, the first mesh for transvaginal repair of pelvic organ prolapse (POP) got a nod from the agency.
Doctors often rely on transvaginal mesh if non-surgical treatment options were unsuccessful.
Pelvic Organ Prolapse
This condition occurs when pelvic floor muscles weaken, causing one or more of the organs in the pelvis to move out of place and bulge into the vagina.
Pelvic organs involved in a prolapse may include the bladder, womb (uterus), urethra, and the top of the vagina. Some risk factors that may increase one’s chance of developing POP include:
- increasing age
- prolonged labor
- one or more pregnancies and vaginal births
This condition most commonly affects the bladder. Two surgical procedures use mesh to treat POP:
- Transvaginal mesh in treating pelvic organ prolapse. In this procedure, the surgeon makes a cut or an incision in the vaginal wall. He or she then proceeds to pull the loose or damaged tissue in the area, then the surgical mesh is implanted to reinforce the wall of the vagina.
- Transabdominal mesh in treating pelvic organ prolapse. This procedure is done by making a small incision in the abdomen, where the mesh is inserted to support organs.
Overall, the idea behind these surgeries is that tissue will grow into the holes of the mesh to create a wall of support.
Stress Urinary Incontinence
In stress urinary incontinence (SUI), moments of physical activity that put increased pressure on the abdomen can cause leakage of urine. These activities may include coughing, laughing, sneezing, or exercising.
A weakened bladder sphincter muscle mainly causes this condition. The bladder sphincter muscle provides muscle control for the flow of urine. But as with POP, it can also be due to factors such as childbirth, aging, and pregnancy.
To treat stress urinary incontinence, a midurethral sling or mesh sling procedure is often performed.
- Midurethral sling procedure. In this surgery, a surgeon uses strips of synthetic mesh to create a sling or “hammock” which will be placed under the urethra to support it and keep it closed.
Why are women filing lawsuits?
It is important to note that the FDA only halted the sale of mesh devices used for the transvaginal repair of pelvic organ prolapse. This means that devices like transabdominal mesh used for POP repair and the bladder sling or midurethral sling used to treat SUI are still on the market.
According to the FDA, it ordered to stop the distribution of transvaginal mesh devices indicated for POP repair because the procedure is riskier and the company did not find enough evidence that its benefits outweigh its potential risks.
As of 2019, the FDA has received 69,000 reports of adverse events related to POP mesh devices. These reports include:
- 64,600 injuries
- 393 patient deaths
Moreover, a survey of 2,220 women who had pelvic mesh devices implanted to treat their stress urinary incontinence and pelvic organ prolapse seems to back these reports up.
In the survey, 59% of the women said that the mesh surgery did not resolve the health issue for which they got the implant. The other 58% said they were left having pain during intercourse.
However, seeing as the FDA only focused on stopping the distribution of transvaginal mesh for POP, many other surgical mesh implants remain on the market.
And as mesh became more widely used for pelvic floor surgeries, more women also came forward to share stories of complications and side effects. In 2016, the FDA classified transvaginal mesh as a high-risk, Class III device.
Adverse Events and Complications
Compared to other treatments for POP and SUI, transvaginal mesh surgery is less invasive. This means that it can be performed through tiny incisions instead of a large opening. Despite this fact, however, it still has a higher complication rate.
A growing body of evidence even suggests that aside from higher complication rates, it also has a lower efficacy rate.
Between Jan. 1, 2008, and Dec. 31, 2010, the FDA said it received a total of 2,874 reports of injury, death, malfunctions, and other complications related to transvaginal mesh implants.
There have been serious adverse events following transvaginal mesh implantation in women. These include:
One of the main concerns with transvaginal mesh devices has been mesh erosion. Also known as extrusion or protrusion, this problem occurs when the mesh wears through the tissues and ultimately forces its way into the vagina, bladder, or other organs.
This serious adverse event can require multiple surgeries to correct. But in some cases, the damage from erosion can be permanent, causing continued pain for the patient even after its removal.
When a transvaginal mesh erodes, it can perforate or puncture other organs. One of the most serious complications of transvaginal mesh repair is the perforation of organs. This adverse event significantly increases the risk for infection and organ damage.
Transvaginal mesh complications may require corrective surgery to repair. However, as with other surgeries, revision surgery also has its own risks. In some cases, multiple surgeries may even be necessary to correct the damage. This almost always means an increased risk of scarring, infection, and excessive bleeding.
Other potentially debilitating effects caused by transvaginal mesh devices include:
- Urinary tract infections
- Scarring of the vaginal wall
- Nerve damage
- Emotional trauma because of the multiple surgeries, pain, and potentially permanent damage patients have to go through
What You Can Do
If you were recently implanted with a transvaginal mesh device and are experiencing problems, you have an option to fight for your rights by holding abusive manufacturers accountable. Filing a transvaginal mesh lawsuit today may very well be your first step to seeking justice.