Transvaginal Mesh FAQs

Published on July 29, 2013 by Laurie Villanueva

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If you or a woman you care about experienced the horrific complications associated with transvaginal mesh, the attorneys at Bernstein Liebhard LLP are here to help you file a transvaginal mesh lawsuit. Please read on for answers to our most Frequently Asked Questions regarding side effects, revision surgeries and the firm’s involvement in the ongoing litigation involving this class of devices.

What is Transvaginal Mesh Used For?

Transvaginal mesh, which is used to treat pelvic organ prolapse (POP) and stress urinary incontinence, (SUI) is surgically implanted into a woman’s vaginal wall to support pelvic floor muscles that may have weakened over time.

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What is Pelvic Organ Prolapse (POP)?

This condition occurs when the uterus, bladder or any other pelvic organ drops out of place and puts pressure on the vaginal walls. Nearly half of all women over age 50 suffer from some form of this disorder, according to the Association for Pelvic Organ Prolapse Support.

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What Causes Stress Urinary Incontinence (SUI)?

Stress urinary incontinence (SUI) occurs when pelvic tissues and muscles that support the urethra and bladder allow the bladder “neck” to weaken and drop during bouts of physical activity. As a result, the urethra may not work properly to prevent the flow of urine. Approximately 15 million adult women in the U.S. are affected by this condition, making it the most common form of incontinence in women.

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How Were Transvaginal Mesh Implants Approved By the FDA?

Transvaginal mesh products were approved under the U.S. Food and Drug Administration (FDA)’s 510(k) clearance process, which allows a product to bypass clinical testing if its manufacturer can prove it is equivalent to one already on the market. Transvaginal mesh is manufactured by companies including C.R. Bard Inc., American Medical Systems, Johnson & Johnson’s Ethicon division and Boston Scientific.

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What Are the Safety Concerns Surrounding Transvaginal Mesh?

The FDA has issued two public health alerts involving the safety of transvaginal mesh since 2008. Both of these warnings were prompted by thousands of adverse event reports filed by women who experienced pain, swelling and other injuries after being implanted with one of these devices. In 2011, the FDA classified the frequency of tranvaginal mesh injuries to occur as “not-rare,” which was an upgrade from the agency’s original stance in 2008 in which the possibility was categorized as “rare.” In many reports of vaginal mesh complications, women claim multiple revision surgeries are often necessary to remove the mesh.

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What Are Considered Vaginal Mesh Complications?

According to adverse event reports filed with the U.S. Food and Drug Administration (FDA), the most common side effects of transvaginal mesh include:

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

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What Actions Have Been Taken By the FDA?

In September 2011, a panel of outside advisors was convened by the FDA to look at safety concerns involving transvaginal mesh. The panel concluded that the devices should be reclassified as a high-risk medical device used to repair pelvic organ prolapse, thus making them ineligible to participate in the agency’s 510(k) approval process. In January 2012, the FDA ordered transvaginal mesh manufacturers to conduct post-market safety studies of their products as a requirement to continue to selling them.

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How Many Women Have Filed Vaginal Mesh Lawsuits?

The number of cases involving this class of devices has grown at a rapid rate. In July 2013, court records showed an estimated 20,000 vaginal mesh lawsuits pending in separate federal litigations (MDL) underway in the U.S. District Court, Southern District of West Virginia. Thousands of additional claims have been filed in state proceedings throughout the U.S. as well.

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Does Filing a Mesh Lawsuit Mean I Am Suing My Doctor?

No, it does not. The transvaginal mesh cases that have been filed in federal and state courts in the U.S. allege the devices were defectively designed by the manufacturer, who failed to conceal their risks to women and their doctors. These are not medical malpractice claims.

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If I Decide to Pursue a Claim, How Much Will I Have to Pay One of Bernstein Liebhard LLP’s Lawyers?

You pay nothing. Our transvaginal mesh lawyers are currently offering confidential case evaluations to any women who may have been injured as a result of transvaginal mesh.

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What Type of Compensation Might I Receive as a Victim of Transvaginal Mesh Complications?

Women allegedly injured by transvaginal mesh may be eligible to receive compensation for any damages related to:

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

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How Soon Should I File My Transvaginal Mesh Lawsuit?

You should take the first steps in filing your claim as soon as possible. All vaginal mesh lawsuits in the U.S. are governed by statute of limitation laws administered by each state, which allows a Plaintiff to bring their case within a certain amount of time. If you miss that deadline, your opportunity to pursue a transvaginal mesh lawsuit will be forfeited. Our lawyers will be happy to investigate your state’s statute of limitation laws.

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What Information Will My Mesh Lawyer Need?

Start keeping track of any out-of-pocket medical expenses you have incurred as a result of your injury, including costs of doctor’s appointments, tests, medications and treatments. You should also keep records of times absent from work caused by your injury and medical care. Additionally, your mesh lawyer will need access to your medical records, so you will need to sign a medical release.

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I see Bernstein Liebhard LLP is located in New York City. Are your mesh lawyers handling lawsuits across the U.S.?

Yes. Bernstein Liebhard LLP is a nationwide law firm, and represents clients in all 50 states.

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

At Bernstein Liebhard LLP, our mesh lawyers understand how unique and sensitive these cases are. That’s why our Firm takes a hands-on approach to all cases we are involved in to better serve our clients. Bernstein Liebhard LLP partner, Jeffrey S. Grand, is currently serving on the Plaintiffs’ Steering Committees in the federal multidistrict litigations created for mesh lawsuits involving products from Boston Scientific, American Medical Systems C.R. Bard, and Ethicon. Mr. Grand was also a member of the trial team that won over $11 million in the first Ethicon mesh trial in New Jersey.

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I’m Ready to File My Claim. What Should My First Steps Be?

Please contact the transvaginal mesh lawyers at Bernstein Liebhard LLP to receive a confidential case evaluation. Our highly experienced legal team has recovered more than $3 billion on behalf of injured individuals since 1993, and will do their best to obtain compensation on your behalf. Call our office today for more information at .

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