What Is Transvaginal Mesh?
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 (POP) and stress urinary incontinence.
Unfortunately, many women have experienced severe transvaginal mesh 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.
After proving effective in the treatment of hernias, mesh implants were brought to market for use in POP surgery in the early 2000s – despite a lack of clinicals trials or sufficient long-term data about their safety. The U.S. Food and Drug Administration (FDA) approved more than 60 vaginal mesh devices, many of which were later pulled from production amidst growing concerns from doctors and the general public. 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.
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
Transvaginal Mesh Complications
Patients have reported side effects ranging from persistent pain and recurrent infections to life-altering problems like nerve damage and organ perforation. Several deaths have also been associated with complications arising from the use of vaginal mesh.
Did you know?
From as early as 2005, reports of complications relating to vaginal mesh had been brought to the FDA’s attention. As more and more reports came to light, the agency took steps to increase public awareness of the risks of vaginal mesh implants and warn doctors against the use of mesh devices. In 2016, the FDA reclassified all transvaginal mesh devices as class III, meaning they are considered high-risk and require premarket approval.
This reclassification came too late for countless women who were unaware of the risks associated with transvaginal mesh implants. In some cases, these women were unaware they were receiving a mesh implant at all.
Risks, Side Effects, and Complications of Vaginal Mesh
A number of life-altering and potentially fatal complications and side effects are associated with transvaginal mesh implants. Some patients experience multiple or recurrent complications. Repeat surgery is often required to correct these complications, at a much higher rate than is associated with non-mesh pelvic surgeries.
Side Effects and Complications of Transvaginal Mesh Implants
- Erosion of mesh through the vaginal wall
- Organ perforation (during or after surgery)
- Dyspareunia (pain during sexual intercouse)
- Vaginal scarring
- Vaginal shrinkage
- Persistent vaginal discharge
- Blood in urine or stool
- Urinary problems
- Pelvic abscesses
- Pelvic and vaginal hematomas (abnormal swelling of clotted blood)
- Fistulas (abnormal communication between organs)
- Neuromuscular problems
- Nerve damage
Some women experience no ill effects after receiving a mesh implant. For others, a complete or partial removal of the mesh may be required to prevent further harm. This is often difficult to do and can require multiple surgeries, with no guarantee of success.
A 2011 study published in the International Urogynecology Journal found that as many as 10% of women who undergo pelvic surgery involving vaginal mesh experience complications. Of the 73 patients studied, surgery to remove some or all of the mesh helped reduce the symptoms in 92% of cases. But no improvement was evident in 8% of patients.
Transvaginal mesh surgery can result in complications like organ perforation as the mesh is being fitted. Between 2008 and 2010, there were seven recorded deaths associated with POP surgery. Of these, three were directly caused by the placement of transvaginal mesh during the procedure. It is possible that some deaths were not recorded, and may have been attributed to malfunction or some other cause.
What To Do If You Experience Side Effects
If you or someone you know is experiencing complications after receiving a vaginal mesh implant, speak to your doctor or gynecologist immediately. Left untreated, these complications may worsen, resulting in infection, severe pain, or even death.
Surgery may be required to remove the implant. Your doctor will be able to advise you about what’s best for you.
If these products have negatively impacted your quality of life, you may be eligible to file a vaginal mesh lawsuit like thousands of other women. If you have concerns, you should consult an attorney for a free legal consultation.
Alternatives to Transvaginal Mesh
If you are affected by POP or SUI, it is important to speak to your doctor as soon as possible. To learn more about the symptoms of these conditions, click here.
There are a number of alternatives to transvaginal mesh implants that can be just as effective and do not carry the same risks. Surgical alternatives include:
Transvaginal Mesh Alternatives
|Native Tissue Repair||Biological Graft|
|Instead of using mesh, this procedure uses tissues from the patient’s own body to support the pelvic floor.||This procedure uses donor tissue (typically taken from a human, cow, or pig) that has been modified so that the host body will accept them. These grafts are incorporated into the patient’s body to support the pelvic floor.|
In some cases, surgery is not required. Your doctor may recommend pelvic floor therapy (such as Kegel exercises) to strengthen the muscles and tissues that support your pelvic organs. You may also be fitted for a pessary device, a plastic device usually made from silicon that can be inserted into the vagina to support the pelvic floor. Unlike mesh, pessary devices can be removed at any time without surgical intervention.
Some lifestyle changes can help reduce the symptoms of POP and SUI. If you are a smoker, your doctor will recommend that you quit, since smoking is linked to chronic coughing that puts pressure on the abdomen. Weight loss can also help to reduce this pressure.
You have a legal right to safe medical devices. If you are concerned about transvaginal mesh, discuss your treatment options with your doctor.
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. The FDA has also issued transvaginal mesh recalls on some products.
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.
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, many women have filed vaginal mesh lawsuit claims against Ethicon – a division of Johnson & Johnson. 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.