Hernia Mesh Lawsuit - A Lawyer's Guide to the Process

Updated

7 signs my hernia mesh is failing

Hernia Mesh Lawsuit Attorney Neil Shouse explains the symptoms a patient may be experiencing if their hernia mesh implant has failed. Some of the most common symptoms of a failed device are burning sensations, bulging in the abdomen caused by an infection, feeling tired all day long, have sexual problems in the bedroom such as impotence, constipation and other digestion issues, feeling sick to your stomach, and most commonly of all, pain. Many patients complain about these symptoms to their doctor who implanted the failed devices, but the doctors will tell them their symptoms are normal, and nothing is wrong. They will tell the patients to go home and take pain medication. But really those doctors may just be afraid to remove the device, because the surgery is very complicated, and can lead to potential liabilities where the doctor may open themselves up to a lawsuit. A CT scan to look and see if the mesh device has migrated, or is otherwise malfunctioning is a prudent course of action for a patient who is suffering from any of the above symptoms. More info at https://www.shouselaw.com/herniamesh/injuries/mesh_failure.html or call (888) 327-4652 for a free consultation. If you or a loved one suffers from a failed hernia device, we invite you to contact us at Shouse Law Group. We can provide a free consultation in office or by phone. We have local offices in Los Angeles, the San Fernando Valley, Pasadena, Long Beach, Orange County, Ventura, San Bernardino, Rancho Cucamonga, Riverside, San Diego, Sacramento, Oakland, San Francisco, San Jose and throughout California.


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 adequately to warn patients 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.

Shouse Law Group is a California-based law firm that is representing victims of defective hernia mesh devices. We take cases throughout the United States. Our lawsuits aim to recover financial settlements for the victims.

Manufacturers of Defective Hernia Mesh Implants Sued for Injuries

Complications from Hernia Mesh Implants

  • Adhesion, where the mesh sticks to internal tissue
  • 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, bowel obstruction, 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 and fever and can lead to sepsis
  • 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
  • Seromas, where fluid collects under the surface of the skin and can be accompanied by an infection
  • Chronic pain, which can be associated with many other complications caused by mesh failure
  • 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 surgery
  • Groin and testicular pain, which could also lead to testicle removal
  • Delayed and/or long-term consequences, which can surface many years after the implant
  • 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, and
  • Many other complications and injuries 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 explain:

Doctor in operating room about to place a mesh inside a hernia patient.
Defective hernia mesh implants can cause serious complications and subsequent pain and suffering.

1. What are the grounds for filing a hernia mesh lawsuit?

Four common claims in surgical mesh injury lawsuits are:

  1. The hernia mesh had a defective design;
  2. The hernia mesh had a manufacturing defect;
  3. The hernia mesh had improper labeling which failed to warn about the dangers; and
  4. 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.

An example of a defective mesh product is C.R. Bard's Kugel 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. Polypropylene is known to cause severe reactions and internal injuries.

Some manufacturers have designed their mesh products with polypropylene (e.g., Atrium, C.R. Bard, Ethicon). Other 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.

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

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 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;
  • 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' 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

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. To prove medical malpractice, the plaintiff would need to show that the doctor engaged in professional negligence. Specifically:

  1. The doctor had a duty of care towards the patient;
  2. The doctor breached that duty by falling short of professional standards of care; and
  3. 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. Who 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 more than 70 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.

2.1 Atrium - Maquet - Getinge Group: C-Qur

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.

2.2 Covidien - Medtronic: Parietex

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 mesh
  • Parietex ProGrip
  • Parietex Plug and Patch.

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 mesh products

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, 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

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, the materials worked against each other. The mesh would shrink and a ring used on the mesh would break, causing serious harm.

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. The mesh is also known to fold over and migrate, causing injury, too. Mesh removal surgery places the person at risk of losing a testicle.

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, 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 migrated, 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.

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, and the problem with this fabric is it separates from the polypropylene. 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.

2.9 Ethicon: Prolene

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 and is less prone to complications.

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 polytetrafluoroethylene (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. Removal surgeries are required.

Lectern in courtroom during a hernia mesh hearing.
Although some bellwether trials will take place, most hernia mesh claims will settle without a trial.

3. What compensation can I get if I sue for hernia mesh injuries?

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.

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

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

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 monetary value to be placed on it. 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.

3.2 What are some settlements and compensation already received by victims?

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.

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.

4. Is the hernia mesh litigation a class action or individual lawsuits?

Individual lawsuits. But in the majority of cases, these lawsuits will be filed and managed as part of multi-district litigation (MDL).

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:

  1. Ethicon, MDL No. 2782 for Physiomesh Flexible Composite. Pending in the U.S. District Court for the Northern District of Georgia.
  2. Bard and Davol, MDL No. 2846 for polypropylene hernia mesh products. Pending in the U.S. District Court for the Southern District of Ohio.
  3. 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.

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 are set throughout 2020. However, the COVID-19 crisis may cause 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.

4.3 Pros and cons of MDLs

MDLs are usually beneficial to hernia mesh plaintiffs for the following reasons:

  1. The playing field against Big Pharma is evened when all the victims join forces.
  2. MDLs are efficient because the judge's pretrial rulings apply to every plaintiff.
  3. The negotiation and settlement process is quicker and easier.

MDLs do have their drawbacks:

  1. 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.
  2. Individual plaintiffs do give up some of their individual bargaining power by joining an MDL.
  3. 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.

A doctor implanting a mesh during hernia surgery. Many surgeries require follow-up revisions.
Many hernia mesh surgeries require a revision. The doctor may remove the malfunctioning mesh. And put in a new one.

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. 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

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.

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.

FDA Hernia Mesh Recalls

The below chart lists hernia mesh product recalls.

Date Posted

Recall
Class

Mesh Product

FDA Reason

Termination Date

Approved through 510(k)?

11/14/18

2

Parietex Composite Parastomal Mesh

Product failure led to hernia recurrence requiring additional surgical treatment

Open

Yes

4/26/18

2

Versatex Monofilament Mesh 50 x 50 cm

Recurrence

Open

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
(adherence)

3/18/16

Yes

8/9/13

2

Atrium C-QUR TacShield

Package design/selection
(adherence)

3/18/16

Yes

8/9/13

2

Atrium C-QUR

Package design/selection
(adherence)

3/18/16

Yes

8/9/13

2

Atrium C-QUR V-Patch

Package design/selection
(adherence)

3/18/16

Yes

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

5.3 What if the FDA recalled your hernia mesh?

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.

Logo of FDA, which makes it easy to get meshes approved.
Most hernia meshes get quick approval through the FDA's 510(k) process.

6. What to do if your pain and suffering is the result of a hernia mesh implant?

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 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.

Contact our attorneys for help...

call center receiving calls for hernia mesh attorneys
Call us 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 at (855) 396-0370 for a free case evaluation by a hernia mesh attorney. Someone is available 24 hours a day, 7 days a week.

Our offices are located locally throughout California, Colorado and Nevada. But we represent clients throughout the United States.

References

  1. See Tingey v. Radionics, 193 Fed. Appx. 747 (10th Cir. 2006).
  2. See Godelia v. Doe, 881 F.3d 1309 (11th Cir. 2018).
  3. 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).
  4. See Jeffress v. Reddy,  77 Fed. Appx. 627 (4th Cir. 2003).
  5. John R. Fischer, "C.R. Bard ordered to pay $3.6 million in lawsuit over defective IVC filter", DotMed.com (April 06, 2018).
  6. In re. Bard, 2846, Southern District of Ohio, Upcoming Court Proceedings; In re. Ethicon, 2782, Northern District of Georgia, main page.
  7. Overview of Device Regulation, FDA.
  8. Recalls, Corrections and Removals (Devices), FDA
  9. 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.

Free attorney consultations...

The attorneys at Shouse Law Group bring more than 100 years collective experience fighting for individuals. We're ready to fight for you. Call us 24 hours a day, 365 days a year at 855-LAW-FIRM for a free case evaluation.

Regain peace of mind...

Shouse Law Defense Group has multiple locations throughout California. Click Office Locations to find out which office is right for you.

Office Locations

Shouse Law Group has multiple locations all across California, Nevada, and Colorado. Click Office Locations to find out which office is right for you.

Call us 24/7 (855) 396-0370