What Women Should Know About Transvaginal Mesh

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Jessica Paluch-Hoerman

Attorney Jessica Paluch-Hoerman, founder of TruLaw, has over 28 years of experience as a personal injury and mass tort attorney, and previously worked as an international tax attorney at Deloitte. Jessie collaborates with attorneys nationwide — enabling her to share reliable, up-to-date legal information with our readers.

This article has been written and reviewed for legal accuracy and clarity by the team of writers and legal experts at TruLaw and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced injury lawyer, Jessie Paluch, you can do so here.

TruLaw does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us by using the chat on the bottom of this page. This article should not be taken as advice from an attorney.

Key takeaways:

  • Transvaginal mesh is a treatment used to help with pelvic organ prolapse and stress urinary incontinence. This medical device supports weakened pelvic muscles but has been linked to severe complications.
  • The FDA halted sales of transvaginal mesh for treating pelvic organ prolapse in April 2019 due to safety concerns. Women should be aware that while it was once common, its use now has restrictions.
  • Different materials are used for transvaginal mesh; some are synthetic, like polypropylene, while others are biological grafts from animal tissue. Decisions on which material to use depend on individual health needs and preferences.

Overview of What Women Should Know About Transvaginal Mesh

On this page, we will discuss an overview of what women should know about transvaginal mesh, transvaginal mesh in female pelvic reconstructive surgery, reoperation for SUI surgery using transvaginal mesh, and much more.

What Women Should Know About Transvaginal Mesh; Support and Advocacy

Intro to What Women Should Know About Transvaginal Mesh

Important considerations regarding transvaginal mesh implants include, but are not limited to:

  • Assessing Advantages and Disadvantages: Considering the benefits and risks of transvaginal mesh implants is a fundamental step toward making an informed decision.
  • Awareness of Complications: Patients considering this treatment option must recognize potential complications such as mesh erosion and pain.
  • Legal Rights and Actions: Patients experiencing adverse effects from mesh implants have pursued legal action, resulting in significant settlements.

If you or a loved one have experienced complications from a transvaginal mesh implant, legal recourse may be available.

Contact TruLaw using the chat on this page for a prompt case evaluation to determine eligibility for a transvaginal mesh lawsuit.

Our experienced legal team offers insights into potential compensation, with settlement estimates ranging between $150,000 and $400,000 based on your injuries.

Table of Contents

Transvaginal Mesh Lawsuit Updates Timeline

June 24th, 2025: Study Links Unique Bacteria on Mesh Implants to Chronic Pain and Complications in SUI Patients

Midurethral mesh slings, commonly used to treat stress urinary incontinence (SUI), have come under increasing legal and medical scrutiny due to serious complications reported by thousands of patients.

Complaints such as chronic pain, infections, mesh erosion, and organ perforation have led to growing concerns about the safety and design of these surgical implants.

New research published in the Applied and Environmental Microbiology journal in June 2025 offers fresh insight into the potential biological causes behind these issues.

The study found that the bacteria colonizing the mesh slings differ significantly from the typical microbial populations found in nearby vaginal, urinary, and skin environments.

In particular, mesh samples from patients with chronic pain showed greater bacterial diversity, including the presence of species such as Enterococcus—suggesting a connection between mesh-specific bacteria and inflammatory complications.

These findings support claims made in numerous lawsuits against mesh manufacturers.

Plaintiffs allege that the devices are defectively designed in a way that fosters harmful bacterial colonization and that companies failed to adequately warn patients or conduct sufficient premarket testing to uncover long-term health risks.

Legal actions seek compensation for a range of damages, including medical costs, lost wages, pain and suffering, and diminished quality of life.

As more scientific evidence emerges, the role of microbial colonization is becoming a key element in both understanding mesh complications and holding manufacturers accountable.

June 6th, 2025: Study Finds TVM Particles May Trigger Autoimmune Response, Raising New Legal Questions

A new study published in Nature Reviews Urology has found that microscopic particles from transvaginal mesh (TVM) implants may trigger autoimmune responses, even after the device has been surgically removed.

The research, led by Dr. Nicholas Farr, links residual polypropylene particles—commonly used in mesh products—to Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA).

According to the study, these particles can remain in surrounding tissue and provoke ongoing immune system activity, potentially worsening symptoms long after mesh removal.

These findings may impact current and future transvaginal mesh lawsuits by challenging earlier conclusions that dismissed any association between mesh implants and autoimmune disease.

In particular, the new evidence calls into question a 2017 study published in the American Journal of Obstetrics and Gynecology, which found no systemic health risks related to mesh use.

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

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.

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.

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 11th, 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 12th, 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 17th, 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

TruLaw is 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.

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

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.

Transvaginal Mesh in Female Pelvic Reconstructive Surgery

Transvaginal mesh is utilized in female pelvic reconstructive surgery to provide support to weakened pelvic structures.

This medical intervention addresses a range of pelvic floor disorders.

Transvaginal Mesh in Female Pelvic Reconstructive Surgery

The Pelvic Anatomy

The pelvic region consists of a complex network of muscles, bones, and organs.

Pelvic muscles provide support to the pelvic organs, including the bladder, bowel, and uterus.

The pubic bone at the front and the spine at the back frame the pelvic floor, with the bladder neck positioned at the front of the pelvic region.

A list of key components within the pelvic anatomy includes:

  • Pelvic muscles: A layer of muscles stretching like a hammock from the pubic bone to the spine.
  • Pelvic organs: Organs resting upon the pelvic floor, including the bladder, uterus, and rectum.
  • Bladder neck: The area where the bladder connects to the urethra, crucial for urinary control.
  • Pubic bone: A central point of attachment for pelvic muscles.

Common Pelvic Floor Disorders

Pelvic floor disorders encompass a variety of conditions that affect the support and function of the pelvic floor.

Stress urinary incontinence and pelvic organ prolapse are two prominent examples.

Stress urinary incontinence is characterized by the unintentional leakage of urine during physical activity, while pelvic organ prolapse occurs when pelvic organs drop from their normal position into or through the vaginal canal due to weakened support structures.

The common pelvic floor disorders include:

  1. Pelvic organ prolapse: A downward displacement of the pelvic organs.
  2. Stress urinary incontinence: Uncontrolled urine leakage prompted by pressure exertion on the bladder.
  3. Pelvic pain: Discomfort that may be associated with underlying pelvic floor disorder.
  4. Pelvic floor disorder: Any disorder that affects the integrity and function of the pelvic floor muscles and tissues.

Surgical Treatments and Nonsurgical Treatments for POP

Pelvic Organ Prolapse (POP) is a condition affecting many women, characterized by the descent of pelvic organs into the vaginal canal.

Surgical Treatments and Nonsurgical Treatments for POP

Treatment options range from nonsurgical to various surgical methods, including the use of surgical mesh to provide support.

Mesh Implant Types

The variety of transvaginal mesh implants used in POP treatment includes synthetic polypropylene meshes, bioresorbable synthetic materials, and animal tissue grafts.

Discover the wide range of mesh implants available include, but not limited to:

  • Synthetic Mesh: Commonly made from polypropylene, these meshes are durable and widely used.
  • Bioresorbable Mesh: Design to lose strength over time and eventually dissolve.
  • Animal Tissue Grafts: Derived from porcine or bovine sources, they are absorbed by the body.
  • Combined Synthetic and Biological Materials: Some newer meshes combine both types of materials for added benefits.

Surgical Procedure Overview

Surgical repair for POP can be executed via different approaches, each with its own methodologies.

A brief summary of the main surgical options:

  1. Transvaginal Mesh Surgery: Involves inserting a mesh through the vagina to support pelvic organs.
  2. Transabdominal Surgical Mesh: The mesh is placed abdominally and provides an alternative to transvaginal placement.
  3. Native Tissue Repair: Utilizes the patient’s own tissues instead of mesh for pelvic organ support.
  4. Mesh Sling: A specific type of mesh used to support the urethra and bladder to treat urinary incontinence related to POP.

Comparative Effectiveness

The effectiveness of surgical interventions varies based on methodology and individual patient conditions.

Here’s a comparative overview of the different surgical methods:

  • Success Rate: Mesh surgeries generally offer a high success rate compared to non-mesh repairs.
  • Complication Risks: Some patients may experience complications associated with mesh, like erosion or infection.
  • Recovery Time: Transvaginal mesh procedures typically have a shorter recovery time in comparison to abdominal placements.
  • Long-Term Outcomes: A significant percentage of mesh surgeries report long-lasting relief from POP symptoms despite the potential for complications.

Post-Surgical Care

After undergoing surgical procedures for POP, several steps are essential for successful post-surgical care.

Key aspects of post-surgical care include, but are not limited to:

  1. Activity Restriction: Limiting physical activities to avoid stress on the repair site.
  2. Pelvic Floor Physical Therapy: Enhancing recovery and strengthening pelvic muscles.
  3. Follow-up Appointments: Monitoring for potential complications such as mesh erosion or infection.
  4. Vaginal Cream: Sometimes prescribed to promote healing and maintain tissue health.

Managing Transvaginal Mesh Complications

Effective management of complications arising from vaginal mesh implants involves a multi-faceted approach, including precise diagnosis, appropriate surgical interventions, and an understanding of the evolving legal and regulatory landscape.

Managing Transvaginal Mesh Complications

Recognizing Complications

Early recognition of mesh complications is crucial for patient care.

Complications can manifest as groin pain, debilitating pain, or problems with bowel movements.

Here are key symptoms to watch for:

  • Weakened vaginal wall, which may indicate mesh exposure or erosion
  • Consistent or intermittent groin pain, suggesting possible nerve involvement
  • Debilitating pain that affects the quality of life and daily activities
  • Difficulties or changes in bowel movements, which could point to mesh-related bowel complications

Removal and Revision Surgeries

When mesh complications become severe, transvaginal mesh removal may be required.

This surgical procedure is delicate and hinges on a few critical steps:

  1. Detailed assessment of mesh exposure or erosion within the vaginal wall or surrounding tissues
  2. Careful dissection and removal of the mesh material to alleviate symptoms
  3. Tailored transvaginal repair of the vaginal wall or affected organs
  4. Post-operative monitoring and support to minimize the risk of further complications

Legal and Regulatory Surgical Mesh Considerations

Legal and regulatory considerations pertaining to transvaginal mesh have evolved significantly.

Highlighted below are important aspects to keep in mind:

  • The FDA regulations have been updated to improve patient safety concerning medical devices like transvaginal mesh.
  • Manufacturers face stricter approval processes to ensure efficacy and safety.
  • Litigations concerning transvaginal mesh complications have led to increased awareness and compensation for affected individuals.
  • Ongoing research and regulation continue to shape the landscape of transvaginal mesh applications and management.

Reoperation for SUI Surgery Using Transvaginal Mesh

Surgical intervention for stress urinary incontinence (SUI) using transvaginal mesh sometimes necessitates reoperation due to complications or recurrent symptoms.

Reoperation for SUI Surgery Using Transvaginal Mesh

The following discussion outlines the long-term outcomes and the vital support systems available for patients undergoing these procedures.

Long-Term Outcomes

In assessing the long-term outcomes of SUI surgery with transvaginal mesh, studies indicate a mix of successes and challenges.

Reoperation rates are a critical measure of surgical success and patient well-being over time.

Here are key findings from long-term studies on SUI surgery using transvaginal mesh:

  1. Some patients have experienced relief from SUI symptoms post-surgery, enhancing their quality of life.
  2. A number of women require further transvaginal repair of pelvic organ prolapse or SUI due to mesh-related complications.
  3. The skill level of the surgeon, particularly those specialized in female pelvic reconstructive surgery, significantly influences outcomes.
  4. Various patient support groups report that a subset of patients experiences complications years after the initial procedure.

Support and Advocacy

Support and advocacy play pivotal roles in the journey of patients dealing with transvaginal mesh complications.

Support and Advocacy

These resources provide healthcare advice, emotional backing, and practical information:

  • Patient support groups offer a platform for sharing experiences and receiving emotional support.
  • Advocacy organizations work towards improving patient care standards and pushing for rigorous long-term studies.
  • Educational resources help patients in making informed decisions about female pelvic reconstructive surgery.
  • Legal support may be available for those who have experienced significant complications following transvaginal mesh procedures.

FDA Ban on Transvaginal Mesh

In response to safety concerns, the FDA has issued a ban on the sale of transvaginal mesh products for pelvic organ prolapse (POP).

FDA Ban on Transvaginal Mesh

Efficacy and safety concerns have led to increased scrutiny and the eventual removal from the market.

Non-Surgical Options

For those seeking alternatives to surgical intervention for POP, a number of non-surgical treatment options are available.

Here are some effective methods patients may consider:

  1. Pelvic floor muscles training, to strengthen the muscles that support pelvic organs.
  2. Behavioral therapy can include bladder training and diet modifications.
  3. Electrical stimulation is a method that encourages muscular contractions to enhance pelvic strength.
  4. Weight management, aimed at reducing pressure on pelvic structures.

Emerging Medical Treatments

Research continues to progress in the development of experimental therapies and future medical advancements.

Below are some areas of exploration:

  • Biocompatible materials, potentially offering safer alternatives to traditional mesh.
  • Stem cell therapy is being studied for regenerative possibilities in pelvic health.
  • Custom-fitted pessaries, designed for individual patients without the need for invasive surgery.
  • Advanced imaging technologies assist in the precise diagnosis and monitoring of POP and related conditions.

Conclusion

Transvaginal mesh has played a significant role in pelvic reconstructive surgery, with a specific focus on transvaginal prolapse repair and efforts to treat stress incontinence.

Conclusion

Advancements in this domain aim to address the nuances and complexities involved in treating POP (pelvic organ prolapse).

Future Perspectives

The future of transvaginal mesh in pelvic reconstructive surgery includes multiple facets.

Researchers and clinicians are focusing on reducing complications while preserving the procedure’s benefits.

Areas of focus and development include, but are not limited to:

  • Innovation in Material: Efforts continue to improve the materials used in mesh products to enhance compatibility and reduce adverse effects.
  • Surgical Techniques: Surgeons are constantly improving their methods to ensure that transvaginal mesh can be employed with precision and safety.
  • Patient Selection: It is a priority to identify patients who may benefit most from transvaginal mesh rather than native tissue pop repair.
  • Long-Term Outcomes: Studies evaluating the long-term effects of transvaginal mesh on both prolapse repair and stress incontinence contribute to a better understanding of its efficacy.
  • Regulatory Scrutiny: Regulatory bodies are closely monitoring mesh-related procedures to ensure patient safety and informed consent.
  • Educational Outreach: There is a concerted effort to educate healthcare providers and patients about the risks and benefits associated with transvaginal mesh.

These endeavors collectively aim to safeguard patient health while optimizing the role of transvaginal mesh in treating pelvic organ prolapse and associated conditions.

Transvaginal Mesh Lawsuit Frequently Asked Questions

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Jessica Paluch-Hoerman

Managing Attorney & Owner

With over 25 years of legal experience, Jessica Paluch-Hoerman is an Illinois lawyer, a CPA, and a mother of three.  She spent the first decade of her career working as an international tax attorney at Deloitte.

In 2009, Jessie co-founded her own law firm with her husband – which has scaled to over 30 employees since its conception.

In 2016, Jessie founded TruLaw, which allows her to collaborate with attorneys and legal experts across the United States on a daily basis. This hypervaluable network of experts is what enables her to share the most reliable, accurate, and up-to-date legal information with our readers!

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You can learn more about this topic by visiting any of our Transvaginal Mesh Lawsuit pages listed below:
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Do I Qualify for a Vaginal Mesh Lawsuit?
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