Who, What & Why About Hernia Mesh Products and Lawsuits
A hernia is a very common medical condition which requires surgery to repair.
There are close to 1 million hernia repair surgeries performed in the U.S. each year, which makes it the most common type of surgical procedure.
The majority of hernia repairs involve the use of a “mesh.” The mesh is similar to a small net or screen, and a surgeon places it on the area surrounding the hernia (attached with stitches, staples or glue).
While hernia mesh products are meant to improve a patient’s outcome, and reduce the risk of a recurrence, there have been many reports of hernia mesh complications, which require removal of the mesh. In some cases, the mesh is replaced with a new product, often referred to as “revision” surgeries.
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A History of Hernia Mesh Products
Earlier mesh products were absorbable – in other words, they were made out of animal byproducts that were designed to be gradually absorbed by the body and eventually disappear after implantation.
These earlier devices had a great safety record, but they did not provide permanent abdominal wall support, and many patients suffered from recurrences.
In the early 2000s, multiple manufacturers introduced permanent hernia mesh devices – made out of a special type of plastic, surrounded by an inert coating material that was supposed to make them biocompatible inside the body.
Because of a loophole in the FDA’s 510(k) process, hernia meshes fall into the category of class II medical devices, which exempts them from the FDA requirement of premarketing approval, which would require clinical testing before marketing.
Through the FDA’s 510(k) process, class II device manufacturers only have to demonstrate that the new product is “substantially equivalent” to a device already on the market (a predicate device).
This means, almost all meshes on the market today can be traced back to a handful of predicate surgical devices available prior to 1976 – at a time they did not have to provide clinical testing for benefits, efficacy or safety.
Devices are then cleared to go to market without any clinical studies.
Who Manufactures Hernia Mesh Products?
There are dozens of companies who make hernia mesh – ranging from a start-up company called TELA Bio, all the way up to big pharma companies like Johnson & Johnson.
The global hernia mesh market is projected to reach $5.78 Billion by 2026, making this an extremely lucrative medical device market.
Why Are People Suing Over Hernia Mesh Products?
While companies like Ethicon (which is a subsidiary of Johnson & Johnson), Atrium, and Bard Davol have recalled more than 200,000 units of their hernia mesh products – the recalls came too late for thousands of people.
As of July 2020, there were 8,739 hernia mesh lawsuits pending against Ethicon, Atrium and Bard Davol in three separate multidistrict litigations (MDLs) and more filed in state courts throughout the country, all claiming the devices caused injuries or complications so severe that people had to have additional surgeries.
What Are the Complications of Hernia Mesh?
The most common hernia mesh complications include:
- Infection (deep, chronic infections may not occur until years after hernia mesh surgery)
- Hernia Recurrence
- Bowel Obstruction (Symptoms – nausea, vomiting, inability to pass gas or stool)
- Bowel / Organ Perforation (Symptoms – nausea, vomiting, severe abdominal pain, abdominal rigidity)
- Rejection (Symptoms – extreme swelling at surgical site, redness, tenderness, pain, flu-like symptoms)
The most serious complications can be deadly – at the very least causing severe pain, and revision surgery is almost always needed to correct the problem.
Nearly one-third of people who have hernia surgeries experience some sort of complication. Complications from hernia mesh can happen right after surgery, or years later.
How Do I Know If My Hernia Mesh Failed?
Usually, there will be signs and symptoms indicating something is wrong.
It’s important to see a doctor and express these concerns. Only your medical provider can determine the root cause of your symptoms and make a determination on whether or not they are related to possible complications from your hernia repair.
According to Dr. Shirin Towfigh, a surgeon at the Beverly Hills Hernia Center, patients feel “unheard and overlooked” when they express concerns about their mesh. She has worked with patients whose lives have been altered drastically following their hernia repair surgery and post-surgical complications – problems have included an inability to have sex, loss of a testicle, inability to wear certain types of underwear, or to be able to sit in a meeting at work because of chronic pain.
A lot of attention has been focused on hernia mesh over the last few years, and Dr. Towfigh believes it will all lead to better and safer hernia surgeries with more focus on patient outcomes.
She said “all of the attention, all of the ads by lawyers, all of the patients who come to us well informed, they are speaking loudly and they’re forcing us to listen. I feel a change would not be made organically if we didn’t have patients, and lawyers, and social media and these websites to push us to do better.”
Who is Eligible to Make a Hernia Mesh Lawsuit Claim?
In most cases, in order to qualify for a lawsuit, people must have been told they need surgery or have already had surgery called hernia mesh revision surgery. This is a surgery to remove mesh, replace it or correct any tissue and/or organ damage caused by the original mesh product placement.
It is highly likely if you have had hernia repair surgery and mesh was used, you have no idea who the manufacturer is of that mesh, and that’s okay.
If you think you may qualify, answering a few questions with one of our intake specialists is the first step.
Questions include when and where procedures were done, how many procedures you have had, any current treatment status, injuries you have sustained as a result of hernia mesh complications.
Hernia Mesh Lawsuit Categories
Most suits filed against hernia mesh fall into three main categories: Defective Design, Manufacturing Defect, and failure to Warn.
Sometimes, lawsuits are filed to preserve the right to sue. Hernia mesh cases have statutes of limitations that impose a timeline on the ability to file a claim. Each state has a time limit to file a claim, which can vary from 1 year to four or more years.
Only an attorney can determine the exact statute of limitations on your claim. The general rule of thumb is that hernia mesh statutes will start ticking from the moment a patient discovers his or her injury stemmed from a defective mesh – this is referred to as the “Discovery Rule”, and it can be interpreted differently in different states and courts.
Before anything becomes an actual “lawsuit” there’s a pre-litigation process which consists of gathering all the evidence needed to “prove-up” the claim. How long this process takes depends on how accurate the information is clients are able to provide in regards to their previous treatment, surgeries, etc.
Many clients have had multiple surgeries, over the course of many years, and understandably this information is not always easy to recollect with accuracy.
Additionally, we are at the mercy of outside medical providers and facilities once we request records, and while some turn-around times are quicker than others – it can still be a time-consuming process.
However, our team is diligent about gathering the information, and over the years we have established relationships with a variety of vendors throughout the country that help to not only expedite this process, but do it much more efficiently than one person in an office requesting thousands of pages of medical records from providers all over the place.
Want to see if you qualify for a hernia mesh lawsuit?
Meet Kitka Galvin – Specialty Practice Manager at VanDerGinst Law – Q&A
Kitka and her team handle all the intake and case management needs of mass tort cases such as hernia mesh, overseen by & in consultation with Mr. VanDerGinst, lead attorney on all of the firm’s mass tort cases.
Q: What’s the most common question you get from potential plaintiffs and how do you respond?
A: How do I know if my hernia mesh has failed?
That’s a medical question – if your doctor has done a revision, or suggested you get a revision, it’s probable that you may be suffering from complications related to the placement of hernia mesh in your body.
Sometimes, people call in to inquire about a claim, but haven’t even talked to their doctor yet about the problems they are having. Don’t go to your doctor for legal advice, and don’t go to your lawyer for medical advice.
Q: What happens after I sign up with your firm, and how long will all this take?
A: Once an intake is completed with our firm, and a case is accepted, it’s only in the preliminary investigation stages.
Until we have obtained medical records from your original surgery and any revision surgeries – including obtaining information about the manufacturer of the hernia mesh product used for your repair- it is difficult to make any solid determinations on whether or not you have a viable claim.
Although each individual case is very important to us, the court takes these cases in batches, because there are so many. It’s impossible to settle them all at one time, and it can be a very long process, 1-2 or more years before cases even begin to reach settlement stages.
Q: What would you like clients to know?
A: We are not suing your doctor, we are suing the manufacturer of this product.
If your doctor had known the potential for complications, he/she likely would not have placed this product inside your body.
These are defective products, and in most cases, complications did not result from any medical procedural wrongdoing.
Q: Why should someone hire us to handle their hernia mesh claim?
A: Those firms that have the largest number of cases, like ours, will get to go to the table first, which means our clients will likely see compensation for their damages before some others.
What’s Happening With Lawsuits That Have Already Been Filed?
Most industry experts are calling this round 2 of mesh lawsuits (with round one referring to C.R. Bard’s Kugel Hernia Devices).
This second round is predicted to have higher settlement values because of more serious and more permanent injuries.
However, based on prior mass tort product liability cases, we anticipate it will be 1-2 years before a global settlement is reached in the current hernia mesh litigation – which means plaintiffs likely won’t receive any settlement compensation until the end of 2021 – a timeline which could be pushed even further out as we begin to see the longer term repercussions of the COVID-19 pandemic.
Outcomes in recent years from hernia mesh lawsuits indicate settlements can range from $3,000 – $1 Million – with averages per plaintiff falling in the $40K – $60K range.
Every Case is Unique
Plaintiff’s need to understand, settlement amounts are based on a number of factors which determine to what extent the defective hernia mesh used in your surgery has impacted you, your health and your life.
- The type of hernia mesh used and whether or not that product was recalled (by the FDA or by the manufacturer)
- The extent and severity of your injuries
- How your injuries have impaired your quality of life (pain & suffering)
- Loss of consortium, or companionship (for damages your spouse or family members may have suffered as a result of your injuries)
- The economic impact you have already suffered, and future economic impact (medical expenses)
- Past and future lost wages
Between 2011 – 2015, C.R. Bard paid out over $500 Million to settle 8,600 lawsuits.
Johnson & Johnson, the parent company of Ethicon (another hernia mesh manufacturer), paid out $120 Million in 2016, to settle 42,000 lawsuits.
Boston Scientific, settled two claims in 2014, which alleged the company smuggled materials from China to manufacture their mesh devices, for $34.5 Million.
No hernia mesh lawsuit settlements in the current mass litigations have been publicly announced. Trials should begin late 2020 or early 2021.
Until these first few trials get underway, it’s difficult to predict when cases will begin to settle – or how much they will be settling for.
Typically, when a global settlement is reached, cases are placed into tiers depending on how strong their cases are – these tiers determine settlement amounts.
The law is tough, being injured is tougher.
We’ll make it easier for you!
Want to see if you qualify for a hernia mesh lawsuit?
The information contained on this website is presented by VanDerGinst Law P.C. It is not intended nor should it be construed as professional legal advice. The information is general in nature about the Firm, the scope of services we offer, and our community outreach, it is not legal advice. Please contact us by phone, email, mail, or via this website for inquiries. Contacting us does not create an attorney-client relationship. Please contact a personal injury attorney for a consultation regarding your situation. This website is not intended to solicit clients outside the State of Iowa and/or the State of Illinois.