Hernia repairs are common – more than one million hernia repairs are performed each year in the U.S. Approximately 800,000 are to repair inguinal hernias, which occur in the inner groin, the rest can occur in other areas of the body.
Faulty Hernia Mesh Products Lead to Recurrence and Re-operations
Hernia repairs are common – more than one million hernia repairs are performed each year in the U.S. Approximately 800,000 are to repair inguinal hernias, which occur in the inner groin, the rest can occur in other areas of the body. A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue.An increasing number of hernia repairs are being done via laparoscopic methods with the promise of faster recoveries and less pain, but, individuals are now coming forward noting that one of the leading hernia mesh products that has led to higher rates of recurrence and reoperations have been required to fix the damage done from the mesh.
Ethicon Physiomesh Composite Mesh Recalled Because of High Rate of Complications
On May 25, 2016, Johnson & Johnson issued an “Urgent Field Safety Notice” to warn of the higher rates of recurrence/reoperation after laparoscopic ventral hernia repair using the Ethicon Physiomesh Composite Mesh. Ethicon’s Physiomesh was a leader of global sales in the laparoscopic hernia repair surgeries from the time it was brought to market in early 2010 until it was voluntarily recalled in May 2016.Lawsuits are currently being filed against Johnson & Johnson, the manufacturer of the Ethicon Physiomesh Composite Mesh as a result of the injuries and complications that occurred as a result of this high rate of recurrence and reoperation.
According to Physiomesh lawsuits that have been filed in several states, Johnson & Johnson should have reported the deaths and serious injuries that occurred as a result of the Physiomesh product to the FDA.
Higher risk of recurrence of hernia or reoperation rates with the Ethicon Physiomesh Composite Mesh were originally identified by two application-oriented outcome tools created to track nation-wide surgical outcomes after groin hernia repair. The Danish Inguinal Hernia Database and the Herniamed German Registry allow all institutions to actively monitor the surgical quality and outcomes of products used in hernia repairs. Both the Herniamed German Registry and Danish Hernia Database – DHDB noted higher-than-expected rate of recurrence and reoperations in patients who used Ethicon Physiomesh in their hernia repair as opposed to other mesh products.
Complications & Side Effects of Ethicon Physiomesh
|Hernia Recurrence||Adhesion (Scar-like tissue that sticks tissues together)|
|Obstruction (blockage of the large or small intestine)||Bleeding|
|Mesh Shrinkage (contraction)||Perforation (hole in neighboring tissues or organs)|
|Mesh Migration||Seroma (fluid build-up at the surgical site)|
|Fistula (abnormal connection between organs, vessels or intestines)|
The recalled mesh was commonly the cause of bowel perforation and obstruction complications. Once there is migration of the mesh and particularly erosion, surgical procedures to fix the complications are generally necessary. These surgical procedures often require a staged operation and a large recovery time.
What is a Laparoscopic Hernia Repair?
In laparoscopic surgical hernia repair, the surgeon makes several small incisions in the abdomen that allows surgical tools to be inserted into the opening and the hernia is repaired. In many cases, surgical mesh is place over the defect to reinforce the wall of the organ.
Laparoscopic surgery is often recommended because it allows individuals to get back to work quicker and generally causes less pain. Generally, the chance of a hernia coming back after laparoscopic surgery ranges from 1 to 10 out of 100 surgeries done, but as noted in the Physiomesh lawsuits, the rate of hernia recurrence was much greater with the Physiomesh hernia patch than with other mesh products used.
Was The Hernia Mesh Used in My Hernia Repair Recalled?
It is important to note that Ethicon Physiomesh recall involved only the Ethicon Physiomesh Composite Mesh product line, it did not include the Ethicon Physiomesh Open Flexible Composite Mesh Device, which remains on the market today.
The Ethicon Physiomesh Open Flexible Composite Mesh Device was FDA approved on October 23, 2014 under a 510(k) process in which it was shown by Johnson & Johnson to be “substantially equivalent” to Ethicon Physiomesh’s Composite Mesh – the very device that Johnson & Johnson just recalled. Under a 510(k) application, the FDA does not require the device to submit clinical trials to prove effectiveness. Instead, it is assumed to be as safe as the previous device on the market.Since the device Ethicon submitted as “substantially equivalent” to their new mesh hernia product has been recalled, many now wonder about the safety and effectiveness of the Ethicon Physiomesh Composite Mesh.
Recalled Ethicon Physiomesh Composite Mesh Products
|Product Name||Product Code||Description / Size||Product Lot|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY0715R||Rectangle 7.5cm x 15cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY1015V||Oval 10cm x 15cm||All unexpired lots impacted by this voluntary productrecall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY1515Q||Square 15cm x 15cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY1520R||Rectangle 15cm x 20cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH ™ Flexible Composite Mesh||PHY1520V||Oval 15cm x 20 cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY2025V||Oval 20cm x 25cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY2030R||Rectangle 20cm x 30cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY2535V||Oval 25cm x 35cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY3035R||Rectangle 30cm x 35cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY3050R||Rectangle 30cm x 50cm||All unexpired lots impacted by this voluntary product recall.|
|Product Name||PROCEDURE PACK PRODUCT CODE||ETHICON PHYSIOMESH MESH PRODUCT CODE||Product Lot|
|Laparoscopic Hernia Pack||ELH5||PHY1515Q||All unexpired lots impacted by this voluntary product recall.|
|Laparoscopic Hernia Pack||ELH10||PHY1515Q||All unexpired lots impacted by this voluntary product recall.|
If I believe my mesh product was recalled what should I do?
The voluntary recall of the Ethicon Physiomesh Composite Mesh product has been communicated to doctors, therefore, the best thing to do is to speak to your physician and continue to follow up as instructed.
TruLaw encourages all individuals harmed by devices such as in the case of a hernia mesh to report the side effects and complications to the FDA. Do not assume that the FDA knows about your complications! Learn how to submit your information to the FDA.
Hernia Mesh Frequently Asked Questions
Sometimes you need a lawyer near you and sometimes its best to hire a lawyer based on the lawyer’s resources and experiences.
The right lawyer for mass-tort litigations may not be your local lawyer. Mass tort cases filed all over the country are often consolidated into a single courtroom in order to move the many lawsuits through the courts in the most effective and efficient way. A lawyer experienced with the multidistrict litigation process with the ability to represent clients in all 50 states, is likely to be a good fit for mass tort litigation.
TruLaw is not afraid to take on the largest drug and medical device companies in the world. We work with trusted legal affiliates to make sure that TruLaw clients have the resources and experiences needed to hold big business accountable when they put profits over people.
Your Hernia Mesh lawsuit is designed to help you financially recover from injuries that were caused by someone else. We hope putting your trust in TruLaw will take away your concern of protecting your legal rights., but it is most important to us that you spend your time recovering physically.
Your lawsuit should assist in covering your medical bills, the amount of income and benefits that you lost as a result of your injury and, if your injuries are permanent, we will look to recover for your permanent disfigurement.
In addition, it is always our hope that your lawsuit will help us to remove dangerous drugs, toxins and devices from the market. We are not only lawyers, but also safety advocates that believe in getting information out to the public so no more people are injured. We hope you will join us in the role as a safety advocate.
We often hear injured people refer to their personal injury case as a “class action” because their case was grouped together in a lawsuit with other injured people. This is most often NOT the case. Often, individual cases are grouped together so the attorneys and judge can address common procedural issues initially, saving time for the injured parties and the court, but this is very generally referred to as a “mass tort.”
A Mass tort refers to civil actions involving numerous plaintiffs against one or a few corporate defendants in state or federal court. Class actions are mass torts that are generally used on financial losses and multidistrict litigations (MDL) are generally used on personal injury claims, often in product liability cases.
MDL is a procedural tool used when plaintiffs have incurred injuries from products manufactured by the same defendant(s). Even when plaintiffs incur injuries from the same defendant(s), the amount of damages they may recover for those injuries are often substantially different from other plaintiffs included in the same lawsuit.
It is important to understand that mass tort cases are an effective tool to getting the attention of the large drug and device companies. MDLs assist lawyers in determining exactly what the drug and device companies knew about the risks their products caused and whether or not they should have warned consumers. Too often, consumers believe that they can file a single lawsuit and get the attention of big drug companies. This is very hard to do.
Technically, MDLs do not happen until a judicial panel transfers individual cases to a single court. Depending on when your lawsuit is filed, you may find yourself automatically transferred to the MDL court or you may wait to learn when and if the JPML believes an MDL is the proper venue for the mass tort.
But, rest assured, even if your case is included in an MDL, TruLaw lawyers will treat your injuries, your medical history and your financial needs separately. We are aware that not all cases are the same.
We understand the frustration in waiting to hear about settlements in product liability lawsuits. Unfortunately, in drug and device cases, we have no choice but to sue some of the most profitable companies in the world. Big Pharma has deep pockets and lawsuits are a cost of doing business for them. They are not inclined to settle until it makes business sense to them.
TruLaw lawyers building our cases with an eye on winning in court as well as settlement, when we believe that is the best result for our clients. We will never settle without advising you of your options, and we will keep you posted on our progress, to the extent we are legally able.
A corporation, by definition is profit seeking. There is no requirement that a corporation act morally. Unfortunately, too often we see dangerous drugs, devices and products remain on the market when corporations prioritize profit over people.
If these same corporations warn consumers of these risks, there is no case. We only pursue lawsuits on behalf of individuals who were not warned of the risk associated with the dangerous drug, device or product on the market.
TruLaw is pursuing Hernia Mesh / Physiomesh Lawsuits because we believe consumers were not properly warned of the risks of injury.
Did a recent Hernia Mesh or “Physiomesh” commercial grab your attention? Did you find our site because you were wondering if you qualify for Hernia Mesh lawsuits?
We built the Hernia Mesh Instant Case Evaluator as a no cost/no obligation place for you to find answers about your legal rights. If you found us today, you are looking for instant answers to whether you should file a Hernia Mesh Lawsuit and we want to help you. We believe that in order for you to make important decisions about your health and your legal rights, you need to start with information. We provide you this valuable information so you are prepared to talk to a lawyer.