Transvaginal Mesh Lawsuit

May 26th, 2025: FDA Proposes Reclassification of Transvaginal Mesh for POP as High-Risk

The U.S. Food and Drug Administration (FDA) announced a proposal to reclassify transvaginal mesh used for treating pelvic organ prolapse (POP) as a high-risk medical device.

If the proposal is finalized, manufacturers will be required to provide comprehensive data on the product’s safety and effectiveness before it can be marketed.

In addition to reclassifying the mesh itself, the FDA is also seeking to elevate the regulatory status of the surgical instruments used to implant and secure the mesh—from low-risk to moderate-risk—reflecting the growing concern over potential complications.

This move follows more than a decade of increasing scrutiny.

The FDA first flagged potential safety issues with vaginal mesh products in 2008 and later issued formal warnings and postmarket surveillance requirements in 2011 and 2012.

The proposed changes are now open for public comment for a 90-day period.

It’s important to note that these reclassifications apply only to mesh intended for vaginal POP repair and related tools; devices used for hernia repair, stress urinary incontinence, or abdominal POP procedures are not included in the proposal.

March 1st 2025: Ongoing Developments in Transvaginal Mesh Litigation

Background: The Rise and Fallout of Transvaginal Mesh Implants

Transvaginal mesh (TVM) implants were introduced in the late 1990s as a solution for pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Intended to reinforce weakened pelvic tissues, these devices quickly gained popularity—but over time, they became linked to serious and often debilitating complications, including chronic pelvic pain, organ perforation, bleeding, and mesh erosion.

These complications have triggered a wave of litigation against mesh manufacturers, as thousands of affected women have sought accountability and compensation.

Resolution of Federal MDLs: A Major Milestone

To manage the sheer volume of cases, many lawsuits were consolidated into multidistrict litigations (MDLs), streamlining the legal process while enabling more efficient case resolution. The final federal MDL for transvaginal mesh concluded in November 2022, with numerous claims settled during the proceedings.

However, the end of the MDL does not prevent individuals from filing personal lawsuits. Women who have experienced mesh-related injuries can still bring individual claims tailored to their specific circumstances.

Why Individual Claims Still Matter

Pursuing a separate lawsuit outside the MDL framework offers several potential advantages:

• Customized Legal Strategy: Each case can be evaluated independently, allowing for personalized legal approaches and negotiation tactics.
• Higher Compensation Potential: Individual cases are not bound by MDL settlement averages, which may lead to greater financial recovery based on the severity of the injuries.
• Greater Plaintiff Control: Those pursuing individual claims often have more input over critical decisions, such as trial participation and settlement acceptance.

The Legal Landscape in 2025

Even with many high-profile settlements behind them, manufacturers continue to face litigation. For example, Johnson & Johnson agreed to a $120 million settlement in January 2016 to resolve around 3,000 claims. Yet, many lawsuits remain active, with both federal and state courts still handling unresolved cases.

Recent Global Developments

In August 2024, 140 women in the UK received compensation for injuries linked to vaginal mesh implants. The claims targeted major manufacturers, including Johnson & Johnson, C.R. Bard, and Boston Scientific, and involved complications such as persistent pain, organ perforation, and mesh migration.

Key Considerations for Potential Plaintiffs

Women considering filing a lawsuit related to transvaginal mesh injuries should keep the following in mind:

• Statute of Limitations: Deadlines for filing vary by state and country. Prompt legal consultation is crucial to avoid missing these time-sensitive windows.
• Medical Documentation: Clear medical records linking the mesh implant to resulting health problems will strengthen a case.
• Specialized Legal Support: Working with attorneys experienced in mesh litigation can significantly improve a claimant’s chance of success.

Conclusion

Despite the closure of the federal MDL, transvaginal mesh litigation remains active and evolving. Women who continue to suffer from complications should explore their legal options, especially as new studies and settlements highlight the ongoing impact of these devices.

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February 3rd, 2025: Oregon Jury Delivers Defense Verdict in Pelvic Mesh Malpractice Case

An Oregon jury has ruled in favor of the defense in a medical malpractice lawsuit involving the implantation of a pelvic mesh device.

The plaintiff accused urologist Dr. Michael Lemmers and the Legacy Health hospital system of negligence, alleging they failed to obtain proper informed consent before implanting the Boston Scientific “Uphold Lite” mesh device during a 2019 procedure to treat pelvic organ prolapse.

The case focused on claims that the patient was not adequately informed of the potential risks associated with the device.

Informed consent cases, particularly in the context of complex medical procedures, are notoriously difficult to win, and the jury’s decision reflects that legal reality.

New Mesh Lawsuits Continue Post-MDL Closure

Despite the formal closure of the vaginal mesh multidistrict litigation (MDL), new lawsuits are still being filed in state courts across the United States.

As of late 2024, legal efforts to hold mesh manufacturers accountable remain active, though outcomes have varied.

Internationally, the issue also persists.

In August 2024, more than 100 women in England received financial settlements for serious complications resulting from mesh implants.

Reported injuries included persistent pain, perforation of the bladder and bowel, bleeding, and mesh erosion through the vaginal wall.

While exact compensation amounts were not made public, the total reached into the millions of pounds.

Study Links Mesh Material to Rapid Degradation

Adding to the growing scrutiny, a recent study from the University of Sheffield in the UK has raised new concerns about the design and material quality of vaginal and pelvic mesh implants.

Researchers found that the plastic commonly used in these devices begins to degrade within just 60 days of implantation.

The study concluded that the material—widely believed to be biocompatible—may actually be prone to early breakdown, leading to inflammation, tissue damage, and long-term health complications.

These findings lend further support to ongoing claims that many mesh implants were fundamentally flawed in both design and manufacturing.

November 1st, 2024: Study Exposes Rapid Degradation of Polypropylene in Vaginal Mesh Implants

Groundbreaking research from the University of Sheffield has revealed significant flaws in the polypropylene (PP) material commonly used in transvaginal mesh (TVM) implants.

The study found that PP begins to degrade within just 60 days of being implanted, with further structural breakdown evident by 180 days.

This degradation, marked by oxidation and the buildup of polypropylene particles in nearby tissues, challenges long-held beliefs about the material’s chemical stability.

As the mesh deteriorates, it causes a growing disconnect between the implant and surrounding tissue, which can trigger inflammation, tissue damage, and chronic pain.

These findings call into question the overall biocompatibility of PP-based mesh devices, which have already been linked to serious complications such as pelvic pain, infections, and urinary problems.

The research adds scientific weight to the ongoing debate about the safety of these implants.

In response to mounting concerns, the NHS placed strict limitations on the use of TVM in 2018, allowing procedures only under a high-surveillance protocol.

The latest study further supports the claims of many women who have filed lawsuits after suffering long-term health issues from mesh implants.

In England alone, more than 100 cases have recently been resolved through settlements.

Advocates are now calling for urgent reforms and the development of safer, more sustainable materials to prevent further harm to patients undergoing treatment for pelvic organ prolapse and stress urinary incontinence.

October 20th, 2024: New Study Reveals Polypropylene Mesh Degrades Quickly, Raising Alarms Over Vaginal Implant Safety

Recent research has revealed that polypropylene—the primary material used in transvaginal mesh (TVM) implants—begins to break down within just 60 days of being implanted in the pelvic region.

This finding intensifies ongoing concerns about the long-term safety of TVM devices, which have been used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) but are linked to a range of serious complications.

Conducted by scientists at the University of Sheffield in the UK, the study used a sheep model, chosen for its anatomical similarities to the human pelvis.

Researchers discovered that polypropylene mesh became stiffer over time, exhibited signs of oxidation, and shed microscopic particles that were absorbed into the surrounding tissue—concentrations of which increased the longer the mesh remained implanted.

These results have sparked renewed calls from patient advocates and medical professionals for urgent reform.

Campaigners argue that the material was not sufficiently evaluated for pelvic use before being introduced into clinical practice.

Sheila MacNeil, an emeritus professor in biomaterials and tissue engineering, stressed the urgent need to develop safer alternatives to prevent further patient harm.

The study’s lead author, Dr. Nicholas Farr, expressed hope that the findings will encourage manufacturers to innovate and improve implant safety.

Meanwhile, Kath Sansom, founder of the patient advocacy group Sling The Mesh, cited the study as further proof of the dangers of polypropylene mesh and called for immediate changes in how pelvic conditions are treated.

This research follows a group settlement in which over 100 women in England received compensation after experiencing debilitating side effects from TVM implants.

Reported complications include chronic pelvic pain, infections, urinary difficulties, and the need for multiple revision surgeries.

The growing body of evidence has prompted medical and legal communities alike to push for stricter oversight, improved patient education, and the exploration of non-mesh alternatives for managing POP and SUI.

October 4th, 2024: Major Breakthrough in Hernia Mesh Lawsuit as Bard Reaches Settlement

The Bard Hernia Mesh multidistrict litigation (MDL) has taken a significant step forward, with a major settlement bringing relief to thousands of affected individuals.

C.R. Bard has agreed to resolve the vast majority of claims filed in both the federal MDL and Rhode Island state court, settling more than 30,000 cases related to injuries caused by its hernia mesh products.

This marks a major conclusion to a lengthy and challenging legal battle that has been ongoing since the MDL was established in August 2018.

The litigation experienced delays due to the COVID-19 pandemic and a series of complex trials across multiple jurisdictions.

A turning point came in early 2024, when the MDL judge paused a planned bellwether trial and ordered the parties into mediation.

Following months of negotiations, the parties have now reached an agreement to compensate victims who experienced complications from Bard’s allegedly defective hernia mesh devices.

The settlement represents a substantial victory for plaintiffs and moves the litigation closer to closure for thousands of injured patients.

June 20th, 2024: Appeals Court Upholds $2.5 Million Verdict in Vaginal Mesh Case Against Coloplast

The United States Court of Appeals for the Eleventh Circuit has affirmed a lower court ruling in the case of Virginia Redding v. Coloplast Corporation, a significant decision in the ongoing litigation over vaginal mesh implants.

The appeal focused on whether Redding’s product liability claim was filed within the statute of limitations under Florida law.

Redding filed her lawsuit on September 18, 2014, asserting that vaginal mesh devices manufactured by Coloplast were defectively designed and caused her serious injuries.

Coloplast contested the suit, arguing it was time-barred due to Florida’s four-year statute of limitations for product liability claims.

The company claimed Redding began experiencing symptoms more than four years before initiating legal action.

However, the appellate court agreed with the lower court’s finding that Redding was not aware—and had no reasonable way of knowing—before September 18, 2010, that her injuries were specifically linked to the mesh implants.

As a result, the court ruled that her claim was timely.

The jury in the original trial awarded Redding $2.5 million in damages.

Coloplast’s post-trial attempt to overturn the verdict through a renewed motion for judgment as a matter of law was also denied by the district court.

This decision underscores the legal challenges involved in product liability cases, particularly around the discovery of injury and the timing of legal claims.

It also marks another notable outcome in the broader landscape of vaginal mesh litigation.

May 1st, 2024: Philadelphia Jury Awards $20 Million in Vaginal Mesh Lawsuit Against Johnson & Johnson Subsidiary

A Philadelphia jury has awarded $20 million in damages to a woman from Cinnaminson, New Jersey, who suffered severe complications from a vaginal mesh implant manufactured by Ethicon, a division of Johnson & Johnson.

The verdict, reached in late April in the Philadelphia Court of Common Pleas, concluded a three-week trial centered on the safety and performance of the TVT-Secur transvaginal mesh device.

The woman had the mesh implanted to treat stress urinary incontinence, but within two months, the device began to erode.

Despite undergoing three separate surgeries in an attempt to remove the mesh, remnants of the device remain in her body, resulting in chronic pain and ongoing urinary issues.

Jurors determined that the device failed to perform as intended and that Ethicon failed to adequately warn healthcare providers and patients about the potential risks.

The jury awarded $2.5 million to cover medical expenses and other non-economic damages.

Additionally, $17.5 million in punitive damages was granted, signaling the jury’s conclusion that Ethicon’s conduct was grossly negligent.

The TVT-Secur device, which was used to address pelvic organ prolapse and urinary incontinence, has since been recalled. However, many patients who received this and other similar mesh products continue to face serious health complications.

This case adds to a growing list of high-value verdicts against Ethicon and Johnson & Johnson over their transvaginal mesh devices, which have been the subject of ongoing litigation due to their link to painful and often irreversible injuries.

April 11, 2024: FDA Confirms SUI Mini-Slings Are as Safe and Effective as Traditional Mid-Urethral Slings

The U.S. Food and Drug Administration (FDA) has concluded its review of final reports from the mandated 522 postmarket surveillance studies on surgical mesh mini-slings used to treat stress urinary incontinence (SUI).

The findings indicate that SUI mini-slings perform as effectively as traditional mid-urethral slings over a 36-month period.

These studies revealed comparable rates and types of adverse events and re-surgery between mini-slings and traditional slings.

As part of its comprehensive evaluation, the FDA also conducted a systematic review of 30 randomized controlled trials published between 2013 and 2023.

This literature review further confirmed that mini-slings offer similar safety and efficacy outcomes when compared to conventional mid-urethral slings.

Surgical mesh slings remain a common treatment for SUI, and the FDA had previously required manufacturers to conduct long-term follow-up research specifically for mini-slings to assess their safety profile.

The newly released data reinforces confidence in the use of mini-slings as a viable option for managing SUI.

The FDA has stated it will continue to monitor these devices to ensure ongoing patient safety and optimal treatment outcomes.

March 12, 2024: Vaginal Mesh Lawsuits Continue as Women Face Ongoing Health Struggles

The legal fight over vaginal mesh implants remains active, with many women still suffering from severe and lasting complications despite widespread awareness of the risks and a surge of lawsuits against manufacturers.

Originally intended to treat urinary incontinence and pelvic organ prolapse, transvaginal mesh implants have instead caused significant harm for countless women worldwide.

Commonly reported issues include chronic pain, mesh erosion into surrounding tissue, and worsening incontinence—often more severe than the original condition.

These complications frequently require multiple revision surgeries, yet complete relief is often out of reach.

Once implanted, the mesh is difficult to remove, and many patients are left dealing with persistent symptoms and long-term medical challenges.

The scale of harm has led to extensive litigation and large financial settlements.

Both healthcare providers and manufacturers now face mounting scrutiny over their role in promoting and utilizing these implants without fully disclosing the potential dangers.

Many women have successfully pursued legal action, bringing attention to the importance of informed consent and the need to consider non-surgical alternatives before proceeding with mesh procedures.

Still, too many patients continue to endure debilitating side effects, with little warning about the possible outcomes.

For those affected, the consequences are far-reaching.

Chronic pain, urinary issues, and the emotional burden of these conditions can significantly diminish quality of life, impacting everything from daily routines to long-term physical and mental well-being.

November 14th, 2023 Vaginal Mesh Lawsuit Continues as UK Settlement Highlights Ongoing Harm

The legal battle over vaginal mesh implants remains active, with recent developments underscoring the serious complications many patients have faced.

In the United Kingdom, a woman was awarded a £1 million settlement after enduring chronic pain and persistent health problems linked to a mesh implant procedure.

Vaginal mesh devices, commonly used to address urinary incontinence and pelvic organ prolapse, have been associated with a range of adverse effects.

Patients frequently report long-term pain, mesh erosion, and the recurrence of symptoms the implants were intended to resolve.

In numerous cases, surgeries were performed prematurely or without fully exploring less invasive alternatives, resulting in preventable harm.

These outcomes have prompted a wave of lawsuits, as individuals seek accountability and compensation for the physical, emotional, and financial toll they’ve endured.

For those affected by unnecessary or mishandled mesh surgeries, legal options may be available.

Compensation can help cover medical expenses, future care, lost income, and other damages.

The growing number of settlements emphasizes the critical need for informed consent and more cautious surgical decision-making.

If you’ve experienced complications from a vaginal mesh implant, you may be eligible to pursue a claim and receive the support you deserve.

October 17, 2023: New Research Supports Safer Alternative to Traditional Vaginal Mesh Implants

Emerging scientific research is shedding light on safer materials for vaginal mesh implants, with promising findings favoring Polyvinylidene Fluoride (PVDF) over the commonly used polypropylene.

A 2023 study published in Diagnostics reports that PVDF meshes demonstrate greater biostability, trigger less inflammation, and result in reduced scarring—factors that significantly lower the risk of chronic pain following surgery.

In a three-year follow-up involving women treated for anterior or apical vaginal prolapse using PVDF meshes, 85.2% experienced successful anatomical outcomes, with few reports of complications like mesh exposure or discomfort.

Despite these advantages, PVDF meshes have yet to gain widespread use in the United States, primarily due to their higher cost compared to traditional polypropylene products.

Dr. Greg Vigna, a physician and legal advocate specializing in mid-urethral sling injuries, has voiced strong concerns about the continued reliance on polypropylene meshes in the U.S.

He urges the adoption of PVDF as a safer alternative and leads a legal team that represents women nationwide who have experienced complications from mesh implants.

June 22nd, 2023: Transvaginal Mesh Surgeries Under Scrutiny for Misinformation and Lasting Harm

Across the globe, countless women have undergone transvaginal mesh procedures without receiving full and accurate information about the risks involved—leading many to suffer severe, life-altering complications.

A recent review of transvaginal mesh case records uncovered alarming patterns in how these surgeries were communicated to patients.

The investigation, which analyzed over 40,000 pages of documentation from 18 women, revealed that poor communication and misleading consent practices left many unprepared for long-term outcomes such as chronic pain, nerve damage, and limited treatment options.

The findings exposed a troubling lack of transparency from medical professionals, resulting in widespread mistrust and inadequate post-operative care.

Many patients were not informed of alternative treatments or the potential for permanent complications.

The review called for the creation of a national registry to monitor mesh implant surgeries and removals, along with major improvements in patient aftercare, medical record-keeping, and physician-patient communication.

Widespread misinformation surrounding transvaginal mesh has caused significant physical and emotional damage.

As a result, legal challenges and public reviews continue to push for critical reforms in women’s healthcare and surgical accountability.

April 21st, 2023: Vaginal Mesh Implants Spark Legal Action and Demand for Better Care

Our Vaginal Mesh Lawyers are actively accepting clients. 

Initially introduced to treat stress urinary incontinence and pelvic organ prolapse following childbirth, vaginal mesh implants have led to widespread health complications, fueling a rise in lawsuits across the globe.

In Scotland alone, thousands of women underwent transvaginal mesh procedures before the practice was halted in 2018.

Many of these women have since reported debilitating side effects such as chronic pain, autoimmune responses, and extreme fatigue.

In many cases, the need for private treatment options has added emotional and financial strain.

To address the crisis, the Complex Mesh Surgical Service (CMSS) was created to assist affected patients.

However, numerous women have voiced frustrations with the system, citing unclear referral processes, delayed appointments, and limited awareness of mesh-related complications among general practitioners.

Some women even found themselves having to educate their own doctors about the risks and symptoms.

The severity of these complications has forced many individuals to leave their jobs and seek mesh removal surgeries—often traveling outside of Scotland for more specialized care.

As a result, a growing number of women are turning to the legal system in pursuit of justice through vaginal mesh lawsuits.

Advocates continue to call for better clinical guidance, quicker access to care, and more comprehensive treatment options to support those living with the long-term effects of mesh implants.

March 24th, 2023: Woman Sues J&J Over Vaginal Mesh Injuries Amid Global Legal Surge

Now Accepting Vaginal Mesh Lawsuit Clients

Our legal team is currently representing individuals who have suffered complications from transvaginal mesh implants.

A recent case involves a 57-year-old woman from Canada who has initiated legal action against Johnson & Johnson, alleging severe health problems resulting from a surgical mesh device manufactured by its subsidiary, Ethicon.

The mesh was implanted in 2008 following a partial hysterectomy, and according to the complaint, it later caused chronic pain and internal organ damage.

For more than a decade, the plaintiff endured worsening symptoms that severely impacted her quality of life, including her ability to work and maintain personal relationships.

In 2021, medical evaluations revealed that the mesh had disintegrated and embedded itself into her organs.

This led to recurrent infections and required multiple surgeries—some of them emergency procedures—to prevent life-threatening sepsis.

Although Johnson & Johnson maintains that its pelvic mesh products are safe and effective, the company attributes its withdrawal from the market to business decisions, not safety concerns.

This position stands in contrast to mounting evidence and lawsuits worldwide that suggest serious risks linked to these devices.

Ethicon has already pulled several mesh products off the market—both for pelvic floor disorders and hernia repair—after reports surfaced of higher-than-expected failure rates and a significant number of revision surgeries.

These product removals have further intensified legal scrutiny and public criticism.

This new lawsuit, filed in Winnipeg, joins a growing wave of international litigation involving surgical mesh.

In countries such as Scotland, governments have begun offering support to affected women, including financial assistance for corrective mesh removal surgeries.

If you or a loved one has experienced complications from a transvaginal mesh implant, contact us today to explore your legal options.

Jan 1st, 2023: Vaginal Mesh Lawsuits Highlight Serious Health Risks and Legal Action

The Vaginal Lawsuit is ongoing. 

The ongoing vaginal mesh litigation centers around serious complications linked to transvaginal mesh implants, which were originally developed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Thousands of patients have come forward, claiming that these implants caused severe and often debilitating side effects. Reported complications include mesh erosion, infections, organ perforation, and painful intercourse.

Many individuals have required additional surgeries to correct these issues, and some continue to suffer from long-term pain and reduced quality of life.

Prominent medical device manufacturers facing legal challenges include Ethicon (a division of Johnson & Johnson), C.R. Bard, American Medical Systems, and others.

Plaintiffs argue that these companies failed to thoroughly test their products and did not adequately warn patients or healthcare providers about the potential for significant harm.

While many claims have been resolved through settlements, others remain active in court.

In response to growing scrutiny and accumulating evidence, some manufacturers have discontinued certain transvaginal mesh products altogether.