Lawsuits for injuries caused by a defective hernia mesh

 

Defective hernia mesh implants can cause serious complications and subsequent pain and suffering. You may be eligible for compensation through a personal injury or product liability lawsuit.

Manufacturers of Defective Hernia Mesh Implants Sued for Injuries

Common Injuries of Hernia Mesh Implants

Compensatory Damages for Hernia Mesh Injuries

  • Economic damages, like lost wages, loss of earning capability, 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 reoccuring.

If you are looking for information on hernias, hernia mesh implants, hernia mesh-related injuries, manufacturers, lawsuits associated with the same, and the FDA's relationship to hernia mesh complications, you have come to the right place. We are dedicated to providing our clients the information they need to make informed decisions about their injuries and their future.

Hernia mesh
Defective hernia mesh implants can cause serious complications and subsequent pain and suffering.

1. Can You File a Hernia Mesh Lawsuit?

You are entitled to file a lawsuit for complications caused by hernia mesh if four certain elements exist:

  • You were owed a duty of care.
  • That duty of care was breached due to some type of action or inaction.
  • You sustained injuries and your injuries were directly and proximately caused by the breach of duty of care.
  • The injuries you suffered are monetarily quantifiable.

Of course, these elements are broad. So to understand if you can indeed file a hernia mesh lawsuit, you need to know how to prove a hernia mesh personal injury lawsuit.

1.1 Were you owed a duty of care?

A hernia is a medical condition that is often very painful and, as such, often needs to be treated. There are many types of hernias, like:

  • Inguinal, a hernia occurring in the groin area
  • Umbilical, a hernia occurring through the belly button
  • Epigastric or ventral, a hernia occurring in the abdominal wall
  • Incisional, a hernia develops where a surgical wound fails to properly heal
  • Femoral, a hernia occurring near the top of your thigh and groin
  • Hiatal, a hernia occurring when the stomach bulges into the chest area.

Hernias do not go away, but they do get larger over time, and when this happens, it increases the pain associated with them. To prevent progressive enlargement and subsequent pain, the tear must be repaired. So, the doctor suggests you finally undergo surgery. He may recommend hernia mesh specifically because it is supposed to allow for speedier recovery and less re-occurrence. There are different types and classifications of hernia mesh products that a a manufacturer makes and a doctor can recommends.

Doctor-Patient Relationship

The doctor who advises the surgery and all other doctors or medical professionals who work with you, treat you, or are otherwise associated with you during the course of your hernia repair, owe you a duty of care. This duty of care is a legal obligation to you as the patient. These medical professionals must adhere to a standard of reasonable care.

To establish the existence of a doctor-patient relationship, ask yourself simple questions like:

  • Was the doctor seeing you for or providing you ongoing treatment for your hernia?
  • Were you submitted to examinations for the purpose of hernia repair?
  • Did you choose to undergo hernia repair surgery?

If you answer yes to any of these pretty obvious questions, then it is safe to say a doctor-patient relationship exists. As such, the doctor owes you a duty of care and treatment with the kind of skill and care expected of a reasonably competent doctor under the same or similar circumstances. Circumstances in doctor-patient situations are defined as:

  • the area of medicine practiced;
  • the customary or accepted medical practices of other competent doctors in the same area;
  • the equipment and facility used and available at the time; and
  • any exigent circumstances.

Doctors also have a duty to warn and advise patients of possible consequences of hernia repair and other treatments.

But in hernia repair lawsuit cases, another duty is owed, one by the manufacturer of the hernia mesh used in the repair.

Medical Device Manufacturers

Any manufacturer of any product meant for consumers owes consumers a duty of care. This principle is true also for medical device manufacturers. They owe a duty of care to medical professionals, hospitals, other medical facilities when their products -- like hernia mesh -- are purchased and used on patients. This duty of care also extends to patients to ensure a safe product when the product is used as intended.

Manufacturers of hernia mesh must use reasonable care when producing these implants so that they are safe and are not defective. This duty also includes the duty to warn of potential risks and to provide adequate instructions on the product's use to the medical professionals who purchase the devices. 1

1.2 Was that duty of care breached?

After establishing a duty of care exists, to sue a doctor, hospital, or hernia mesh manufacturer, you must also demonstrate their respective duties of care were breached.

Doctors Breach of Duty of Care

In cases of doctors or medical professionals, a breach occurs when he or she fails to meet the appropriate standard. Generally speaking, the standard is established according to what other medical care professionals would provide under the same or like circumstances. Specifics of that standard may also be determined or established by the state.

Examples of a doctor's breach of duty can include:

  • failing to diagnose a hernia accurately
  • failing to insert a hernia mesh implant properly
  • making a serious mistake during a hernia repair operation (e.g., leaving a surgical tool inside the patient's body).

Proving a doctor breached his or her duty of care may require evidence from:

  • witness testimony,
  • expert testimony,
  • documentation from patient's medical history,
  • among other forms of evidence.

Hospital Breach of Duty of Care

When you are admitted to a hospital, like for a hernia repair operation, the hospital owes you a duty of care. In hernia mesh cases, this duty may be something like ensuring a safe facility and properly working equipment as well as ensuring the doctor and medical team administering the hernia mesh repair are qualified according to medical standards. Examples of a hospital breach of its duty of care include:

  • failing to provide sanitary conditions during a hernia mesh repair operation, which can result in infection, or
  • allowing a doctor or surgeon to operate in its facility even though he or she does not have the requisite skill and diligence in accordance with the accepted standard.

Proving a hospital breached its duty of care may involve:

  • witness testimony
  • expert testimony
  • review of the facility and equipment
  • review of medical charts, or
  • other documentation or evidence depending on the circumstances of the case.

Hernia Mesh Manufacturer Breach of Duty of Care

A manufacturer breaches its duty of care when the product is defective. A defect can fall under three main categories:

  1. Design defect,
  2. Manufacturing defect, and
  3. Marketing defect.

A hernia mesh manufacturer is the usual suspect in hernia mesh lawsuits because so many of these products have been found defective. And all three of these categories have played a role in hernia mesh lawsuits.

Design Defect

Defectively designed hernia mesh implants are those that may have been properly manufactured but the design is at issue and causes injury. In these cases, a claimant may not have discovered the defective product until years after the mesh was implanted and the injury manifests as severe pain. In other cases, the manufacturer may have been aware of the defect but chose to conceal it.

  • 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 a fabric to cover the polypropylene, hoping the fabric would prevent injury. The fabric, however, erodes over time and exposes the polypropylene to internal tissue.

Manufacturing Defect

In this case, a mesh product may have been designed without fault but the making of it is or was a problem. Atrium's C-Qur product is a good example here. Some of the 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.

Marketing Defect

Marketing defects include the manufacturer's failure to properly recommend, warn, and instruct anyone using the product about anything related to the intended use, actual use, and potential risks and complications of the product. Manufacturers are legally obligated to warn patients of foreseeable but not necessarily obvious dangers of its mesh implant. Marketing defect has been a major part of hernia mesh lawsuits throughout the United States and Canada.

1.3 Were you harmed by the breach?

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, meaning the defect implant was 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.

To fill in the first blank, you may have experienced any number of the following injuries that have been directly linked to defective implants.

  • Adhesion, where the mesh sticks to internal tissue
  • 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
  • Seroma, 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, 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, complications, and
  • Many other complications and injuries depending on your specific case
  • Hernia mesh revision surgery made necessary by failure of the original implant.

1.4 Can the harm be quantified in terms of money?

The harm you endure from a hernia mesh implant must be quantifiable in terms of money. This means, in the least, that you have medical bills to show for the injury you sustained and endure.

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 the serious complications.

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 have their 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

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.

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: Dual Mesh

Gore-Tex's Dual Mesh 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 persons 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 is eligible for compensation of 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 a 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 the state 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 a little more complicated to determine because there is no value already attached to it -- just the pain and suffering. In hernia mesh 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 includes the physical pain you may experience from the complications, including any surgical procedures required to address the complications. Mental and emotional anguish refer 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 suffering from the hernia mesh injury suffers 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 payout $319 million.

4. Should I join a class action lawsuit or sue by some other means?

If you have suffered injuries that are a direct cause of the hernia mesh used in your repair surgery, then yes, you should think about filing a claim. There have been and are thousands of settled and pending lawsuits. All these complaints have alleged or are alleging the hernia mesh implants caused injuries from intense, chronic pain to life-threatening infections. You should always consult with an attorney to determine your options.

Some of these lawsuits have been consolidated into a multi-district lawsuits while others -- though limited -- have been combined as a class action lawsuit. Whether you file an individual complaint, are transferred to a MDL, or join a class action lawsuit depends on the:

  • mesh product,
  • the manufacturer, and
  • the circumstances of your case, including the injuries you sustain and the specific issues of the case.

4.1 What is a hernia mesh lawsuit?

A hernia mesh lawsuit is one where you file a claim against a manufacturer for a defective product used in your repair surgery. This defective product, you claim, caused you injuries. The manufacturer, you claim, is responsible because of a defective design, problem with manufacturing the implant, or failure to warn of all potential consequences. The lawsuit is your means to obtain fair and just compensation for the economic and non-economic damages you have experienced but for the hernia mesh used in your operation.

A lawsuit can be expensive and time-consuming. Fortunately, in terms of the expense of a legal representative, most attorneys work on a contingency fee basis. That means we do not get paid unless we win the lawsuit for you -- you do not have to put up any money to sue the manufacturer.

Unfortunately, in terms of the time and effort put into the lawsuit, there's not much that can be done. There are a lot of steps to a medical device liability or medical malpractice lawsuit. These steps include:

  • Complaint. During this stage, your attorney will investigate the claims made by you and prepare a complaint detailing the factual allegations and outlining the legal claims for relief. After the complaint is filed, the defendant will respond with an answer.
  • Pre-trial Discovery, Depositions, and Motions. Now that the lawsuit is well on its way, this stage of the process is the “meaty” part. Your attorney will request documents and admissions about certain facts and will provide question -- known as interrogatories -- for the defendant to answer. The defendant, too, will request the same. Depositions will be taken, involving witness interviews under oath and before a court reporter. Your attorney will also file pre-trial motions -- like motions to clarify procedural issues or exclude evidence -- and attend hearings on those motions.
  • Trial. Your day in court has arrived. Your attorney will argue the merits of your case and cross-examine or counter cross-examine witnesses. The jury will convene to determine the fate of your case. Once a verdict is rendered, the judge will enter a judgment based on the verdict, and this judgment may include an award amount for you. A trial could endure for several weeks, depending on the complexity of it.
  • Post-Verdict/Appeal. After trial and an entering of the judgment, either party can file post-trial motions depending on the decision. If the manufacturer is found liable, then the manufacturer may file a motion to set aside the verdict. The manufacturer could also choose to appeal. If there is no appeal, your attorney will work with the defendant to secure payment of compensation.

Throughout the course of this process, too, your attorney will likely continue to talk with the attorneys for the defendant. A settlement can be reached at any time, including during trial.

Lawsuits against Covidien hernia mesh products -- like Parietex Composite Mesh, Parietex Surgical Mesh, and Parietex ProGrip Mesh -- are being sought on an individual basis. But most other lawsuits against other manufacturers have been consolidated into a MDL.

4.2 What is an MDL?

Sometimes you do not get to choose where your lawsuit will be heard. If there is multi-district litigation (MDL) relevant to your case, your case will automatically be moved -- and that is what has happened to many victims suing Atrium, Bard, and Ethicon.

MDL occurs when civil cases are consolidated because the issues are common. Your lawsuit will be transferred to a single court for pre-trial proceedings, like discovery. The court rules on all pre-trial proceedings You get to keep your attorney and once the pre-trial proceedings have concluded, your case will be transferred back to the appropriate court.

Because so many victims of hernia mesh have the same or related issues, MDLs have been the more prevalent means to compensation in recent years. Current MDLs include:

  • Ethicon, MDL No. 2782, regarding Physiomesh Flexible Composite, pending in the U.S. District Court for the Northern District of Georgia;
  • Bard and Davol, MDL No. 2846, regarding polypropylene hernia mesh products, pending in the U.S. District Court for the Southern District of Ohio or the Western District of Mississippi;
  • Atrium, MDL No. 2753, regarding C-QUR hernia mesh, pending in the New Hampshire District Court.

If you decide to file a lawsuit, your attorney will advise you of your options and whether those options are limited or not.

4.3 What is a class action lawsuit?

A class action lawsuit involves a group of people who have suffered the same or similar injuries and have come together to sue a common defendant they hold responsible for those injuries. There are over a million hernia mesh repairs a year and tens of thousands have been injured by them.

The process for a class action can be complex, but generally speaking, it must first be certified by after meeting certain criteria:

  • The number of class members is so high it is impractical for the court to hear all the individual cases.
  • The class members experienced the same or similar injuries.
  • Class representatives represent and can protect the interests of the whole class.

A class action is basically one case with one outcome. You have the option to opt in or out of class action lawsuits. There are benefits to joining as much as there are benefits to filing your own lawsuit.

Because there are thousands of cases throughout the country, it seems hernia mesh class action lawsuits would be logical. There are, however, no class action lawsuits in the U.S., but there are in Canada. There was a class action lawsuit against Bard in 2014 due to injuries sustained from its Composix Kugel hernia mesh patch. That lawsuit settled for $1.375 million.

In general, class action lawsuits have not been many though injuries to mesh products have been many. The reason is simple:

  • There are more than one mesh manufacturer at fault.
  • There are more than one mesh implant causing injury.
  • The injuries can vary dramatically from one case to another case.

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 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 a 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 the marketed devices may have been defected, 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 suing 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. 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 related to an internal infection caused by the mesh. 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 these types of hernia mesh cases, 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

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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 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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