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 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.
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 being used by surgeons.
Shouse Law Group is a California-based law firm that is representing victims of defective products. We take cases throughout the United States. Our lawsuits aim to recover financial settlements for the victims.
Manufacturers of Defective Hernia Mesh Implants Being Sued for Injuries
- 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
- Infections, which is 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 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
- 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
Potential Damages for Hernia Mesh Injuries
- Economic damages, such as lost wages, loss of earning capacity, medical bills and 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 compensation can I get if I sue for hernia mesh injuries?
- 4. Should I join a class action lawsuit or sue by some other means?
- 5. How does the FDA oversee hernia mesh safety?
- 6. What is a hernia?
- 7. What to do if your pain and suffering is the result of a hernia mesh implant?
Four common claims in surgical mesh injury lawsuits are:
- The hernia mesh had a defective design;
- The hernia mesh had 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
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 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 design example is the choice made by manufacturers to use polypropylene. For example, Atrium, C.R. Bard and Ethicon make mesh products with polypropylene. Polypropylene 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.
According to a 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 an 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.
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 FDA sent warning letters and ultimately shut down one facility for a time.
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
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’ attorneys 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
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
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 mesh 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.
The C-Qur mesh came on the market in 2006. Atrium first owned it but 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 has been recalled, 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.
Covidien, recently acquired by Medtronic, brought its Parietex mesh product onto 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.
Parietex is available as different mesh options:
- Parietex Composite (PO) mesh (which has a collagen barrier that disappears quickly)
- Parietex Plug and Patch
- Parietex ProGrip (which has a polylactic acid layer (“PLA”) and thousands of hooks)
Each of the above has its own unique problems, too. Complications include migration, perforation, bowel obstruction, and recurrence.
ST hernia mesh is a resorbable coated mesh line. Genzyme was the original make of the Sepramesh 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.
One of the first hernia mesh implants to be recalled, the Composix Kugel has been the subject of three recalls in 2005, 2006, and 2007. Made of a polypropylene base and a layer of ePTFE (polytetrafluoroethylene), the materials worked against each other. The mesh would shrink and a ring used on the mesh would break, causing serious harm.
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.
Bard’s PerFix Plug came on the market in the late 1990s and uses polypropylene mesh, too, to treat inguinal hernias. This type of plug comes looks likes a shuttlecock but can also come as an onlay patch. This patch has been shown to erode and migrate, causing organ perforation and intense pain. The cone tip applies severe pressure that results in additional pain. These injuries have been known to take years before it materializes as pain and the injury is discovered. See also our article on the Bard Marlex hernia 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, and the problem with this fabric is it separates from the polypropylene, despite being adhered by polydioxanone (PDS). The primary risk is bowel complications and required mesh removal surgery.
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.
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.
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.
Compensation is available to lawsuit plaintiffs who suffer injury from hernia mesh implants. Compensation covers economic and non-economic damages. The value of these damages can be:
- determined via negotiations and finalized in a 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 lawsuit may be.
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 $43,000 – $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 because there is no value already attached – just the pain and suffering. In hernia mesh lawsuit cases, non-economic compensation is usually limited to pain and suffering as well as mental or emotional anguish. But could also include loss of enjoyment or loss of consortium.
Pain and suffering include the physical pain you may experience from the complications. Including any surgical procedures required to address the complications.
Mental and emotional anguish refers to your mental and emotional state caused by the injury. Of course, this type of compensatory damages does not come with a monetary value. No amount of money can compensate truly for your pain and emotional distress.
But, that said, fair and just compensation includes compensation for non-economic damages. Determining the value of your non-economic damages can be tricky. It may require experts assigned to determine this very thing.
In California, as most other states, there is no standard formula to make calculating non-economic damages relatively 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 — to arrive at a figure, but this “formula” does not take into consideration important factors.
In all actuality, to arrive at a fair and just figure, factors that should be considered include:
- 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.
A person, for example, 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.
Manufacturers of hernia mesh implants will do what they can to minimize your pain and suffering. Their efforts are meant to lower the value of the sum of your compensatory damages.
A skilled attorney will use evidence to maximize your 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, too, for loss of consortium. This type of claim occurs when the injury has directly impacted the marriage negatively. For example, if the spouse with the hernia mesh injury suffers from severe depression and/or is unable to enjoy a physical relationship with the spouse.
There have already been 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 settlement specific to hernia mesh includes C.R. Bard. In 2014, it settled 6,000 lawsuits, committing to pay out $319 million.5
Transvaginal mesh contains many of the same dangerous materials as hernia mesh. More than 100,000 lawsuits were filed against the makers of transvaginal mesh, and that litigation settled for approximately $3 billion.
Individual lawsuits. But in the majority of cases, these 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. 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, there are three federal hernia mesh MDLs. Each is against a different medical device manufacturer:
- Ethicon, MDL No. 2782 for Physiomesh Flexible Composite. Pending in the U.S. District Court for the Northern District of Georgia.
- Bard and Davol, MDL No. 2846 for polypropylene hernia mesh products. Pending in the U.S. District Court for the Southern District of Ohio.
- Atrium, MDL No. 2753 for C-QUR hernia mesh. Pending in the New Hampshire District Court.
All of these MDLs are still in the pre-settlement phase. But in the coming months, the judges will allow a handful of the individual 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.
Note that Covidien hernia mesh lawsuits have let not been consolidated into an MDL. Victims may file suit on an individual basis.
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.
This too is uncertain. Bard and Ethicon jury trials were expected throughout 2020. But the COVID-19 crisis caused postponements.6
The plaintiffs’ attorneys 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.
MDLs are usually beneficial to hernia mesh plaintiffs for the following reasons:
- The playing field against Big Pharma 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 federal level.)
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.
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 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.
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 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 market than it does to approve it.
FDA Hernia Mesh Recalls
The below chart lists hernia mesh product recalls.
|Mesh Product||FDA Reason||Termination Date||Approved through 510(k)?|
|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|
When people’s hernia mesh are 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.
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.
The two main types of hernias are abdominal and groin. They, in turn, include several different subtypes.
- Umblical – Intestines pushing through belly button area
- Incisional – 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
- 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 a injury, such as a gunshot or stabbing
- 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 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.
You must seek medical attention. 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 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.
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
- If you know it, the manufacturer and model of your mesh device
Contact our attorneys for help…
Our medical device attorneys have the commitment, the resources, and the legal capabilities to help you with your hernia mesh lawsuit. Contact us today 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.
We represent clients throughout the United States.
- 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 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).
- 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
- 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.