Transvaginal mesh is a synthetic surgical material that is implanted through the vagina to support weakened pelvic floor muscles. Transvaginal mesh devices are used in the surgical repair of pelvic organ prolapse and stress urinary incontinences.

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Pelvic organ prolapse occurs when any pelvic organ, such as the uterus or bladder, drops out of place and places pressure on the walls of the vagina. This often uncomfortable condition is the result of pelvic muscles that have weakened over time, most often due to childbirth. According to the Association for Pelvic Organ Prolapse Support, half of all women over age 50 suffer from some form of the disorder.

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According to the U.S. Food & Drug Administration (FDA), stress urinary incontinence occurs when the pelvic tissues and muscles that support the bladder and urethra become weak and allow the bladder “neck” to drop during bursts of physical activity. This descent can prevent the urethra from working properly to control the flow of urine. The condition affects an estimated 15 million adult women in the U.S, making it the most prevalent form of incontinence in women.

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Transvaginal mesh products were approved under the FDA’s 510(k) clearance protocols, which do not require that a device undergo human clinical testing if the manufacturer can show it is substantially equivalent to an already-approved product. Thus, the high rates of complications associated with transvaginal mesh were not apparent until the devices were implanted in tens of thousands of women.

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Since 2008, the FDA has issued two safety alerts to inform the public that it had received thousands of complication reports associated with the use of transvaginal mesh to treat pelvic organ prolapse and stress urinary incontinence. According to the FDA, transvaginal mesh complications related to prolapse repair can no longer be considered rare. The agency also warned that some of these injuries have resulted in hospitalization, as well as repeated surgical procedures to remove failing mesh. Even after multiple procedures, some women continued to suffer from vaginal mesh complications.

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According to the FDA, the most commonly reported vaginal mesh complications include:

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

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In September 2011, the FDA convened a panel of outside advisors to examine the safety concerns surrounding transvaginal mesh. The panel concluded that surgical mesh used to transvaginally repair pelvic organ prolapse should be reclassified as a high-risk medical device, which would make such products ineligible for 510(k) approvals. In January 2012, the FDA ordered the manufacturers of transvaginal mesh used in prolapse surgery to conduct postmarket safety studies of their products to help the agency better understand their safety profiles.

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No. Despite the serious complications associated with these products, the FDA has not issued a transvaginal mesh recall. However, calls are mounting for the agency to do so.

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As of July 2013, some 20,000 transvaginal mesh lawsuits had been filed against American Medical Systems, Inc., Boston Scientific Corp., C.R. Bard, Johnson & Johnson’s Ethicon unit and other manufacturers of transvaginal mesh products in federal multidistrict litigations underway in U.S. District Court, Southern District of West Virginia. Thousands of additional claims have been filed in state courts throughout the country.

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Yes. In July 2012, a California Superior Court jury awarded more than $5 million to a woman who was injured by C.R. Bard’s Avaulta Plus device. C.R. Bard was ordered to pay more than $3 million of the judgment, while the woman’s doctor was held responsible for the remainder. In March 2013, a New Jersey Superior Court jury awarded more than $11 million in compensatory and punitive damages to a woman injured by Ethicon’s Gynecare Prolift devices.

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No. The transvaginal mesh lawsuits currently pending in courts throughout the country allege that these products were defectively designed and manufactured. They further alleged that the medical device companies that marketed vaginal mesh concealed its risks and failed to provide adequate warnings to the public and medical community. These are not medical malpractice claims, and no doctors or other healthcare professionals are named as defendants in the lawsuits.

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By filing a vaginal mesh lawsuit, women injured by these products may be able to obtain compensation for any damages related to their injury, including:

• Medical bills
• Lost wages
• Pain and suffering
• Loss of quality of life
• Permanent disability
• Emotional distress
• Loss of Consortium for spouse

If any of the defendants named in your lawsuit are found guilty of “intentional misconduct” and “gross negligence,” you may also be entitled to punitive damages.

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Nothing. Our transvaginal mesh attorneys are offering free legal evaluations to any woman injured by one of these products.

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It will not cost you anything to file your mesh lawsuit. Bernstein Liebhard LLP is representing transvaginal mesh clients on a contingency-fee basis, which means that you will not have to pay any attorney’s fees or expenses UNLESS a recovery is made in your case. If you do receive a settlement or jury award, a portion of the recovery will be set aside for the firm’s fees, all of which is clearly spelled out in our retainer agreement.

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You should file as soon as possible. All transvaginal mesh lawsuits are governed by statutes of limitations, which only grant plaintiffs a specific amount of time in which to file a claim. Missing the deadline means you will lose your right to compensation forever. Since statutes of limitations vary by state, your vaginal mesh lawyer will immediately investigate those issues to ensure your legal rights are protected.

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Your mesh attorney will need access to your medical records, so you will need to sign a medical release. It’s also a good idea to start keeping track of any out-of-pocket expenses you incur because of your injury, including the cost of your doctor’s appointments, tests, treatments, and medications. You should also keep a record of days you missed work due to your injury and medical care.

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This can vary widely depending on the complexity of your case. But in general, it usually takes around two years to go through discovery and prep a case for trial. While many mesh lawsuits do settle out of court, this usually will not occur until a case has been readied for trial.

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Yes. Bernstein Liebhard LLP is a nationwide law firm, and our mesh attorneys are able to represent clients in all 50 states.

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Bernstein Liebhard LLP is representing hundreds of women in vaginal mesh lawsuits, and our mesh attorneys understand the unique and sensitive nature of these cases. One of the Firm’s partners, Jeffrey S. Grand, serves on the Plaintiffs’ Steering Committees in the federal multidistrict litigations established for mesh lawsuits filed against American Medical Systems, Boston Scientific, C.R. Bard, and Ethicon. Mr. Grand also serves as Co-Liaison Counsel in two consolidated litigations underway in New Jersey for C.R. Bard and Ethicon claims, and was a member of the trial team that won more than $11 million in New Jersey’s first Ethicon mesh trial.

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If you are ready file your mesh lawsuit, please contact the vaginal mesh lawyers at Bernstein Liebhard LLP for your free, no obligation case evaluation. Since 1993, our highly experience legal team has recovered more than $3 billion on behalf of injured consumers, and they will do everything necessary to ensure you are fairly compensated. To find out more, simply pick up the phone and call our office today, at .

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