Transvaginal Mesh Revision Surgery

Transvaginal mesh might have been developed with the best intentions, but the problems it can cause often result in painful and sometimes ineffective mesh removal surgery.

Transvaginal mesh is used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Women with these conditions have muscles and tissues that loosened and stretched over the years.  This may be caused by time, pregnancies or earlier surgical procedures.

The condition may be severe enough that these muscles and tissues can no longer hold up the uterus, bowel or bladder. Due to this lack of support, the organs can descend and collapse forward into the vaginal wall.

Symptoms of organ prolapse can include:

• Painful sexual intercourse
• Incontinence
• Constipation
• Pain
• Overactive bladder
• Pressure
• Organs pressing into the vagina.

If any of these complications are severe enough, surgical treatment may be an option.

Transvaginal mesh surgery

Traditionally, surgery was used for “pinching together” the affected tissues.  Sutures were used to decrease the swell. These procedures were not highly successful, so the Food and Drug Administration (FDA) approved in 2002 the first transvaginal mesh product as a treatment for POP. Several manufacturers have since marketed surgical mesh products made to treat POP and SUI.

The mesh looks like netting, and is used by surgeons to create a bandage or strap that holds organs in the pelvic area. The first surgeries involved making an incision and implanting the mesh through it.  Surgeons later developed a less invasive procedure through the vagina.  The benefit was less scarring and it was hoped it would decrease the recovery period.

This type of surgery can be successful, but can also cause great harm.

Vaginal mesh side effects can include:

• Mesh erosion through the vaginal walls
• Pain
• Infections
• Bleeding
• Painful intercourse
• Perforation of organs
• Urinary issues
• Prolapse problems returning
• Neuro-muscular issues
• Scarring or shrinkage of the vagina
• Emotional problems

The FDA stated in 2008 that it had received over a thousand complaints concerning vaginal mesh side effects. An additional 2,800 adverse event reports were sent to the FDA between January 2008 and December 2010. In July 2011, the FDA issued a warning to patients and healthcare providers of severe side effects that can happen after transvaginal mesh surgery.

The FDA published a safety communication in July 2011 warning physicians and patients that severe complications could occur after transvaginal mesh was implanted. The FDA also announced it wasn’t clear that using mesh to treat POP was more effective than traditional methods, and that it may even come with greater risk of injury to patients.

A study in the International Urogynecology Journal published in 2012 found comparable initial success rates for traditional and mesh surgeries, but complication rates with vaginal mesh were higher.

Mesh removal surgery

If the situation is serious enough, the mesh will require revision surgery. This follow up mesh removal surgery may cause more problems than the first operation.

Some women needing numerous surgeries have filed legal action against the mesh manufacturers to compensate them for what they’ve had to suffer through.

Mesh removal surgery may be very difficult and not completely successful for several reasons:

• The mesh, made of a fine material, is made to last a lifetime.
• Normally, mesh is embedded into nearby tissue.  Surgeons need to carefully cut it out, which can result in injuries to the tissue.
• The surgeon will try to avoid future complications and attempt to save tissue, which may result in some mesh fragments being left behind.

Research into revision surgery complications has found:

• Early intervention is the key to success.
• Mesh removal surgery is most beneficial to those with some types of nerve injury.
• In a study of 57 women with vaginal mesh side effects, 71 percent reported less pain or cessation of pain, though 50 percent had persistent pain and 25 percent reported painful intercourse.

Revision surgery lawsuits

Due to the serious complications resulting from transvaginal mesh, thousands of cases have been filed against mesh manufacturers. Plaintiffs allege vaginal mesh makers didn’t warn them about the chances of severe health complications, and failed to sufficiently test the mesh products prior to putting them on the market.

So many women have filed federal lawsuits that the U.S. Judicial Panel on Multidistrict Litigation has gotten involved.  All federal vaginal mesh lawsuits have been moved into seven different consolidated litigations, six of them are in the Southern District of West Virginia.

Manufacturers who have been sued include C.R. Bard, American Medical Systems, Coloplast, Boston Scientific, Ethicon, Mentor Corporation and Cook Medical.

Outcomes in some of these cases include:

• In 2012, a jury in a California state court returned a $5.5 million verdict, including $5 million for the plaintiff’s medical expenses, pain and suffering, and other damages, plus $500,000 for her husband’s loss of consortium claim. C.R. Bard was held responsible for paying $3.6 million of the verdict,
• The first federal lawsuit against mesh device maker C.R. Bard went to trial in July 2013. The jury found the defendant didn’t adequately test its Avaulta implant, didn’t use “reasonable care” in designing the implant, and caused the plaintiff’s injuries by failing to warn her doctor about Avaulta’s risks. The jury returned a verdict of $2 million against Bard, which included $250,000 in compensatory damages and $1.75 million in punitive damages because of Bard’s “conscious indifference to [the] consequences” of its conduct.
• A jury in New Jersey state court returned an $11 million verdict against Ethicon for injuries caused by its Gynecare Prolift.

Each case is unique.  A transvaginal mesh lawsuit may or may not have similar results.

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