Urgogynaecological mesh, also commonly known as transvaginal mesh is used to treat bladder leaks in women that occur while they participate in low to high impact activities such as, jogging or weight lifting, or when they have sudden abdominal contractions from a cough or sneeze. Around 20% of post menopausal women are affected by this issue. This can be an extremely uncomfortable situation and mesh surgery was thought to have a low complication rate.
Another common use for mesh is for patients suffering from pelvic organ prolapse. This can affect up to 50% of women who have given birth and occurs when the bladder (or other organ) shifts or “sags” out of place. This can happen when the pelvic muscles and ligaments have become weak or damaged.
There are many complications that mesh has been a solution for. The most common are listed below:
- Pelvic Prolapse – This occurs when the ligaments or muscles in the pelvic area become weak or damaged due to childbirth or hormonal issues as a result of menopause. The muscles and ligaments loose their elasticity and do not hold in the surrounding organs properly. Damage to these muscles and ligaments can also come from stress heavy activity such as lifting weights.
- Uterine Prolapse – This occurs when the ligaments, muscles and tissue in your pelvis becomes weak. It can cause complications within the bladder or rectum causing them to fail.
The most common treatment for these complications has been vaginal mesh repair. A net-like implant is inserted into the pelvic area to support the weakened muscles and ligaments and hold the organs in place. The mesh is normally sutured in place or placed with a tissue fixation device.
While symptoms can be slight, pelvic organ prolapse and uterine prolapse can be debilitating and make it hard to complete every day tasks from going to the bathroom, to walking up stairs. It can also make it extremely difficult to urinate or have sex. For women with these symptoms, a specialist normally will recommend transvaginal mesh surgery.
How Does it Work?
Transvaginal mesh is a net-like implant device that comes in a number of different forms. Different manufacturers use different shapes such as the sling, tape, mesh, ribbon, and hammock. The aim of all of these devices is to give lasting and permanent support to the pelvic area to make sure that the organs are held in place. The surgery is usually performed by inserting the device through the vagina or the abdomen (transabdominal). The surgery is performed with the idea that the sutures and tissue fixation devices are temporary and the implant will be further secured by tissue that grows into place and supports the device.
When Was it Discovered?
The original device, called TVT (trasvaginal tape) has been used in the US, Europe and Australia since the early 2000’s. Clinical trials showed the advantages of these devices over traditional surgery procedures. The traditional surgical solution was a long process with an extended recovery time. There were also a number of complications with the procedure. In contrast, a typical TVT procedure only took 30 minutes and the patient is released the same day. Because of the success of TVT for incontinence, doctors were confident that it would work for pelvic prolapses as well. Unfortunately this was not thoroughly tested and by 2010, 25% of prolapse interventions were treated with TVM.
What is the Controversy?
There are growing concerns that the efficacy of TVM or TVT treatment for pelvic organ prolapse is extremely low and carries a much higher complication rate than expected. Studies conducted in the United Kingdom have shown that 1 in every 15 women that has a TVM or TVT implant, when used to treat prolapse, has to have it removed. The complications have been so extensive, that there have been many class action lawsuits brought to fruition to compensate patients. The US Food and Drug Administration released a reclassification for TVM implants in 2012, referring to them as “high-risk devices”.
What Are the Complications?
Once of the most common symptoms experienced by TVM patients is exposure or erosion. This happens then the mesh pokes through the vaginal wall, or even cuts away tissue in the pelvic region. This leads to the formation of fistulas, vaginal scarring, painful sex, back, leg and pelvic pain. These complications can occur years after the surgery and can become extremely difficult to treat. Another common symptom is shifting. This is when the mesh shifts and can press up against organs potentially having extremely painful effects. Because this mesh is designed to be permanent and become embedded into the surrounding tissue, surgical removal can be risky and painful. Mesh removal surgeries can sometimes take hours and can present significant risk to the patient.
What Are the Mesh Brands?
The two most common brands of mesh that are deemed to be faulty are Bard and Ethicon. These two types of TVM implants have been the focus of numerous mass tort lawsuits in recent years.
Should I be Worried?
Many women that have undergone TVM or TVT surgery are unlikely to have any complications. If you have had the treatment to treat prolapse and you are experiencing unusual pain or discomfort, we recommend reaching out to your doctor immediately. Your doctor or specialist can then discuss things such as complication rates, surgery and surgery complications for you to make an informed decision on whether to have the mesh removed or not. If you are suffering from complications related to a faulty mesh implant, we also recommend seeking the advice of an attorney. As mentioned above, the FDA has warned the public about the risk of these devices, and the manufacturers need to be held accountable.
Since 2012, women who have sued companies over transvaginal mesh received at least 20 verdicts in state and federal courts with a total of about $300mm. The FDA has shut down completely the sales of the mesh in the United States back in April 2019 after tens of thousands of women have filed lawsuits against mesh manufacturers. We would like to note that throughout these lawsuits, injured patients recurred to pre-settlement funding companies for an advance from their settlements due to the injuries and loss of income helping them to overcome the financial chaos these lawsuits brought upon innocent victims.
Information supplied by Baker Street Funding, a litigation funding company designed to strategically connect select legal funding opportunities with an extensive network of sophisticated partners and staff.