Transvaginal mesh, which was designed to treat pelvic organ prolapse (POP), stress urinary incontinence (SUI), and other pelvic floor disorders, was first approved for surgical implantation in 1996. Unfortunately, in the decades since, it’s become clear that this device poses the risk of serious—and sometimes even life-threatening—complications.
While surgical mesh in general is still widely used to treat a host of conditions, transvaginal grafts in particular are no longer available. In 2019, the FDA ordered all manufacturing of transvaginal mesh implants to cease immediately. They determined the devices did not come with a reasonable assurance of safety or effectiveness. As such, their risks outweighed their benefits.
If you or someone you love underwent surgery for a pelvic floor disorder prior to 2019, there’s a good chance that transvaginal mesh was used. And if you or your loved one has since developed health problems as a result, your family may have grounds for legal action.
Read on to learn more about these devices, as well as their potential complications and associated lawsuits.
Hernia meshes, which are still used, are also associated with various dangers. If you or a loved one is experiencing symptoms that might be related to a surgically-inserted hernia mesh, be sure to read our guide to hernia mesh lawsuits.
- What Is Transvaginal Mesh?
- What Are the Symptoms of a Transvaginal Mesh Complication?
- Major Lawsuits and Investigations
- Which Transvaginal Mesh Devices Were Recalled?
- What Should I Do If I Have Been Affected by Transvaginal Mesh?
- Do I Qualify to Be Part of a Transvaginal Mesh Lawsuit?
- How Does a Transvaginal Mesh Lawsuit Work?
- How Long Does It Take to Settle a Transvaginal Mesh Lawsuit?
- Why Transvaginal Mesh Lawsuits Often Take Years
- What Is the Statute of Limitations on a Transvaginal Mesh Lawsuit?
- How Much Can You Get From a Transvaginal Mesh Lawsuit?
- How Long Does It Take to Get Your Money After You Settle a Lawsuit?
- Final Thoughts
What Is Transvaginal Mesh?
Transvaginal mesh refers to a medical device that’s used to reinforce the walls of the pelvis. Before the FDA cleared transvaginal mesh for use in clinical settings, doctors usually treated conditions like POP with hysterectomies.
Since implanting transvaginal mesh is much less invasive than performing complicated abdominal surgery, though, it quickly became the preferred modality. What’s more, strengthening the pelvic walls with mesh scaffolding appeared to be just as effective—if not more so—at both restoring the patient’s health and preventing recurrence.
The FDA recognized four categories of mesh for transvaginal implantation. Devices were categorized based on how they reacted inside the body. The categories included:
Comprised of plastic or polyester, non-absorbable synthetic devices were once the top choice for surgeons. Not only did these meshes react better with connective tissue, but they also had a lower rate of infection than their absorbable counterparts.
As their name implies, absorbable synthetic devices were absorbed by the new tissue that grows around them. These devices were especially effective at strengthening ligaments in the pelvic area.
Derived from natural materials, like animal products, biologic meshes degraded over time. Most often made of cow or pig tissue, these devices were gradually replaced by the body’s own tissue.
Composite meshes were made from a combination of non-absorbable synthetic, absorbable synthetic, and biologic materials. As such, some portions of these devices were absorbed while others remained in place permanently.
What Are the Symptoms of a Transvaginal Mesh Complication?
Understanding the kinds of complications that transvaginal mesh can cause—and their associated symptoms—is essential if you intend to take legal action. Should this medical device fail during or sometime after implantation, the patient can experience:
- Nerve damage
- Neuro-muscular issues
- Organ perforation
- Autoimmune problems
- Vaginal scarring and the subsequent shrinkage of the canal
The earliest warning signs of transvaginal mesh-related problems—which may not arise from months or even years after implantation—depend on the complication in question. Generally speaking, though, symptoms typically include some combination of the following:
- Bleeding unrelated to menstruation
- Nausea and vomiting
- Discomfort in the pelvic area
- Painful intercourse
- Incontinence or urinary blockages
Major Lawsuits and Investigations
Since medicine is far from an exact science, there are no guarantees when it comes to health care. When a woman undergoes surgery for a pelvic floor disorder, though, it’s reasonable for her to assume that she won’t end up in a worse condition than she was prior to the procedure.
This is because manufacturers have a duty of care to produce devices that won’t cause harm when used as instructed. Unfortunately, it’s become clear that transvaginal mesh products—even when implanted properly—do not fall into this category.
Complications caused by these devices have warranted more than 108,000 lawsuits against their manufacturers, yielding roughly $8 billion in settlements for affected parties—so far. As of November 2019, there were still thousands of pending claims against C.R. Bard, American Medical Systems, Boston Scientific, and Ethicon.
These manufacturers have been accused of:
- Intentionally misrepresenting the safety and effectiveness of their transvaginal mesh products
- Failing to test their devices properly
- Failing to confirm the extent of the risks their devices pose
- Failing to devise safe and effective means for removing the products as needed
- Failing to warn the medical community, patients, or the public about the potential complications their devices can cause
Which Transvaginal Mesh Devices Were Recalled?
Only one specific transvaginal mesh device has technically been recalled; however, the FDA has issued safety notices, organized advisory committees, and ordered manufacturers to stop the production of all others.
The ProteGen Sling Recall
The first transvaginal mesh product on the market, the ProteGen Sling was also the first—and only—device to be recalled. The manufacturer, Boston Scientific, recalled the product in 1999 over safety concerns. Primarily used to treat stress urinary incontinence, the sling caused “higher than expected” rates of infection, urethrovaginal fistula, and vaginal erosion.
The sling was never actually implanted in a human vagina prior to entering the market, nor did it undergo controlled clinical trials. Perhaps most troubling, though, is the fact that other manufacturers produced devices based on the sling’s original design, yet the ProteGen recall did not affect their approval status.
The FDA’s Response
The FDA started receiving reports that transvaginal mesh products were causing unanticipated complications in 2005; however, it wasn’t until 2016 that the administration finally classified the use of surgical mesh for transvaginal repair as “high risk.”
In the years between, they issued a number of safety notices and held one committee meeting. Since manufacturers kept producing the devices, though—and providers kept using them—hundreds of thousands of patients who sought treatment for a pelvic floor disorder were put at risk. In 2010 alone, approximately 75,000 women received a transvaginal mesh implant to combat POP, and an additional 200,000 underwent the procedure for SUI.
The FDA finally ordered manufacturers to stop selling transvaginal mesh products in 2019. Similar devices that are implanted abdominally, though, remain on the market today.
What Should I Do If I Have Been Affected by Transvaginal Mesh?
If a transvaginal mesh product has hurt you or someone you love, your family may be able to hold the manufacturer or surgeon financially accountable for the associated damages. Since there’s no class action lawsuit, you’ll have to proceed on your own. That doesn’t mean, however, that you’re alone in this fight.
Most of these claims are being handled under multidistrict litigations (MDLs), which essentially combine several small but similar cases into a single, larger suit. This serves to expedite the proceedings, reduce the costs for all parties involved, keep the courts from being flooded with claims, and ensure consistent rulings.
Although these cases are consolidated, the plaintiffs remain entitled to individual awards. As such, each is responsible for gathering his or own evidence of liability and damages. Since building a strong claim is inherently challenging—and calls for considerable resources, not to mention access to a vast legal network—it’s wise to hire a personal injury attorney before getting started.
To learn more about transvaginal mesh lawsuits and their eligibility requirements, fill out our form to have a licensed lawyer contact you. Since the initial case evaluation will be free, you’ve got nothing to lose.
Do I Qualify to Be Part of a Transvaginal Mesh Lawsuit?
The easiest way to determine whether you have grounds for a transvaginal mesh lawsuit is by consulting an attorney. A lawyer experienced in these suits will let you know if taking legal action could be worthwhile by evaluating the following.
The Device in Question
Who manufactured your transvaginal mesh product? And what was the name of the device in question? This information, which should be noted in your medical records, will provide a starting point for your attorney’s investigation. It will also allow your legal team to review any existing MDLs that reference the same product, as you may be able to join one.
The Complications You Suffered
Unfortunately, just because you suffered complications following implantation doesn’t mean you’re automatically entitled to a monetary award. Since every medical procedure carries risk, an operation that doesn’t go as planned doesn’t necessarily warrant litigation. In order to have grounds for a transvaginal mesh lawsuit, you must have suffered complications that could have been prevented had the manufacturer or surgeon exercised reasonable care.
To give your claim the best chance of success, start a personal injury journal as soon as it becomes clear that your body is not responding to the device as it should. Write detailed entries about the symptoms you experience, including their severity, duration, and prescribed treatment. Such entries will help your lawyer build a strong suit on your behalf.
How Does a Transvaginal Mesh Lawsuit Work?
If you file a transvaginal mesh lawsuit, be prepared to navigate complicated proceedings, especially if your case is grouped into an MDL. Since most claims end up joining an MDL, you’ll want to find an attorney who’s well-versed in such proceedings.
After you bring your individual suit, it will be sent to a state or federal court that’s equipped to handle it alongside all the others.
Who Should I Name in My Suit?
Most transvaginal mesh suits are brought against manufacturers. There are some scenarios, though, in which the patient’s medical provider is partially or wholly to blame for the associated complications.
If your doctor failed to inform you of the device’s risks, for example, or did not provide adequate follow-up care, you may have grounds for a medical malpractice claim in lieu of or in addition to a product liability suit.
On What Grounds Can I Sue?
A knowledgeable personal injury lawyer can help you determine whom to sue and why by conducting a thorough investigation. When it comes to transvaginal mesh-related complications, there are four common reasons to proceed with litigation.
If a manufacturer produced and sold a device with a design flaw, they’re liable for any damages that result. Unlike other kinds of tort claims, defective design cases are founded on strict liability, which means the defendant is responsible regardless of whether they were aware of the defect in question.
In other words, you won’t have to prove negligence to win a defective design transvaginal mesh suit. Instead, you’ll have to demonstrate how you suffered complications despite using the device as intended. To bolster your claim, you will need to identify the flaw on the device’s original schematics.
Thus far, the largest verdict against a transvaginal mesh manufacturer was awarded on the grounds of a design defect. In 2015, a jury ordered Boston Scientific to pay Deborah Barba $100 million because their Pinnacle and Advantage Fit mesh implants had design flaws. An appeal judge deemed the award excessive, and Barba walked away with $2.5 million in compensatory damages and $7.5 million in punitive damages instead—still a sizable sum.
Sometimes, a device’s design is perfectly safe, but something goes wrong during the manufacturing process. If the meshes are produced in an unsanitary facility, for example, the patients who end up using them will be vulnerable to infection.
To win a case on the grounds of a manufacturing defect, you’ll have to prove that the product was defective when it left the plant. You’ll also have to prove that the defect in question was wholly responsible for the complications you suffered.
Gathering the evidence needed to prove these essential elements—everything from the facility’s standard operating procedures to the workers’ depositions—certainly poses a challenge. Fortunately, if you enlist help from a resourceful lawyer, you can focus on your health while your legal team does all the work. Fill out our form to have one contact you.
Manufacturers have an obligation to list all known hazards on every product’s packaging. When it comes to medical devices, they must also inform practitioners of less obvious complications and usage limitations. Failing to so so—by labeling meshes as a cure-all for pelvic floor disorders when they’re not, for example—could prove disastrous.
If a patient suffers because his or her provider was ill-informed, he or she might name both the manufacturer and surgeon in the subsequent suit. This is because practitioners have an obligation to follow the most widely accepted standard of care.
If an implant’s label claims the device can treat conditions that are typically addressed in some other way, it’s up to the provider to do additional research before deviating from the standard treatment for the condition in question.
If your transvaginal mesh was neither recalled nor defective but you still suffered complications, your surgical team may be to blame. Perhaps they used the wrong size, for example, or inserted it improperly.
Because medicine is not an exact science, malpractice is one of the most challenging grounds on which to build a case. In addition to demonstrating how your doctor deviated from the most widely accepted standard of care, you’ll have to prove that the complications you suffered were a direct result of said negligence.
Since this calls for a comprehensive investigation, it’s wise to enlist help from a resourceful attorney. Fill out our form to have one contact you.
How Long Does It Take to Settle a Transvaginal Mesh Lawsuit?
Because transvaginal mesh lawsuits are incredibly complex—and legal proceedings are inherently unpredictable—there’s no way to determine on day one precisely how long your case will take to resolve.
A personal injury lawyer can evaluate the most common factors that will influence the duration of the proceedings, though, to give you some idea of what to expect. Such factors include the extent of your injuries, the complexity of your case, the grounds on which you intend to sue, and the number of defendants you will be naming.
Your legal team can also review similar suits that are no longer pending to let you know what may happen along the way. If your case joins an MDL, for example, it will likely be a couple of years before a verdict is reached. Generally speaking, most MDL suits are resolved within three to five years.
Why Transvaginal Mesh Lawsuits Often Take Years
When facing the stress that comes with health complications—not to mention mounting medical bills, lost wages, and a host of other associated damages—three to five years can feel like an eternity. Unfortunately, there’s not much you or your legal team can do to speed up the proceedings.
Lawsuits must pass through a number of stages, each of which can take several months—or longer. Stages include outlining a demand package, filing a formal complaint, conducting discovery, attending mediation, submitting pre-trial motions, and going to trial.
While the parties may settle at any point during these proceedings, claims seeking seven-figure payouts—like many of those involving transvaginal mesh-related complications—tend to go all the way to trial. When so much is at stake, defendants are rarely inclined to meet the plaintiff’s demands and will refuse to do so unless ordered by a judge or jury.
What Is the Statute of Limitations on a Transvaginal Mesh Lawsuit?
Statutes of limitations are essentially filing deadlines. Although every state allows for exceptions, injured parties generally have a limited amount of time to file a formal lawsuit after they’ve been wronged. If you attempt to bring your suit after the applicable deadline has passed, the court will likely dismiss your case.
For personal injury suits, including those involving transvaginal mesh-related complications, most states have a two-year statute of limitations. In a state with such a deadline, you would have two years from the date on which you knew—or should have known—that you were suffering complications related to your implantation to take legal action.
As there are a number of exceptions that can either shorten or extend the filing deadline, though, it’s best to consult an attorney as soon as possible.
How Much Can You Get From a Transvaginal Mesh Lawsuit?
The total value of your transvaginal mesh claim will depend on a number of factors, including:
- The severity of the complications you suffered and the extent of their associated damages
- The strength of the evidence you present
- The liable party’s total available insurance coverage
- Any applicable damage caps imposed by the state in which you file
- Whether you took reasonable measures to mitigate damages
- Whether you’re entitled to a punitive award in addition to the standard compensatory damages
Just as filing deadlines vary from state to state, so do recoverable damages. They typically include medical bills, lost wages, reasonably necessary replacement services, emotional distress, loss of enjoyment in life, and pain and suffering. Your spouse or life partner may also be entitled to compensation for loss of consortium.
It’s important to remember that you won’t be able to recover a single dime, though, unless you can prove you actually incurred these damages. As such, you should make sure to save all the bills, receipts, invoices, and paystubs that correspond to any recoverable damages. As for tracking your non-monetary losses, keep a personal injury journal, and write about the ways in which your condition is hurting your quality of life.
How Long Does It Take to Get Your Money After You Settle a Lawsuit?
From the day you hire an attorney to the day your case is resolved, it will probably feel like a lifetime has passed. Unfortunately, it could still be quite a bit longer before you actually secure the funds you’re owed.
This is because all applicable expenses must be deducted from the award. Examples include health insurance liens, medical bills, court costs, and contingency fees. Once all these expenses have been sorted out, you should receive a check for the remaining balance.
While there’s no guarantee that a transvaginal mesh lawsuit will yield a satisfactory settlement, there’s only one way to find out. If your life was forever changed because a manufacturer or practitioner failed to act with reasonable care, call an attorney to determine the best way to proceed, or fill out our form to have one reach out to you.