After a series of recent television ad campaigns, you may be asking “What is transvaginal mesh?” Recent concerns about the safety of transvaginal mesh (TVM) products have created new awareness about these surgical devices, but many women remain uninformed about this potentially fatal surgical implant.
Since the early 2000s, hundreds of thousands of women in the U.S. have had pelvic surgery involving transvaginal mesh. This net-like implant is used to hold up the muscles and tissues of the pelvic floor to correct pelvic organ prolapse and stress urinary incontinence.
Unfortunately, many women with a TVM implant have experienced severe complications. This can include pain and bleeding that may negatively impact their life even after the implant is removed. In some (much rarer) cases, these complications have resulted in death.
The U.S. Food & Drug Administration (FDA) has yet to issue a complete recall for transvaginal mesh products, although many manufacturers have discontinued their products amidst growing consumer concerns. These manufacturers have also faced lawsuits from over 100,000 women who experienced complications after receiving an implant. If complications have arisen from your vaginal mesh implant, you may be eligible to file a claim.
What Is Transvaginal Mesh Used For?
Transvaginal mesh is used to correct two common conditions: pelvic organ prolapse and stress urinary incontinence. It is estimated that 11% of American women require surgery to correct one of these conditions in their lifetime.
Transvaginal mesh implants are one treatment option that can correct pelvic organ prolapse and stress urinary incontinence. Doctors began using TVM to treat these conditions in the early 2000s, after similar mesh implants proved effective in the repair of hernias.
Pelvic Organ Prolapse (POP)
POP is a deeply uncomfortable condition that can happen to women of all ages. It occurs when the muscles and tissues that make up the pelvic floor become weakened and can no longer support the pelvic organs. As a result, the pelvic organs (including the bladder, rectum, and uterus) can drop and may bulge out of the vagina.
The most common type of POP is called cystocele. This is when the bladder descends into the vagina. The uterus may also descend (this is called a uterine prolapse). Additionally, it is possible for the rectum to bulge into the back wall of the vagina (rectocele).
A woman’s lifetime risk of developing POP is estimated at 30-50%, but only 2% of women ever show symptoms. These symptoms include:
- A bulging sensation in the vagina
- Feelings of pain or pressure in the pelvis and/or lower back
- Pain during sex
- Difficulty urinating
Stress Urinary Incontinence (SUI)
Stress urinary incontinence is caused by a weakening of the pelvic floor. This can lead to the neck of the bladder descending, preventing the urethra from properly controlling the flow of urine.
If you have SUI, you may find you experience urinary incontinence when performing activities that put pressure on your abdomen. For example, you may experience uncontrollable urine leakage when:
- Coughing or sneezing
- Lifting a heavy item
- Standing up
- Having sex
Risks of Transvaginal Mesh
Surgical procedures that included the use of transvaginal mesh were initially considered more successful than those without due to the durability of the implant and the shorter recovery period. This led to the widespread use of transvaginal mesh in pelvic surgery.
Out of 300,000 POP surgeries on female patients in the U.S. in 2010, a third involved the use of mesh (of which the majority were transvaginal). In the same year, 260,000 thousand American women had surgery for SUI, with 80% of these procedures involving transvaginal mesh.
The viability of the treatment was called into question when thousands of women experienced severe complications, including pain, bleeding, and death. Today, the FDA has classified transvaginal mesh as high-risk, and few doctors recommend its use.
Types of Transvaginal Mesh
There are four different types of transvaginal mesh products, each of which carries risk of complication. The surgeon’s understanding of the products and their individual benefits and risks can impact the outcome of the surgery.
Non-Absorbable Synthetic TVM
The most common type of TVM, non-absorbable synthetic mesh is durable and has a lower risk of infection compared to absorbable products. Non-absorbable synthetic mesh products are made from synthetic materials like plastic, with the vast majority (around 90%) being made from polypropylene.
Absorbable Synthetic TVM
Absorbable synthetic TVM products are made from absorbable materials like Vicryl or Dexon. They are designed to aid tissue growth at the implant site as they are absorbed into the body. Since absorbable TVM degrades over time, it is not used as a long-term solution.
Biological grafts are made from animal tissue (human, cow, or pig). This tissue undergoes some modification to decrease the likelihood of the host body rejecting the graft. Like absorbable synthetic mesh, this material degrades over time, and it results in fewer infections.
Composite TVM products are created from a combination of absorbable, non-absorbable and biological materials described above. They are designed to harness all the benefits of each material type, while minimizing their weaknesses.
Manufacturers and Brands of Transvaginal Mesh
A number of pharmaceutical companies have been responsible for producing and distributing vaginal mesh products. Below is a partial list of pharmaceutical companies that have produced transvaginal mesh products, and the brands they distributed.
|American Medical Systems (owned by Endo Pharmaceuticals)|
|Ethicon (a division of Johnson & Johnson)|
Some manufacturers (such as Ethicon and C. R. Bard) have ceased distribution of some or all of their mesh products as a result of lawsuits. Other products have been recalled by the FDA.
Ethicon Abbrevo Transvaginal Mesh Problems
In October 2008, the FDA released a Public Health Notification regarding significant issues from the erosion and contraction of Ethicon Abbrevo TVM products, leading to surgeries and further complications. In July 2011, the federal agency further updated that notification to warn that these complications are not rare in patients who have been fitted with transvaginal mesh. Here is a timeline of the FDA’s actions against transvaginal mesh.
Investigating the issue further, the FDA found consumer and physician reports of transvaginal mesh complications as early as 2005. In short, the agency found that the most common complication is the erosion of mesh after pelvic organ prolapse surgeries. This erosion can debilitate patients, and it frequently leads to additional required surgeries.
As a result of these problems Ethicon – a division of Johnson & Johnson – has been the subject of many lawsuits over Abbrevo transvaginal mesh products. Some have been settled with awards to the plaintiffs, but many cases are ongoing. Currently there is a pending multidistrict litigation (MDL) against Ethicon. The U.S. District Court Southern District of West Virginia is overseeing MDL 2327.