Transvaginal Mesh Lawsuit | 2025 Latest Updates

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Transvaginal Mesh Lawsuit Overview

Transvaginal mesh implants have been linked to thousands of severe complications. These devices, which are used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI), have been associated with life-threatening health issues. The primary allegations against manufacturers include defective design and negligence. The FDA has received thousands of reports connecting these implants to serious complications.

Latest Transvaginal Mesh Lawsuit Updates

• January 2015 – As of January 2015, more than 60,000 mesh lawsuits have been filed in state and federal courts throughout the U.S., including approximately 10,000 cases involving C.R. Bard, 18,000 cases involving American Medical Systems, 14,000 cases involving Boston Scientific, 22,000 cases involving Ethicon, 1,700 cases involving Coloplast, 300 cases involving Cook Medical, and 100 cases involving Neomedic [1].
• 2014 – Endo International Plc, owner of AMS, agreed to pay over $1.6 billion to resolve medical malpractice lawsuits. These settlements primarily involved women who underwent one reconstructive surgery or no revisions to repair injuries allegedly caused by the mesh [2].
• 2012 – In June 2012, Johnson & Johnson’s Ethicon division recalled several brands of mesh including Gynecare Prolift Kit, Gynecare Prolift + M Kit, Gynecare TVT Secure, and Gynecare Prosima Pelvic Floor Repair System Kit after more than 1,000 transvaginal mesh lawsuits had been filed [3].
• 2012 – A month after the J&J Gynecare recall, C.R. Bard stopped selling its Avaulta Plus line of vaginal mesh after a California jury awarded a patient $5.5 million after being injured by one of the devices [4].
• 1999 – Boston Scientific pulled its ProteGen brand pelvic mesh off the market amid safety concerns. The ProteGen was the first surgical mesh designed exclusively for transvaginal applications and paved the way for many other products to reach the U.S. market [5].

Transvaginal Mesh Reports and Statistics

According to the New England Journal of Medicine (NEJM) study, approximately 3.5% of women implanted with surgical mesh suffered from complications arising after surgery, compared to only about 0.5% of women who received colporrhaphy.

The rate of stress urinary incontinence (SUI) was more than 12% for women who received a mesh device compared with only 6.3% for those who received colporrhaphy. The study also found that 3.2% of women who received mesh required revision surgery to correct problems with the device.

A study conducted by Russian scientists involving 677 test subjects treated at six different medical centers who underwent mesh repair for POP from 2006 to 2010 found that 152 women (22.5%) experienced intra-operative, early postoperative, and mesh-related complications [6].

Transvaginal Mesh Injuries & Side Effects

Transvaginal mesh implants have been linked to numerous severe complications that can significantly impact quality of life.

• Mesh erosion: Erosion through vaginal walls
• Chronic pain: Persistent discomfort and pelvic pain
• Infections: Urinary issues and recurring infections
• Organ perforation: Damage to bladder, bowel, and blood vessels
• Sexual dysfunction: Vaginal scarring and dyspareunia (painful intercourse)
• Surgical complications: Need for corrective surgeries
• Bleeding: Pelvic hematomas, vaginal hematomas, and significant blood loss
• Mesh complications: Protrusion into the bladder, mesh shrinkage, pelvic abscess, development of fistulas

Transvaginal Mesh Recall Information

There have been at least 3 recalls for surgical mesh devices:

• 1999: Boston Scientific pulled its ProteGen brand pelvic mesh off the market amid safety concerns.
• June 2012: Johnson & Johnson’s Ethicon division recalled Gynecare Prolift Kit, Gynecare Prolift + M Kit, Gynecare TVT Secure, and Gynecare Prosima Pelvic Floor Repair System Kit.
• July 2012: C.R. Bard stopped selling its Avaulta Plus line of vaginal mesh after a California jury awarded a patient $5.5 million.

Transvaginal Mesh Settlement Amounts

Settlement amounts vary based on the severity of complications, medical treatments required, and legal representation.

If you have suffered from complications, you may be eligible for compensation.

Mesh Products & Manufacturer List

Several manufacturers produce transvaginal mesh products, each with its own range of offerings.

Some of them are:

• Johnson & Johnson
  • Ethicon TVT
  • Gynecare TVT
  • Gynemesh PS
  • Prolene Polypropylene Mesh Patch
  • Secur
• Bard
  • Avaulta Plus™ BioSynthetic Support System
  • Avaulta Solo™ Synthetic Support System
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh
• American Medical Systems or AMS
  • SPARC®
• Boston Scientific
  • Advantage™ Sling System
  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Prefyx Mid U™ Mesh Sling System
  • Prefyx PPS™ System

Transvaginal Mesh Litigation

As of Jan. 2015, more than 60,000 mesh lawsuits have been filed in state and federal courts throughout the U.S. Among them:

• Approximately 10,000 cases involving C.R. Bard
• Approximately 18,000 cases involving American Medical Systems
• Approximately 14,000 cases involving Boston Scientific
• Approximately 22,000 cases involving Ethicon
• Approximately 1,700 cases involving Coloplast
• Approximately 300 cases involving Cook Medical
• Approximately 100 cases involving Neomedic.

In 2014, Endo International Plc, owner of AMS, agreed to pay about $1.3 billion to resolve medical malpractice lawsuits.

In most cases, these settlements involve women who have undergone 1 reconstructive surgery or no revisions to repair injuries allegedly caused by the mesh. Women who have undergone repair surgery have not been included in the settlements.

Do You Qualify for a Transvaginal Mesh Lawsuit?

You may qualify for a transvaginal mesh lawsuit if:

• You received a transvaginal mesh implant.
• You experienced serious side effects including mesh erosion, infections, organ perforation, chronic pain, or required revision surgery.
• The injuries required medical treatment or hospitalization.
• You can provide medical documentation linking your injuries to the transvaginal mesh implant.

Evidence Required for a Transvaginal Mesh Lawsuit

Evidence includes:

• Medical records documenting your injuries and surgeries
• Proof of the transvaginal mesh implant
• Expert testimony on the product’s safety
• Any communication with healthcare providers or the manufacturer regarding the complications

Damages You Can Recover

Compensation may include:

• Medical expenses
• Lost wages
• Pain and suffering
• Costs for additional surgeries
• Punitive damages

The amount depends on the severity of injuries and the impact on your life.

Statute of Limitations for Transvaginal Mesh Lawsuits

The statute of limitations for filing a lawsuit varies by state but typically ranges from one to three years from the date of injury or discovery of the complications.

​​Related: Ethicon Physiomesh Hernia Patch Lawsuit

See all the defective medical devices lawsuits we’ve taken on.

FAQs

1. What evidence is needed to support a transvaginal mesh lawsuit?

Evidence includes medical records documenting your injuries and surgeries, proof of the transvaginal mesh implant, expert testimony on the product’s safety, and any communication with healthcare providers or the manufacturer regarding the complications.

2. What compensation can be sought in a transvaginal mesh lawsuit?

Compensation may include medical expenses, lost wages, pain and suffering, costs for additional surgeries, and punitive damages. The amount depends on the severity of injuries and the impact on the victim’s life.

3. How long do I have to file a lawsuit for injuries caused by transvaginal mesh implants?

The statute of limitations for filing a lawsuit varies by state but typically ranges from one to three years from the date of injury or discovery of the complications. Consult with a lawyer to understand the specific timeline for your case.

4. How do I file a transvaginal mesh lawsuit?

Filing a transvaginal mesh lawsuit involves consultation with a lawyer to evaluate your case, gathering medical records of complications and surgeries, your attorney filing claims against the manufacturer, and either negotiating a settlement or going to trial.

5. Which transvaginal mesh products have been involved in lawsuits?

Products involved in lawsuits include Johnson & Johnson’s Ethicon TVT and Gynecare products, Bard’s Avaulta systems, American Medical Systems (AMS) products like SPARC, and Boston Scientific products such as the Advantage Sling System and Obtryx Mesh Sling.

6. What are the risks associated with transvaginal mesh compared to traditional procedures?

According to the NEJM study, mesh devices carry higher risks than traditional procedures. About 3.5% of women implanted with surgical mesh suffered complications compared to only 0.5% of women who received colporrhaphy. The rate of SUI was more than 12% for mesh recipients versus 6.3% for colporrhaphy patients.

7. What has the FDA said about transvaginal mesh products?

The FDA has issued safety communications warning that surgical placement of transvaginal mesh to repair POP may expose patients to a greater risk of side effects than other treatment options [7]. The FDA has received thousands of reports linking these implants to severe complications.

Get a Free Transvaginal MeshLawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for transvaginal mesh complications. The statute of limitations typically ranges from one to three years from the date of injury or discovery.

The Medical Device & Products Liability Litigation Group at Schmidt & Clark, LLP is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in transvaginal mesh and vaginal mesh lawsuits. Our personal injury attorneys are handling individual litigation nationwide and currently accepting new transvaginal mesh product complication cases in all 50 states

Our services include:

• Free, confidential consultations.
• No upfront costs or fees.
• Payment only if we win your case.

References

1. https://www.classaction.com/transvaginal-mesh/settlement/
2. https://www.reuters.com/article/breakingviews/endo-agrees-to-830-million-settlement-of-vaginal-mesh-cases-idUSBREA3T15G/
3. https://www.aorn.org/outpatient-surgery/article/2012-June-ethicon-to-stop-selling-transvaginal-mesh
4. https://www.icij.org/investigations/implant-files/leading-manufacturer-exits-vaginal-mesh-market/
5. https://www.cebm.ox.ac.uk/research/transvaginal-mesh
6. https://pmc.ncbi.nlm.nih.gov/articles/PMC4165670/
7. https://www.govinfo.gov/content/pkg/USCOURTS-ca4-15-01454/pdf/USCOURTS-ca4-15-01454-1.pdf