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Hernia Mesh Lawsuit Overview
Thousands of people each year suffer from a hernia, which is the protrusion of an organ or tissue through an opening in its surrounding walls. A ventral hernia is one that commonly occurs in the abdominal wall where the muscles have weakened, which can result in a bulge or a tear. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) say that approximately 350,000 – 500,000 ventral hernia repairs are performed each year in the United States.
According to the American College of Surgeons, based on outcomes reported in the last ten years, there is typically a 4% chance a hernia can recur and a 2% risk of returning to surgery due to complications. According to the U.S. Food and Drug Administration (FDA), some of the adverse side effects reported for hernia repair surgery and associated with a hernia mesh device include infection, pain, intestinal complications, formation of a mass/lump/bulge, adhesions, vomiting, nausea, fever, redness, revision surgery, or recurrence of the hernia. To learn more about the complications associated with hernia mesh, jump to the Complications section.
They are numerous manufacturers like Gore Medical, Davol and Ethicon that make hernia mesh. In fact, hernia mesh has become the standard hernia repair solution, with almost 90% of hernia repairs utilizing this method. Our team of hernia mesh lawyers focus on the products developed by Ethicon.
Johnson & Johnson’s Ethicon Division had a flexible composite hernia mesh device which was commonly used in minimally invasive surgeries to repair abdominal hernias or other issues related to connective tissue beneath the skin that require a reinforcing or bridging material. Jump to the Ethicon Section to learn more about them.
In May 2016, Ethicon withdrew it’s flexible composite hernia mesh from the U.S. market after studies revealed complications associated with its use in minimally invasive hernia repairs. These studies indicated a much higher recurrence and revision rate from hernia repairs using hernia mesh compared to similar devices used for this type of procedure. Ethicon was not able to determine the cause of the issue, and, hence, removed this product from the worldwide market. As a result of these findings, families are filing legal claims against Ethicon since those who were affected by the recall claim the hernia mesh device used for hernia surgeries was defective and subjected patients to unnecessary risks.
Avram Blair and Associates P.C. has filed several hernia mesh lawsuits and is actively investigating all hernia mesh claims. Our hernia mesh lawyers are passionate about helping individuals and families injured by defective products. Clients come first. We believe people deserved to be treated with respect and attention. We offer free initial consultations with an experienced attorney. Phone calls are always returned promptly, and we are always available to answer our clients’ questions.
Avram Blair is licensed to practice law in Texas, Pennsylvania, and New York. He is also licensed to practice before the United States District Courts for the Southern Districts of New York and Texas, as well as the United States Court of Appeals for the Third Circuit.
He is a practicing Hernia Mesh Lawyer and is involved in every Hernia Mesh Lawsuit the firm files.
Did You Suffer After a Hernia Mesh Operation?
If you suffered health problems after undergoing a hernia mesh procedure, then you may qualify for compensation. You may also qualify if you underwent a second surgery to correct a recurring hernia. Recovery may include past and future medical bills, lost wages, diminished quality of life, and pain and suffering.
What is hernia mesh used for?
Hundreds of thousands of people each year suffer from a hernia, which is a bulge of tissues that can develop in several parts of your body for various reasons. A hernia can be present at birth or may develop over time due to increased pressure in the abdominal cavity. Some situations that can cause such pressure include pregnancy, lifting excess weight, a strain or trauma, chronic cough, increased fluid in the abdomen, and tumors or masses.
There are various types of hernias, which are often classified by their anatomical location. For example, an abdominal hernia is when an organ or piece of tissue begins to protrude through a weak spot in the abdominal wall from its normally contained space. One of the most common types of hernias is a ventral hernia, which occurs in the abdomen at the site of a previous surgery.
Hernia mesh is a medical device used to strengthen a hernia repair. Surgical mesh is implanted into the compromised muscle wall to aid the healing process and keep further damage from occurring. There are two common types of mesh used in a hernia repair procedure:
Synthetic Hernia Mesh
This type of mesh comes in two forms, knitted, and non-knitted. Produced in sheets, they may be made of materials that are absorbable, non-absorbable or a mixture of both. Common synthetic hernia mesh products are made of polypropylene, and look like window screens or plugs. Mixed mesh products are often coated with collagen, cellulose or an absorbable fatty acid.
Biologic Hernia Mesh
Typically made of animal skin or intestine, these products are disinfected, then processed to be used as a suitable hernia repair. Most of the tissue used for this type of mesh product is derived from pigs or cows. They are often referred to as “porcine” or “bovine” mesh repair products.
Hernia mesh repairs made from non-absorbable material are permanent, remaining in the body for the duration of the patient’s lifetime. Absorbable repairs do exactly what their name alludes too, absorb into the body over time. Synthetic mesh repairs are the current favored technique.
Types of Hernia Surgery
There are two types of hernia surgery, laparoscopic and open. In laparoscopic surgery, a very small incision is made. Surgical tools are then inserted through the opening to perform the repair. While this option is a bit more expensive, there is less blood loss and down time. Typically, a patient is restricted from strenuous activity for two weeks, and may resume activity at week four.
Open surgery involves making an incision near the hernia site to make the repair. Strenuous activity is typically restricted to three week, and the patient may resume normal activity by week six.
Some of the adverse side effects reported by the U.S. Food and Drug Administration (FDA) for hernia repair surgery and associated with hernia mesh include infection, pain, intestinal complications, formation of a mass/lump/bulge, adhesions, vomiting, nausea, fever, redness, revision surgery, or recurrence of the hernia. To learn more about the complications associated with hernia mesh, jump to the Hernia Mesh Complications Section.
Hernia surgery, like any medical procedure, carries no guarantee. Yet, if you were injured from a flaw in the product or a defective product itself, you might be able to file a product liability lawsuit against the surgical mesh manufacturer.
Hernia Mesh Surgery Complications
Hernia mesh is intended to become implanted in the tissues (like the abdominal wall) to strengthen weakened areas, and repair pain caused by hernia occurrences. This device was used in minimally invasive surgeries to repair abdominal hernias or other issues related to connective tissue beneath the skin that require a reinforcing or bridging material. Although hernia mesh surgery is fairly common and non-invasive, studies indicated a higher risk of developing complications with hernia mesh repairs compared to other devices.
According to the U.S. Food and Drug Administration (FDA), the most common adverse events reported for hernia repair surgery include the following:
- Scar-like tissue that sticks tissues together (adhesion)
- Hernia recurrence
- Intestinal blockage
- Perforation (a hole in neighboring tissues or organs)
- Mesh migration
- Mesh shrinkage (contraction)
These complications sometimes necessitate additional surgeries—referred to as revision surgery—to remove the device and repair damage. However, because synthetic surgical mesh was designed to integrate itself into the tissue and stay in the body indefinitely, removal of the mesh is extremely difficult. Blood vessels and tissues grow around the mesh, requiring doctors to remove it in pieces, one surgery at a time. In some cases it may not ever be possible to remove all the mesh. Even if the mesh can be removed, some patients are still be left with some of the complications associated with these repairs.
Did You Suffer After a Hernia Mesh Operation?
We can help you determine if you have a case to file suit and recover compensation for the injuries you’ve suffered as a result of the hernia mesh implantation.
Avram Blair and Associates’s team of hernia mesh lawyers have been aggressively fighting for their clients.
I can not say thank you enough to Avram Blair and Associates for handling my case, after the unexpected loss of my wife. They were always professional and were prompt with updates about my case. I appreciated how considerate they were and that they always asked how my family was doing each time we spoke. I would highly recommend them. They are a firm that is knowledgeable and willing to go the extra mile for their clients.
I have tried for the past week to put words to how grateful I am to you and your entire team for what you have done for me. Unfortunately, there are no words to express the depth of my gratitude. Once diagnosed, it moved from fear and sadness, to being grateful to be alive, then slowly to resolve to do ‘something’ to acknowledge what I believe to be a wrong. Without your team I know that doing nothing would have haunted me for the rest of my life.
Johnson & Johnson (Ethicon Division)
Johnson & Johnson is the eighth largest pharmaceutical company and the world’s largest seller of healthcare products. While remaining wildly successful, the company has been associated with numerous scandals over the years, including the recall of 31 million bottles of Tylenol in 1982.
Ethicon is the subsidiary of Johnson & Johnson responsible for wound-closing products, including sutures, staplers, ligatures, and hernia mesh. They are currently facing nearly 4,000 federal lawsuits and countless suits in state courts concerning its mesh products.
Ethicon’s Flexible Composite Mesh
Ethicon’s Flexible Composite Hernia Mesh is a synthetic or biologic material permanently implanted in a patient to repair hernias.
In May 2016, Johnson & Johnson’s Ethicon Division withdrew it’s hernia mesh product from the U.S. market after studies revealed complications associated with its use in minimally invasive hernia repairs. These studies indicated a much higher recurrence and revision rate from hernia repairs using hernia mesh compared to similar devices used for this type of procedure.
Timeline of Hernia Mesh Lawsuits Against Ethicon
- March 2010 – Ethicon’s Flexible Composite Hernia Mesh is available for use in the U.S. market. It was approved without a clinical trial, through the FDA’s 501(k) application. This means it was approved because it was “similar” to other types of hernia mesh on the market.
- April 2016 – Lawsuit filed against Ethicon after patient suffered severe complications in 2015 from a hernia repair using Ethicon’s Flexible Composite mesh. This will be the first hernia mesh trial, with a date set for January 22, 2018 before Judge J. Phil Gilbert.
- May 2016 – Urgent field notice is released after two studies in Germany and Denmark show higher hernia recurrence and re-operation rates among patients using Ethicon’s hernia mesh, compared to other similar products.
- May 2016 – Johnson & Johnson issues a voluntary global market withdrawal for its Ethicon Flexible Composite Hernia Mesh due to an increased risk of side effects.
- September 2016 – A lawsuit was filed against Ethicon by a woman from Florida. The hernia mesh grew into her intestines, which required surgery and caused serious health problems.
Additional hernia mesh lawsuits involving injuries and complications allegedly related to Ethicon’s hernia mesh device are currently being filed.
More Information on Hernia Mesh Lawsuits
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Hernia Mesh Lawsuit Information
Are you entitled to compensation?
Hernia repair surgery is one of the most common procedures performed in the U.S. About half-a-million are performed each year, and the majority of the time a medical device, called a hernia mesh is used to repair the wound.
Ethicon’s Flexible Composite hernia mesh is one of many devices manufactured for this purpose. However, patients are now filing lawsuits against it’s manufacturer after alleging severe pain and complications were caused by the hernia mesh. Many of these lawsuits are being filed after Ethicon issued a recall for their hernia mesh product, and after studies suggested higher rates of complications and revision surgeries compared to similar medical devices.
If you experienced complications or suffered health problems after undergoing a hernia mesh procedure, you may be entitled to compensation for the following:
- Medical expenses, past and future, including the costs of additional surgeries to remove the mesh or address complications or failure of the original surgery
- Lost wages
- Lasting damage
- Diminished quality of life
- Pain and suffering
Many individuals who suffered hernia mesh complications have filed suit against it’s manufacturer, Ethicon. Most of these lawsuits blame the mesh manufacturers, not the surgeons who implanted the hernia mesh. In other words, if you are suffering complications from hernia mesh surgery, you may be able to receive compensation without suing your own doctor. In many cases, surgeons relied on information provided by mesh manufacturers and the U.S. Food & Drug Administration (FDA). This information failed to fully reveal the dangers associated with this product, meaning your doctor was kept in the dark to the same extent you were. For this reason hernia mesh litigation is focused on the manufacturers.
Basis for a Claim
There are many circumstances that might provide the basis for a lawsuit, including, but not limited to, failure of the manufacturer to meet its legal obligations set forth by the FDA. You may have additional grounds for bringing a claim against the physicians, hospital, and other caregivers involved in your surgery.
Each case is different and each patient is distinct. An expert attorney with a thorough understanding of the law as well as the facts regarding mesh implants, their manufacturer, and the complications that may arise can help you evaluate the unique circumstances of your case, determine your options, and advise you on how to proceed.
If you do have grounds for a lawsuit, it doesn’t mean those responsible for your suffering will simply write you a check. The manufacturers and physicians have deep pockets, lawyers, and insurance companies on their side. Confronting them requires skill and fortitude — you need an advocate who will fight for the just compensation to which you are legally entitled.
Some of the legal grounds on which you might have a case against a manufacturer include:
- Negligence: Device manufacturers have a duty to design, produce, label, and market a product to avoid harm to the public. Complaints state that these companies are “guilty of carelessness, recklessness, negligence and willful, wanton, outrageous and reckless disregard for human life.”
- Fraudulent misrepresentation: Defendant companies presented their products as safe and effective, when they were not.
- Failure to warn: Mesh manufacturers did not warn the public that mesh might, and in fact did very early on, fail to implant correctly and cause complications.
- Failure to properly test: Mesh manufacturers did not properly test these devices before selling them.
- Consumer risk: Mesh manufacturers were aware of the dangers of hernia mesh but continued to profit from their sales.
- Failure to recall: Mesh manufacturers did not stop selling the product even though there was early evidence of the harm it could cause.
Statute of Limitations
As with any product liability or personal injury litigation, there are strict statutes of limitation. You only have a limited amount of time to file a suit once your adverse symptoms begin. These limitations vary by state and jurisdiction. In most cases, however, you do not get a second chance. It is therefore imperative that you contact an attorney as soon as you begin to experience adverse symptoms because that’s when the countdown begins.
Steps to Filing a Lawsuit
In order to file a lawsuit and receive just compensation, we must first conduct an investigation to establish that injured by hernia mesh. We will order your medical records and review them at no charge to you. Once we conduct this review, we will discuss when and where to file a claim on your behalf. You will never owe us anything unless we obtain a recovery for you.
We Can Help You
Additional activities may be required depending on the unique circumstances of your case, and there are numerous legal procedures to complete. It may feel overwhelming to tackle all this work and take on a confrontation with a big medical device manufacturer while you are dealing with chronic pain or other complications from your hernia repair surgery. Avram Blair & Associates, P.C. can help. We have experience hernia mesh lawyers handling these types of cases and we have staff standing by ready to assist you.