A lawyer's guide to hernia mesh lawsuits


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. These 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 thousands of lawsuits pending against multiple manufacturers, most of them as part of a federal multi-district litigation. 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 across the United States. Our lawsuits seek to recover money settlements for the victims, including compensation for

  • medical bills,
  • lost wages,
  • pain and suffering, and
  • punitive damages.

Manufacturers of Defective Hernia Mesh Implants Sued for Injuries

Common Injuries of 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 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 encompass all the above injuries, reactions, and complications
  • 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

Even if the mesh product used in your repair surgery was defective, you are not eligible to file a lawsuit unless it caused you actual harm. In other words, the defective implant must be the direct and proximate cause of your harm. A simple way to understand what this means to you specifically is to complete the following sentence according to your unique experience:

“I would not have experienced ________ (damages, complications, and injuries) but for the _______ mesh product."

Compensatory Damages for Hernia Mesh Injuries

  • Economic damages, like lost wages, loss of earning capacity, medical bills, miscellaneous costs
  • Non-economic damages, like 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:

Hernia mesh
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 hernia 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 like time bombs waiting to go off.

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 bad reactions and internal damage:

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.

1.2 Manufacturing defect

Even the safest medical devices can become dangerous if they are constructed poorly. And since 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.

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 pretty 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.

1.4 Medical malpractice

An otherwise safe hernia mesh can cause massive health problems if the surgeon implants it incorrectly. 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.1

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's the few that are defective that are causing serious complications and are the subject of the mesh lawsuits.

Manufacturers that did or do dominate the U.S. market with their mesh models include but are not limited to:

  • Atrium Medical Corporation
  • Covidien
  • C.R. Bard
  • Ethicon
  • Gore Medical
  • Genzyme Corporation.

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 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 coating on both sides of the mesh prevented 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.

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 in a hernia mesh lawsuit?

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 because there is 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 and 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, and those 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.

Additionally, 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.

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

Individual lawsuits. But in the majority of cases, these lawsuits transfer to an existing 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 lawsuit 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-litigation phase. But in the coming months, the judges will allow a few 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 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.

Probably 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. The first Bard bellwether trials are slated for the end of 2019. And the first Ethicon trials not until 2020.

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.

5. What role does the Food & Drug Administration play in hernia mesh devices and consumer safety?

Any medical device on the market must be approved by the Food & Drug Administration (FDA). Consumers often feel that the FDA is their first line of defense, that the FDA is there to protect them from harm. The FDA, after all, is tasked with approving drugs and medical devices before they enter the market. The FDA also monitors the safety of these devices while they are on the market, using adverse event reports and post-market studies to identify medical devices that may be defective or otherwise problematic and harmful to a person.

Though the FDA approves hernia mesh products, consumers have still suffered injuries from defective medical devices. Here's what you should know about the FDA and hernia mesh devices.

5.1 What is the FDA approval process for hernia mesh?

For most medical devices, the FDA's approval process is generally rigorous, expensive, and time-consuming, known as the premarket approval (PMA) process. This process requires the manufacturer to prove a medical device like hernia mesh is safe and effective. Proof generally involves the results of clinical and laboratory studies identifying positive, desired outcomes.

But for hernia mesh products, the FDA used the 510(k) clearance process. This process is quicker and does not require evidence from clinical and laboratory studies to prove the mesh is safe and effective. The primary requirement is showing that 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 that do not raise new questions as to the safety and effectiveness of the product.

The problem with this process and hernia mesh is that marketed devices may have been defective, and new devices have been approved based on these defective products, meaning the new implants may have been inherently defective, too. If proper studies have been required for each new device, then the defects may have been determined before anyone was harmed and suffered -- in some cases irreparable -- damage and pain.

5.2 What is the FDA's monitoring process to ensure safe hernia mesh products?

After the FDA approves a medical device for the market, it monitors it for safety. But this monitoring is dependent on external entities or persons reporting problems as opposed to any proactive steps on behalf of the FDA itself.

For example, when a consumer undergoes hernia repair and experiences unanticipated complications due to the mesh itself, he or she may complain to his or her doctor. The doctor or the patient or both may file an adverse event report with the FDA. It is these reports that the FDA monitors.

When it becomes clear there is a problem with a specific device, the FDA investigates and may send warning letters. If a problem is found, the device is recalled.2 A recall can be voluntary or mandatory, depending on the issues. If the problem is corrected, the recall is removed and the device can be placed back on the market. If the problem is not corrected and indeed cannot be corrected, the device is no longer permitted on the market.

FDA Hernia Mesh Recalls

The below chart provides hernia mesh product recalls, the reason for its recall, and -- among other information -- if it was approved via the 510(k) clearance process.

Date Posted

Recall
Class

Mesh Product

FDA Reason

Termination Date

510(k)?

2/23/18

2

Atrium ProLite

Under investigation for incorrect configuration

Open

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 does it mean to your case if the FDA recalled or not a hernia mesh product that injured you?

Consider a recent study that identified two-thirds of all recalled mesh implants were approved through the 510(k) process.3 In this study, the researchers reviewed 113 recalls of hernia mesh products the FDA determined caused serious health problems and/or death. These recalls occurred between 2005 and 2009. The findings of the study are startling:

  • Only 21 devices of the 133 recalls were approved via the PMA process.
  • Eighty of the 113 recall mesh devices were approved via the 510(k) process.
  • Twelve recalled products were exempt from any FDA regulation.

Though these figures would seem to suggest the FDA is at fault -- in part at least -- for mesh injuries and deaths, however limited the latter is, the FDA is not held accountable. But the recalls can be used as part of your attorney's strategy when bringing a lawsuit against a hernia mesh manufacturer whose product caused your injuries.

It is, therefore, important to your case to retain a hernia mesh device lawyer with comprehensive knowledge of FDA recalls, how it works, and how it can be applied to your case to benefit you.

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

If you have a mesh implant and have had any complications that could be related to that mesh product, 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 if 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, after you have been treated or at least know what caused your injury, seek legal assistance. It does you no harm to talk confidentially with a personal injury lawyer to determine if you have a case or not. Also, rest assured most attorneys take these kinds of cases on a contingency fee basis, so that means two important things: (1) you pay nothing upfront; and (2) your attorney fees are contingent on winning your case.

So, get the medical help you need immediately, and then contact the Shouse Law Group. You don't 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 Medical Device Liability Attorneys for a Free Consultation

Call support2

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 case evaluation and to find out more about hernia mesh lawsuits and to discuss your specific case. Someone is available 24 hours a day, 7 days a week, and we do not charge a fee for the initial, confidential consultation.

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

References

  1. 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).
  2. U.S. Food & Drug Administration. Recalls, Corrections and Removals (Devices). Updated July 9, 2018.
  3. 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.

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