Transvaginal Mesh Lawsuit

Transvaginal mesh products were presented as an effective treatment for stress urinary incontinence and pelvic organ prolapse (POP), but unfortunately pelvic mesh has been linked to dangerous complications that could give rise to as many as 50,000+ transvaginal mesh lawsuits.  The FDA has issued several public safety notices regarding vaginal mesh side effects, and plaintiffs have already been awarded millions in damages based on mesh injuries.

For patients whose doctors used surgical mesh in medical procedures, it is important to understand the dangers and to know your legal rights. An experienced product liability lawyer can help victims determine their eligibility for filing a claim and holding manufacturers accountable.

Why are transvaginal mesh lawsuits being filed?

Lawsuits are being filed because patients believe that mesh manufacturers failed to live up to obligations.  Manufacturers of medical devices must ensure that their products are safe, that they are designed and tested properly, and that they do not cause harm when used as intended.

Women who file a vaginal mesh lawsuit allege the defendants are liable for:

• Negligence
• Fraud
• Design defects
• Failure to test and inspect the product
• Strict liability
• Failure to warn of vaginal mesh side complications

Unfortunately, evidence indicates that many manufacturers did little testing before they put mesh products on the market. Manufacturers were able to do this because the surgical mesh was brought to market under a special FDA rule that allows for expedited clearance.

The FDA allows for a fast-tracked approval under its 510(k) clearance program if there is an existing medical device already on the market that is similar. Because various types of surgical mesh had already been approved, manufacturers were not required to perform clinical trials before their products were released. The outcome has been devastating, as the FDA received more than 1,000 complaints of adverse outcomes from vaginal mesh use just between 2005 and 2007 alone.

It is these patients and other women who experienced life-shattering complications after receiving vaginal mesh who are now bringing lawsuits to recover damages.

Side effects of transvaginal mesh

Any woman who experiences unexpected side effects as a direct result of pelvic mesh problems may have grounds to file a vaginal mesh lawsuit.

Some of the different types of complications that women are reporting that have given rise to claims include:

• Erosion of the vaginal mesh
• Perforation of the bladder or other pelvic organs
• Chronic pain, especially discomfort during sex
• Pain in the abdomen
• Vaginal scarring or abnormal vaginal bleeding
• Recurrent pelvic organ prolapse (POP)
• Urinary incontinence
• Infection

Often, the only way to reduce or treat complications from mesh is for additional surgical procedures to remove the product from the body. This is not a simple procedure, especially in cases where there has been erosion of the surgical mesh into the vaginal walls or when the mesh has penetrated pelvic organs.

Multiple revision surgeries may be required, which can be painful, costly and dangerous. The surgery can cause its own complications and side effects, including permanent organ damage and scarring.  Even when surgery is performed, there is also no guarantee of complete recovery and many women continue to experience debilitating problems.

Holding mesh manufacturers accountable

Women who wish to hold manufacturers liable for damages will need to prove that the mesh failed to work as promised and was the direct cause of harm. Ample evidence has come to light in recent years that plaintiffs can use to help them prove that the mesh is potentially dangerous.

In fact, the FDA has issued several notices and communications highlighting surgical mesh risks. For example:

• In October of 2008, the FDA was prompted to issue a safety notice after receiving more than 1,000 complaints. Even after the initial notification of mesh complications was issued, the FDA received another 2,874 reports of adverse events between 2008 and 2010.
• In July of 2011, the FDA issued another warning, this time making clear that side effects and complications associated with transvaginal mesh are not rare as originally thought. A year later, the FDA also ordered manufacturers to conduct clinical trials in order to assess the benefits and risks of mesh products in light of mounting evidence that mesh is no more effective at treating SUI or POP than traditional treatment methods.

Although the FDA has not mandated a recall of all surgical mesh products, some manufacturers have taken action on their own. In 2012, for example, a unit of Johnson & Johnson called Ethicon took four Gynecare mesh products off the market amidst escalating vaginal mesh lawsuits.

Ongoing transvaginal mesh litigation

With the FDA warnings coupled with numerous scientific studies suggesting that as many as ten percent of women experience mesh complications within a year after their surgery, thousands of patients have already begun to take action.

Lawsuits have already been filed against:

• America Medical Systems (AMS)
• Boston Scientific
• C.R. Bard
• Coloplast
• Cook Medical
• Ethicon
• Mentor Corporation

Many of these complaints have been consolidated in transvaginal mesh multidistrict litigation (MDL), which means that multiple cases filed in different states have all been brought before one federal judge. Each plaintiff maintains an independent or separate claim, but consolidating all vaginal mesh lawsuits in an MDL allows the same judge to rule only once on certain pertinent issues relevant to all cases, instead of having to consider that issue individually for each and every case.

Six multidistrict litigations were formed in the U.S. District Court for the Southern District of West Virginia, and a seventh multidistrict litigation against Mentor Corp. has been consolidated into the U.S. District Court in the Middle District of Georgia.  The MDLs are moving forward with bellwether or test trials to give plaintiffs and defendants a better idea of the strength of their cases.

Trials, verdicts and settlements

Mesh manufacturers were dealt a blow, however, as vaginal mesh plaintiffs have already been successful in several suits.  One recent West Virginia bellwether case ended with the plaintiffs being awarded $2 million in damages from C.R. Bard, prompting the company to settle with several more claimants.

More mesh manufacturers are also reportedly in settlement negotiations and agreements could be reached to allow plaintiffs compensation without having to pursue transvaginal mesh lawsuits through a full trial to a jury verdict.

A skilled vaginal mesh lawyer can help plaintiffs negotiate out-of-court settlements or argue cases before a jury to receive full and fair compensation for their complications.

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