Transvaginal Mesh 101
Transvaginal mesh is a surgical mesh typically made from polypropylene, a type of plastic. It’s referred to as “transvaginal” because the mesh is implanted through the vagina. Thousands of women have had this mesh implanted to correct certain health issues, but complications with the mesh and the procedure have sparked lawsuits and controversy that has the public questioning the safety of this mesh.
Who Is It For?
A mesh implant may be recommended for women experiencing stress urinary incontinence and pelvic organ prolapse. These two conditions are common after childbirth, a hysterectomy and menopause.
Why Is It Prescribed?
Surgical mesh is not a new concept. Designed to correct abdominal hernias in the 1950s, surgical mesh was used to patch the abdominal wall. The mesh was a successful treatment for hernias, and doctors began searching for new applications for the product. In the 1970s, surgeons began using the mesh to treat pelvic organ prolapse (POP) by inserting it abdominally.
In 1996, the FDA approved the very first vaginal mesh product for the treatment of urinary incontinence, and in 2002, the first vaginal mesh implant product would be approved for the treatment of POP. Stress urinary incontinence and POP are the two conditions that transvaginal mesh is typically prescribed for, but it may also be prescribed for pelvic floor disorder.
Treating Pelvic Organ Prolapse
Pelvic organ prolapse occurs when the pelvic muscles weaken to the point where the uterus, bladder and rectum descend into the vagina. Vaginal childbirth can put women at a greater risk for this condition. In fact, a woman is eight times more likely to develop POP after giving just two vaginal births.
Symptoms of POP include:
- Lower backache
- Bleeding or spotting
- Stretching or pulling sensation in the groin
- Feeling bloated in the lower abdominal region
It’s not just childbirth that puts women at risk for POP. Other causes include:
- Chronic cough
- Spinal cord injury
- Multiple sclerosis
- Muscular dystrophy
Doctors can test for POP through a cotton swab test, pelvic floor strength test or bladder function test. In the early stages of this condition, doctors may be able to diagnose the condition using an X-Ray, MRI, cystoscopy, colonoscopy or an ultrasound.
To treat this condition, surgeons place the pelvic mesh underneath the descended organs. The mesh creates a hammock-like structure that helps keep the organs in their proper place. Once the mesh is in place, it’s anchored to ligaments or muscles using sutures or other medical devices. In time, the tissues will grow and fill the pores of the mesh, making it more stable.
Treating Stress Urinary Incontinence
Stress urinary incontinence (SUI) occurs when the bladder becomes stressed by normal, everyday activities, like laughing or sneezing. This causes the bladder to leak urine. SUI is another condition that is commonly seen in women who have given one or more vaginal births.
To diagnose this condition, the doctor may give a rectal or pelvic exam. In addition, the doctor may also use the following tests to determine whether or not SUI is the root cause of the leakage.
- Urinary stress test
- Blood work
To treat this condition, a mesh sling can be used to keep the neck of the bladder and the urethra closed to stop the leakage.
Vaginal Mesh Complications
Surgical mesh can be inserted abdominally, but vaginal insertion is a quicker, less invasive option. In 2010, 208,000 women had a vaginal mesh implanted to treat incontinence, while 75,000 received the implant to treat POP.
Transvaginal mesh implants are not without complications, and many of these complications are serious and difficult to fix.
Complications and side effects of vaginal mesh implants include:
- Nerve damage
- Severe pelvic or genital pain
- Recurrence of incontinence or prolapse
- Vaginal scarring
- Mesh degradation
- Autoimmune and neuro-muscular problems
- Vaginal shortening
- Vaginal bleeding
- Urinary retention
- Pain during sexual intercourse
- Blood in the urine or stool
- Vaginal discharge
This extensive list includes some alarming side effects, but the two most severe complications are organ perarfotion and mesh erosion.
Many of the complications on this list can occur with any pelvic reconstructive surgery. However, mesh erosion is a side effect that is unique to the surgical mesh product. Erosion occurs when the mesh moves through the wall of the vagina and in some cases, the surrounding organs.
This movement can cause:
- Severe pain
- Damage to the bowel or bladder
- A recto-vaginal fistula
If these complications occur, the patient is forced to undergo additional surgeries to repair the damage and remove the device.
Organ perforation is an unfortunate risk associated with transvaginal mesh implants. This occurs when the coarse edges of the mesh actually puncture nearby organs or the vagina.
A 2013 study compared the effects of transvaginal mesh and colporrhaphy procedures. Researchers found that women who opted for the surgical mesh procedure experienced:
- 5% rate of bladder perforation
- 2% rate of additional surgeries to repair erosion
- 3% rate of recurring stress urinary incontinence
In 2008, the FDA issued a warning to surgeons about the complications associated with transvaginal mesh after receiving more than 1,000 reports of problems between 2005 and 2007. The FDA issued a second warning in 2011 after the reports of complications amassed to 2,874.
Between 2008 and 2010, seven deaths were reported to be associated with the mesh after being used to repair POP. Three of those deaths were related to the placement procedure of the mesh.
When complications are experienced, revision surgery is often necessary to repair the damage, replace the mesh or remove it completely. Repair or removal of the mesh can be a very complex process that may involve multiple procedures.
In some cases, particularly with women who have POP, removing the mesh is the only option. But removing the mesh is not a simple process, and can take three or more surgeries to remove it completely. Some women undergo seven or more surgeries.
Not only is the removal of the mesh time consuming and incredibly complex, it’s also very painful. The procedure is one that requires the hand of an extremely skilled surgeon. The surgeon’s job is to remove the fine pieces of mesh that may have attached to nearby tissues and organs.
Because the vaginal mesh procedure is considered permanent, complete removal may not be possible. Even if the mesh is successfully removed, a small number of women may still experience complications.
The complications associated with these mesh implants is concerning, but there may be recourse for patients who have experienced severe and debilitating complications.
Transvaginal Mesh Lawsuit
To date, more than 49,000 federal lawsuits have been filed against seven of the mesh manufacturers. The majority of lawsuits target two manufacturers, one of which has already paid out $54.5 million to settle a number of cases outside of court. To settle 400 cases, another manufacturer has paid $16 million.
Many individual woman have also been awarded damages ranging from two to eleven million dollars. On the highest end of the spectrum, the woman who was awarded 11 million in damages had to undergo 18 surgeries to correct the complications associated with the implant.
Women who have experienced complications may be able to obtain compensation for:
- The cost of medical care – including the cost of additional surgeries.
- Loss of quality of life
- Lost wages
- Pain and suffering
Settlements and Verdicts
Jury verdicts often sway in the favor of the victims of vaginal mesh complications. As a result, manufacturers are more likely to settle the case outside of the courtroom.
The case against manufacturer C.R. Bard, Inc. went to trail in July of 2013 and featured damaging evidence of internal company memos and several hours of video from a former company executive. The evidence was more than enough to convince the jury that C.R. Bard, Inc. did not test its mesh product properly or use reasonable care when creating the implant. Out of the $2 million verdict, $250,000 was awarded as compensatory damages, and $1.75 million as punitive damages.
This is just one of many cases where jury verdicts were in favor of the plaintiff, and more targeted mesh manufacturers are settling their cases before they have a chance to go to trial.
Although thousands of lawsuits have been filed, there are still numerous other women that have experienced complications, but have yet to come forward and seek recourse. Women who have had vaginal mesh implants should take steps to determine whether or not their implant has been recalled.