Vaginal Mesh Lawsuit – January 2025 Update

The Vaginal Mesh Lawsuit Is An Active Lawsuit

See If You Qualify!

Women are filing vaginal mesh lawsuits alleging their pelvic mesh implants led to injuries like organ perforation, chronic pelvic pain, sexual dysfunction, fistulas, and other severe injuries. These lawsuits accuse manufacturers like Johnson & Johnson, Boston Scientific, and C.R. Bard of not properly disclosing the potentially dangerous side effects of transvaginal mesh (TVM) products. 

Women harmed by vaginal mesh implants say they did not know the mesh could degrade inside their bodies and cause severe injuries, even years after insertion. Women allege vaginal mesh manufacturers knowingly sold defective TVM products. Women have suffered financial, physical, and mental setbacks associated with their injuries. In an effort to gain compensation for these losses, women are filing state and federal lawsuits against vaginal mesh manufacturers.

Vaginal Mesh Lawsuit News and Updates

December 23, 2024: Transvaginal Mesh Lawsuits Continue To Be Filed Nationwide

Women who have been harmed by faulty vaginal mesh products are continuing to file lawsuits across the country. Although some women have received settlements from previous pelvic mesh multidistrict litigations (MDLs), many women are still taking legal action against mesh manufacturers. Individuals may be entitled to compensation if they suffered adverse health effects after having vaginal mesh implanted. 

October 21, 2024: Study Shows Polypropylene in Vaginal Mesh Begins to Degrade 60 Days After Insertion

A new study published by researchers at the University of Sheffield found that polypropylene, a substance traditionally used in transvaginal mesh implants, can degrade 60 days after it is implanted in a woman’s body. As it degrades, substances used in the mesh can migrate to the tissue near the site of the implant causing severe harm in some women. 

August 19, 2024: Over 100 Women in England Receive Vaginal Mesh Complications Payout 

According to The Guardian, 140 women are set to receive payouts after suffering complications related to their vaginal mesh implants. The women, based in England, all suffered traumatic injuries after their surgeries. It is expected that the payouts will total in the millions once all women have been compensated. Complications related to the vaginal mesh implants include organ perforation, chronic pain, bleeding, and mesh erosion. 

June 3, 2024: Study Indicates Pain Associated with Pelvic Mesh Profound

A study published in the British Medical Journal (BMJ) reviewed nine eligible studies consisting of thousands of patients who received pelvic mesh implants. Many of these patients reported significant pain and other complications related to their pelvic mesh implantation. Despite reporting concerns to their healthcare providers, women often felt that their injuries were dismissed as unimportant or denied altogether. 

April 11, 2024: FDA Provides Update on Urogynecological Surgical Mesh

The U.S. Food and Drug Administration (FDA) has provided an update on urogynecological surgical mesh. The FDA continues to review and evaluate Medical Device Reports (also known as adverse event reports) related to vaginal mesh. The FDA also noted that a review of 522 Stress Urinary Incompetence (SUI) Mini-Slings Studies found them to be just as effective as traditional mid-urethral slings.

About the Vaginal Mesh Lawsuit:

What Is Vaginal Mesh?

Vaginal mesh, which is also called transvaginal mesh or pelvic mesh, is a medical device usually made of a synthetic material. These net-like devices are used to treat conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). As many as one in four women experience pelvic floor disorders, including POP, in their lifetimes. 

Vaginal mesh works by reinforcing weakened vaginal walls, which ultimately helps to support the organs of the pelvis, including the bladder, uterus, and rectum. While there are multiple types of vaginal mesh, it is often non-absorbable and designed for long-term use.

Types of vaginal mesh:

• Non-absorbable synthetic mesh: Made from synthetic materials, including polypropylene, that are not supposed to break down or be absorbed. These devices are designed to provide permanent support.
• Absorbable synthetic mesh: This mesh is also made from synthetic material but is designed to break down or absorb over time. The device encourages new tissue growth and is designed to provide temporary support.
• Biologic mesh: Unlike the other types of vaginal mesh, biologic mesh is derived from animal tissues such as cow or pig tissues. 

In addition to the above types of vaginal mesh, there is also composite mesh, which is made of different kinds of mesh materials. Once implanted, the device allows tissue to grow into the mesh for additional support of the pelvic organs. The device is surgically implanted through the vaginal wall to help prevent organ prolapse and urinary incontinence.

What Does Vaginal Mesh Do?

Vaginal mesh is a medical device inserted in the vaginal wall during surgery to help support or reinforce the pelvic floor. It is most often implanted to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). 

When these meshes are used to treat POP, the devices support organs in the pelvis, including the bladder, uterus, and rectum. These organs may have descended as a result of a weakened tissue structure. When vaginal mesh is used to treat SUI, it helps prevent leakage by placing a mesh sling beneath the urethra.

Transvaginal mesh (TVM), is implanted by a surgeon. The doctor may use various means to insert the mesh device.

Surgical methods to implant vaginal mesh:

• Transvaginal approach: Inserted through an incision in the vagina. Most often used for pelvic organ prolapse repair. It is the most common approach utilized.
  

• Transabdominal approach: Also known as sacrocolpopexy and used for more complex cases, the vaginal mesh is inserted through an incision in the abdomen and attached to the sacrum.
  

• Midurethral Sling Procedure: Used for treating Stress Urinary Incontinence, this minimally invasive technique inserts a narrow mesh strip beneath the mid-urethra via the abdomen or thigh/groin area. 

If successful, pelvic mesh can reinforce tissue that was weakened near the pelvis, alleviating symptoms like incontinence. However, lawsuits filed nationwide allege the mesh is prone to complications after insertion, including migration, erosion, organ perforation, and chronic pain.

Side Effects of Vaginal Mesh: Problems, Issues, and Complications

Vaginal mesh has common and severe side effects. Women across the globe have reported dangerous complications related to their vaginal mesh implants that have caused irreparable harm and chronic pain. 

Common complications of vaginal mesh:

• Erosion: The mesh, particularly when made of polypropene, is reportedly prone to erosion. It can erode through the tissue in and around the vagina, causing it to become exposed. Symptoms of mesh erosion include discomfort, discharge, bleeding, and painful intercourse. In some cases, the erosion may be asymptomatic and only detected during a routine exam.
  

• Pain and Infection: Pelvic pain and discomfort, as well as pain during intercourse, is a common complication of vaginal mesh and should be reported to a healthcare provider. Infection is also a potential side effect.
  

• Incontinence: Urinary problems such as increased urgency, frequency, or urinary tract infections may result from vaginal mesh implantation. 

Severe complications of vaginal mesh:

• Organ Perforation: If the mesh migrates or erodes, it may perforate the bladder, urethra, or rectum. These perforations can also occur during insertion. Any perforation may lead to the formation of a fistula or infection.
  

• Shrinkage of the Mesh: Over time, the mesh can shrink or contract, resulting in severe pain and discomfort during intercourse.
  

• Neuro-Muscular Problems: Some patients have also reported pain related to nerve entrapment or irritation. Neuro-muscular problems are most common in the leg, groin, or back. 

Signs of Vaginal Mesh Erosion

Vaginal mesh erosion is a potential complication of surgery. Erosion occurs when the mesh wears through the tissues of the vagina. Symptoms of mesh erosion include abnormal discharge, bleeding, discomfort, incontinence, and other urinary problems. 

Signs of Vaginal Mesh Extrusion

When the mesh protrudes into nearby pelvic organs or vaginal tissues, it is known as extrusion or exposure. This complication often presents with pain and discomfort and may require surgical intervention. 

Injuries Caused By Transvaginal Mesh Products

Women who experience severe side effects due to their TVM implants can experience a wide range of injuries. Some of those injuries include:

• Mesh exposure due to erosion
• Painful sexual intercourse (dyspareunia)
• Urinary problems
• Vaginal bleeding
• Vaginal pain
• Vaginal scarring and shortening
• Fistula
• Obstruction of the urethra
• Injuries to bowel or bladder (perforation)
• Injuries to nerves (neuralgia)

Many of these complications can be serious and severely impact a woman’s quality of life. These injuries can occur years after an implant.

Treatment for Vaginal Mesh Complications

In some instances, the complications associated with vaginal mesh implantation require excision or removal. Surgery to remove the mesh may be needed if a patient is experiencing chronic pain, infection, bleeding, or other signs that the mesh may have migrated, eroded, or perforated an organ. 

Even after a faulty vaginal mesh is removed, a woman can experience continued complications that impact her physical and mental wellbeing. Women can continue to suffer chronic pelvic pain, vaginal pain, loss of mobility and an impaired quality of life. 

Other Harms Resulting from Vaginal Mesh Injuries

Multiple studies have examined how vaginal mesh injuries can affect women. One study found that after experiencing severe side effects and injuries related to faulty TVM products, some women experienced:

• Psychological trauma
• Increased anxiety and fears 
• Suicidal thoughts
• Severe impacts to intimate relationships

At King Law, we understand the physical and mental toll vaginal mesh injuries take on a woman. We are ready to help you take legal action and fight for compensation for these injuries.

FDA Reclassifies Vaginal Mesh As High-Risk Medical Device

On January 5, 2016, the U.S. Food and Drug Administration (FDA) reclassified surgical mesh used for transvaginal pelvic organ prolapse repair as a high-risk (Class III) medical device. The FDA noted that the reclassification of the devices from a Class II (moderate-risk) to the highest-risk category was due to a rise in adverse event reports and the fact that the products presented an unreasonable risk of illness or injury. 

A Class III medical device requires premarket approval (PMA). In contrast, a Class II device does not need to go through a rigorous review and can enter the market via a 510(k) premarket notification process. Before the reclassification, a 2011 advisory panel had called for additional safety recommendations. The FDA had also ordered postmarket surveillance studies to be conducted. 

In April 2019, the FDA ordered that sales of all transvaginal mesh devices for Pelvic Organ Prolapse be halted. Several manufacturers, including Johnson & Johnson (Ethicon), had voluntarily withdrawn their vaginal mesh products prior to this announcement.

Vaginal Mesh Manufacturers Involved in Lawsuits

Multiple manufacturers have been involved in vaginal mesh lawsuits throughout the country and abroad. Due to the large number of lawsuits filed against these companies, many cases were consolidated into multidistrict litigation (MDL) at district courts nationwide. Although there are no active MDLs for vaginal mesh victims, women can still file lawsuits against manufacturers.

Patients have already filed more 100,000 lawsuits against pelvic mesh manufacturers, including Johnson & Johnson, Boston Scientific, AMS, C.R. Bard, and Coloplast, Many of these lawsuits have resulted in successful settlements or verdicts for women harmed by vaginal mesh. 

Many of these MDLs have been resolved with significant settlements. Even though these MDLs are complete, women who suffer new injuries are encouraged to seek counsel from a qualified legal representative. Women can still file lawsuits for vaginal mesh complications.

Major Manufacturers of Vaginal Mesh Lawsuits:

• Ethicon (Johnson & Johnson)
  • MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation – Terminated on 3/19/2021
  • Devices included the Gynecare Prolift, which was introduced in 2005 for Pelvic Organ Prolapse repair. 
  • J&J stopped selling vaginal mesh products in 2012 after numerous adverse reports.
  • Multiple lawsuits were filed against the company, including those for deceptive marketing, resulting in multimillion-dollar awards and settlements.
    

• Boston Scientific:
  • MDL No. 2326 | In Re Boston Scientific Corp., Pelvic Repair System Products Liability Litigation – Terminated on 2/11/2021
  • Products included the Uphold™ LITE Vaginal Support System, Xenform™ Soft Tissue Repair Matrix, Pinnacle™ Lite Posterior  and Polyform™ designed for POP repair. Distribution and sale of these products ended in 2019 after the FDA’s announcement.
  • Paid over $100 million to settle approximately 2,970 lawsuits. 
  • Other products included the Obtryx Sling System and Pinnacle Pelvic Floor Repair Kit.
    

• C.R. Bard:
  • MDL No. 2187 | In Re C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation – Terminated on 12/21/2020.
  • Pain approximately $200 million to resolve claims related to vaginal mesh products. 
  • Products include the Avaulta Plus, Avaulta Solo, and the Align Urethral Support System. 

Common injuries reported in legal complaints filed against these manufacturers include chronic pelvic pain, infection, organ perforation, and discomfort during intercourse. These injuries can present years after insertion, meaning women should monitor for symptoms and consider taking legal action if they recently discovered an injury.

Eligibility Criteria to File a Vaginal Mesh Lawsuit

Prior to filing a BioZorb lawsuit, plaintiffs must meet certain eligibility requirements. These requirements include proof of implantation of a BioZorb marker and documented complications. 

Eligibility criteria for a vaginal mesh lawsuit:

• Patient must have received a pelvic mesh implant prior to December 31, 2021.
• Patient must have undergone revision or removal surgery.
• Patient must not be represented by another attorney.
• Patient must not have previously settled any pelvic mesh claim

Additionally, women pursuing a vaginal mesh claim will need to present proof of:

• Verified Complications: Must have suffered a verifiable complication related to the vaginal mesh implantation, including mesh erosion or extrusion, chronic pain, infection, organ perforation, or urinary problems.
• Impact on Quality of Life: Injuries must have had an adverse impact on your quality of life, including affecting your sexual function, mental or physical well-being, or mobility.

Recoverable Damages in a Vaginal Mesh Lawsuit

Recoverable damages in a vaginal mesh lawsuit may include both economic and non-economic losses. Compensatory damages in a lawsuit often involve compensation for medical expenses, lost wages, and more. In rare instances, individuals may receive punitive damages.

Damages you can potentially recover in a vaginal mesh lawsuit:

• Past and future medical expenses: Patients who suffered complications after vaginal mesh implantation may be entitled to past and future medical costs, including compensation for surgeries, medications, hospital stays, and more. 
• Lost wages and loss of future income: Income lost as a result of vaginal mesh injuries may be recoverable. 
• Pain and suffering: While harder to quantify, some individuals may be entitled to compensation for the physical pain and emotional suffering caused by their injuries. 
• Loss of consortium: Individuals who suffered a loss of sexual relations from their spouse as a result of their injuries may be able to claim additional damages related to loss of consortium.
• Punitive damages: Such damages are awarded in cases where a manufacturer intentionally disregarded safety concerns about their products or failed to warn consumers. Punitive damages are designed to punish manufacturers for their intentional misconduct or gross negligence and to deter similar behavior in the future.

Evidence Needed to File a Vaginal Mesh Lawsuit

Transvaginal mesh lawsuits generally require substantial evidence to be successful. It is recommended to consult with an experienced attorney to determine the evidence that may be necessary to substantiate your claim.

Evidence that may be necessary to file a vaginal mesh lawsuit:

• Medical records: Proof of surgery, including the initial implantation, post-operative reports, infection records, and diagnostic imaging, may all prove critical to your case. Consultation notes and referrals to specialists can help to prove the severity of your injuries. 
• Personal accounts: Personal logs documenting symptoms such as pain and discomfort, as well as photographic evidence, can help to support your case. 
• Expert testimony: An attorney can assist in retaining expert witnesses to testify about the potential complications associated with vaginal mesh, design defects of the products, and compliance issues that manufacturers have faced from state and federal regulators. 
• Proof of lost wages: Employment records indicating missed work or diminished earning capacity may result in additional damages for lost wages.
• Marketing materials: Marketing materials and other information about the product can help to show how the vaginal mesh was advertised, including any safety statements that were made.

How to File a Vaginal Mesh Lawsuit

There are several steps to filing a vaginal mesh lawsuit. It is critical to discuss your case with an attorney who is well-versed in product liability litigation to help ensure you receive the best possible outcome for your claim. 

Steps to file a vaginal mesh lawsuit:

1. Consult with a vaginal mesh attorney: The first step in a vaginal mesh lawsuit is to consult with a qualified attorney. An attorney can help determine if you meet the eligibility requirements necessary to file a claim. 
2. Gather the necessary evidence: With the help of an attorney, the necessary evidence will need to be gathered. Evidence that can help to substantiate a vaginal mesh claim includes comprehensive medical records, expert testimony, and a personal statement.
3. File the complaint: With the necessary evidence collected, the attorney can then file the complaint. The attorney will ensure that all legal requirements are met prior to filing, including that the claim is filed within the statute of limitations. From there, the attorney will help to navigate the legal process.

Vaginal Mesh Lawsuit Statute of Limitations

The statute of limitations in a vaginal mesh lawsuit is state-specific and should be reviewed by an experienced attorney. Several factors may affect the amount of time a person has to file a claim, including the date the injury was discovered (known as the “discovery rule”). Generally, for vaginal mesh lawsuits, the statute of limitations begins when the patient was advised of complications due to pelvic mesh. The deadline to file a lawsuit may be between 1 and 6 years.

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. It is important to know the date of the initial implantation and the date of diagnosis or discovery of any related complications. Failing to file a lawsuit within the state-specific statute of limitations can result in the forfeiture of the right to compensation. Acting promptly can help to ensure that your case is filed timely and that evidence is preserved.

Vaginal Mesh Settlement and Payout Amounts

The estimated payout range for vaginal mesh lawsuits is between $175,000 and over $450,000. Tens of thousands of women have already received settlements. Several factors will influence the potential value of each case, including the severity of the injuries, the impact to a woman’s physical and mental health, the date of diagnosis, and the ability to prove that the mesh was the cause of the harm.

Contact a Vaginal Mesh Lawyer

Individuals who suffered harm after a vaginal mesh implantation may be entitled to compensation. It is essential to contact an attorney as soon as possible as there may only be a limited amount of time to file a claim. The legal team at King Law has extensive experience handling product liability lawsuits against medical device manufacturers. If a vaginal mesh implant was detrimental to your wellbeing, our team is ready to fight for you. Contact King Law at (585) 496-2648 to schedule a consultation. 

Frequently Asked Questions (FAQs)