Why Is Vaginal Mesh Surgery Controversial?
- Last Updated: June 12th, 2025
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.
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Key takeaways:
- Vaginal mesh surgery, originally used to treat pelvic organ prolapse and stress urinary incontinence, became controversial due to severe complications including mesh erosion, pain, infection, and organ perforation, leading the FDA to ban transvaginal mesh for POP repair in 2019.
- Patients who experienced complications from vaginal mesh can pursue legal action with potential settlements ranging from $40,000 to $450,000, though statutes of limitations vary by state and typically begin when complications are discovered.
- Treatment options for mesh complications include observation, physical therapy, medications, and surgical removal, though complete removal isn't always possible, and approximately one-third of patients continue experiencing pain even after removal procedures.
Why Is Vaginal Mesh Surgery Controversial?
Question: Why is vaginal mesh surgery controversial?
Answer: Transvaginal mesh surgery has become controversial due to complications reported in some cases following the surgical procedure.
Originally introduced to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), transvaginal mesh was seen as a promising solution for weakened pelvic muscles and tissues.
On this page, we’ll discuss this question in further depth, legal rights for women harmed by vaginal mesh, steps to take if you’ve had vaginal mesh complications, and much more.
What Is Vaginal Mesh Surgery and How Does It Work?
Vaginal mesh surgery involves permanently implanting synthetic or biological mesh material to reinforce weakened or damaged tissue in the pelvic floor.
POP occurs when the muscles and tissue of the pelvic floor become stretched, torn, or weakened, and can no longer support pelvic organs such as the bladder, bowel, or uterus.
As a result, the organs drop from their normal position and bulge (prolapse) into the vagina.
Some patients have experienced severe side effects, leading to numerous lawsuits against manufacturers.
Legal experts argue that companies misrepresented the risks and benefits of vaginal mesh, downplaying potential complications while exaggerating its effectiveness.
The controversy has been further fueled by reports of surgeons implanting mesh products without adequate training in vaginal surgery techniques.
When surgeons perform these medical procedures, they place mesh through incisions in the vaginal wall to create a supportive hammock beneath the organs.
It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI.
The mesh becomes integrated into surrounding tissues as the body heals.
If you or a loved one has suffered after receiving a transvaginal mesh implant, you may be eligible to seek compensation.
Contact TruLaw using the chat on this page to receive an instant case evaluation that can determine if you qualify for the Transvaginal Mesh Lawsuit today.
Table of Contents
Transvaginal Mesh Lawsuit Updates Timeline
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.
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.
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.
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.
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.
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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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Types of Vaginal Mesh Procedures
There are three main surgical treatments performed with surgical mesh to treat pelvic floor disorders:
- Transvaginal mesh procedures;
- Transabdominal mesh procedures; and
- Mini-sling procedures.
Transvaginal mesh procedures involve placing mesh through vaginal incisions to treat anterior or posterior wall prolapse.
Transabdominal procedures access the pelvic area through abdominal incisions for apical prolapse repair.
Mini-sling procedures specifically address stress urinary incontinence using smaller mesh strips placed beneath the urethra.
Most surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms.
Each procedure type targets different pelvic floor conditions.
Transvaginal approaches primarily treat cystocele (bladder prolapse) and rectocele (rectal prolapse), while transabdominal methods address uterine or vaginal vault prolapse.
Most patients with pelvic organ prolapse are asymptomatic.
Prolapse symptoms become more bothersome as the bulge protrudes past the vaginal opening.
Materials Used in Vaginal Mesh Implants
The synthetic materials used can be either absorbable, non-absorbable, or a combination of absorbable and non-absorbable materials.
Most vaginal mesh products use polypropylene, a permanent synthetic plastic material that remains in the body indefinitely.
Some manufacturers also produce mesh from biological materials derived from animal tissues.
Surgeons have used surgical mesh since the 1950s to repair abdominal hernias; in the 1970s, gynecologists specializing in female pelvic medicine began implanting surgical mesh for the abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP.
Major manufacturers historically included Boston Scientific, Coloplast, and Ethicon, producing products like Uphold Lite, Xenform, and ProteGen.
On April 16, 2019, after reviewing their premarket approval (PMA) applications, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse (Boston Scientific Uphold Lite, Boston Scientific Xenform, and Coloplast Direct Fix Anterior) to stop selling and distributing their products immediately.
Major Complications and Side Effects of Vaginal Mesh
The FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair.
These complications have profoundly impacted women’s lives, with the FDA reporting that it had received 2,874 reports of injury, death, malfunctions, and other transvaginal mesh-related complications from Jan.1, 2008, to Dec. 31, 2010.
Common Physical Complications
The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation, and urinary problems from mesh eroding into surrounding tissues.
Research shows 9.8% of patients undergoing surgical mesh insertion for SUI experienced a complication peri-procedurally, within 30 days or within 5 years of the initial mesh insertion procedure.
Mesh exposure represents the most frequent complication.
This occurs when the mesh moves or erodes through the vaginal wall, sometimes extending into nearby organs like the bladder or rectum.
Women experiencing erosion report pain, bleeding, infections, painful intercourse, or the exposed mesh becoming visible or felt inside the vagina.
One study reported a 32% corrective rate for SUI surgery involving a midurethral sling procedure, while others found the rate of mesh-related complications to be approximately 15% to 25%.
Bacterial colonization may contribute to additional complications, as 44 samples (90%) were culture positive, with a higher diversity of species and more Gram-negative bacteria and polymicrobial cultures in the MRC cohort than the reference cohort.
Impact on Daily Life and Relationships
Most participants experienced negative emotions as a result of mesh complications and subsequent continuous pain.
These ranged from feeling robbed, trapped, regretful, anxious, and suicidal.
The psychological toll extends beyond physical symptoms, with women’s lives having been irreversibly altered for the worse owing to mesh complications, causing chronic pain and impacting their quality of life.
Sexual dysfunction proves particularly distressing.
Physical pain includes pain during sexual intercourse (dyspareunia).
Physical limitations can also affect basic activities that prevent women from sitting comfortably, exercising, or performing routine tasks.
Revision Surgery Challenges
Complete transvaginal mesh removal is possible for some women, while only part of the mesh can be removed in other women due to issues from the type of mesh that was originally used.
The difficulty increases over time as tissue grows around and embeds the mesh.
Revision surgery removes or repairs transvaginal mesh implants, but it’s a difficult procedure and may cause pain compared to the initial mesh procedure.
Studies indicate 1 in every 30 women may need a repeat surgery to remove or revise the mesh, up to 10 years after the initial operation.
Patients were also excluded if they were unable to provide informed consent, were undergoing chronic immunosuppressive therapy, or had an autoimmune disorder.
Multiple revision surgeries often become necessary, with over 50% of women who experienced erosion with non-absorbable synthetic mesh needing to have the mesh surgically removed.
Some patients required two or more operations after the mesh was removed.
Why Did the FDA Issue Warnings About Vaginal Mesh?
The FDA’s escalating safety actions regarding vaginal mesh stemmed from an alarming pattern of adverse events.
Issued safety communications in 2008 and 2011 that warned doctors and consumers about an increase in adverse event reports related to mesh used for urogynecological procedures.
Timeline of FDA Safety Communications
The regulatory journey began with growing concerns about complications associated with mesh.
In 2008, the FDA issued its first public health notification regarding transvaginal mesh, following receipt of over 1,000 adverse event reports from nine surgical manufacturers since 2005.
Initially, the safety communication described complications from transvaginal mesh as rare.
The situation escalated dramatically when, from January 2008 to December 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI), with 1,503 reports related to POP repairs and 1,371 associated with SUI repairs.
This prompted stronger action.
The FDA issued an update on July 13, 2011, noting complications associated with surgical mesh for transvaginal repair of POP are not rare and that it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair, and it may expose patients to greater risk.
In 2016, the FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices.
Finally, July 2018 was the deadline for applications to be filed for premarket approval for any surgical mesh marketed for transvaginal pelvic organ prolapse (POP) repair.
Manufacturers that did not file PMAs by this deadline were required to withdraw their products from the market.
April 16, 2019: The FDA ruling ordered all manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling and distributing their products immediately.
Clinical Evidence That Led to FDA Action
We analyzed 1,103 MDRs submitted to the MAUDE database from 2005 to 2007 for pelvic mesh adverse events.
The FDA’s analysis revealed concerning patterns.
The most frequent complications reported to the FDA include mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, urinary problems, and voiding dysfunction.
Scientific scrutiny intensified when the panel recommended that to support a favorable benefit-risk profile, the effectiveness of surgical mesh for transvaginal repair of POP should be superior to native tissue repair at 36 months and the safety outcomes for surgical mesh for transvaginal repair of POP should be comparable to native tissue repair.
In reviewing the PMAs submitted by the two manufacturers, the agency determined they failed to provide an adequate assessment of the long-term safety of these devices and failed to demonstrate an acceptable long-term benefit of these devices compared to transvaginal surgical tissue repair without the use of mesh.
The evidence showed transvaginal mesh products for treating POP have been approved on the basis of weak evidence over the last 20 years.
The MAUDE database was limited in its ability to collect, quantify, and standardize real-life adverse events related to transvaginal mesh.
Despite these limitations, the accumulated evidence proved sufficient for regulatory action, as the FDA had not found conclusive evidence that using transvaginally placed mesh improves clinical outcomes any more than traditional non-mesh treatments, and it may expose patients to greater risk.
Legal Rights for Women Harmed by Vaginal Mesh
Women experiencing complications from vaginal mesh implants have legal recourse through product liability claims.
The main claims are that manufacturers produced faulty products and failed to warn the public of the health risks.
Since litigation began, over 100,000 Transvaginal Mesh Lawsuits have been filed across courts in the United States on behalf of women injured by vaginal mesh and pelvic mesh products.
Grounds for Vaginal Mesh Lawsuits
Transvaginal mesh lawsuits claim that several manufacturers of transvaginal mesh knew that their products were defective and could cause complications such as erosion, organ perforation, severe pain, painful sex, mesh migration and other serious issues that require surgical management to remove the mesh.
Legal theories supporting these claims include design defects, manufacturing defects, failure to warn, and negligent marketing practices.
Following Food and Drug Administration communications about the safety of transvaginal prolapse, more than 73,000 patients with complications from the treatment of pelvic organ prolapse (POP) or stress urinary incontinence (SUI) have filed product liability claims.
Courts have recognized that a recent study conducted by researchers at the University of Sheffield in England reveals that most vaginal and pelvic mesh implants may have been fundamentally flawed in their design and manufacturing.
Successfully resolved cases demonstrate viable legal grounds.
Around 140 women in England who suffered severe side effects from vaginal mesh implants have won a settlement, expected to total “millions of pounds,” after taking legal action against manufacturers Johnson & Johnson, Bard, and Boston Scientific.
Compensation Available in Mesh Cases
The estimated payout range for vaginal mesh lawsuits is between $175,000 and over $450,000.
Compensation typically covers multiple categories of damages.
Damages that can be recovered in a vaginal mesh lawsuit include past and future medical expenses, lost wages, pain and suffering, loss of consumption, and in rare cases, punitive damages.
A Philadelphia jury issued one of the largest transvaginal mesh verdicts to Susan McFarland for $120 million in 2019.
As of May 2025, average vaginal mesh settlement amounts have ranged from $40,000 to $450,000. Plaintiffs who have taken their cases to trial have received millions in jury verdicts, but some of these verdicts have been overturned or reduced after appeal.
Settlement values depend on the severity of the injury, the ability to prove the connection between the injury and the mesh, and any statements made by manufacturers.
Statute of Limitations Considerations
Time limits for filing vary by state.
Every state has its statute of limitations ranging from 1 to 6 years, generally starting from the date the claimant either underwent mesh surgery or discovered the complications related to the mesh.
The discovery rule states that the statute of limitations begins when the plaintiff knew or should have known that the vaginal mesh caused the injury or complications.
Product liability statutes of limitations are not always as straightforward as they seem.
Many women assume they are out of time when, in reality, they may still have a valid claim.
This situation arises because in most states, the deadline doesn’t necessarily start when the mesh was implanted but rather when complications first became apparent, which could be years later.
As long as the first occurrence of your vaginal mesh complications occurred with the last one or two years, you will probably not have to worry about the statute of limitations.
Given these variations, it is important to consult with a transvaginal mesh lawyer to determine whether you meet the eligibility requirements.
Steps to Take If You've Had Vaginal Mesh Complications
Taking prompt action when experiencing mesh-related problems proves important for both medical treatment and legal remedies.
If you have concerns about complications as a result of vaginal mesh, you should inform your GP.
Early intervention often leads to better outcomes.
Medical Documentation and Treatment
A complete medical history is the first key to a comprehensive and assertive diagnosis of mesh-related complications.
Document all symptoms meticulously, including pain, bleeding, infections, painful intercourse, vaginal discharge, or the mesh becoming visible or felt inside the vagina.
Medical evaluation should include comprehensive testing.
Your doctor will use imaging tests to see where the mesh is placed and locate the area that’s causing problems.
Your doctor may use ultrasound, CT, MRI, or another test that involves a thin, flexible tube and a camera to examine the inside of your bladder (cystoscopy), rectum (proctoscopy), or colon (colonoscopy).
Treatment options vary based on severity.
Approaches to the management of mesh-related complications in pelvic floor surgery include observation, physical therapy, medications, and surgery.
For minor complications, in less severe cases, mesh complications can be treated with vaginal estrogen cream and time to allow tissues to heal.
When surgery becomes necessary, specialized expertise matters.
Complete transvaginal mesh removal is possible for some women, while only part of the mesh can be removed in other women due to issues from the type of mesh that was originally used.
Surgeons with specialized training use the least invasive approach to remove the portion of mesh that’s causing symptoms and restore pelvic health.
Evaluating Your Legal Options
Begin by securing comprehensive medical records documenting your mesh complications.
Medical expenses are calculated through bills and documentation of expenses related to the vaginal mesh complication that caused your injury.
Preserve all documentation related to your initial surgery, complications, and subsequent treatments.
Contact Jessica Paluch-Hoerman at TruLaw for a free case evaluation using the chat on this page.
Health care providers recommend consulting with an attorney to determine whether you meet the eligibility requirements.
During the consultation, you should bring your medical records, surgical reports, diagnostic imaging results, and documentation of all symptoms and treatments.
Key questions to ask during your consultation include timeline considerations for your specific case, potential compensation based on your injuries, litigation strategy options, and the expected duration of your case.
An attorney can help determine if you meet the eligibility requirements necessary to file a claim.
Remember that you will not have to pay anything to file a lawsuit through a contingency agreement.
This arrangement ensures access to legal representation regardless of financial circumstances.
Jessica Paluch-Hoerman and TruLaw work on contingency, meaning you pay legal fees only if your case achieves a favorable outcome.
Failing to file a lawsuit within the state-specific statute of limitations can result in the forfeiture of the right to compensation.
Contact TruLaw immediately using the chat feature on this page to receive an instant case evaluation and determine whether you qualify to join others in filing a vaginal mesh lawsuit today.
How Can A Transvaginal Mesh Attorney from TruLaw Help You?
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 damaged tissue and other 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 recognize 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.
TruLaw: Accepting Clients for the Transvaginal Mesh Lawsuit
Transvaginal mesh lawsuits are being filed by women across the country who suffered serious complications from pelvic mesh implants used to treat pelvic organ prolapse and stress urinary incontinence.
TruLaw is currently accepting clients for the Transvaginal Mesh lawsuit.
A few reasons to choose TruLaw for your Transvaginal Mesh lawsuit include:
- If We Don’t Win, You Don’t Pay: The Transvaginal Mesh lawyers at TruLaw and our partner firms operate on a contingency fee basis, meaning we only get paid if you win.
- Expertise: We have decades of experience handling product liability cases similar to the Transvaginal Mesh lawsuit.
- Successful Track Record: TruLaw and our partner law firms have helped our clients recover billions of dollars in compensation through verdicts and negotiated settlements.
If you or a loved one suffered pain, infection, bleeding, organ damage, or other complications after receiving a transvaginal mesh implant, you may be eligible to seek compensation.
Contact TruLaw using the chat on this page to receive an instant case evaluation that can determine if you qualify for the Transvaginal Mesh lawsuit today.
Transvaginal Mesh Lawsuit Frequently Asked Questions
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!
Additional Transvaginal Mesh Lawsuit resources on our website:
Here, at TruLaw, we’re committed to helping victims get the justice they deserve.
Alongside our partner law firms, we have successfully collected over $3 Billion in verdicts and settlements on behalf of injured individuals.
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At TruLaw, we fiercely combat corporations that endanger individuals’ well-being. If you’ve suffered injuries and believe these well-funded entities should be held accountable, we’re here for you.
With TruLaw, you gain access to successful and seasoned lawyers who maximize your chances of success. Our lawyers invest in you—they do not receive a dime until your lawsuit reaches a successful resolution!
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Here, at TruLaw, we’re committed to helping victims get the justice they deserve.
Alongside our partner law firms, we have successfully collected over $3 Billion in verdicts and settlements on behalf of injured individuals.
Would you like our help?
