American Medical Systems settled approximately 42,000 vaginal mesh lawsuits for $2.6 billion, with individual compensation ranging from $40,000 to $450,000 depending on injury severity and number of revision surgeries required.
FDA reclassified transvaginal mesh to high-risk Class III devices in 2016 after studies showed 42% of women experienced complications including mesh erosion, organ perforation, and chronic pain requiring multiple surgeries.
Women can still file AMS mesh lawsuits in state courts in 2025 under the discovery rule, which starts the statute of limitations when injuries are linked to mesh rather than at mesh implantation date.
What is the American Medical Systems Lawsuit?
Question: What is the American Medical Systems lawsuit?
Answer: The American Medical Systems lawsuit involves tens of thousands of women seeking compensation for severe injuries caused by AMS transvaginal mesh products, including the Apogee, Perigee, Elevate, and SPARC bladder sling devices used to treat pelvic organ prolapse and stress urinary incontinence.
These product liability lawsuits were consolidated in MDL No. 2325 in the Southern District of West Virginia, where plaintiffs alleged that AMS failed to adequately test their mesh devices and concealed known risks of complications including mesh erosion, organ perforation, chronic pelvic pain, and infection.
On this page, we’ll discuss this question in further depth, medical complications associated with AMS mesh products, how to join thousands of women nationwide filing a Transvaginal Mesh lawsuit, and much more.
Legal Experts Continue Investigating American Medical Systems Vaginal Mesh Lawsuit
American Medical Systems (AMS), now a subsidiary of Endo Pharmaceutical, stands as one of the most prominent defendants in the extensive transvaginal mesh litigation landscape.
The company has faced substantial legal scrutiny following widespread complications from its pelvic mesh products designed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
With approximately $2.6 billion paid in settlements to date, AMS became the first manufacturer to offer a major transvaginal mesh settlement agreement, establishing a precedent that would influence the entire industry’s approach to resolving these claims.
The litigation against AMS encompasses thousands of women who experienced severe complications from implanted mesh products including the Perigee, Apogee, and Elevate implants.
These legal actions allege that AMS failed to adequately test their devices and neglected to provide sufficient warnings about potential risks to both patients and healthcare providers.
The consequences of these alleged failures have resulted in life-altering injuries for numerous women, leading to one of the largest mass tort litigations in recent medical device history.
If you or someone you love has experienced mesh erosion, organ perforation, or chronic pain from an American Medical Systems vaginal 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 help you determine if you qualify to file a Transvaginal Mesh Lawsuit today.
American Medical Systems History of Settlement Agreements
The financial implications of the AMS transvaginal mesh litigation have been considerable and continue to evolve.
In 2014, AMS made history as the first company to announce major pelvic mesh settlements, agreeing to pay $830 million to resolve approximately 20,000 claims.
This settlement established a framework that other manufacturers would later follow in addressing their own litigation challenges.
Following the initial settlement, Endo International, AMS’s parent company, demonstrated continued commitment to resolving outstanding claims.
In August 2017, the company allocated an additional $775 million to settle another 22,000 cases, bringing the total settlement amount to approximately $2.6 billion.
These settlements represented a fundamental acknowledgment of the scope and severity of the complications experienced by women who received AMS mesh implants.
Potential Compensation for AMS Mesh Device Complications
Despite the resolution of approximately 95% of transvaginal mesh cases through settlements or verdicts, the legal landscape remains active in 2025 with future transvaginal mesh settlements anticipated.
Law firms across the country continue to accept new cases, particularly for women whose complications have recently manifested or were only discovered years after the initial implantation.
The shift from multidistrict litigation (MDL) to state court proceedings has created new opportunities for individualized case evaluation and potentially higher settlement values.
Previous settlement amounts and payouts for AMS mesh lawsuits include:
April 2014 Master Settlement Agreement: AMS became the first manufacturer to offer a major settlement, allocating $830 million to resolve approximately 20,000 claims at an average of $41,500 per case, establishing the framework for industry-wide settlement negotiations
August 2017 Supplemental Agreement: Endo International set aside an additional $775 million to resolve 22,000 outstanding cases, averaging $35,227 per claim, addressing cases filed after the initial settlement cutoff date
Cumulative Settlement Impact: Total payouts reached approximately $2.6 billion, making AMS one of the largest settlement contributors in the transvaginal mesh litigation landscape
2025 Reserve Status: Endo maintains $50.7 million in Qualified Settlement Funds for remaining cases and late-filed claims, indicating ongoing financial commitment to resolution
The closure of the original seven MDLs in November 2022 marked a transitional phase in transvaginal mesh litigation.
While the federal MDLs closed between 2020-2022, new cases continue to be filed in state courts across the country, with recent litigation activity in jurisdictions such as California, Pennsylvania, New Jersey, Delaware, and states where additional consumer protections exist (such as Kentucky where residents are protected by the Kentucky Consumer Protection Act).
Each state’s statute of limitations (typically ranging from two to six years from the date of injury discovery) determines filing deadlines, though some courts have recognized the “discovery rule” for latent injuries that manifest years after implantation.
The FDA’s April 16, 2019, order requiring manufacturers to stop selling and distributing transvaginal mesh for POP repair represented a watershed moment in medical device regulation.
This decisive action followed years of mounting evidence regarding complications and the agency’s determination that manufacturers could not demonstrate reasonable assurance of safety and effectiveness for these devices.
The regulatory action specifically targeted transvaginal mesh products for POP repair, including devices from Boston Scientific (Uphold Lite, Xenform) and Coloplast (Direct Fix Anterior).
The FDA’s reclassification of these devices to Class III (high risk) in 2016 had previously established stricter premarket approval requirements, which manufacturers ultimately failed to meet.
Transvaginal Mesh Regulatory Framework
As of 2025, no FDA-approved surgical mesh products for transvaginal POP repair are marketed in the United States.
The agency maintains its position that these devices present potential additional risks compared to native tissue repair, including mesh exposure and erosion, resulting in an unfavorable benefit-risk profile for patient safety.
The FDA permitted the use of transvaginal mesh for procedures that include:
Abdominal/Laparoscopic POP Repair: Mesh placement via abdominal approach (open, conventional laparoscopic, or robotic-assisted) continues with FDA approval when anchoring to the sacrum, avoiding the complications associated with transvaginal placement
Sacrocolpopexy Procedures: Suspension of the vaginal apex to the anterior longitudinal ligament of the sacrum using mesh remains the gold standard for vault prolapse.
The FDA continues its oversight through post-market surveillance studies, adverse event monitoring, and epidemiological research to better understand the long-term safety profile of permitted mesh uses.
Medical Complications Associated with AMS Mesh Products
The medical complications associated with AMS transvaginal mesh products have been extensively documented through clinical studies, FDA adverse event reports, and patient testimonies.
These complications range from immediate post-surgical issues to long-term chronic conditions that may require multiple revision surgeries and ongoing medical management.
Mesh erosion remains the most frequently reported complication, occurring when the synthetic mesh material gradually pushes through the vaginal wall.
These conditions often lead to severe pain, infection, bleeding, and recurrent urinary tract infections that can persist despite antibiotic treatment.
The synthetic polypropylene material used in most mesh products can trigger inflammatory responses and tissue degradation of the vaginal canal.
Organ Perforation and Internal Injuries
AMS mesh can perforate vital pelvic organs including the bladder, bowel, blood vessels, and urethra either during initial implantation or through gradual erosion over time.
These perforations represent some of the most serious complications associated with transvaginal mesh, often requiring emergency surgical intervention to prevent life-threatening infections and further medical interventions.
The following documentation of your AMS mesh complications can be used to support your vaginal mesh case:
Initial Implantation Records: Complete operative reports identifying the specific AMS product (Perigee, Apogee, or Elevate), lot numbers, implant date, and surgeon’s notes documenting the original POP/SUI diagnosis requiring mesh intervention
Revision Surgery Documentation: Detailed surgical reports from revision surgeries includes photographs of explanted mesh, extent of tissue excision required, organs affected, and surgeon’s assessment of mesh-related damage
Diagnostic Imaging Evidence: MRI, CT scans, or ultrasound studies demonstrating mesh migration, erosion through vaginal walls, organ perforation, or mesh shrinkage/contraction, with radiologist reports confirming mesh-related pathology
Ongoing Treatment Records: Documentation of chronic pain management, physical therapy for pelvic floor dysfunction, urogynecology consultations, treatment for recurrent infections, and psychological counseling for mesh-related trauma
Expert Medical Opinions: Board-certified urogynecologist or pelvic surgeon testimony establishing causation between AMS mesh and complications, distinguishing mesh injuries from underlying conditions, and projecting future medical needs
The treatment for organ perforation typically requires reconstructive surgery, with some women needing temporary colostomies or permanent urinary diversions.
Even after surgical repair, many women experience ongoing complications from scar tissue and organ damage.
If you or a loved one experienced organ perforation or other serious injuries from AMS vaginal mesh, 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 an AMS Vaginal Mesh lawsuit today.
Chronic Pain, Sexual Dysfunction & Other Secondary Health Consequences
Beyond the primary complications, women with AMS pelvic mesh implants frequently experience cascading health effects that impact multiple aspects of their lives.
Chronic pelvic pain can lead to mobility limitations, sleep disturbances, and psychological distress including anxiety and depression.
Sexual dysfunction represents another substantial consequence of mesh complications.
Pain during intercourse (dyspareunia) affects not only the patient but also impacts intimate relationships and quality of life.
Partners may also experience discomfort from exposed mesh during sexual activity, a complication that has been documented in medical literature and legal proceedings.
The need for revision surgeries poses additional risks and challenges.
Procedures to have mesh removed completely are technically demanding, often requiring specialized surgical expertise and carrying higher risks than the initial implantation.
Common psychological health conditions associated with pelvic mesh complications include:
Depression and Mental Health Challenges: Development of depressive symptoms requiring professional intervention, with studies showing women who underwent mesh surgery had 2.43 times higher rates of depression, anxiety, or self-harm compared to those without surgery
Anxiety Responses to Pain Unpredictability: Heightened anxiety and psychological distress stemming from the unpredictable nature of pain episodes, with qualitative research documenting participants experiencing feelings of being “trapped” and “punished” by their condition
Partnership Disruption and Intimacy Loss: Documented strain on intimate relationships, with research showing 1.88 times higher rates of sexual dysfunction and participants reporting complete loss of sexual intimacy affecting their marriages and partnerships
Progressive Social Withdrawal: Development of social isolation identified as the main emerging theme in qualitative studies, with women reporting avoidance of family gatherings and friendships due to pain-related limitations
Self-Harm Ideation in Severe Cases: Participants in multiple studies reported experiencing suicidal thoughts, with one woman stating “I did have suicidal thoughts… I just looked at all my painkillers,” highlighting the severity of psychological distress
Identity Transformation and Self-Worth Erosion: Women describing feeling “robbed” of their former lives and experiencing fundamental changes to their sense of self, with participants reporting they felt like “a shadow” of their former selves according to qualitative research findings
Treatment options for mesh-related chronic pain remain limited and often ineffective.
Pain management approaches including nerve blocks, physical therapy, and medication provide only temporary relief for most women.
Complete mesh removal, while sometimes necessary, carries significant risks and may not resolve established pain patterns due to permanent nerve damage.
Studies show that even specialized pelvic pain centers struggle to adequately manage these complications, leaving women with few options for meaningful improvement.
The impact on intimate relationships cannot be overstated, with research documenting how transvaginal mesh complications affect not just sexual activity but overall relationship quality.
Partners report feeling helpless watching their loved ones suffer, while women describe losing a fundamental aspect of their identity and connection with their partners.
Eligibility Requirements for Filing an AMS Mesh Lawsuit
Determining eligibility for an AMS transvaginal mesh claim requires careful evaluation of multiple factors.
The fundamental requirement involves demonstrating a causal connection between the AMS mesh product and the complications experienced.
This connection must be supported by comprehensive medical documentation and, in many cases, expert medical testimony.
The following eligibility criteria to file an AMS mesh claim may include:
Verified AMS Product Implantation: Medical records confirming surgical implantation of Perigee, Apogee, or Elevate mesh systems between 2005-2019, with operative reports identifying the specific product model and confirming AMS as the manufacturer
Documented Mesh Complications: Medical evidence of erosion/chronic pelvic pain lasting more than 6 months, revision surgery requirements, organ perforation, and severe infections requiring IV antibiotics or hospitalization
Continuous Treatment Documentation: Ongoing medical care records showing persistent symptoms despite conservative treatment attempts, multiple physician visits for mesh-related issues, failed attempts at non-surgical management, and progression of complications over time
Quality of Life Impact Assessment: Documentation of inability to perform daily activities, work restrictions or disability claims related to mesh complications, sexual dysfunction affecting intimate relationships, and psychological treatment for anxiety/depression secondary to transvaginal mesh injuries
Statute of Limitations Timelines: Filing within 1-6 years of injury discovery (varies by state), with discovery rule applying from date complications were linked to mesh rather than implant date, requiring prompt legal consultation to preserve claim viability
Potential claimants must provide evidence of receiving an AMS-manufactured mesh product, typically the Perigee, Apogee, or Elevate systems.
Medical records should clearly identify the specific product implanted, the date of implantation, and any subsequent complications or revision surgeries.
The timing of complications relative to implantation plays a vital role in establishing causation and meeting statute of limitations requirements.
Statute of Limitations Considerations
The statute of limitations for transvaginal mesh claims varies significantly by state, typically ranging from one to six years from the date of injury discovery.
The “discovery rule” applies in most jurisdictions, meaning the limitations period begins when the plaintiff knew or should have known that their injuries were related to the mesh implant.
This provision has allowed many women to file claims years after their initial surgery when complications finally manifested or were properly diagnosed.
Recent legal developments continue to shape statute of limitations applications.
The 11th Circuit’s pending review of a statute of limitations challenge in a mesh injury case, expected to be decided in 2025, may establish important precedents for future claims.
Potential claimants should seek legal consultation promptly to ensure their claims remain viable under applicable state laws.
If you or a loved one experienced complications from AMS vaginal mesh, time limits for filing a pelvic mesh lawsuit continue to run.
Contact TruLaw using the chat on this page to receive an instant case evaluation and determine whether statutory deadlines affect your ability to seek compensation.
Types of Damages Available in Vaginal Mesh Lawsuits
Victims of defective vaginal mesh implants may pursue compensation through various legal theories, including product liability, negligence, and failure to warn.
The damages available reflect both the immediate and long-term impacts of mesh complications, which often require multiple revision surgeries and result in permanent injuries.
Courts have recognized the profound effect these devices have had on women’s physical health, emotional well-being, and family relationships, leading to substantial verdicts and vaginal mesh settlements across different jurisdictions.
The types of damage that can be claimed in an AMS mesh claim include, but are not limited to:
Medical Expenses (Economic Damages): Past surgical costs including initial implantation and revision surgeries, ongoing treatment expenses for pain management and pelvic floor therapy, future medical costs for anticipated procedures, prescription medications, and specialized care projected over life expectancy
Lost Income and Earning Capacity: Documentation of missed work during recovery periods (typically 6-12 weeks per surgery), reduced work capacity due to chronic pain or mobility limitations, career changes necessitated by physical restrictions
Pain and Suffering (Non-Economic Damages): Compensation for chronic pelvic pain syndrome, physical discomfort during daily activities, emotional distress from permanent injuries, and diminished quality of life
Loss of Consortium: Spouse’s claim for loss of companionship, sexual relations impacted by dyspareunia (painful sexual intercourse) or partner discomfort from exposed mesh, emotional support disruption, and services typically provided in marital relationship
Punitive Damages: Available in jurisdictions permitting punishment for egregious conduct, based on evidence of inadequate pre-market testing, suppression of adverse event data, and continued marketing of the device despite knowing of the increased risks
The calculation of damages in mesh cases often requires extensive medical documentation and expert testimony to establish the causal relationship between the implant and injuries.
Economic damages are typically supported by medical records, billing statements, and vocational assessments, while non-economic damages rely on testimony about daily limitations and quality of life impacts.
Given the sophistication of these cases and the need to project future medical costs (particularly for younger women who may require decades of additional treatment) many plaintiffs work with life-care and financial planners to document the full-extent your injuries to consider any and all future healthcare needs.
Women experiencing transvaginal mesh complications may still be eligible to pursue compensation from the manufacturers of transvaginal mesh devices based on their individual circumstances.
While the federal MDLs closed between 2020-2022, new cases continue to be filed in state courts across the country, with recent litigation activity in jurisdictions such as California, Pennsylvania, New Jersey, and Delaware.
Each state’s statute of limitations (typically ranging from two to six years from the date of injury discovery) determines filing deadlines, though some courts have recognized the “discovery rule” for latent injuries that manifest years after implantation.
If you or someone you love has experienced transvaginal mesh complications of any kind, you may be qualify to pursue compensation.
Contact TruLaw using the chat on this page to receive an instant case-evaluation that can help determine your eligibility to join thousands of women nationwide filing Transvaginal Mesh lawsuit claims in 2025.
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 medical device litigation cases, Jessica Paluch-Hoerman and our partner law firms work with litigation leaders and medical experts to prove how defective transvaginal mesh implants caused you harm.
TruLaw focuses on securing compensation for medical expenses, revision surgeries, severe pain and suffering, lost income, and other damages resulting from your transvaginal mesh injuries.
We understand the physical and emotional toll that Transvaginal Mesh complications have on your life and provide the personalized guidance you need when seeking justice.
Meet the Lead Transvaginal Mesh Attorney at TruLaw
Meet our lead Transvaginal Mesh attorney:
Jessica Paluch-Hoerman: As founder and managing attorney of TruLaw, Jessica brings her experience in product liability and personal injury to her client-centered approach by prioritizing open communication and personalized attention with her clients. Through TruLaw and partner law firms, Jessica has helped collect over $3 billion on behalf of injured individuals across all 50 states through verdicts and negotiated settlements.
How much does hiring a Transvaginal Mesh lawyer from TruLaw cost?
At TruLaw, we believe financial concerns should never stand in the way of justice.
That’s why we operate on a contingency fee basis with this approach, you only pay legal fees after you’ve been awarded compensation for your injuries.
If you or a loved one experienced pain, bleeding, infection, organ perforation, mesh erosion, or other complications from vaginal mesh devices, you may be eligible to seek compensation.
ContactTruLaw using the chat on this page to receive an instant case evaluation and determine whether you qualify to join others in filing aTransvaginal Mesh lawsuit today.
TruLaw: Accepting Clients for the Transvaginal Mesh Lawsuit
Transvaginal mesh lawsuits are being filed by women across the country who suffered 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 vaginal 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 vaginal mesh implant, you may be eligible to seek compensation.
ContactTruLaw using the chat on this page to receive an instant case evaluation that can determine if you qualify to join thousands of women nationwide pursuing compensation by filing a Transvaginal Mesh lawsuit today.
Based on current 2025 data, AMS mesh settlements typically range from $40,000 to $450,000, with stronger cases averaging between $150,000 and $400,000.
Settlement amounts vary significantly based on factors including severity of complications, number of revision surgeries required, and impact on quality of life.
Boston Scientific, which acquired AMS in 2011, has paid approximately $830 million to settle over 20,000 cases involving Perigee, Apogee, and Elevate implants, with individual payouts averaging $40,000-$43,000 in mass settlements, though cases taken to trial or negotiated individually often achieve higher compensation.
The AMS mesh lawsuits include all transvaginal mesh products manufactured by American Medical Systems before Boston Scientific’s 2011 acquisition, specifically: Elevate, Apogee, Perigee, SPARC, MiniArc, MiniArc Precise, Monarc, BioArc, and IntePro Lite systems.
These polypropylene mesh devices were marketed for treating pelvic organ prolapse and stress urinary incontinence between 2005-2011.
Any woman implanted with these products who experienced complications including erosion, infection, organ perforation, or chronic pain may have a valid claim.
Essential evidence includes operative reports documenting the specific mesh product implanted, post-operative medical records showing complications, pathology reports from revision surgeries confirming mesh-related tissue damage, and imaging studies demonstrating mesh migration or erosion.
Additional supporting documentation includes infection records, diagnostic test results, medical bills showing financial losses, and physician statements linking injuries to the device.
Your attorney will also need surgical documentation, lab results, evidence of conservative treatment attempts, and records of any hospitalizations related to mesh complications.
AMS mesh lawsuits typically take anywhere from 6 months to several years to resolve, with most cases settling within 18-36 months of filing.
Simple cases with clear liability and documented damages may settle in 6-8 months, while sophisticated cases that require extensive discovery or trial preparation can extend from 3 to 4 years.
The timeline depends on factors including jurisdiction, strength of evidence, and whether the case proceeds to trial or settles during negotiations.
State court cases generally move faster than the former federal MDL process.
Experienced attorneys can identify your mesh manufacturer through several methods: obtaining operative reports that contain product identification codes, reviewing hospital purchasing records that link surgeries to specific inventory, and requesting surgical documentation including product stickers or lot numbers.
Medical facilities maintain detailed records for 7-10 years including billing codes specifying exact devices used.
Your surgeon’s office may also have preference cards documenting favored products during your surgery timeframe.
Don’t delay seeking legal help attorneys have dedicated resources and medical record specialists trained to investigate and confirm whether you received an AMS product even without initial documentation.
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.
Legally Reviewed
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.
Fact-Checked
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.
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