Transvaginal Mesh Injury Overview

Transvaginal mesh (TVM) is a flexible patch implanted in the vaginal wall to strengthen its structure. Surgeons used to employ pelvic mesh to correct two conditions: pelvic organ prolapse and stress urinary incontinence. But the FDA ordered all device manufacturers to stop marketing and distributing transvaginal mesh for pelvic organ prolapse in April 2019.

Pelvic organ prolapse (POP) is a weakening of the pelvic muscles that allows organs to slip out of place. Stress urinary incontinence (SUI) is the loss of bladder control from coughing, sneezing, exercise, and other strenuous activities.

In recent years, researchers have linked TVM surgical mesh to several serious complications. As a result, many patients have filed product liability lawsuits against mesh manufacturers. This article offers an overview of these complications. It also discusses how transvaginal mesh lawsuits work.

What Is Transvaginal Mesh?

Medical professionals have used surgical mesh since the 1950s. Surgeons initially used it for hernia repair and other reconstructive surgeries. In the 1970s, doctors started using mesh to help with pelvic organ prolapse.

Around that same time, surgeons began using mesh products to help with stress urinary incontinence. TVM is a net-like material surgeons use to strengthen and reconstruct weak pelvic walls.

Depending on the type of mesh your doctor uses, the material may remain in your body permanently. Other mesh devices absorb into your body and gradually weaken.

Manufacturers of Transvaginal Mesh

Several companies manufacture and distribute transvaginal mesh. Some major manufacturers include Boston Scientific, C.R. Bard, and Ethicon (a subsidiary of Johnson & Johnson). Another company, American Medical Systems, was one of the first manufacturers to settle a large class of TVM lawsuits.

Most transvaginal mesh devices carry the risk of serious complications. As a result, plaintiffs have filed personal injury lawsuits against almost all pelvic mesh product manufacturers.

Types of Transvaginal Mesh

There are three main types of transvaginal mesh products. Two contain synthetic (man-made) materials. The third contains animal products.

The three types of surgical mesh devices include:

• Non-absorbable: These stay in your body forever. Non-absorbable meshes don't break down as easily as absorbable meshes. This doesn't mean your doctor won't need to perform revision surgeries. Sometimes, patients experience more severe problems with non-absorbable mesh because it doesn't disappear over time.
• Absorbable: This is another synthetic type of mesh. Over time, your body absorbs the mesh material. When this happens, you may need additional surgeries or treatment.
• Animal-derived: These TVM contain animal materials, usually from a pig or a cow. These are also absorbable and weaken over time.

Regardless of your TVM type, there is a risk of adverse health consequences.

U.S. Food and Drug Administration and TVM

The U.S. Food and Drug Administration (FDA) didn't have the authority to regulate medical devices until 1976. Any devices already on the market were grandfathered in. At first, the FDA categorized TVM as a Class II medical device. This meant they posed a risk to human health, but the benefits outweighed the risks. It wasn't until 2019 that the FDA reclassified the device as a Class III, high-risk medical device.

In 2019, however, the FDA declared that manufacturers could no longer market TVM for POP. They could still distribute the devices for SUI. Companies had to withdraw their TVM for pelvic organ prolapse products from the market immediately.

One of the primary reasons the FDA issued a mandatory withdrawal was because of the severe complications they caused. We will discuss these complications and the ensuing lawsuits below.

Common TVM Complications

Before the FDA ordered a withdrawal of TVM for POP, it issued several warnings about these products. In 2008 (updated in 2011), the FDA warned that the complications of TVM were frequent. They often required extensive medical treatment. In many cases, patients had to undergo revision surgeries due to these severe complications.

Not only were the devices dangerous, but many patients experienced a re-occurrence of POP or SUI. This made the FDA question the effectiveness of the procedures.

Mesh Erosion

One of the most common TVM complications is mesh erosion. This occurs when the mesh breaks down and erodes shortly after the surgeon places it in the patient's body. Since the mesh fragments are entwined with the tissue, removing them can be complicated.

Organ Perforation

Organ perforation is another common side effect of TVM procedures. Sharp pieces of mesh left over from mesh erosion can slice and perforate nearby organs. This can cause internal bleeding. Due to the perforations, urine and fecal matter may also enter the body. Perforations can lead to severe infections.

Patients who experience mesh erosion or organ perforation usually require extensive treatment. Treatment includes:

• Surgical procedures
• IV therapy
• Blood transfusions
• Drainage of hematomas or abscesses

Transvaginal Mesh Injury Lawsuits

TVM complications can cause patients a great deal of pain. They severely impair patients' quality of life. Treatment for patient injuries can also result in substantial medical bills. This is why so many patients have filed transvaginal mesh injury lawsuits against the manufacturers.

Plaintiffs have been suing the manufacturers of TVM for over 10 years. Below is a summary of the significant TVM lawsuits.

South Dakota Woman Sues Johnson & Johnson

In 2013, a New Jersey jury awarded $3.35 million to a South Dakota woman who sued Johnson & Johnson. The plaintiff alleged that the company did not adequately warn her doctor of the potential dangers of a vaginal mesh implant. She also claimed that the defendant misrepresented its product in brochures.

American Medical Systems Settles Thousands of Vaginal Mesh Lawsuits

Over the years, thousands of patients have sued American Medical Systems (AMS) for injuries due to TVM complications. The company settled most of these cases for undisclosed amounts. But AMS settled claims for publicly disclosed amounts in those instances.

In 2013, a New Jersey jury awarded $11 million to a woman who said her injuries were due to defects in AMS' Gynecare Prolift mesh products.

In 2014, American Medical Systems settled a lawsuit involving over 20,000 claimants for $830 million. The company had settled a prior claim for more than $54 million. Plaintiffs in these cases argued that AMS intentionally marked a dangerous product and failed to warn patients and doctors about the risks of its TVM.

In February 2023, the United States Supreme Court upheld a verdict of more than $20 million a jury granted to the state of California. By February 2024, the company had resolved all but 194 cases pending in a federal multidistrict litigation.

C.R. Bard Settles Thousands of TVM Cases

In October 2014, C.R. Bard agreed to settle over 500 claims for just $21 million. The judge said it was unhappy with this low amount. It threatened the company that if it didn't resolve all outstanding claims, it would face billions in jury verdicts.

In December of that same year, C.R. Bard settled claims filed by attorneys general in 48 states for $60 million.

Finally, in 2015, the mesh manufacturer settled the remaining 3,000 claims for $200 million.

Boston Scientific Settles More Than 95% of All Legal Claims

Like many other vaginal mesh manufacturers, Boston Scientific faced numerous lawsuits filed by the various states. In all, 47 states filed legal claims against the company. In 2021, the company settled these claims for $189 million.

Before settling the state claims, Boston Scientific had settled 3,000 lawsuits in April 2015 for close to $120 million. That same year, the manufacturer resolved the remaining 350 lawsuits for an undisclosed amount.

Boston Scientific faced claims both in the United States and Australia. In March 2023, the company paid more than $8 billion for TVM lawsuits. It settled another set of claims for over $105 million.

Coloplast Faces Lawsuits in West Virginia

In January 2014, Coloplast settled 400 lawsuits in the Southern District of West Virginia for $16 million. Coloplast has resolved all legal claims regarding TVM. They faced the second-fewest amount of lawsuits as compared to other TVM manufacturers.

Product Liability Law

Most TVM lawsuits involve the manufacturers or sellers of medical devices. The courts may hold these parties liable for placing a dangerous or defective product on the market.

Generally, people who suffer an injury from a defective medical device can sue any party in the distribution chain. This includes the following:

• Designer
• Manufacturer
• Distributor
• Wholesaler
• Retailer

Successful claimants can recover compensation for medical bills, lost wages, and pain and suffering. In rare cases, the courts may also award the plaintiff punitive damages. This only happens when the judge wants to punish the defendant or make an example out of them.

Under product liability law, a product must meet the consumer's ordinary expectations. This means that it must be as safe as possible. Manufacturers must also warn consumers (patients) about any risks of their products.

For example, a claimant bringing a transvaginal mesh lawsuit may argue that the mesh had a design defect. They may claim the defendant designed the device, knowing it would erode over time. Plaintiffs can also claim that the defendants engaged in defective marketing since they didn't provide adequate warnings. After all, the device manufacturers marketed TVM as a long-term solution to several conditions.

Medical Malpractice

Medical device manufacturers aren't the only ones who may be responsible for patient injuries. Surgeons and medical professionals who implant your mesh may be liable as well. For example, a doctor who improperly implants the mesh may be responsible for medical malpractice. The same is true if the doctor was negligent in how they handled the surgery.

A doctor may also be liable if they don't disclose the possible risks and complications of transvaginal mesh implants.

Your attorney could file a medical malpractice lawsuit against the medical professional in these cases. Depending on how egregious the doctor's behavior was, you may be able to recover punitive damages.

Class Action Lawsuits vs. Individual Lawsuits

One of the first steps for people wanting to file a transvaginal mesh lawsuit is deciding whether to join a class action suit or file a private lawsuit. Both have advantages and disadvantages.

A class action lawsuit involves multiple claimants with similar injuries who want to sue the same defendant. One advantage of a class action lawsuit is that plaintiffs don't have to attend court proceedings.

This is important for claimants who are still recuperating from revision surgery. It also benefits plaintiffs who want to stay out of the public eye. Due to their size, class action suits significantly impact society at large. Class action lawsuits alert the public to possible dangers.

Private lawsuits, on the other hand, are filed by a single plaintiff. Claimants usually have a better chance of receiving a substantial jury verdict or settlement. The plaintiffs in a class action lawsuit must split the settlement proceeds.

Sometimes, these cases involve hundreds or thousands of people. It can also take much longer for a class action lawsuit to resolve.

Filing a Transvaginal Mesh Surgery Claim

Filing a transvaginal mesh lawsuit can be difficult. It requires hours of research and in-depth knowledge of product liability law. Before moving forward with your vaginal mesh lawsuit, speak with a legal professional.

You must file your claim before the statute of limitations expires. In most states, you only have two or three years to file your transvaginal mesh case. Your attorney will need time to review and prepare your case. Don't wait until the last minute to find a product liability attorney near you today.

Most product liability lawyers offer new clients a free case review. Visit FindLaw.com's attorney directory to find a lawyer in your area.