How to Determine If You Have a Valid Vaginal Mesh Lawsuit?

The transvaginal mesh litigation has targeted multiple manufacturers whose products have been associated with severe complications in women.

These mesh devices, initially promoted as safe and effective solutions for pelvic floor disorders, became the center of one of the largest medical device mass torts in history.

Holding Mesh Manufacturers Accountable

Several major medical device companies have faced legal action over their transvaginal mesh products, resulting in billions of dollars in settlements and verdicts.

Lawsuits have alleged that these manufacturers failed to adequately test their products before marketing them, misrepresented the safety and efficacy of the devices, and neglected to warn patients and physicians about potential risks.

Major manufacturers named in transvaginal mesh lawsuits include:

• Ethicon (Johnson & Johnson) – The Gynecare division of Ethicon faced over 40,000 lawsuits for products including the Gynecare Prolift, TVT Secur, and Gynecare Prosima systems.
• C.R. Bard – Named in thousands of lawsuits over the Avaulta Plus, Avaulta Solo, and Align Urethral Support System. Bard paid approximately $200 million to resolve claims related to their pelvic mesh products.
• Boston Scientific – Faced litigation over products including the Pinnacle Pelvic Floor Repair Kit, Obtryx Sling System, and Uphold LITE Vaginal Support System.
• American Medical Systems (AMS) – Now owned by Endo International, AMS settled claims involving their Perigee, Apogee, and Elevate implants for more than $1.6 billion.
• Coloplast – A Danish company whose products, including the Restorelle DirectFix Anterior mesh, have been named in lawsuits.
• Mentor Corporation – Before being acquired by Johnson & Johnson, Mentor produced the ObTape Vaginal Sling, which was implanted between 2003 and 2006.
• Cook Medical – Faced litigation over its Surgisis Biodesign products, which utilize biological rather than synthetic mesh materials but have still been associated with adverse events.

Recalled Vaginal Mesh Products

Only one transvaginal mesh product—Boston Scientific’s ProteGen Sling—has been officially recalled, making it a unique case in the history of mesh devices.

Most manufacturers have instead “voluntarily withdrawn” their products from the market in response to FDA actions and mounting litigation, a distinction that has significant implications for patients and the legal landscape.

The following products have been recalled or withdrawn from the market:

• ProteGen Sling (Boston Scientific) – The first FDA-cleared mesh product for stress urinary incontinence (SUI) and the only one officially recalled.
• Gynecare Products (Ethicon) – In 2012, Ethicon discontinued sales of four products worldwide: the Gynecare Prolift Kit, Gynecare Prolift + M Kit, Gynecare TVT Secur, and Gynecare Prosima Pelvic Floor Repair System Kit.
• Mentor ObTape Vaginal Sling – Withdrawn from the market in 2006 after reports of high rates of vaginal extrusion.
• Multiple Products Following FDA Reclassification – After the FDA reclassified transvaginal mesh for pelvic organ prolapse as Class III (high-risk) devices in 2016 and required premarket approval (PMA) applications, most manufacturers chose to discontinue their products rather than conduct costly clinical trials.

Additional discontinued products include the AMS Apogee and Perigee Systems, AMS Single Incision Sling System, Bard Avaulta Plus Biosynthetic Support System, Bard Avaulta Solo Support System, and Adjust TM Adjustable Single Incision Sling.

The FDA’s regulatory actions, particularly the 2019 order for manufacturers to cease selling mesh for transvaginal repair of anterior compartment prolapse, effectively ended the market for these devices, though mesh products for stress urinary incontinence and abdominal implantation for pelvic organ prolapse remain available with specific regulatory controls.

For women who have received any of these mesh products and experienced complications, understanding which specific device was implanted is crucial information when considering legal action, as different settlements and legal strategies may apply based on the manufacturer and product involved.

Our Transvaginal Mesh attorney at TruLaw is dedicated to supporting clients through the process of filing a Transvaginal Mesh lawsuit.

With extensive experience in product liability cases, Jessica Paluch-Hoerman and our partner law firms work with litigation leaders and medical experts to prove how defective mesh implants caused you harm.

TruLaw focuses on securing compensation for medical expenses, revision surgeries, pain and suffering, lost income, and other damages resulting from your transvaginal mesh injuries.

We understand the physical and emotional toll that Transvaginal Mesh complications have on your life and provide the personalized guidance you need when seeking justice.

Meet the Lead Transvaginal Mesh Attorney at TruLaw

Meet our lead Transvaginal Mesh attorney:

• Jessica Paluch-Hoerman: As founder and managing attorney of TruLaw, Jessica brings her experience in product liability and personal injury to her client-centered approach by prioritizing open communication and personalized attention with her clients. Through TruLaw and partner law firms, Jessica has helped collect over $3 billion on behalf of injured individuals across all 50 states through verdicts and negotiated settlements.

How much does hiring a Transvaginal Mesh lawyer from TruLaw cost?

At TruLaw, we believe financial concerns should never stand in the way of justice.

That’s why we operate on a contingency fee basis—with this approach, you only pay legal fees after you’ve been awarded compensation for your injuries.

If you or a loved one experienced pain, bleeding, infection, organ perforation, mesh erosion, or other complications from transvaginal mesh implants, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation and determine whether you qualify to join others in filing a Transvaginal Mesh lawsuit today.

Proving that transvaginal mesh directly caused a patient’s injuries is a main challenge in mesh litigation.

Successful vaginal mesh lawsuits must establish a clear causal link between the implanted device and subsequent health problems.

This causation element requires substantial medical documentation, expert testimony, and a detailed timeline that connects the mesh implantation to specific injuries.

Manufacturers often defend against these claims by suggesting alternative causes for symptoms or arguing that complications represent known surgical risks rather than product defects.

Medical Proof of Mesh Injuries

Building a successful vaginal mesh case requires thorough medical documentation that links the mesh product to specific injuries.

Medical records serve as the foundation of this evidence, providing objective confirmation of both the mesh implantation and resulting complications.

Key medical evidence used to establish causation includes:

• Operative reports – Surgical documentation from the original implantation procedure establishes which specific mesh product was used, its placement technique, and any complications noted during surgery.
• Pathology reports – When mesh removal or revision surgery is performed, pathology analysis of excised tissue samples can confirm mesh erosion, tissue inflammation, and adverse biological responses.
• Diagnostic imaging – Ultrasound, CT scans, and MRIs can visualize mesh migration, fixation, or erosion into adjacent organs.
• Clinical notes – Documentation of patient symptoms, physical examination findings, and physician assessments provides a chronological record of health changes following mesh implantation.

Many successful cases have combined multiple forms of medical evidence to present an overwhelming causation argument.

Timeline Considerations in a Vaginal Mesh Lawsuit

The chronological relationship between mesh implantation and the onset of complications plays a key role in establishing causation and determining legal eligibility.

A clear timeline that demonstrates the emergence of symptoms following mesh placement helps strengthen the causal connection between the device and subsequent injuries.

Important timeline factors in vaginal mesh litigation include:

• Pre-implantation health status – Documentation of a patient’s pelvic health before mesh surgery establishes a baseline for comparison.
• Latency periods – While some mesh complications appear immediately after surgery, others develop gradually over months or years.
• Symptom progression patterns – The pattern of symptom development often follows recognizable trajectories specific to mesh complications.
• Statute of limitations considerations – Legal deadlines for filing mesh claims vary by state but typically range from 1-6 years.
• Multiple revision surgeries – Many patients undergo a series of surgeries attempting to address mesh complications.
• Consistent medical opinions – Sequential medical records showing that multiple providers independently attributed symptoms to mesh complications strengthen the timeline of causation.

The strongest vaginal mesh cases include detailed timelines that demonstrate clear patterns of normal pelvic function before implantation, emergence of specific mesh-related complications within expected timeframes, progression of symptoms consistent with known mesh failure modes, and medical documentation connecting each step in this causal chain.