Did you receive a hernia mesh implant and then suffer complications such as chronic pain, bulging, constipation, diarrhea, indigestion and/or sexual dysfunction? You may be eligible to bring a lawsuit against the company that made the mesh. In this article, our attorneys will explain the process.
A hernia mesh lawsuit is a legal claim against the mesh manufacturer by a patient who suffered complications and injuries as a result of mesh failure. The lawsuits allege that the implant devices were defectively designed and that the manufacturers failed to warn patients adequately of known and foreseeable risks and side effects. So far, the only major settlement in this litigation was approximately 3,000 plaintiffs who settled with C.R. Bard in 2011 for $184 million. However, there are thousands of more lawsuits pending that are likely to settle in the near future.
There are currently tens of thousands of lawsuits pending against multiple manufacturers, most of them as part of federal multi-district litigations. We have compiled a list of hernia mesh brands and products currently the subject of litigation. Many of them are still on the market and still being used by surgeons.
Shouse Law Group is representing victims of defective medical devices. We take cases throughout the United States. Our lawsuits aim to recover money settlements for the victims.
What defective hernia mesh manufacturers are being sued?
What are the symptoms of hernia mesh failure?
- Adhesion, where the mesh sticks to internal tissue (more common with meshes that are coated)
- Erosion of the implant device, which can cause fever, infection, pain, and nausea
- Abdominal pain, which is often accompanied by nausea and associated with adhesion to the abdominal wall, bowel obstruction, nerve damage, and infection
- Bowel obstruction, where the mesh has migrated and/or adhered to the tissue, preventing proper use of the bowels and leading to subsequent diarrhea or constipation, including the inability to pass gas
- Infections that occur more than 30 days after the implant surgery; infections are often accompanied by severe headaches, fever and sweating, and can lead to sepsis (more common with meshes that are coated)
- Migration, where the mesh moves from its original site of implantation
- Perforation of organs or tissues, which often occurs after the mesh erodes, shrinks, or otherwise gains the ability to migrate – some patients need to get colostomies or partial removal of their bowels
- Seromas, where fluid collects under the surface of the skin and can be accompanied by an infection
- Chronic pain throughout bodily connective tissues and joints, which can be associated with many other complications caused by mesh failure and ensuing inflammation
- Mesh failure, where it overall fails to do what it was intended to do and requires mesh removal
- Recurrence of the hernia following mesh surgery, which often requires additional intraperitoneal or inguinal surgery
- Groin and testicular pain, which could also lead to testicle removal from damage to the spermatic cord
- Delayed and/or long-term consequences, which can surface many years after the implant, far longer than any hernia mesh studies or clinical trials took into account
- Cancer, which can develop from infected mesh (learn more about hernia mesh and cancer)
- Hernia mesh revision surgery made necessary by the failure of the original implant at the incision site; and sometimes, a person’s medical issues prevent him/her from getting a necessary revision surgery
- Many other complications and injuries, including a rash, renal failure, liver problems, autoimmune disorders, neurological changes, dental problems, or dyspareunia (painful sex), depending on your specific case
What are the potential damages for hernia mesh injuries?
- Economic damages, such as lost wages, loss of earning capacity, medical bills and other miscellaneous costs
- Non-economic damages, such as pain and suffering, emotional distress, mental anguish, loss of enjoyment, and loss of consortium
- Punitive damages in rare cases to punish the manufacturer and prevent the same from reoccurring.
If you are looking for information on hernias, hernia mesh implants, mesh-related injuries, manufacturer liability, how to bring a legal claim, and the FDA’s relationship to hernia mesh complications, you have come to the right place. In the sections below, our hernia mesh lawsuit attorneys will answer the following 7 key questions about the current litigation:
- 1. What are the grounds for filing a hernia mesh lawsuit?
- 2. Whom do you sue if you can file a hernia mesh lawsuit?
- 2.1 Atrium – Maquet – Getinge Group: C-Qur
- 2.2 Covidien – Medtronic: Parietex
- 2.3 Davol – C.R. Bard: ST Mesh Products
- 2.4 Davol – C.R. Bard: Composix Kugel mesh
- 2.5 C.R. Bard: 3DMax
- 2.6 C.R. Bard: PerFix Plug and Marlex
- 2.7 Ethicon – Johnson & Johnson: Proceed mesh
- 2.8 Ethicon Physiomesh
- 2.9 Ethicon: Prolene
- 2.10 Gore: DuelMesh
- 3. What is the average payout for a hernia mesh lawsuit?
- 4. Is the hernia mesh litigation a class action or individual lawsuits?
- 5. How does the FDA oversee hernia mesh safety?
- 6. What is a hernia?
- 7. What to do if your pain and suffering are the result of a hernia mesh implant?
- 8. How do I qualify for a hernia mesh lawsuit?
1. What are the grounds for filing a hernia mesh lawsuit?
Four common claims in surgical mesh injury lawsuits are:
- The hernia mesh had a defective design;
- There was a manufacturing defect;
- The hernia mesh had improper labeling which failed to warn about the dangers; and
- The doctor who implanted the hernia mesh committed medical malpractice
1.1 Defective design
When the blueprint of a hernia mesh is inherently dangerous, it is considered a defective design. No amount of quality manufacturing or transparent labeling can compensate for a medical device with design flaws.
Sometimes the manufacturer is unaware of the defect. In other cases, the manufacturer may have been aware of the defect but chose to conceal it. Either way, defectively designed hernia meshes are inherently dangerous devices.
Hernia mesh manufacturers are held to a “strict liability” standard. This means they are liable if:
- The mesh’s defective design posed a foreseeable risk; and
- The mesh was manufactured and used as it was supposed to be
Typical evidence of design defects is the original hernia mesh design schematics. Plaintiffs’ attorneys will also call upon expert witnesses who can testify about the mesh’s design problems.1
An example of a defective type of hernia mesh product is C.R. Bard‘s Kugel hernia mesh, which used a ring to make insertion easier. But the ring can break easily and migrate, causing serious injuries.
Another defective product design example is the choice made by manufacturers to use polypropylene, which is known to cause severe reactions and internal injuries. An extremely cheap material, polypropylene can deteriorate and shrivel over time. A byproduct of petroleum, it can be found in such disposable products as bottles and fishing line. Atrium, C.R. Bard and Ethicon make mesh products with polypropylene.
According to an MSMD (Material Safety Data Sheet) by chemical company LyondellBassel, polypropylene should never be permanently implanted in the human body. But medical manufacturers have often relied on it for implantation devices that turned out to be defective, such as bladder slings for urinary incontinence and pelvic mesh for prolapse. Instead of relying on pig skins or high-quality plastics, mesh manufacturers used inexpensive and dangerous material for its design.
Some manufacturers like Ethicon with its Proceed mesh used fabric to cover the polypropylene. The fabric, however, erodes over time and exposes the polypropylene to internal tissue.
1.2 Manufacturing defect
Even the safest medical devices can become dangerous if they are constructed poorly. And because hernia meshes are so fragile, the slightest deviation from the original design and intended materials can cause serious injuries.
One example is Atrium’s C-Qur. Some of its facilities were known to be unsanitary, affecting the mesh products. In fact, the U.S. Food and Drug Administration sent warning letters and ultimately shut down one facility for a time.
Another example is Bard, which is accused of using non-medical grade polypropylene which degrades and ultimately fails.
In order to prevail on a manufacturing defect claim, the plaintiff would need to show:
- The hernia mesh had a manufacturing defect when it left the manufacturer’s possession; and
- This defect was a substantial factor in causing the plaintiff’s harm
Helpful evidence would include testimony from the workers who actually constructed the hernia mesh. Ideally, surveillance video exists of the workers cutting corners while making the mesh. Expert testimony may prove valuable as well.2
1.3 Improper labeling/ failure to warn
Every medical device has risks. It is up to the manufacturers to disclose these risks so that doctors and patients are fully informed. Specifically, hernia mesh manufacturers must:
- Warn physicians of non-obvious dangers that the mesh may cause; and
- Inform physicians how these dangers can be avoided
Instead, hernia mesh manufacturers oversold their devices as cure-alls while failing to emphasize their risks. Had the marketing been complete and accurate, many patients might have elected not to get the hernia mesh implanted in their bodies.
Failure to warn is a straightforward claim to prove. The plaintiffs’ hernia mesh lawyers would show how the mesh packaging and instructions omitted necessary warnings. And doctors and patients can testify that this omission misguided their decision to implant the mesh.3
1.4 Medical malpractice
An otherwise safe hernia mesh can cause massive health problems if the surgeon implants it incorrectly, uses the wrong mesh type or size, or fails to seal it properly. Sometimes doctors use mesh when it is completely unnecessary, like for many small hernias caused by laparoscopic surgery.
To prove medical malpractice, the plaintiff would need to show that the doctor engaged in professional negligence. Specifically:
- The doctor had a duty of care towards the patient;
- The doctor breached that duty by falling short of professional standards of care; and
- This breach caused the patient’s injuries and damages
Medical records are key to proving that a doctor committed medical malpractice. Testimony by fellow medical staff can also help shed light on the doctor’s mistakes.4
2. Whom do you sue if you can file a hernia mesh lawsuit?
The liable party in most hernia mesh cases is the manufacturer of the defective mesh product. There are dozens of hernia mesh products on the market and most are safe. It is the few that are defective that are causing serious complications and are the subject of the hernia lawsuits.
Some of the most defective mesh implants are products of these manufacturers. If you had one of the below products inserted and complications arose, you may be entitled to sue the manufacturer.
(If you do not know which hernia mesh you had, request a copy of your medical records.)
2.1 Atrium – Maquet – Getinge Group: C-Qur
The C-Qur mesh came on the market in 2006. Atrium first owned it, but it was later acquired by Maquet (a subsidiary of Getinge Group) in 2011. Maquet now makes C-Qur. The C-Qur incorporates an omega-3 fatty acid coating in lieu of polypropylene. This coating, however, causes severe allergic reactions in some people. Infections can become life-threatening and removal of the C-Qur is difficult and can lead to further injury. The C-Qur packaging was recalled in 2013, but not the device.
Atrium also manufactures the ProLoop Plug. It is on the market, but patients are reportedly suffering problems from its polypropylene materials.
Other Atrium C-QUR products include the Mesh, TacShield, OVT Mesh, RPM Mesh, Edge Mesh V-Patch, Lite Mesh V-Patch as well as the C-QUR Mosaic and C-QUR V-Patch. The coating comes from fish oil, which can cause inflammation.
One plaintiff who brought a C-QUR lawsuit is James Brown, who required a revision surgery three years after implant. He suffered scarring and continues to endure pain.
2.2 Covidien – Medtronic: Parietex
Covidien, recently acquired by Medtronic, brought its Parietex mesh product to the market in 1999. The Parietex uses polyester in lieu of polypropylene. But this material has similar complications. The polyester mesh shrinks and contracts after it is inserted, which can cause the mesh to tear and break from internal tissue. When this happens, the mesh migrates, causing additional complications and severe pain. The mesh’s unsealed edges may also fray and tear.
Parietex is available as different mesh options:
- Parietex Composite (PO) mesh (which has a collagen barrier that disappears quickly)
- Parietex Plug and Patch System
- Parietex ProGrip Self-Fixating (which has a polylactic acid layer (“PLA”) and thousands of hooks)
- Parietex Composite Ventral Patch
- Parietex Flat Sheet Mesh
- Parietex Folding Mesh
- Parietex Composite Parastomal (PCO PM) Mesh
- Parietex Composite Hiatal Mesh (PCO 2H)
- Parietex Hydrophilic Anatomical Mesh
- Parietex Surgical Mesh
- Parietex Optimized Composite Mesh
- Parietex Composite Open Skirt (PCO OS) Mesh
- Parietex Optimized Open Skirt Mesh
- Parietex Lightweight Monofilament
Each of the above has its own unique problems, too. Complications include migration, perforation, bowel obstruction, and recurrence.
2.3 Davol – C.R. Bard: ST hernia patch products
ST hernia mesh is a resorbable coated mesh line. Genzyme was the original make of the Sepramesh IP and Sepra Technology (ST) coating, but in December 2007, Bard acquired the licensing rights to this technology. Bard used the technology to create its own ST coating line for ventral hernia meshes, which included:
- Ventralight ST
- Ventralex ST
- Ventrio ST.
The ST coating uses polypropylene, a substance we know directly causes harm to patients.
2.4 Davol – C.R. Bard: Composix Kugel patch
The Composix Kugel has been the subject of three recalls in 2005, 2006, and 2007, including a Class I recall – reserved for devices that can cause serious harm. It is made of a polypropylene base and a layer of ePTFE (polytetrafluoroethylene), and the materials worked against each other. The mesh would buckle and shrink. And a memory coil ring – called a PET ring – used on the mesh would break, causing perforation and fistulas.
Note that unlike the kugel mesh, the Composix E/X mesh does not have metal memory rings between the fibrous layer and the mesh.
One of the Composix Kugel victims is Vicky Sanders, whose complaint claimed that Bard used, “substandard, adulterated, and/or non-medical grade polypropylene and raw materials used to make the Composix Kugel product which deviated from their material and supply specifications.”
2.5 C.R. Bard: 3DMax
The 3DMax is a heavy-weight mesh using polypropylene. A lighter version was released in 2008. This mesh is specifically used to treat inguinal hernias, but the mesh erodes through soft tissue and then adheres to the spermatic cord, cause great pain and sexual dysfunction. A curved device used with no sutures or tacks, this mesh is also known to fold over and migrate, causing injury, too. Mesh removal surgery places the person at risk of losing a testicle.
Note that many inguinal hernias do not even need meshes to be fixed. The Shouldice, Bassini, and McVay Repair techniques – involving only sutures – have a high success rate by surgeons.
One plaintiff who brought a 3DMax lawsuit was Michael Miller, who got the mesh implanted in Saratoga Springs, New York. He had a recurrence within a month, requiring an additional operation and implantation of a PerFix Plug. His pain and hernias continued, and he developed eating and sexual problems.
2.6 C.R. Bard: PerFix Plug and Marlex
Bard’s PerFix Plug came on the market in the late 1990s and uses polypropylene mesh to treat inguinal hernias. This type of plug looks likes a shuttlecock but can also come as an onlay patch. This patch can erode and migrate, causing organ perforation and intense pain. The cone tip applies severe pressure that results in additional pain.
PerFix Plug injuries have been known to fester for years before they manifest as pain. See also our article on the Bard Marlex hernia mesh.
Note that other Bard products with problems include the Mesh Dart, the Visilex, the Sperma-Tex, the Modified Kugel Hernia Patch, and Sepramesh IP Composite Mesh.
2.7 Ethicon – Johnson & Johnson: Proceed Mesh
The Proceed is a light-weight mesh that came onto the market in 2003. It uses fabric over polypropylene so that the polypropylene does not come into contact with internal organs. The fabric is oxidized regenerated cellulose. The problem with this fabric is it separates from the polypropylene, despite being adhered to by polydioxanone (PDS). The primary risk is bowel complications and required mesh removal surgery.
2.8 Ethicon Physiomesh
The Physiomesh was taken off the market in 2016 even though its maker claims it did not recall the mesh. Numerous complications, however, have been linked to this mesh by thousands of people. It is believed the absorbable coating called Monocryl prevents the mesh from properly incorporating with the host tissues.
Note that in 2018, the judge in the Ethicon multi-district litigation (discussed below in section 4) published Rules for Preserving Physiomesh. Patients must instruct their doctors to keep the mesh when it is removed during surgery and then ship it to Steelgate in Florida. Both the defense and prosecution can then evaluate the samples, and each side is entitled to be present when the other side is inspecting it.
One plaintiff who brought a Physiomesh lawsuit is Lillian Graham. Following her implant operation at Jacksonville, Florida, she developed a fistula, infection, organ damage, and adhesions, and her mesh wadded up. She required two revision surgeries.
2.9 Ethicon: Prolene Hernia System (PHS)
On the market since 1997, the prolene is a plug similar to Bard’s PerFix plug that uses polypropylene. The original prolene mesh used heavy-weight polypropylene while a newer version uses a light-weight polypropylene (“Ultrapro Hernia System) and may be less prone to complications.
Another product posing problems is the Prolene 3D.
2.10 Gore-Tex: DualMesh
Gore-Tex‘s DualMesh was released in 1995 and is not used to any great extent today. This mesh product was made of ePTFE. This material has a propensity to degrade and allows bacteria to grow in the pockets caused by the degradation. Other complications include adhesion, bowel obstruction, organ perforation, and seromas. Additional surgeries may be required.
3. What is the average payout for a hernia mesh lawsuit?
These lawsuits are still in litigation. Compensation for hernia mesh claims can cover economic and non-economic damages. The value of these damages can be:
- determined via negotiations and finalized in a hernia mesh settlement, or
- decided upon by a jury and entered as a judgment by the court.
The amount of compensation you receive is dependent in part on:
- the value of your economic damages; and
- an estimation of your non-economic damages.
Knowing what can be claimed can help you better understand what the value of your own hernia lawsuit may be.
3.1 What specific compensatory damages can you claim?
Patients who have suffered complications or have otherwise been injured by a hernia mesh product are eligible for compensation for those injuries. This includes economic losses and non-economic damages.
Economic damages are easier to determine because they have a value already attached to it or a value relatively easy to determine. Most common examples include:
- Medical bills
- Lost wages if you suffered a partial or total disability, and
- Miscellaneous out-of-pocket expenses, like travel to and from medical appointments.
Past and future expenses, like future medical bills and future wage losses, can also be claimed. These claims are usually made when the complications are long-term and complex. There are many factors, like prognosis and personal medical history, that go into the projections of these costs.
For example, imagine your hernia mesh perforated an organ, caused an MRSA infection, and required mesh removal. Your current medical bills may have already amounted to $25,000. It is anticipated the MRSA infection may need to be treated with long-term therapy/suppression at an estimated cost of another $10,000. In the short term, while recovering, you missed work for several months at a total of $8,000, but in the long term, you are anticipating another year off work or reduced work hours estimated at $16,000. Your economic damages would – hypothetically – total $59,000.
There is no cap on economic damages regardless of the state where your injury occurred. The total sum of your economic damages is the total sum of the compensation owed to you under this type of damages.
Non-economic damages are more complicated to determine. In hernia mesh lawsuit cases, non-economic compensation is usually limited to pain and suffering as well as mental or emotional anguish. But it could also encompass loss of enjoyment, loss of quality of life, or loss of consortium.
Pain and suffering is the physical pain you may experience from hernia mesh complications. This includes any surgical procedures required to address the complications. And mental and emotional anguish refers to your mental and emotional state caused by the injury.
Of course, non-economic damages do not come with a monetary value. No amount of money can compensate truly for your pain and emotional distress. Determining the value of your non-economic damages can be tricky and may require experts.
In California – like most other states – there is no standard formula to make calculating non-economic damages easy or consistent. Some lawyers may say it is a matter of multiplying economic damages by two or three — three reserved for more severe cases. But this “formula” does not take into consideration important factors as:
- The type and severity of your hernia mesh complications and injury
- The length of time recovery is expected to take
- Whether there will be any permanent disability, scarring, or disfigurement
- How the injury will affect daily activities
- How the injury will affect relationships with family and friends; and
- Your medical prognosis.
For example, a person who develops chronic, debilitating pain from the damage due to the hernia mesh will have greater pain and suffering than a person who had revision hernia surgery without complication and recovered quickly.
A skilled attorney will use evidence to maximize your hernia mesh settlement or award, allowing only a state’s cap on non-economic damages to limit what you receive. That said, not all states have damage caps. The states that do have them run the gamut from $250,000 to $750,000. Also, damage caps can differ within these states depending on if the tort case is personal injury, product liability, or medical malpractice.
Moreover, spouses may file a derivative claim for loss of consortium. This type of claim occurs when the injury has directly impacted the marriage negatively, such as depression or the inability to have sexual relations.
3.2 What are some settlements and compensation already received by victims?
There have already been lawsuit settlements and verdicts throughout the United States for hernia mesh complications. These cases may help you understand what to expect from pending lawsuits today.
One notable hernia mesh settlement includes C.R. Bard. In 2014, it settled 6,000 hernia mesh implant lawsuits, committing to pay out $319 million. And in 2011, C.R. Bard paid $184 million to settle about 2,600 Kugel Mesh cases.5
The transvaginal mesh contains many of the same dangerous materials as hernia mesh. More than 107,000 lawsuits were filed against the makers of transvaginal mesh, and that litigation – consolidated in West Virginia – settled for approximately $8 billion.
4. Is the hernia mesh litigation a class action or individual lawsuits?
Individual lawsuits. But in the majority of cases, these hernia mesh implant lawsuits will be filed and managed as part of multi-district litigation (MDL). There is often more strength in numbers than in a one-off lawsuit.
An MDL resembles a class action. In both cases, similar victims band together to sue the same defendant in one federal court. In a class action, all plaintiffs are together in one lawsuit. In a mass tort MDL, each plaintiff has his or her own claim against the defendant.
Currently, the hernia mesh MDLs are coming out of the pre-settlement phase. The pre-settlment phase is where both sides file pre-trial motions and exchange “discovery” (evidence). But currently or in the near future, the judges are allowing a small, select number of plaintiffs to go to trial. These are called “bellwether” trials.
The results of these bellwether trials will set the stage for settlement negotiations with the remaining plaintiffs. If the plaintiffs win their trials and get awarded high damages, this will likely translate to higher value settlements for all the plaintiffs. From start to finish, MDLs may take several years.
Currently, there are three federal hernia mesh MDLs, amounting to more than 18,000 lawsuits as of 2021. Each is against a different medical device manufacturer:
- Ethicon, MDL No. 2782 for Physiomesh Flexible Composite. Established in 2017, this MDL is out of the U.S. District Court for the Northern District of Georgia. It currently has more than 3,365 cases. The four bellwether trials were scheduled for 2021, but they have been delayed until further notice. Judge Richard Story is presiding. The four plaintiffs are Danielle Guffy, James Bovian, Jeffrey Smith, and Diane and Jim Crumbley.
- Bard and Davol, MDL No. 2846 for polypropylene hernia mesh products. Established on August 2, 2018, this MDL is out of the U.S. District Court for the Southern District of Ohio. It currently has more than 13,000 cases. The first trial started on August 2, 2021.
- Atrium, MDL No. 2753 for C-QUR hernia mesh. Established in 2016, this MDL is out of the New Hampshire District Court. It currently has about 2,624 cases. The first trial was set for July 7, 2021, but it seems to have settled out of court. Judge Landya McCafferty will preside over the upcoming bellwether trials.
Note that Covidien Parietex mesh lawsuits have not been consolidated into an MDL. Victims may file a complaint on an individual basis. (Medtronic purchased Covidien in 2015.) Also note that the W.L. Gore & Associates Gore-Tex DualMesh lawsuits have not been consolidated into an MDL either. Victims can file on an individual basis.
Finally, note that several dozen Physiomesh lawsuits were consolidated into a multi-county litigation in New Jersey’s Atlantic County in 2018. That is like a state-level MDL.
4.1 How big will the hernia mesh settlement be?
That is uncertain and will depend in large part on how the “bellwether” trials turn out. The final settlement will be either “global” or “inventory.”
A global settlement is when the hernia mesh manufacturer gathers all the plaintiffs’ law firms together and settles with everyone collectively. An inventory settlement is when the manufacturer goes to individual law firms and reaches individual deals.
Most likely some of the settlements will be on an inventory basis. When this happens, the manufacturer will usually go first to the law firms that have the most cases and do the best job of working up their cases.
Note that plaintiffs who had revision surgery and/or serious injuries will probably get the highest settlements.
4.2 When will the hernia mesh settlement be?
This too is uncertain. Bard and Ethicon jury trials were expected throughout 2020. But the COVID-19 crisis caused postponements. The first Bard bellwether trial is scheduled for the summer of 2021.6
The plaintiffs’ hernia mesh lawyers are pressing for things to proceed as quickly as possible. And the hernia mesh manufacturers are also anxious for these MDLs to settle to help stem bad publicity.
4.3 Pros and cons of MDLs
MDLs are usually beneficial to hernia mesh plaintiffs for the following reasons:
- The playing field against Big Pharma and their army of political lobbyists and attorneys is evened when all the victims join forces.
- MDLs are efficient because the judge’s pretrial rulings apply to every plaintiff.
- The negotiation and settlement process is quicker and easier.
MDLs do have their drawbacks:
- Individual plaintiffs may feel powerless or removed from the case. This is especially true if the MDL is in a court far away from where they live.
- Individual plaintiffs do give up some of their individual bargaining power by joining an MDL.
- Unlike class actions, MDLs do not allow plaintiffs to “opt-out.”
But in general, MDLs are the quickest and easiest way for medical device victims to get paid.
(MCLs – multi-county litigations – are similar to MDLs but on a state rather than the federal level.)
5. How does the FDA oversee hernia mesh safety?
The Food & Drug Administration (FDA) must approve all medical devices on the market. The FDA also monitors their safety. They use adverse event reports and post-market studies to identify problems. Then if necessary, they issue recalls.
Still, millions of consumers suffer injuries from FDA-approved devices. Here is what you should know about the FDA and hernia mesh.
5.1 What is the FDA approval process?
The FDA’s approval process is generally rigorous. It is called the premarket approval (PMA) process. It requires the manufacturer to prove a medical device is safe and effective. Proof generally involves clinical and laboratory results.
But for hernia mesh products, the FDA uses the 510(k) clearance process. It is quicker and does not require results from studies. The main requirement is showing there is another equivalent device on the market. All that needs to be shown is that — compared to the marketed device — the new device has:
- The same intended use and technological characteristics, or
- The same intended use but different technological characteristics. And they do not raise new questions regarding safety and effectiveness.
This process is problematic because it allows surgeons to use untested devices. If a defective hernia mesh gets by the normal FDA approval process, then 510(k) clearance opens the door to all other similar meshes that are also defective to get quick approval.
If proper studies have been required for each new device, then the defects may have been determined before anyone was harmed.7
Note that many coatings in flexible composite meshes (that have coatings) have not been tested. Manufacturers get away with this by not calling these coatings a barrier, which would require PMA. Meanwhile, coated meshes are in high demand and sell for much more than uncoated meshes.
5.2 What is the FDA’s monitoring process?
After the FDA approves a medical device for the market, it monitors it for safety. But it relies on external entities or persons reporting problems. The FDA does not take any proactive steps itself.
For example, when consumers experience mesh complications, they may complain to their doctor. The doctors or patients or both may file an adverse event report with the FDA. It is these reports that the FDA monitors. But in many cases where there may be problems, no one files an adverse event report. (Note that medical manufacturers must report any lawsuits to the FDA.)
When it becomes clear a specific device has issues, the FDA investigates and may send warning letters. If a problem is found, the device is recalled.8
A recall can be voluntary or mandatory, depending on the issues. If the problem is corrected, the recall is removed and the device can return to the market. If the problem is not corrected and unfixable, the device is permanently recalled.
In short, it takes a lot longer to remove a defective device from the market than it does to approve it.
5.3. How do I know if my hernia mesh was recalled?
The below chart lists hernia mesh recalls.
|Date Posted||Recall |
|Mesh Product||FDA Reason||Termination Date||Approved through 510(k)?|
|2/22/21||2||Covidien Parietex hydrophilic anatomical mesh||Incorrect device is contained in the package||Open||Yes|
|12/3/20||2||PROCEED Surgical Mesh |
Hernia Mesh Oval
|And a customer found a hair inside of the primary packaging of a single unit.||Open||Yes|
|3/21/19||2||Gentrix Surgical Matrix Thick||Nonconforming Material/Component||5/7/2020||Yes|
|11/14/18||2||Parietex Composite Parastomal Mesh||Product failure led to hernia recurrence requiring additional surgical treatment||5/7/2020||Yes|
|4/26/18||2||Versatex Monofilament Mesh 50 x 50 cm||Recurrence||Not listed on website.||Yes|
|2/23/18||2||Atrium ProLite||Under investigation for incorrect configuration||7/30/18||Yes|
|8/19/16||2||TIGR Matrix Surgical Mesh||Manufacturer implementing additions to the product’s instructions for use concerning certain inguinal hernia repairs||12/23/16||Yes|
|8/9/13||2||Atrium C-QUR Edge||Package design/selection |
|8/9/13||2||Atrium C-QUR TacShield||Package design/selection |
|8/9/13||2||Atrium C-QUR||Package design/selection |
|8/9/13||2||Atrium C-QUR V-Patch||Package design/selection |
|6/2/14||2||Bard Ventralight ST Mesh with Echo PS” 8″ Circle||Packaging process control||12/23/15||Yes|
|6/2/14||2||Bard Ventralight ST Mesh with Echo PS™ 7″X9″||Packaging process control||12/23/15||Yes|
|6/2/14||2||Bard Ventralight ST Mesh with Echo PS” 6″X8″||Packaging process control||12/23/15||Yes|
|6/2/14||2||Bard Ventralight ST Mesh with Echo PS” 6″X10″||Packaging process control||12/23/15||Yes|
|6/2/14||2||Bard Ventralight ST Mesh with Echo PS” 6″ Circle||Packaging process control||12/23/15||Yes|
|6/2/14||2||Bard Ventralight ST Mesh with Echo PS” 8″X10″||Packaging process control||12/23/15||Yes|
|6/2/14||2||Bard Ventralight ST Mesh with Echo PS” 4.5″ Circle||Packaging process control||12/23/15||Yes|
|6/2/14||2||Bard Ventralight ST Mesh with Echo PS” 12″X14″||Packaging process control||12/23/15||Yes|
|6/2/14||2||Bard Ventralight ST Mesh with Echo PS” 10″X13″||Packaging process control||12/23/15||Yes|
|6/2/14||2||Bard Composix L/P Mesh with Echo PS” 8″X10″||Packaging process control||12/23/15||Yes|
|6/2/14||2||Bard Composix” L/P Mesh with Echo PS” 7″x9″||Packaging process control||12/23/15||Yes|
|6/2/14||2||Bard Ventralight” ST Mesh with Echo PS” 4″x6″||Packaging process control||12/23/15||Yes|
|1/23/14||2||Bard Composix L/P with Echo PS 10″ X 13″||Labeling Change Control||12/23/15||Yes|
|1/23/14||2||Bard Composix L/P with Echo PS 6″ X 8″||Labeling Change Control||12/23/15||Yes|
|9/20/12||2||Bard Ventralight ST Mesh. – Ellipse 8″ x 10″||Mixed-up of materials/components||9/3/13||Yes|
|9/20/12||2||Bard Ventralight ST Mesh. – Ellipse 7″ x 9″||Mixed-up of materials/components||9/3/13||Yes|
|5/23/11||2||Bard Soft Mesh 4″x6″ Flat||Labeling mix-ups||10/28/11||Yes|
|5/2/11||2||Bard Ventralex” Hernia Patch Medium Circle||Labeling mix-ups||10/27/11||Yes|
|11/23/10||2||Bard Mesh Pre-shaped||Process Control||10/27/11||Yes|
|5/4/10||2||Bard Ventrio Small Oval Hernia Patch 8cm X 12cm||Labeling mix-ups||10/27/11||Yes|
|1/28/09||3||Bard 3D Max Mesh, Pre-formed Knitted Polypropylene||Mixed-up of materials/components||5/2/12||Yes|
|2/22/06||1||Bard Composix Kugel Mesh X-Large Patch |
Oval with ePTFE, 7.7” x 9.7”
|Memory recoil ring could break & lead to bowel perforation, chronic enteric fistula||Completed||Yes|
|2/22/06||1||Bard Composix Kugel Mesh X-Large Patch |
Oval with ePTFE, 10.8” x 13.7”
|Memory recoil ring could break & lead to bowel perforation, chronic enteric fistula||Completed||Yes|
|2/22/06||1||Bard Composix Kugel Mesh X-Large Patch |
Oval with ePTFE, 8.7” x 10.7”
|Memory recoil ring could break & lead to bowel perforation, chronic enteric fistula||Completed||Yes|
|4/3/14||2||Ethicon Proceed||Under investigation by firm for incomplete seal & sterility||Open||Yes|
|1/14/11||2||Ethicon Proceed||Nonconforming material/component (delamination)||Open||Yes|
|1/26/06||2||Ethicon Proceed||Delamination & polypropylene concerns||9/28/06||Yes|
|2/1/11||2||Covidien AutoSuture SURGIPRO Polyproylene Mesh Clear 3″ x 5″||Packaging process control (sterility issue)||1/10/13||Yes|
5.4 What if the FDA recalled your hernia mesh?
When people’s hernia mesh is recalled, their case against the manufacturer is strengthened. The recall is proof the device may be defective. The plaintiff’s attorney then just has to connect that defect to the patient’s injuries.
Consider a recent study that identified two-thirds of all recalled mesh implants were approved through the 510(k) process:9 Researchers reviewed 113 recalls of problematic hernia mesh products. These recalls occurred between 2005 and 2009. The findings of the study were startling:
- Only 21 devices of the 133 recalls were approved via the PMA process.
- 80 of the 113 recalled devices were approved via the 510(k) process.
- 12 recalled products were exempt from any FDA regulation.
Most meshes get FDA-approved without being rigorously vetted. And some that do get vetted turn out to be defective anyway. An FDA recall can only help a plaintiff’s attorney argue that the device was defective and caused the plaintiff’s injuries.
6. What is a hernia?
When there is a weak spot in the abdominal wall, organs and tissues (fascia) can protrude through it. This lump is called a hernia. Some are born with hernias (“congenital”), and others are acquired with age.
Either way, hernias are unsightly and can be tremendously painful. Common risk factors including lifting heavy objects, pregnancy, age, and repeated vomiting or coughing. Men are more likely to develop hernias than women.
The two main types of hernias are abdominal and groin. Groin hernias make up three-fourths of every hernia case. They, in turn, include several different subtypes.
- Umbilical – Intestines pushing through belly button area
- Incisional – A sac of fat protruding through surgery incision, and this can occur years after the operation; high-risk factors include having taken corticosteroids, having respiratory problems, being overweight, or being elderly
- Spigelian – The bowel protruding below the navel
- Hiatal – When the stomach protrudes through the diaphragm, particularly in obese patients
- Epigastric – Fat protruding between navel and sternum
- Muscle – Common after sports injuries, when muscles protrude through the abdomen
- Paraesophageal – The stomach protrudes along the esophagus, which can lead to volvulus (the stomach twisting)
- Traumatic diaphragmatic – A hernia following an injury, such as a gunshot or stabbing
- Congenital diaphragmatic – during fetal growth, the diaphragm fails to close, leading to lung problems
- Inguinal – More common in males due to descending testicles, when intestines protrude through the lower belly
- Femoral – More common in women due to wider pelvises, when belly fat protrudes into the thigh
- Obturator – More common in pregnant women, when fat protrudes into the thigh
Ideally, surgeons can use patients’ native tissues and sutures to repair a hernia. But in some situations, a mesh may be necessary. Surgeons place meshes in one of three ways:
- Overlay – between subcutaneous tissue and the rectus abdominis
- Inlay – between rectus abdominis layers
- Underlay – between rectus abdominis and peritoneum
When mesh started being researched in the 1950s, doctors presumed thicker was better. But now doctors agree thinner, light-weight meshes are preferable.10
7. What to do if your pain and suffering are the result of a hernia mesh implant?
You must seek medical attention, especially if the complications have not stopped 30 days after the implant surgery. There are several causes of hernia mesh device failure and resulting injuries. For instance, if you have severe headaches and never before experienced these kinds of headaches until after hernia repair surgery using mesh – regardless of whether the headaches started immediately or years later – it could be a symptom of a defective hernia mesh implant. Always make sure your doctor or other healthcare provider knows about your hernia mesh repair surgery.
Then contact the Shouse Law Group. You do not want to wait to contact an attorney because the statute of limitations sets limits on how long you have to file a claim. If you fail to file within the time limit – set on a state-by-state basis – you lose your eligibility to file. In the hernia mesh litigation, statutes of limitations run anywhere from one year to six years, again depending on the state. And there may be factors in your specific case that shorten or lengthen your deadline to file suit.
8. How do I qualify for a hernia mesh lawsuit?
Call Shouse Law Group for a free case evaluation on whether you meet the qualifications for a hernia mesh claim. When you call, we will ask you to provide the following information:
- The date of your hernia surgery and any revision surgeries
- A list of your symptoms and complications (so make sure to document them as they occur)
- If you know it, the manufacturer and model of your mesh device
For additional help…
Our medical device attorneys have the commitment, the resources, and the legal capabilities to help you with your hernia mesh implant lawsuit. Contact us for a free case evaluation by a hernia mesh attorney.
Someone is available 24 hours a day, 7 days a week to speak with you and your loved ones. Disclaimer: Results cannot be guaranteed.
We represent clients throughout the United States from all 50 states and Washington, D.C.
- See Tingey v. Radionics, 193 Fed. Appx. 747 (10th Cir. 2006); also see Francesco Gossetti, Linda D’Amore, Francesca Ceci, Maria Romana Grimaldi, Paolo Negro, “Surveillance of Surgical Meshes in Ventral Hernias and Unpredictability of Their History,” Annals of Surgery, (April, 2018); the term “meshoma” refers to when meshes move or bunch up, resembling a tumor. And “composite” means that the mesh has a coating. See also Dunja Kokotovic, Thue Bisgaard, Frederik Helgstrand, Long-term Recurrence and Complications Associated With Elective Incisional Hernia Repair, JAMA (October 18, 2016)(“Mesh implantation prevented the need for subsequent reoperation in relatively few patients, suggesting that the benefits associated with the use of mesh are partially offset by long-term complications associated with its use.”). See also Mohamed Mohamed Elawdy, Emad E. Mousa, Samer El-Halwagy, Ahmed Mohamed Eltanahy, Mohamed M. Salaheldin & Yasser A. Razek, “Hernia Mesh Migration into Urinary Bladder a Cause of Recurrent Stones: A Case Report“, Indian Journal of Surgery volume 83, pages 321–323 (2021). See also Joseph Ryan Leach, Bryan Manoukian & Lygia Stewart, “Mesh on the move: a case report of total transmural surgical mesh migration causing bowel obstruction“, Clinical Journal of Gastroenterology volume 14, pages 136–140 (2021).
- See Godelia v. Doe, 881 F.3d 1309 (11th Cir. 2018).
- Terry M. Henry, Melanie S. Carter, Lauren E. O’Donnell, and Naomi Zwillenberg. April 14, 2017, Understanding a Medical Device Manufacturer’s Broad Duty to Warn. Medical Device and Diagnostic Industry (Qmed); see Burton v. R.J. Reynolds Tobacco Co., 397 F.3d 906 (10th Cir. 2005).
- See Jeffress v. Reddy, 77 Fed. Appx. 627 (4th Cir. 2003).
- John R. Fischer, “C.R. Bard ordered to pay $3.6 million in lawsuit over defective IVC filter“, DotMed.com (April 06, 2018); C.R. Bard Extends Settlement in Kugel Mesh Litigation, Cision PR Newsire (2011)(The Kugel patch was recalled in 2005 due to risk of fistulas and bowel perforations. An MDL formed in 2007 in Rhode Island. Bard won the first bellwether trial in 2010. It lost the second, resulting in a $1.5 million verdict to plaintiffs Christopher and Laure Thorpe. The MDL closed in 2017, following a decade of litigation).
- In re. Bard, 2846, Southern District of Ohio, Upcoming Court Proceedings; In re. Ethicon, 2782, Northern District of Georgia, main page.
- Overview of Device Regulation, FDA.
- Recalls, Corrections and Removals (Devices), FDA. See also Brad Perriello, J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh, Mass Device ()
- Zuckerman DM, Brown P, Nissen SE. Medical Device Recalls and the FDA Approval Process. Arch Intern Med.2011;171(11):1006–1011. doi:10.1001/archinternmed.2011.30.
- Back in 1955, Dr. Francis Usher began researching various materials used to treat hernias, including Teflon. He settled on polypropylene, and his method became known as the Lichtenstein repair. Francis Cowgil Usher, M.D., Baylor College of Medicine. See Hernia Mesh Surgical Implants, FDA. See also Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair, ClinicalTrials.gov (“This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain.”). See also Mylan T Nguyen, Rachel L Berger, Stephanie C Hicks, Jessica A Davila, Linda T Li, Lillian S Kao, Mike K Liang, Comparison of outcomes of synthetic mesh vs suture repair of elective primary ventral herniorrhaphy: a systematic review and meta-analysis, JAMA Surg. (May 2014)(“Mesh repair has a small reduction in recurrence rates compared with suture repairs for primary ventral hernias, but an increased risk of seroma and SSI was observed. Further high-quality studies are necessary to determine whether suture or mesh repair leads to improved outcomes for primary ventral hernias.”). , Ventral hernia repair with synthetic, composite, and biologic mesh: characteristics, indications, and infection profile, (Aug 22, 2012)(“Synthetic PP mesh is an appropriate, durable material for extra-peritoneal placement in uncomplicated, clean VHR. Expanded polytetrafluoroethylene and composite meshes are suitable for intraperitoneal placement during laparoscopic VHR. Biologic meshes may be appropriate for contaminated fields or other special situations, but there is no consensus on when or how to use them.”). See also Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias (SITUP), ClinicalTrials.gov (“With this prospective cohort study the investigators want to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects.”). See also F. E. Muysoms, J. Bontinck & P. Pletinckx, Complications of mesh devices for intraperitoneal umbilical hernia repair: a word of caution, Hernia volume 15, pages 463–468 (2011)(“Several mesh devices for the treatment of umbilical and other small ventral hernias have become available in recent years. These meshes have a dual layer consisting of a permanent or temporary barrier against adhesion formation between the viscera and the intraperitoneally exposed part of the mesh. We have seen several patients with serious late complications of these meshes placed intraperitoneally. Some of these patients needed small bowel resection and mesh removal. Others developed a recurrence because of improper deployment of the mesh in the intraperitoneal position. We think that, if preperitoneal deployment of such mesh devices is possible, this should be the preferred position, notwithstanding the fact that these meshes have a dual layer. There is a complete lack of convincing data on these mesh devices in the medical literature. No long-term data have been published, and, for three of the four mesh devices available, no publications on their use in humans were found. We think that surgeons adopting innovative mesh devices should register and follow their patients prospectively, at least until there are enough published studies with sufficiently large patient samples, acceptable follow up times, and favourable outcomes.”). See also Laura Landro, A Secret for Patients Undergoing Hernia Repair, Wall Street Journal (February 28, 2012)(“Hernia repair, one of the most common surgical procedures, carries a risk many patients don’t consider: chronic pain after surgery. More than 30% of patients may suffer from long-term chronic pain and restricted movement after surgery to fix a hernia, a bulge of the intestine or body fat through a weak area in the abdomen, studies show. Damage to nerves and muscles from the hernia may cause lingering discomfort. New synthetic mesh devices, though better than traditional sutures at reinforcing the abdominal wall, can irritate nerves and carry a slightly higher risk of infection.”).