Mesh Recall Lawsuit | Get the Right Lawyer

If you or a loved one experienced pelvic organ prolapse, stress urinary incontinence, or severe complications following transvaginal mesh implantation, you may be entitled to pursue compensation.

At Schmidt & Clark, we are dedicated to helping individuals who have suffered due to defective surgical mesh products. Our experienced legal team is here to guide you through the process and fight for the compensation you deserve.

Contact Schmidt & Clark today for a free, no-obligation consultation.

Transvaginal Mesh Lawsuit Overview

Transvaginal mesh lawsuits are currently being filed nationwide on behalf of women who suffered serious injuries after receiving transvaginal mesh products for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

The primary allegations against manufacturers include design defects, failure to warn about potential risks, and negligence in manufacturing these devices.

Over 100,000 lawsuits have been filed against major manufacturers including Johnson & Johnson’s Ethicon, C.R. Bard, American Medical Systems (AMS), and Boston Scientific.

Latest Transvaginal Mesh Lawsuit Updates

• February 1, 2025 – Johnson & Johnson’s Ethicon unit has been ordered to pay a $41 million penalty in a lawsuit filed by a woman who experienced severe complications after receiving Ethicon’s Gynecare TVT. The Philadelphia jury ruled that Ethicon’s device was defectively designed and that the company was negligent in manufacturing the device.
• August 15, 2024 – A jury in Bergen County, New Jersey, has awarded $68 million ($33 million in compensatory damages and $35 million in punitive damages) to a plaintiff who claims she was severely injured by C.R. Bard’s Avaulta Solo Support System and Align Datuator Urethral Support Systems.
• June 2022 – Ethicon (a division of Johnson & Johnson) recalled the following brands of surgical mesh after the company was hit with more than 600 lawsuits over the devices: Gynemesh PS, Gynecare Prolift, Gynecare TVT, and Prolene Polypropylene Mesh Patch.
• 2021 – Several other medical device manufacturers copied the Boston Scientific Protegen design and released mesh products of their own. Due to the similarities between these products and the original Protegen sling, the FDA issued a regulation which allows products to enter the market without having to undergo rigid testing.

Related Article: Vaginal Mesh Lawyers & Lawsuits

Transvaginal Mesh Statistics

The use of surgical mesh has been associated with severe health complications, and a new study by the American Urological Association (AUA) suggests that even women who haven’t experienced complications may still be at risk for future problems.

Over 100,000 lawsuits related to transvaginal mesh products have been filed, making it one of the largest mass torts in U.S. history. According to FDA data, approximately 10% of women who receive transvaginal mesh implants experience serious complications within the first year.

The transvaginal mesh market reached $1.3 billion in sales by 2021, with over 3 million women worldwide having received these implants. Healthcare costs associated with mesh complications are estimated to exceed $1.2 billion annually.

FDA Reports and Statistics

In October 2008, the U.S. Food & Drug Administration (FDA) issued a Public Health Notification (PHN) warning physicians and patients of adverse complications linked to the transvaginal placement of surgical mesh for the repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).

Over the past several years, the FDA has received thousands of reports of injuries linked to mesh devices when used for POP but repair. These reports include complications that required additional surgery to remove or repair damaged tissues and implanted using a “minimally invasive” technique.

According to the FDA’s MAUDE database, there have been over 10,000 adverse event reports related to transvaginal mesh products between 2011 and 2023, with more than 35% requiring surgical intervention.

Related Article: Obturator Neuralgia (Symptoms & Treatment)

Transvaginal Mesh Injuries & Side Effects

Surgical mesh products have been linked to numerous severe complications that can significantly impact patients’ quality of life. The most frequent complications include:

• Erosion through vaginal epithelium: Mesh wearing through the vaginal wall causing pain and infection
• Infection: Severe infections that can lead to systemic complications
• Organ perforation/dyspareunia: Damage to surrounding organs and painful intercourse
• Urinary problems: Difficulty urinating, incontinence, or worsening of existing conditions
• Recurrence of prolapse and/or incontinence: Failure of the mesh to properly support organs
• Tissue erosion: Breakdown of surrounding tissue leading to inflammation
• Vaginal scarring: Formation of scar tissue that can cause chronic pain
• Nerve damage: Injury to surrounding nerves resulting in chronic pain

Do You Qualify for a Transvaginal Mesh Lawsuit?

You may qualify for a transvaginal mesh lawsuit if:

• You received a transvaginal mesh implant between 2002 and present
• You experienced serious side effects including erosion, infection, organ perforation, or chronic pain
• Your injuries required medical treatment, additional surgeries, or hospitalization
• You can provide medical documentation linking your injuries to the mesh implant

Evidence Required for a Transvaginal Mesh Lawsuit

To pursue a successful transvaginal mesh legal action, you will need to provide:

• Medical records documenting the mesh implant procedure
• Proof of the specific mesh product used (Ethicon TVT, Gynecare TVT, Prolene Polypropylene Mesh Patch, etc.)
• Documentation of complications and subsequent treatments
• Medical expenses related to complications
• Evidence of pain, suffering, and impact on quality of life

Damages You Can Recover

Compensation from a transvaginal mesh lawsuit may include:

• Medical expenses for past and future treatments
• Lost wages and diminished earning capacity
• Pain and suffering, both physical and emotional
• Loss of consortium and enjoyment of life
• Punitive damages against manufacturers in cases of gross negligence

Transvaginal Mesh Recall Information

There have been a total of three nationwide recalls for mesh devices since they first hit the market in 1999. Boston Scientific recalled its Protegen surgical mesh in 1999, followed by a number of injury reports. Johnson & Johnson’s Ethicon division recalled several mesh products in 2012, including Gynecare TVT.

In April 2019, the FDA ordered manufacturers to stop selling and distributing surgical mesh products intended for transvaginal repair of anterior compartment prolapse. This decision came after the FDA determined that manufacturers had not demonstrated that these devices were safe and effective for their intended use.

Statute of Limitations for Transvaginal Mesh Lawsuits

The statute of limitations for filing a transvaginal mesh lawsuit varies by state, typically ranging from 1-6 years from the date of injury or from when you discovered (or should have discovered) that your injury was caused by the mesh implant.

It’s crucial to consult with an attorney as soon as possible to ensure your claim is filed within the applicable timeframe. Some states have implemented a “discovery rule” that extends the deadline if you didn’t immediately connect your symptoms to the mesh implant.

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FAQs

1. What Are Transvaginal Mesh Lawsuits?

Transvaginal mesh lawsuits are legal actions filed against manufacturers of surgical mesh products used to treat pelvic organ prolapse and stress urinary incontinence. These lawsuits allege that the devices were defectively designed, inadequately tested, and that manufacturers failed to warn about serious risks associated with their use.

2. How Much Compensation Can I Receive From a Mesh Lawsuit?

Compensation can include medical expenses, pain and suffering, lost wages, and costs for revision surgeries. The amount varies based on the specifics of your case and the severity of complications. Recent settlements have ranged from $40,000 to multi-million dollar verdicts, with the notable $68 million award in a Bard mesh lawsuit.

3. How Successful Have Mesh Lawsuits Been in the Past?

Many mesh lawsuits have resulted in significant settlements or verdicts in favor of plaintiffs. Success depends on the evidence presented, the extent of injuries, and the strength of the legal case. Major manufacturers have paid billions in settlements, with Johnson & Johnson alone setting aside over $4 billion for mesh-related claims.

4. What Evidence Do I Need to Provide for a Mesh Lawsuit?

You will need to provide medical records, proof of the mesh implant, documentation of complications, and any related medical expenses. Your attorney can help gather and organize this evidence to build a strong case linking your injuries directly to the transvaginal mesh product.

5. How Long Does It Take to Settle a Mesh Lawsuit?

Most transvaginal mesh cases settle within 1-3 years, though some complex cases may take longer. Factors affecting timeline include the manufacturer involved, the extent of injuries, and whether the case proceeds individually or as part of multidistrict litigation.

6. Can I Still File a Lawsuit if My Mesh Was Implanted Years Ago?

Depending on your state’s statute of limitations and when you discovered your injuries were related to the mesh, you may still be eligible to file a lawsuit. Many states have “discovery rules” that extend the filing deadline if you only recently connected your symptoms to the mesh implant.

7. What Companies Manufacture Transvaginal Mesh Products?

Major manufacturers include Johnson & Johnson (Ethicon TVT, Gynecare TVT, Gynemesh PS, Prolene Polypropylene Mesh Patch), C.R. Bard (Avaulta products), American Medical Systems (SPARC), and Boston Scientific (Advantage Sling System, Obtryx products).

8. How Do I Know if My Complications Are Related to My Mesh Implant?

Common signs of mesh-related complications include pelvic pain, vaginal bleeding, painful intercourse, recurrent infections, and urinary problems. A medical professional can help determine if your symptoms are related to your mesh implant through physical examination and diagnostic tests.

See all medical device lawsuits our lawyers have taken on.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action for transvaginal mesh injuries. Most states only allow 1-3 years from the date of injury or discovery to file a lawsuit. Don’t delay in seeking the compensation you deserve.

Our experienced team of transvaginal mesh attorneys offers:

• Free, confidential consultations
• No upfront costs or fees
• Payment only if we win your case

We have significant experience in the area of defective medical devices and mesh-related injuries. Our firm has successfully represented numerous individuals injured by defective mesh products, and we are handling individual litigation nationwide.

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