Transvaginal Mesh Basics – Background to the Lawsuits
Transvaginal Mesh Basics – Background to the Lawsuits
An overview of vaginal mesh implants, lawsuits, settlements and how we got here
Transvaginal mesh was designed to treat female patients who have experienced vaginal collapse, organ prolapse or stress urinary incontinence. These medical mesh devices have a storied history that includes lawsuits, recalls and devastating complications. Transvaginal mesh is banned in some countries. Learn more about transvaginal mesh lawsuits and whether you can join an active case.
What is a transvaginal mesh implant, and who uses it?
Transvaginal mesh — also known as urogynecologic surgical mesh or pelvic mesh — is used to provide additional support when repairing tissue that has been weakened or damaged. The majority of mesh available is a combination of synthetic materials and animal tissue (cow and pig, mostly). The mesh, which is used in both knitted and non-knitted sheet forms, can absorb into the body for short-term repair or be a permanent implant. The absorbable kind of transvaginal mesh is intended to encourage new tissue growth and add strength to the injured area.
Transvaginal mesh has been used for pelvic organ prolapse, vaginal collapse and stress urinary incontinence. Tweet this
There are many different varieties of TVM implants and they come in various forms: tape, ribbon, mesh, sling and hammock. Transvaginal mesh implants can be broken down into four different types:
Absorbable synthetic: This mesh degrades over time as it is absorbed into the body. It encourages tissue growth at the surgical site, which helps the body to strengthen pelvic ligaments.
Non-absorbable synthetic: This plastic or polyester implant is intended to stay there permanently. Approximately 90% of non-absorbable synthetic mesh is made of polypropylene, a type of plastic. More than 50% of FDA-approved mesh implants are in this category. This is the most popular implant, as it supposedly reacts better with connective tissue and assists the body in repairing itself. These also thought to have the lowest rate of infection. However, see issues with the use of polypropylene in the human body as pointed out by a leading plastics expert.
Biologic: These are the “natural products” created from disinfected animal tissue, which degrade over time and absorb into the body.
Composite: These are made from a combination of absorbable synthetic, non-absorbable synthetic and biologic mesh.
Surgery is conducted either through the abdomen (transabdominal) or through the vagina (transvaginal). The mesh is inserted through a small incision and is held in place by sutures, plastic "legs" on the mesh, or other tissue fixation devices.
When is transvaginal mesh used? (Who is it for and what does it treat?)
The only other non-surgical therapies available are:
pelvic floor exercises
pessaries (small silicone or plastic implants to hold organs in place)
surgery without mesh (when the surgeon uses the patient’s own tissue as support)
However, mesh (TVM) has still been the primary choice for doctors. In POP cases, it is permanently implanted so that the weakened vaginal wall is reinforced. In terms of SUI repair, it supports the urethra or bladder neck by acting as a sling.
What is pelvic organ prolapse (POP) and what are the symptoms?
Pelvic organ prolapse usually presents with pain and discomfort when moving, though sometimes the patient has no symptoms at all.
When organs begin to sag or fall into the vaginal canal because of weak pelvic muscles, mesh is inserted to reinforce the area. The typical organs affected by prolapse are the rectum, bowel, bladder or uterus, though the bladder is most common. Mesh can be surgically placed on the front, top or back wall of the vagina to provide support. The mesh acts as a sling (and is often referred to as a "bladder sling" when used in this context), holding up sagging organs.
Sometimes women experience a vaginal vault prolapse after a hysterectomy. A hysterectomy is the surgical removal of all or part of the uterus. When the vagina collapses in on itself because there is no more uterus to hold things up, mesh is implanted on the top of the vagina and inserted into connective tissue to keep the area stable. Up to 50% of women who've had children suffer from pelvic organ prolapse.
What is stress urinary incontinence and what are the symptoms?
This is when the bladder leaks urine because of increased pressure during physical activity.
This affects up to 20% of women, particularly after childbirth or menopause. Transvaginal mesh supports the urethra when the pelvic muscles are weakened. There are no symptoms other than the unintentional leakage of urine when patients cough, sneeze, have sex, laugh, stand up — basically, when they put any pressure on the bladder. This is, obviously, highly inconvenient and embarrassing for women.
Transvaginal surgical mesh as we know it has been around since the 1970s, though it was originally used for hernia repairs before that, dating back to the 1950s. Some products even use a type of mesh that was created in 1954.
At first, doctors would just cut the mesh into the size and shape they wanted for each patient. Once manufacturers noticed that mesh was being used in this way, they started producing products specifically meant for POP and SUI surgical candidates.
Enjuris tip: If your surgeon recommends transvaginal mesh implant surgery, get a second opinion — or even a third.
Mesh manufacturers started making kits next, which included mesh cut to size, tools and surgical instructions. Companies made these at such a high volume that problems were bound to arise — and arise they did.
Most of the later mesh kits were based on the ProteGen Sling, which was recalled by the Food and Drug Administration in 1999 after learning there was a “higher than expected rate of vaginal erosion.” It is also interesting to note that prior to the ProteGen Sling’s FDA clearance, it had literally never been inserted into a human vagina.
However, the first public health safety warning did not come until 2008.
Types of transvaginal mesh on the market and their history
The most common product used is TVT, or transvaginal tape, which has been around since the early 2000s. Doctors like this type of product because a procedure takes 30 minutes as opposed to hours.
In terms of vaginal mesh, there are different kinds available, depending on whether you are treating for POP or SUI. For instance, the models that treat POP are referred to as “synthetic mesh” or “biomesh.” SUI mesh, on the other hand, is called a “bladder sling.”
During the rush to create the first transvaginal mesh “kit,” medical device manufacturers made more than 100 different products. Each company tried to stand out from the others, though one can only reinvent the wheel so many times; this resulted in the devices sharing common characteristics. This also likely led to so many recalls, as mesh kits were often based on other kits that were available, as well as the ProteGen Sling, the “grandmother of them all.”
These are some popular products on the market that have presented with complications (C.R. Bard and Ethicon no longer make transvaginal mesh products, though others still manufacture them):
Pinnacle Pelvic Floor Repair Kit
Uphold Vaginal Support System
Aris Transobturator Sling
Align Urethral Support System
Pelvilace Support Systems
Uretex Urethral Support Systems
Endo / American Medical Systems
Bio Arc Slings
Johnson & Johnson / Ethicon
Gynecare Prolift Kit
Gynecare Prolift + M Kit
Gynecare Prosima Pelvic Floor Repair System
Gynecare TVT Secur
Complications leading to transvaginal mesh lawsuits
While short-term clinical studies showed that the most common mesh products had a high efficacy rate and a low rate of complications for SUI, more comprehensive trials show that there is a higher rate of complication surrounding mesh implants for POP. There is little evidence to support the products' use in the long term, either. In fact, NHS records revealed that one in 15 women with the most common mesh implants will require a surgery to extract it.
As of December 2017, the world’s health community was abuzz regarding the complications surrounding these products. The United Kingdom has even discussed banning them altogether after a surge of negative reporting. The National Institute for Health and Care Excellence (which goes by the adorable acronym NICE), a top watchdog group, has stated that it is unacceptable to wait until 2019 for a ban to go into effect. Meanwhile, the treatment has been banned by Australia’s Therapeutic Goods Administration as of November 2017, with regulatory agencies adopting that stance in January 2018.
U.K. watchdog group National Institute for Health and Care Excellence says waiting until 2019 to ban transvaginal mesh is unacceptable. Tweet this
The health community has taken this position because far too many women were experiencing complications.
As of 2011, the FDA had received approximately 4,000 complaints regarding transvaginal mesh procedures during the past six years.
Complaints discussed the following issues:
Vaginal shrinkage (as scar tissue builds)
There are many more symptoms that have not been included in transvaginal mesh lawsuits, such as back pain, leg pain, hip pain and even extensive neurological issues. But the farther away it is from the surgical site, the more trouble lawyers have connecting the dots. The symptoms listed above are the ones that have succeeded in litigation. Read more about transvaginal mesh lawsuits and complications.
When a patient presents with complications, surgeons may attempt alternative treatments prior to mesh removal, such as an estrogen cream to encourage vaginal repair. Additionally, if less than 5 mm of mesh is exposed, the surgeon might choose to simply cut it out and leave the rest of the implant intact.
Transvaginal mesh complication rates have been studied, though researchers produced varying results; between 7% and 21% of patients have experienced problems with their implants.
When patients experience conditions like mesh erosion or organ perforation, they will likely need additional surgeries to revise the problem. Since mesh implants were designed to stay in the body and hopefully encourage tissue growth, removing them is painful and can require many surgeries, as blood vessels and tissue keep the mesh rooted in place. This means doctors must remove the implant one piece (and one surgery) at a time.
In December 2017, BMJ Open published a study stating that 61 mesh devices on the market had not gone through clinical trials. These went through a less stringent FDA approval process known as 510(k), as there were already “substantially similar” products on the market. However, those marketed products also had complications: Ethicon’s Mersilene Mesh and Boston Scientific’s ProteGen Sling. Ethicon was found not to have properly warned U.K. surgeons of complications, and they had not tested it adequately before mass-marketing the product. And when we say “inadequate testing,” we mean, for example, that the TVT-Secur device was only tested in sheep and 31 human women for a grand total of five weeks.
@BMJ_Open 2017 study says 61 transvaginal mesh devices did not go through clinical trials. Tweet this
For women who have had a vaginal sling inserted for urinary incontinence, approximately one in 30 patients will need a revision surgery in less than 10 years. This study was published by JAMA Surgery in their December 2015 issue.
In 2016, certain marketed mesh products (those used for POP rather than SUI) were reclassified by the FDA as Class III high-risk devices, which are supposed to go through the Premarket Approval Application process. This is a stricter method of testing devices to make sure they are up to FDA standards. The FDA issued 119 orders for manufacturers of 126 devices, which told those companies that they must conduct postmarket surveillance studies.
This did not bode well for mesh manufacturers. Of those 119 orders, 79 manufacturers simply recalled their transvaginal mesh devices from the market rather than provide data. Then 26 changed their “indications for use” so the reclassification order no longer applied to their product. Two manufacturers gave up entirely, shutting up shop. And one even had the gall to say the device was not vaginal mesh.
Bans and limitations on transvaginal mesh products
As of January 2018, three countries have issued bans or market bans (as mentioned, the U.K.’s top watchdog agency, NICE, recommended that mesh should only be used for research purposes because of potential complications). However, U.K. regulatory agencies have yet to adopt NICE’s guidelines.
Australia was the first to take action, though New Zealand is currently the only country to issue a complete ban on these products for gynecological uses. The FDA has not taken a position yet, though they strengthened their warnings in 2011 when they said that complications were “not rare.”
How to know if you have a transvaginal mesh lawsuit
If you are experiencing any of the following symptoms, you might qualify to join an active case:
Infection: Studies have reflected that bacteria can grow on the implant, which results in infection.
Mesh erosion: If the mesh has damaged the vaginal walls or other internal organs, it is said to have "eroded."
Pain: Mesh can cut through tissues, shrink, damage nerves and cause scar tissue to build. This can result in painful movement or even painful intercourse.
Recurring incontinence: This can be a new symptom after receiving an implant; if the patient received mesh specifically for incontinence, it can actually make the condition worse.
Recurring prolapse: The mesh implant might not solve the problem of prolapsed organs and cause the issue to recur.
Urinary issues: Mesh implants can block the bladder, making urination difficult or painful.
A transvaginal mesh lawsuit will likely be for defective products (also known as products liability). If the surgeon implanted it incorrectly, however, it could be a case for medical malpractice.
With product liability cases, courts use one of two theories to analyze what happened: negligence or strict products liability. The latter term means that the person's intent is irrelevant, as long as the product was defective in some way.
A transvaginal mesh implant that did not work the way it was intended could fall into one of three categories for defective products, or possibly even more than one:
Design defects: Even a perfectly made product can endanger the end user if the defect was part of its design. A product is unreasonably dangerous if it does not perform as expected when used in its intended manner.
Failure to warn: Also called “marketing defects,” these focus on actions in the supply chain. The product was properly designed, but it did not have the correct instructions or warnings. This lack of guidance made the product unreasonably dangerous to its intended consumers.
Manufacturing defect: Even if the product were designed to be safe, the end result did not reflect that design. If that product then causes an injury to its intended user, the manufacturer can be held liable.
Based on these definitions, a transvaginal mesh implant that harmed patients would likely qualify as a manufacturing defect. It was designed to be safe, but the actual implant harmed patients.
You can choose to file your own case in state or federal court, depending on where you are located and where the defendant is headquartered. If you are in one state and the defendant is in another, you will need to file a federal case.
You can also choose to join an existing multidistrict litigation suit, or MDL. Sometimes this decision is made for you by the Judicial Panel on Multidistrict Litigation, which is a group of seven federal district judges who are in charge of all MDLs. They do this when many similar cases have common questions of fact.
There are currently no class-action lawsuits pending for transvaginal mesh (the last one stopped accepting new claims in 2016), but there are plenty of MDLs. Attorneys generally prefer MDLs over class-actions because they offer many advantages and the awards tend to be larger.
How does an MDL work?
In an MDL, hundreds or even thousands of similar cases are grouped together for efficiency's sake. If each case has the same or similar claims, judges don't want to hear and re-hear the same case over and over again, especially if they all share common questions of fact. So, they came up with this litigation model that streamlines discovery and avoids duplicative evidence. Plaintiffs' cases are consolidated in federal court, bringing in victims from all over the country.
For example, let's say you file a claim against ABC Mesh Manufacturers in the federal district court closest to you. Then, your attorney might receive a motion to transfer your case into an existing MDL that is pending in another district court; this is usually somewhere central and convenient to a majority of plaintiffs. That decision might be made by the Judicial Panel on Multidistrict Litigation, or your attorney might move to transfer.
Every similar case is consolidated for pre-trial purposes and discovery, meaning interviews, depositions, and motions. The same judge hears all of the discovery for every case in the MDL, and once that part of the trial is complete, your individual claim will be returned to the original district court where you filed. That way, you can complete the case based on any pretrial rulings from the MDL judge.
Approximately 100,000 vaginal mesh lawsuits are pending before Judge Joseph Goodwin in West Virginia, though many have settled, gone to trial or have been dismissed. As of November 2017, more than 40,200 individual mesh claims were still pending. In February 2012, the Judicial Panel on Multidistrict Litigation consolidated cases against three companies in the Southern District of West Virginia.
A total of 867 lawsuits were filed in this action between 2008 and 2017, though the judge asked the JPML to stop adding cases.
He stated that too many cases did not have enough evidence or that they were barred by the statute of limitations (the filing window). However, the MDL has not been closed, and six cases are pending. Women can also choose to file claims against ObTape in state court.
By June 2017, mesh manufacturers had paid out billions in defense of their products. Ethicon was the only device manufacturer that won a defense verdict. At least 18 cases in the West Virginia MDLs have been tried, settled, put on hold or dismissed. In 10 of those bellwether trials, plaintiffs have won verdicts totaling more than $49 million.
Bard, Boston Scientific and Ethicon all lost multiple bellwether trials. Plaintiffs' awards ranged from $14.5 million in compensatory damages and $4 million in punitive damages (Boston Scientific) to $20 million (Ethicon).
How to find and hire the right lawyer for your transvaginal mesh lawsuit
First, talk with your surgeon to see what must be done if you are experiencing pain or discomfort at your implant site. You might be able to fix the issue without surgical intervention. The most important thing is to get you out of pain and make sure your implant is not failing.
Second, talk to an attorney as soon as is practical. You can try searching for "transvaginal mesh implant lawsuits attorney" on Google, but you will see there are tons of lawyers advertising their talents. How do you know which is best? To narrow it down, try looking for a lawyer who has experience with defective products (AKA products liability), medical malpractice and medical devices in your state. You can try a Google search like "Tennessee defective products mesh attorney” substituting Tennessee for your own state, for example.
Pick a few attorneys from that search and limit it to your town, if there are too many, as you will want someone local if possible. Most attorneys’ websites have a section for past verdicts and settlements; see if they have dealt with medical device manufacturers before and whether they were successful. Then, interview your final candidates. Have they tried cases before regarding transvaginal mesh? Were they part of an MDL? How much did they recover for their clients?
Many women prefer a female attorney for this sort of case. It is a sensitive topic and will require extensive medical testimony about a woman's most intimate place. There are many female attorneys who are ready, willing and able to help.
Also, keep in mind that each state has a statute of limitations, which is the time available to file your case. Once you are past that time frame, you lose the ability to file. Some states only offer one year for cases, so you should act fast. An attorney will be able to preserve your claim.
Products liability law (AKA defective products law) is very specialized. You’ll want a lawyer who has many years of experience and knows how to coordinate with possible multidistrict litigation vaginal mesh lawsuits already in the works.
If you have not met with an attorney yet, consider looking through the Enjuris directory for someone in your state who can help you bring a vaginal mesh lawsuit.