Bard Vaginal Mesh: An Overview

Surgical mesh products, also known as vaginal, transvaginal, or pelvic mesh, were developed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women.

These conditions can cause considerable discomfort and lower quality of life.

Pelvic organ prolapse occurs when the pelvic organs, such as the uterus, bladder, or rectum, move from their natural positions and bulge into the anterior vaginal wall.

Stress urinary incontinence (SUI) results in the involuntary release of urine during physical activities, such as laughing, sneezing, or exercising.

Surgical mesh devices were designed to offer a solution.

Patients can undergo female pelvic reconstructive surgery to have mesh inserts placed in the pelvic region.

A transvaginal mesh implant can provide support and stability to these pelvic organs, help restore normal bladder function, and alleviate the associated symptoms.

C.R. Bard, Inc. was one of the leading manufacturers of these products.

C.R. Bard vaginal mesh devices include:

• Bard Avaulta Solo Synthetic Support System for POP
• Bard Avaulta Plus BioSynthetic Support System for POP
• Bard Pelvitex Polypropylene Mesh for SUI
• Bard PelviSoft Biomesh for SUI
• Bard Pelvicol Tissue for SUI
• Bard PelviLace for SUI

These products are made of synthetic materials, including polypropylene and polyester, which have been linked to complications in many patients.

Bard Vaginal Mesh Lawsuits: Reasons Behind the Litigation

Over the years, C.R. Bard’s vaginal mesh products have faced substantial legal scrutiny due to complication reports from women who received these implants.

The key reasons behind the Bard vaginal mesh lawsuits include:

• Chronic Pain and Discomfort: Many patients report chronic pelvic pain and discomfort due to the mesh eroding into surrounding tissues or organs, affecting their daily activities and quality of life.
• Infections and Inflammation: Some patients experience infections or inflammation in the surrounding tissues due to mesh implants, leading to further complications like sepsis.
• Mesh Erosion: One of the most common and concerning complications is mesh erosion. This problem occurs when the mesh erodes through the vaginal wall or other pelvic organs, leading to severe pain, infection, and complications.
• Vaginal Bleeding: The erosion of mesh can also cause vaginal bleeding, which can be severe and require medical intervention.
• Vaginal Scarring: Many women reported experiencing painful and extensive vaginal scarring after the implantation of Bard vaginal mesh. This condition can lead to chronic discomfort and pain during sexual intercourse.
• Organ Perforation: The sharp edges of the mesh products can cause perforation or puncture in surrounding organs, including the bladder or bowels. These cases require surgical treatment.
• Serious Complications: Women who received Bard transvaginal mesh implants have reported a range of serious complications, including abnormal discharge, urinary problems, pelvic abscess, and recurrent urinary tract infections. These complications can significantly impact their quality of life.
• Recurrent POP and SUI: In some cases, the transvaginal mesh devices failed to adequately address pelvic organ prolapse or stress urinary incontinence, necessitating further surgeries and exacerbating patients’ health issues.

Vaginal mesh complications have affected thousands of women with Bard mesh implants.

As a result, numerous plaintiffs have filed lawsuits against C.R. Bard, Inc., and other manufacturers of similar products to seek compensation for their injuries and related damages.

Settlements for Bard Vaginal Mesh Lawsuits

Bard vaginal mesh lawsuits have resulted in several settlements over the years.

Amultidistrict litigation (MDL) was established in 2012 to consolidate the numerous cases related to Bard’s mesh products.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) established a streamlined process for these cases to expedite the legal proceedings.

After years of litigation, the Bard vaginal mesh MDL resulted in several substantial settlements, with the defendants agreeing to pay billions of dollars to settle thousands of lawsuits.

While the MDL has been largely resolved, individuals injured by Bard vaginal mesh might still be eligible to file lawsuits in state courts.

Settlements in vaginal mesh lawsuits vary depending on the specifics of each case.

Some plaintiffs have received compensation for medical expenses, pain and suffering, lost wages, and more.

It’s crucial for individuals who have experienced complications related to Bard’s vaginal mesh to consult with an experienced transvaginal mesh lawyer to assess their potential case and determine eligibility for compensation.

Here are significant Bard vaginal mesh settlements reached over the years:

• July 2012: A California jury found C.R. Bard responsible for a woman’s injuries, awarding her $3.6 million in damages.
• October 2014: C.R. Bard settled over 500 vaginal mesh lawsuits and paid $21 million to the plaintiffs.
• August 2015: The vaginal mesh manufacturer paid $200 million to settle another 3,000 transvaginal mesh lawsuits.
• April 2018: A New Jersey jury awarded a woman $23 million in damages and her husband $10 million for loss of consortium in a case against C.R. Bard. The manufacturer had to pay $35 million in punitive damages. However, an evidence error by the trial judge led to the verdict’s reversal in 2021.
• September 2020: Becton Dickinson and Co., C.R. Bard’s parent company, agreed to pay $60 million to settle with 48 states and Washington, D.C., to resolve allegations of concealing the risks of its vaginal mesh implants.

These are just a few of the most significant settlements in Bard’s vaginal mesh lawsuits.

Many other cases have settled for undisclosed amounts.

It’s essential to note that each case is unique, and the outcome of one lawsuit does not guarantee a similar result in another.

However, these settlements have provided some compensation to women who have suffered from complications related to Bard’s vaginal mesh products and brought awareness to the potential dangers of these devices.

Current Status of Ongoing Litigation

The Bard vaginal mesh lawsuit landscape has evolved, and MDL cases have been resolved.

There were seven major vaginal mesh MDLs with seven leading manufacturers, including C.R. Bard.

The combined number of cases in these MDLs reached over 100,000, making it one of the most extensive mass tort litigations in U.S. history.

As mentioned, the latest MDL was closed in November 2022, and cases were remanded back to their original state courts.

The number of lawsuits and severity of complications of transvaginal mesh products are proof of the risks and adverse effects that individuals have faced.

However, Bard’s legal battles are far from over.

Even as MDL cases have been resolved, there are still ongoing individual lawsuits and potential class action lawsuits against the manufacturer.

Women who have experienced complications related to transvaginal mesh products should consult with a qualified transvaginal mesh lawyer to understand their legal options and determine if they should file a lawsuit against C.R. Bard.

While the resolution of MDL cases may seem like the end of this litigation, it is essential to remember that victims may be eligible to still pursue justice through individual lawsuits and settlements.

Individuals should stay informed about ongoing developments and consult with a transvaginal mesh lawyer to understand their legal options.

If you or a loved one have experienced complications from Bard’s vaginal mesh products, it is crucial to seek legal guidance and determine if you are eligible for compensation. 

Comparing Bard With Other Vaginal Mesh Products

For a broader perspective on the issue of vaginal mesh complications, it’s vital to touch upon other brands and types of vaginal mesh that have been linked to injuries.

Some other companies that have faced litigation related to their mesh products include:

• American Medical Systems, Inc.
• Boston Scientific Corp.
• Ethicon, Inc. (a subsidiary of Johnson & Johnson)
• Coloplast Corp.
• Cook Medical, Inc.
• Neomedic

These companies have faced thousands of lawsuits and paid significant amounts in settlements.

The similarities between the allegations against these companies and Bard highlight the widespread issue of vaginal mesh complications and emphasize the need for stricter regulations and patient safety measures.

FDA Guidance, Recalls, and Regulations

The U.S. Food and Drug Administration (FDA) approved the first transvaginal mesh product in 1996 through the 510(k) clearance process.

This process allowed medical devices to be marketed and approved without clinical trials if they were considered substantially equivalent to previously approved products.

It also allowed other companies to introduce their mesh products without conducting proper testing or clinical trials.

This lack of oversight resulted in a flood of vaginal mesh products on the market, leading to the widespread use of these devices by the 2000s.

Soon after the influx of mesh products, reports of complications and injuries started emerging.

These adverse events ranged from mild discomfort to severe injuries, including mesh erosion, infections, and organ damage.

The FDA received thousands of complaints from patients and healthcare professionals regarding transvaginal mesh products.

Since then, it has been actively regulating vaginal mesh products.

On October 20, 2008, the FDA issued a public health notification to address concerns about complications associated with surgical mesh devices used in pelvic organ prolapse repair and stress urinary incontinence treatment.

The notice stated that complications and adverse events from these devices are rare but could lead to severe consequences.

On July 13, 2011, the FDA released an update to its 2008 public health notification, stating that using surgical mesh for the transvaginal repair of pelvic organ prolapse was a “continuing serious concern.”

The agency announced that complications were “not rare” anymore.

They were still investigating whether transvaginal POP repair with mesh was more effective than traditional non-mesh repair or whether it exposed patients to increased risks.

On January 5, 2016, the FDA reclassified surgical mesh devices for transvaginal repair of pelvic organ prolapse from class II (moderate risk) to class III (high risk).

This new classification required premarket approval (PMA) applications for transvaginal mesh products, meaning manufacturers had to conduct clinical trials and provide evidence of safety and effectiveness before marketing their products.

The FDA also mandated that manufacturers had to file for PMA by July 5, 2018, if they wanted to continue marketing their transvaginal mesh products.

This mandate led to manufacturers halting the marketing of their vaginal mesh products,

On April 16, 2019, the FDA finally ordered all manufacturers of transvaginal mesh products to stop selling and distributing their products on the market.

The agency cited that the PMAs submitted by manufacturers did not prove the safety and effectiveness of these products.

Ultimately, the FDA’s actions and regulations regarding transvaginal mesh products highlight the need for better oversight in the medical device industry.

It is also a cautionary tale for the use of other medical devices approved through the 510(k) clearance process without proper testing and clinical trials.

Despite the FDA’s efforts to regulate vaginal mesh products, thousands of women have already suffered complications and injuries.

Victims of Bard’s vaginal mesh products and other brands have filed lawsuits seeking compensation for their damages, including medical expenses, lost wages, and pain and suffering.

Eligibility for Bard Vaginal Mesh Lawsuits

If you or a loved one have a Bard vaginal mesh implant and have experienced complications or injuries, you may be eligible to file a claim against the company.

While eligibility criteria can vary, some general factors may determine whether you have a viable case:

• Nature of Injuries: To be eligible for a Bard vaginal mesh lawsuit, you must have suffered injuries or complications related to the mesh implant. This damage may include mesh erosion, chronic pain, infection, urinary problems, or other severe complications.
• Timeline of Implantation: The timeline of implantation is a crucial factor. Generally, the complications must have arisen after the implantation of the Bard vaginal mesh device. Consult with an attorney to determine if your case falls within the statute of limitations.
• Medical Documentation: Proper medical documentation of your injuries and complications is vital to support your claim. Medical records, surgical reports, and other relevant documents can be valuable evidence.
• Consultation With a Transvaginal Mesh Lawyer: To navigate the complex legal landscape of Bard vaginal mesh lawsuits, consult with an experienced transvaginal mesh lawyer. They can evaluate your case, provide legal guidance, and help you determine your eligibility for a lawsuit.

TorHoerman Law: Your Transvaginal Mesh Lawyer

The C.R. Bard vaginal mesh lawsuit highlights the significant complications that many women have experienced after receiving these transvaginal mesh implants.

While the MDLs have been largely resolved, individuals may still have legal recourse through state courts.

If you or a loved one have suffered complications from a C.R. Bard vaginal mesh implant, TorHoerman Law can help you seek justice and compensation for your damages.

Our experienced team of attorneys can assist you in navigating the legal process and fighting for your rights. 

Contact TorHoerman Law today for a free, no-obligation consultation.

You can also use the chatbot on this page to find out if you qualify for the Bard vaginal mesh lawsuit instantly.