Transvaginal Mesh Information

Transvaginal Mesh has been used to treat stress urinary incontinence and pelvic organ prolapse in hundreds of thousands of women.  More than 200,000 women undergo surgery to repair POP each year, and another 135,000 will undergo a surgical procedure to correct SUI.  Many women who trusted their doctors to perform surgeries that would correct their problems and allow them to return to normal functioning have instead suffered severe pain and injuries, often beyond repair.  These women face multiple corrective surgeries, oftentimes without any relief.

Lawsuits to compensate women who have suffered injuries due to Transvaginal Mesh are underway.  Let us help you recover the compensation you are entitled to—Call us to speak directly to an attorney who can help you explore your legal options.

What is it?

Transvaginal Mesh (TVM) is a type of surgical mesh, similar to a woven fabric.  It is used to treat stress urinary incontinence and pelvic organ prolapse.

Pelvic organ prolapse occurs when the muscles and tissue that support the pelvic organs become stretched, damaged, or weakened, thereby causing the organs they support to sag and drop into the vagina.  The pelvic organs include the bladder, cervix, uterus, small intestines, urethra, and rectum.

These different prolapses go by different names:

• Bladder:  Cystocele

• Small Bowel:  Entrocele

• Rectum:  Rectocele

• Vagina:  Vaginal Vault

Each pelvic organ prolapse case is different, and has a different cause, including:

• Vaginal delivery
• Aging
• Hysterectomy or prior pelvic surgery
• Menopause
• Intense physical activity
• Obesity
• Family history
• Chronic straining or coughing
• Constipation

Oftentimes there are no symptoms of pelvic organ prolapse, but when women do experience symptoms, they include:

• A feeling of heaviness in the pelvic area
• Pelvic pressure that worsens with activity
• Problems inserting tampons
• Pain during intercourse
• A bulge in the vagina
• Urinary incontinence (leakage of urine)
• Difficulty having a bowel movement
• Pulling or aching feeling in the lower abdomen or pelvis

While some instances of pelvic organ prolapse are dealt with through lifestyle changes or observation, others are serious enough to require surgery.  This is when TVM may be used instead of traditional stitches.

What makes Transvaginal Mesh so dangerous?

TVM was marketed as a more effective alternative to stitches, claiming a higher success rate for surgeries.  But the results have been anything but successful.  The following is a list of the most common complications:

Mesh Erosion

Erosion of TVM occurs when the mesh pulls away from the vaginal wall and into the surrounding organs.  It may even shift so far as to protrude out of the vagina itself.  When this occurs it is called extrusion or exposure.

This is a serious condition that can result in the following:

• Damage to the bladder, urethra, or vaginal wall
• Perforation of the bowels
• Abscesses
• Intense Pain

Surgical exploration may be necessary to get a complete picture of the damage the mesh has done.  Because it is a permanent implant, even the multiple surgeries that follow may not correct the issues.

The FDA itself states that mesh erosion is the most commonly and consistently reported complication of TVM, and that “Mesh erosion can require multiple surgeries to repair and can be debilitating for some women.  In some cases, even multiple surgeries will not resolve the complication.”

Mesh Contraction

Contraction occurs when the mesh contracts or shrinks after being implanted.  Symptoms of this condition are vaginal shortening, vaginal tightening, and vaginal pain.  It may also require multiple surgeries to address.  It can also result in serious pain for both partners during sexual intercourse.

Other Serious Complications

• Pain, infection, and bleeding
• Dyspareunia, or pain during intercourse
• Organ perforation
• Urinary problems
• Recurrent prolapse
• Neuro-muscular problems
• Vaginal scarring and shrinkage

What does the FDA say?

Despite the fact that thousands of women continue to suffer as a result of TVM, the FDA has yet to recall the product, and surgeons may continue to use the product in surgeries.  But due to the massive number of complaints that the FDA was receiving, it undertook a systematic review of the scientific literature to evaluate whether or not TVM was safe and effective.  The review revealed the following:

• When surgical mesh is used in pelvic organ prolapse surgeries, the patient is subjected to additional risks that she would not be at risk for if traditional stitches were used
• Transvaginal placement of mesh leads to higher problem rates than mesh placed abdominally
• Most transvaginal mesh surgeries provide no additional benefit to traditional surgeries
• Even when the transvaginal surgical repair provides better anatomic results, the patient may still suffer more serious and painful symptoms

The FDA has noted a five-fold increase in deaths, injuries, or malfunctions tied to vaginal mesh for prolapsed organs, leading to an advisory panel pushing the FDA to classify transvaginal mesh as a high-risk device needing human testing.

Who manufactures TVM?

• C.R.Bard
• Gynecare
• Ethicon
• Mentor Corp
• Johnson & Johnson
• Tyco Covidien
• American Medical System
• Boston Scientific
• Avaulta
• Sofradim
• Uretex

The simple kits that doctors receive to perform these surgeries include a piece of pre-cut mesh and disposable surgical tools, but are priced at over $2000.  With hundreds of thousands of women undergoing this surgery, the pharmaceutical companies who manufacture these products profit while the patients become another set of victims.