Vaginal Mesh FAQs

Published on June 25, 2013 by Sandy Liebhard

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If you were injured by a pelvic mesh implant, you don’t have to wait for a recall to start the process of filing a transvaginal mesh lawsuit. Simply call the attorneys at Bernstein Liebhard LLP to learn more, and find answers below to our most Frequently Asked Questions regarding side effects, revision surgeries, and the growing litigation involving these devices in the U.S.

What is Transvaginal Mesh Used For?

Transvaginal mesh belongs to a class of devices used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. The implant is surgically attached to a woman’s vaginal wall to support muscles on the pelvic floor that may have weakened with time, and oftentimes childbirth.

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How was Transvaginal Mesh Approved by the FDA?

Transvaginal mesh implants on the market today were approved through the U.S. Food and Drug Administration (FDA)’s 510(k) process, which allows for a product to sidestep human testing if its maker can prove it to be equivalent to one that was already approved. It is noteworthy to add that many devices now involved in thousands of transvaginal mesh lawsuits were modeled after Boston Scientific’s ProtoGen implant, which was recalled in 1999.

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What Are the FDA’s Concerns About Transvaginal Mesh?

The medical community’s concerns about the dangers of transvaginal mesh have been fueled by a growing number of lawsuits filed in the U.S. by women who allegedly sustained injuries. Thousands of adverse event reports alleging mesh erosion, vaginal scarring, perforated organs, urinary problems and other side effects have also been filed with the agency. In light of this information, the FDA has issued two public health alerts. The first was announced in 2008 and categorized the risk for vaginal mesh complications as “rare,” which was followed by a second warning in 2011 that classified the potential as “not rare.”

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What Are Some Complications Associated with Transvaginal Mesh?

The FDA has identified the following transvaginal mesh complications as the most common:

  • Mesh erosion (also called exposure, extrusion or protrusion)
  • Chronic pelvic pain
  • Recurrence of pelvic organ prolapse (POP) or stress urinary incontinence (SUI)
  • Scarring
  • Mesh shrinkage
  • Urinary problems
  • Perforated organs
  • Chronic Infections
  • Bleeding
  • Urinary problems
  • Sexual dysfunction, including pain during intercourse
  • Emotional problems
  • Neuromuscular problems
  • Chronic discharge
  • Damage to blood vessels and/or tissue

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What Action Has the FDA Taken to Address The Frequency of Transvaginal Mesh Complications?

In addition to the public health alerts the agency issued in 2008 and 2011, officials organized a Safety Communication in 2011 that brought together a panel of outside advisors to discuss the matter. The panel concluded that transvaginal mesh devices should be reclassified as Class III, indicating that they are high-risk. In January 2012, the FDA ordered 33 manufacturers to produce post-market safety information on their products in order to keep selling them.

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How Many Vaginal Mesh Lawsuits Have Been Filed?

According to documents released this summer, some 20,000 transvaginal mesh lawsuits were pending in separate federal litigations underway in the U.S. District Court, Southern District of West Virginia. These cases have been filed over products manufactured by C.R. Bard, Ethicon, American Medical Systems and Boston Scientific. In state proceedings established in the U.S., hundreds of claims have also been filed.

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How Much Will it Cost to Pursue a Vaginal Mesh Lawsuit?

When you file a transvaginal mesh lawsuit with Bernstein Liebhard LLP, you pay nothing unless a recovery is made on your behalf. The Firm is currently inviting anyone who may have been injured as a result of these devices to call today for a free and confidential case review.

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When Should I Start the Process of Filing a Claim?

The answer is right away, given your state’s statute of limitation laws, which dictate how long a potential plaintiff has to come forward in filing their case. In some U.S. states, the statute of limitations is dependent on when the individual’s injuries began to manifest, while others base it on when the connection was made between the injury and the cause (in this case, a transvaginal mesh implant). If you are not sure which category your case falls under, our lawyers will be happy to investigate the matter on your behalf.

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What Information Will My Transvaginal Mesh Lawyer Need?

Be sure to keep track of medical records and any other out-of-pocket expenses related to your injury. This may include testing, treatment, appointment costs or medications you were prescribed. You should also keep times of the times you were absent from work due to treatment. After you sign a medical release with one of our vaginal mesh attorneys, we can further access your records.

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Why Should I Hire Bernstein Liebhard LLP to Handle My Transvaginal Mesh Lawsuit?

Our Firm understands the emotional and physical ramifications these kinds of injuries can bestow upon a woman’s life, and how overwhelming this situation can be. That’s why our vaginal mesh lawyers take an active approach to all cases we are involved in. As a result, we believe our clients are better served. On a broader scale, Bernstein Liebhard LLP is present in various state and federal litigations currently pending in the U.S. Firm partner, Jeffrey S. Grand is currently serving on the Plaintiffs’ Steering Committees in four separate federal litigations that have been established in the Southern District of West Virginia, which are currently handling suits over products by American Medical Systems, Boston Scientific, C.R. Bard, and Johnson & Johnson’s Ethicon.

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What Should My First Step Be in Filing a Claim?

The first thing you need to do is call a transvaginal mesh lawyer at Bernstein Liebhard LLP. Since 1993, our legal team has recovered more than $3 million behalf of our clients. Call us today to start the process of receiving the compensation you deserve at .

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