Vaginal Mesh Lawsuit 2024 Updates - Vaginal Mesh Litigation
Vaginal mesh implants, often used to treat pelvic organ prolapse and stress urinary incontinence, have unfortunately been linked to serious complications like erosion, pain, and infections. Thousands of women sued the manufacturers. They claim the companies didn’t properly test these products or provide enough warning about the risks involved. As of 2024, vaginal mesh lawsuits have led to settlements totaling millions of dollars across 48 states, with around $8 billion paid out in verdicts and settlements. While most transvaginal mesh lawsuits—about 95%—have been settled, new cases continue to be filed. At Ethen Ostroff Law, we’ll walk you through what a vaginal mesh lawsuit involves, expected settlement amounts, the common complications tied to these devices, and more.
Transvaginal Mesh: What Is It Exactly?
Transvaginal mesh, also referred to as vaginal mesh, is a device used to treat pelvic organ prolapse and stress urinary incontinence (SUI). These conditions happen when the pelvic muscles become weak, causing organs like the bladder or uterus to shift into the vagina. In the 1970s, doctors used surgical mesh for abdominal repairs. By the 1990s, they started using a similar mesh inserted through the vagina to treat SUI. The FDA approved the first transvaginal mesh in 1996, allowing it on the market because it was just like existing devices. This led to several companies producing their versions by the 2000s.
Soon after, patients and doctors started noticing serious issues with the mesh. Problems like mesh erosion, organ perforation, infections, chronic pain, and urinary issues became common. Many women needed additional surgeries to fix these problems, causing significant physical and emotional distress.
Top Makers of Vaginal Mesh in the United States
Here’s a look at some of the key players in the country’s vaginal mesh market:
- Boston Scientific Corporation: Headquartered in Massachusetts, Boston Scientific has made significant strides in medical devices, including transvaginal mesh. They offer products like the ProtoGen Sling, Advantage Sling System, Pinnacle Pelvic Floor Repair Kit, and the Uphold Vaginal Support System.
- Coloplast Corporation: This Danish company has a strong presence in the U.S., focusing on a range of healthcare solutions, including pelvic mesh. Their products include the Restorelle DirectFix Anterior and the Arise Sling.
- C.R. Bard, Inc: Known for a broad range of medical products, C.R. Bard also produces transvaginal mesh. Their lineup features the Avaulta Plus BioSynthetic Support System, the Avaulta Solo Synthetic Support System, Pelvicol Tissue, and PelviSoft Biomesh.
- Endo Pharmaceuticals Inc. (formerly American Medical Systems): Specializing in devices for stress urinary incontinence, Endo Pharmaceuticals offers options like the MiniArc Sling, the Lynx Suprapubic Mid-Urethral Sling System, and the Pinnacle Pelvic Floor Repair Kit.
- Ethicon, Inc: As part of Johnson & Johnson, Ethicon is a major name in surgical mesh, particularly for pelvic issues. Their popular products include the Gynecare Prolift Kit, Gynecare Prolift + M Kit, Gynecare TVT Secur, and the Gynecare Prosima Pelvic Floor Repair System.
- Other Notable Manufacturers: A few other companies that have been involved in producing vaginal mesh include Covidien plc, Mentor Worldwide LLC, Sofradim Production, and Tyco Healthcare (IVS Tunneller).
Vaginal Mesh Complications
Many women have faced serious problems because of defects in vaginal mesh products. These issues can affect both physical and emotional health. Here are some common complications:
- Bleeding: Unexpected bleeding after surgery could mean the mesh is eroding or damaging nearby organs like the bladder.
- Emotional Distress: The physical pain and complications can lead to emotional stress, which is often part of what victims are compensated for.
- Infection: Mesh implants can cause infections that may need antibiotics or even surgery to fix.
- Mesh Erosion: The mesh can wear through vaginal tissue or nearby organs, causing pain and often requiring more surgeries.
- Organ Perforation: In some cases, the mesh can puncture organs like the bladder or bowel, needing immediate medical care and more surgery.
- Pain: Ongoing pain in the pelvic area, during sex, or even while sitting or walking is a common issue.
- Return of Original Problem: Sometimes, the pelvic organ prolapse or stress urinary incontinence comes back, requiring further treatment.
- Urinary Issues: Some women experience urinary problems, like incontinence or frequent infections, after getting the mesh.
- Vaginal Scarring: The mesh can cause scarring or shrinking of vaginal tissue, making sex uncomfortable or painful.
FDA Warnings and Growing Public Concern
In 2008, the FDA warned about transvaginal mesh, highlighting risks like erosion, pain, infections, and organ damage. They urged companies to better inform patients about these dangers.
By 2011, the FDA intensified their warnings, noting that serious complications with mesh for pelvic organ prolapse (POP) were common and that mesh didn’t show clear benefits over non-mesh treatments. This spurred national attention, with media coverage fueling concerns. They also discovered that mesh shrinkage could cause severe pain.
In 2012, the FDA required companies to conduct studies on mesh safety and effectiveness. By 2016, they reclassified transvaginal mesh for POP as a high-risk device, demanding proof of safety before it could be sold. By 2019, the FDA banned the sale and distribution of transvaginal mesh for POP repair, finding it wasn’t proven to be safe or effective.
Vaginal Mesh Litigation
Since the first lawsuit in 2009, thousands of cases have been filed against companies like Johnson & Johnson, C.R. Bard, Boston Scientific, American Medical Systems, and Coloplast over transvaginal mesh issues.
The lawsuits claim:
- The companies were careless in designing, testing, and marketing their mesh products.
- They didn’t properly warn doctors and patients about serious risks.
- Women who faced complications like pain, infections, and costly treatments are seeking compensation.
- The companies misled the public about the safety of these implants.
Complications reported include:
- Mesh erosion and damage to organs.
- Pain during sex and life-threatening infections.
- A case of death linked to sepsis from repeated urinary tract infections.
- Lasting injuries, extra surgeries, and financial struggles from medical bills and lost income.
In short, the lawsuits argue that the manufacturers:
- Misled the FDA and the public about safety.
- Didn’t properly test the devices.
- Didn’t research the risks.
- Didn’t make safe removal methods.
- Didn’t warn about potential complications.
These issues continue to drive transvaginal mesh litigation to hold these companies accountable.
Defendants in Vaginal Mesh Lawsuits
Several companies have faced legal action over vaginal mesh implants, resulting in major settlements for affected women. Companies and products involved include:
- Boston Scientific: Obtryx Sling System, Pinnacle Pelvic Floor Repair Kit, Advantage Fit Sling System, and Solyx Single-Incision Sling System.
- C.R. Bard: Avaulta Plus, Avaulta Solo, and Bard Align.
- Coloplast: Restorelle Y-Mesh, Restorelle Flat Mesh, and Arise Sling.
- Cook Medical: Surgisis Biodesign Urethral Sling.
- Endo Pharmaceuticals and American Medical Systems: RetroArc Retropubic Sling System and MiniArc Sling.
- Johnson & Johnson and Ethicon: OBTape, Gynecare Prolift, Gynecare TVT Obturator, and TVT-Secur.
- Neomedic
These companies have been held responsible for problems with their vaginal mesh products.
Vaginal Mesh Multidistrict Litigations
As more vaginal mesh lawsuits piled up, the Judicial Panel on Multidistrict Litigation combined federal cases into several multidistrict litigations (MDLs) starting in 2012. Each MDL focused on a specific manufacturer to make handling the cases more efficient.
The lawsuits were grouped into seven MDLs, covering these manufacturers: C.R. Bard, American Medical Systems, Boston Scientific, Ethicon, Coloplast, Cook Medical, and Neomedic. This created one of the largest mass tort cases in U.S. history, with over 100,000 cases.
District Judge Joseph R. Goodwin in Charleston, West Virginia, oversaw these MDLs. Although many cases have been resolved, new lawsuits are still being filed in 2024. Several bellwether trials were held.
Status of Vaginal Mesh MDLs
As noted, the transvaginal mesh lawsuits were grouped into seven major MDLs in federal court. Each MDL focused on a different manufacturer:
- American Medical Systems
- Boston Scientific
- C.R. Bard
- Coloplast
- Cook Medical
- Ethicon
- Neomedic
At their peak, these MDLs involved around 100,000 cases. Here’s a breakdown of the four largest:
- Ethicon – 40,761 cases
- Boston Scientific – 26,617 cases
- American Medical Systems – 21,367 cases
- C.R. Bard – 15,868 cases
As of 2024, approximately 95% of the cases in these MDLs have been resolved, with billions paid out in settlements. While new vaginal mesh lawsuits continue to be filed, they are not being processed through these MDLs.
Status of Transvaginal Mesh Settlements and Verdicts
As of September 2024, around 95% of transvaginal mesh lawsuits have been settled or resolved through verdicts. However, lawyers are still taking on new cases. Manufacturers have paid over $8 billion in settlements and verdicts to date. Key developments include:
American Medical Systems:
In 2014, American Medical Systems settled 20,000 claims for up to $830 million.
The company set aside $775 million in 2017 to settle 22,000 claims.
Total settlement costs have reached approximately $2.6 billion.
No new settlements have been announced as of September 2024, though liabilities of about $50.7 million for pelvic mesh cases remain.
Boston Scientific:
- In March 2023, Boston Scientific settled a class-action lawsuit in Australia for $105 million.
- In 2021, it agreed to a $189 million settlement with 47 states.
- The company settled 3,000 lawsuits for $119 million in April 2015 and an additional 350 lawsuits in December 2017.
- Boston Scientific has been involved in agreements to resolve around 50,000 cases.
C.R. Bard:
- C.R. Bard has resolved most federal MDL cases, but some remain in New Jersey’s multicounty litigation.
- In 2012 and 2013, Bard lost lawsuits resulting in $3.6 million and $2 million judgments.
- Bard settled over 500 lawsuits for $21 million in 2014 and an additional 3,000 cases for $200 million in August 2015.
- In 2020, Bard agreed to pay $60 million to settle claims with 48 states.
- As of September 2024, some cases are still pending in New Jersey courts.
Coloplast:
- Coloplast settled about 400 lawsuits for $16 million in January 2014.
- Claimants reportedly received around $40,000 each.
- The company considers its MDL cases closed as of September 2024, with no additional settlements or verdicts reported.
Ethicon:
- Ethicon has settled most individual cases for undisclosed amounts, following several bellwether trial losses.
- In 2013, a New Jersey jury awarded $11 million in a case involving Ethicon’s Gynecare Prolift.
- In February 2023, Ethicon paid nearly $10 million to settle claims by the state of Kentucky over misleading marketing practices.
- The U.S. Supreme Court upheld a $302 million judgment from California.
- As of September 2024, 27 Ethicon cases remain open in a federal MDL.
Vaginal Mesh Lawsuits News and Updates
September 2, 2024. In Oregon, a state court jury is reviewing a malpractice case involving a urologist and a hospital. They’re accused of implanting a Boston Scientific “Uphold Lite” mesh despite FDA warnings, leading to severe complications for the plaintiff. Boston Scientific is no longer involved in the case.
August 24, 2024: An Alabama woman has sued Coloplast in Minnesota, claiming their pelvic mesh devices caused chronic pain and complications. She alleges negligence and fraudulent practices, saying Coloplast didn’t adequately warn about the risks of their products.
August 19, 2024: In England, 140 women who suffered severe complications from vaginal mesh implants have reached a settlement, estimated in the millions, with Johnson & Johnson, Bard, and Boston Scientific. The complications included chronic pain and infections, with many needing further surgery.
August 9, 2024: Great Britain is introducing a compensation system for women harmed by faulty pelvic mesh implants. Starting in 2025, affected women will receive a fixed amount of £20,000, with additional compensation available for severe cases.
July 26, 2024: A Massachusetts federal court case against Boston Scientific involves a defective mesh implant. The plaintiff experienced severe pain and symptoms after surgery, leading to ongoing medical issues and the need for further surgery.
July 22, 2024: A federal appeals court reinstated a transvaginal mesh lawsuit after clarifying that plaintiffs only need to show that an alternative design could reduce injury risk, not eliminate it. The court found the initial trial had wrongly restricted expert testimony.
June 21, 2024: The Eleventh Circuit upheld a $2.5 million verdict against Coloplast Corp. for a defective pelvic mesh. The court found the claim was filed within the statute of limitations, rejecting Coloplast’s argument that the claim was too late.
June 4, 2024: A study found that mid-urethral sling surgeries for stress urinary incontinence have risks, especially for older women and those on hormone replacement therapy. The study highlighted the importance of considering individual patient histories when recommending these devices.
May 26, 2024: A new lawsuit in Minnesota targets Coloplast over its Supris mesh device. The plaintiff claims the mesh caused severe complications and requires ongoing treatment, alleging Coloplast failed to warn of the risks associated with the device.
March 14, 2024: A federal court in Massachusetts has allowed a woman’s lawsuit against Boston Scientific to proceed. She claims pain and disfigurement from the Obtryx pelvic mesh, which was implanted to treat pelvic disorders.
February 26, 2024: A couple from West Virginia has filed a lawsuit against Boston Scientific over a defective pelvic mesh. They allege that the mesh caused severe pain and complications, and that Boston Scientific misled patients about its safety.
February 4, 2023: A study comparing robotic sacrocolpopexy and transvaginal mesh surgery found that while both improved voiding function, robotic surgery was linked to a higher risk of new stress urinary incontinence.
January 22, 2023: A small study in the Czech Republic found that most women had improved sexual function after transvaginal mesh surgery for pelvic organ prolapse. However, the study’s small size means more research is needed.
December 7, 2023: A new lawsuit against Boston Scientific involves a Solyx BlueSling implant. The plaintiff claims it caused significant pain and complications, with parts of the mesh remaining after removal surgery.
October 27, 2023: In 2015, Boston Scientific settled with 1,200 victims for $53 million. A point allocation formula was used to distribute the funds, and some claimants later sued their attorneys for mishandling their cases, but these claims were dismissed.
October 24, 2023: Over the past year, 27 new vaginal mesh lawsuits have been filed against Boston Scientific, with most still pending. Some cases have already been settled.
October 20, 2023: A Maryland woman has filed a lawsuit against Boston Scientific over an Advantage Fit mesh implant. She experienced ongoing pain and urinary issues and is suing for design defects and failure to warn.
September 1, 2023: Boston Scientific settled a Georgia lawsuit over its Obtryx mesh, which caused chronic pain and complications. The settlement terms were undisclosed, but the case highlights ongoing issues with mesh products.
August 14, 2023: The 8th Circuit Court dismissed a vaginal mesh lawsuit because the expert report was submitted late. The case could have been viable with timely expert testimony.
July 25, 2023: The New Jersey Supreme Court ruled that Bard’s exclusion of FDA 510(k) clearance evidence deprived it of a fair trial. The court called for a new trial, allowing this evidence in the punitive damages phase.
March 24, 2023: The 11th Circuit upheld a $500,000 verdict against Coloplast for a pelvic mesh case. The court supported the jury’s finding that the mesh caused the plaintiff’s injury and rejected Coloplast’s arguments.
April 12, 2022: Coloplast was ordered to pay $2.5 million in a lawsuit over defective pelvic mesh. The jury found Coloplast had misrepresented the mesh’s safety and failed to provide adequate warnings.
Stay informed with the latest transvaginal mesh lawsuit update to understand your legal options and potential compensation for mesh-related injuries.
Vaginal Mesh Litigation in 2024
Vaginal mesh lawsuits are still active. Many cases are still pending against different manufacturers. While a lot of these cases have been settled, some companies are still fighting them in court, and new lawsuits keep coming in.
In 2024, there’s a trend towards handling these cases individually rather than through class actions. Lawyers believe that filing cases one by one can lead to higher settlements or verdicts, as the potential compensation is often greater compared to what might be achieved in a MDL setting.
Legal Allegations in Vaginal Mesh Lawsuits in 2024
The legal claims in today’s vaginal mesh lawsuits are pretty much the same ones that have been central to these cases from the beginning. Here’s a quick look at the main types of claims people are making in most vaginal mesh injury lawsuits these days.
- Breach of Express Warranty: This claim is about broken promises made by the manufacturers. They guaranteed the mesh’s safety and effectiveness through ads and product information. When these promises proved false, patients were misled and suffered as a result.
- Breach of Implied Warranty: This involves the expectation that the mesh would be fit for its intended use. Even without explicit promises, there’s an assumption that products will work as expected. The mesh failed to meet these basic standards, leading to patient harm.
- Deceptive Trade Practices: The companies misled consumers with false or misleading statements about the mesh. They created a false impression of safety and compliance with standards, tricking patients into using a dangerous product.
- Failure to Warn: The manufacturers didn’t provide enough warnings about the risks associated with the mesh. This lack of proper warnings left patients and doctors unaware of potential dangers, leading to preventable injuries.
- Fraudulent Concealment: This involves the deliberate hiding of important information about the mesh’s risks. The companies knew about the dangers but chose not to disclose them, preventing patients from making fully informed decisions.
- Misrepresentation: The companies gave false or misleading information about the mesh, exaggerating its safety and effectiveness. This deception led to patients suffering from a product that didn’t perform as promised.
- Negligence: The mesh makers failed to properly design, test, and manufacture the product. Their lack of care resulted in significant pain and harm for many women who sought relief from pelvic conditions.
- Strict Product Liability: Under this claim, the manufacturers are held responsible for putting a defective product on the market. The mesh was inherently flawed and caused harm to many patients, regardless of whether the manufacturers were negligent.
How to File a Transvaginal Mesh Lawsuit
If you’ve had issues with a transvaginal mesh implant, knowing your legal options is key. Here’s a simple guide to filing a transvaginal mesh lawsuit:
- Consult with an Attorney: Start by meeting a lawyer experienced in product liability. They’ll review your medical records, evaluate the evidence, and explain your rights and possible compensation.
- File the Complaint: Your lawyer will officially start your vaginal mesh lawsuit by filing a complaint in court. This outlines your injuries, problems with the mesh, and your claims against the manufacturers.
- Gather Evidence: Your lawyer will collect all necessary evidence, like medical records and expert opinions, to support your vaginal mesh lawsuit.
- Multidistrict Litigation (MDL): Many cases are grouped into MDL to make the process more efficient. This allows individual cases to be heard while sharing resources among plaintiffs.
- Negotiation and Settlement: After filing, your vaginal mesh lawsuit may go to negotiations. Often, manufacturers offer settlements to avoid lengthy trials.
- Trial: If no settlement is reached, your vaginal mesh lawsuit will go to trial, where a jury will decide the outcome.
Navigating a transvaginal mesh lawsuit can be complex. If you’re dealing with complications from these implants, Ethen Ostroff Law can help you understand your options and seek justice.
Vaginal Mesh Lawsuit Eligibility
To qualify for a vaginal mesh lawsuit, the following criteria must be met:
- Y-Mesh Implant for Pelvic Organ Prolapse (POP): The woman must have been implanted with Y-Mesh to treat POP.
- Eligible Y-Mesh Brands: The Y-Mesh must be one of the following brands:
- Boston Scientific – Upsylon™ Y-Mesh
- C.R. Bard – Alyte® Y-Mesh Graft
- Coloplast – Restorelle® Y
- Johnson & Johnson – ARTISYN™ Y-Shaped Mesh
- Revision or Removal Surgery: The woman must have undergone revision or removal surgery, or it must be recommended by a doctor.
- Statute of Limitations: The claim must be filed within the statute of limitations for transvaginal mesh injury claims, which varies by state (e.g., 2 years in Pennsylvania).
For further guidance, consult a transvaginal mesh lawsuit attorney.
Evidence for Vaginal Mesh Lawsuits
To back up your vaginal mesh lawsuit, you’ll need to gather several types of evidence. Here’s what you might need:
- Medical Records: Documents from your doctors that detail your treatments, surgeries, and any ongoing issues related to the vaginal mesh.
- Hospital Bills: Any bills from hospitals or clinics showing the costs of your treatment and recovery.
- Personal Testimony: Your own story about the pain and suffering you’ve experienced because of the mesh, including how it has affected your daily life.
- Proof of Financial Losses: Records showing any financial impact, like lost wages or extra costs from dealing with the complications.
- Witness Testimony: Statements from friends, family, or others who can support your claims about how the vaginal mesh has impacted your life.
Gathering this evidence can help build a stronger case and show the full impact of the vaginal mesh on your life.
Damages in Vaginal Mesh Lawsuits
If you win a vaginal mesh lawsuit, you could receive various types of damages to make up for your suffering. Here’s what you might potentially receive:
- Emotional Damages: For the mental stress and emotional pain caused by the complications from the mesh.
- Loss of Consortium: If the mesh problems have hurt your relationship with your spouse, you might get compensation for the loss of companionship and support.
- Lost Quality of Life: Payments for how the mesh issues have affected your daily life and overall enjoyment.
- Lost Wages: Compensation for any income you lost because you couldn’t work due to mesh-related problems.
- Medical Expenses: Reimbursement for the cost of treatments, surgeries, and ongoing medical care related to the mesh.
- Pain and Suffering: Damages for the physical pain and discomfort you’ve experienced because of the mesh.
- Permanent Disability: If the mesh has caused long-term or permanent disability, you could get compensation for how it affects your daily activities.
- Other Compensatory and Punitive Damages: You might also receive additional damages to cover other losses or to punish the manufacturers for their actions.
Understanding these damages can help you know what to expect and what you might be able to claim in your lawsuit.
Why a Vaginal Mesh Lawyer Is Essential
Having a vaginal mesh lawyer is crucial for your lawsuit. Here’s why:
- Navigate the Legal Process: Lawyers know the ins and outs of legal procedures. They’ll guide you through every step of your case, from filing to court appearances.
- Protect Your Rights: They ensure your rights are protected, explain your options, and represent your interests throughout the process.
- Gather Evidence: Your lawyer will collect and organize all necessary evidence, including medical records and expert opinions, to support your case.
- Negotiate with Insurance Companies: They handle negotiations with insurance companies to secure fair compensation and resolve any disputes.
- Represent You in Court: If your vaginal mesh lawsuit goes to trial, your lawyer will present your case and advocate for you in court.
Hire Ethen Ostroff Law
When it comes to your vaginal mesh case, choosing Ethen Ostroff Law ensures that you’re in good hands. We’ll walk you through each step of the procedure and get you the compensation you deserve. With us, you’ll have a reliable partner dedicated to reaching the best possible outcome for your lawsuit. Contact Ethen Ostroff Law for a free case review.
Frequently Asked Questions on Vaginal Mesh Lawsuits
What Is the Average Settlement for A Pelvic Mesh Lawsuit?
Settlements for pelvic mesh lawsuits usually range from $150,000 to over $400,000, but they can be as low as $40,000 in some cases, especially those handled through multidistrict litigation or class actions.
What Is the Average Payout for A Mesh Lawsuit?
The average payout for a transvaginal mesh lawsuit typically falls between $150,000 and $450,000, depending on the severity of injuries and individual case details.
How Much Is a Settlement for A Pelvic Mesh Lawsuit?
Settlements for pelvic mesh lawsuits generally range from $40,000 to over $450,000. Some trial cases have even resulted in multi-million-dollar verdicts.
Is It Too Late for A Mesh Lawsuit?
It’s not too late to file a transvaginal mesh lawsuit in 2024. Lawyers are still accepting claims from those affected by vaginal mesh complications.
Can You Join a Vaginal Mesh Class Action?
Most vaginal mesh class action MDLs are closed to new cases. However, you can still file an individual product liability lawsuit against the manufacturer, which will proceed independently from any class actions.
