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Although many are under the impression that the Food and Drug Administration (FDA) requires medical device manufacturers to thoroughly and rigorously test their products prior to obtaining approval, this is not always the case. In the case of hernia mesh implants, the FDA allowed hernia mesh manufacturers to use the 510(k) clearance process, which is a fast-track program that can rush products onto the market. Unfortunately, this process allowed the sale of defective hernia mesh products which led to serious complications in many patients after surgery.
On this page, we explain everything about hernia mesh implants, from common complications to which companies are under fire to trial dates for lawsuits in 2020 and beyond. This information is provided to help you answer the question you might be asking yourself or your attorney: do I qualify for compensation?
Hernias occur when there is weakness in the muscular abdominal wall, which consequently allows tissue or part of the intestine to poke through the weak area. Along with abdominal or umbilical hernias, there are many other common types of hernias that surgeons can repair by either stitching them to enclose the section of protruding bowel or tissue, or they can use mesh to cover the hole and strengthen the area where the weakness was located.
Hernia mesh implants can be used on the following types of hernias:
Inguinal hernias are the most common type of hernias, with incisional hernias being the second most common type. Unfortunately, due to fast-tracking surgical hernia mesh implants, many of these implants have failed due to design defects, leading to serious complications.
Many patients who have had their hernias repaired with surgical hernia mesh implants have reported numerous side effects. Some of the more common injuries linked to these hernia mesh implants include the following:
Many hernia complications are the result of surgeons implanting the mesh after a laparoscopic hernia repair surgery. The laparoscopic procedure increases the risk of the hernia mesh touching other organs, which could cause the formation of adhesions or fistulas between the mesh and those organs, thus causing multiple issues. This has caused some manufacturers to take their hernia mesh implants off the market, including Ethicon Inc., the manufacturer of the Physiomesh hernia mesh implant.
A September 26, 2018 article published by the BBC found that, in England, based on the number of hernia mesh procedures conducted each year, in the past six years, between 68,000 and 170,000 patients may be at risk for serious complications related to hernia mesh surgeries. The article stated that the injury rate for those who had hernia mesh implants was a significant 12-30%. These individuals could also face permanent disabilities or become suicidal. In the U.K., as the National Health Service trusts do not always require follow up with patients, and as the Medicines and Health products Regulatory Agency has continued to stand by the safety of hernia mesh implants, it is difficult to accurately predict the actual complication rate. However, it is clear that the rate of complications related to hernia mesh is not small. This, coupled with the seriousness of the side effects related to hernia mesh indicates that their effectiveness is clearly outweighed by the risks of this product.
Every year, more than 100,000 hernia mesh devices are implanted in the U.S. alone. Until recently, only a fraction of the hernia mesh implants on the market have been recalled for medical reasons.
When a pharmaceutical drug or medical device violates FDA law, manufacturers will generally issue a recall to correct the violation. This means that the FDA rarely has to recall products directly.
The first hernia mesh recall was issued in late 2005 by Davol Inc., a subsidiary of C.R. Bard. The recall was extended in 2006 and again in 2007.
In 2014, the Food & Drug Administration announced a number of hernia mesh implant recalls and started to warn the public about the device. The reasons given for the recalls ranged from poor performance to packaging errors to adverse events. Companies targeted by the FDA included C.R. Bard (for the potential hazard of the defective mesh ring breaking apart and leading to bowel perforations, among other complications), Ethicon Inc. (for the potential hazard of the mesh losing its laminate coating), and Atrium Medical Corporation (for improper packaging).
Ethicon Inc. recalled its Physiomesh product in May 2016 after the implant was linked to several hernia recurrences and revision surgeries. Along with recalls in the United States, parent company Johnson and Johnson has also recalled Physiomesh in Europe and Australia due to complications.
Like most hernia mesh implants, Physiomesh is made from polypropylene. This is the same material used to make bladder slings and transvaginal mesh, both of which have resulted in thousands of lawsuits. For Physiomesh, the manufacturer also used an absorbable material on each side of the polypropylene material. The FDA’s 501(k) fast-track clearance procedure was used to get faster approval for their product.
To date, there have been several lawsuits filed involving defective hernia meshes, including a suit filed in September 2016 by a Florida woman, Joann Quinn. The lawsuit alleges Physiomesh caused bowel and abdominal adhesions that required surgery. However, the doctor reported he could not remove all of the adhesions and Ms. Quinn could suffer from pain and further complications for the rest of her life.
Numerous physicians have submitted hundreds of documents to the FDA and Johnson & Johnson related to the defective nature of the Proceed hernia mesh. Ethicon Inc. has stated that it has no idea why the Physiomesh is defective nor was it aware of any way to limit complications for those patients who already had the defective mesh implanted for hernia repair surgery. You can start a hernia mesh lawsuit today by contacting us today and we will help you find the right attorney.
The first trial against the manufacturer of the defective Physiomesh products has been set for 2018. The lawsuit, the first brought against the company related to Physiomesh, was brought by a plaintiff, Matthew Huff. Huff was implanted with the mesh in 2013 to repair his hernia. In the lawsuit, Huff alleges that when he went to the hospital after his hernia repair procedure complaining of chills, fever, nausea, and severe pain, doctors found an infection had developed around the mesh implant. This tissue infection had caused several abscesses and a fistula to develop, for which Huff required surgery.
A trial was originally set for July 31, 2017. However, as both sides requested the court more time to prepare due to the complexities of the issues involved in the case, the trial date was moved to 2018. Subsequent to Huff’s lawsuit, several other attorneys have filed lawsuits against the company alleging complications due to Physiomesh.
Atrium Medical Corporation is also facing multiple lawsuits involving their hernia mesh product, C-Qur. Atrium Medical Corporation also used the 501(k) fast-track approval procedure for C-Qur, obtaining regulator’s approval for the product in 2005. Many of the lawsuits related to C-Qur allege this product caused allergic reactions because the polypropylene material is coated with fish oil.
In addition, plaintiffs and attorneys alleged that C-Qur adhered to the bowels, causing them to twist or even perforate. Some lawsuits have stated that the fish oil coating peeled off, causing the defective mesh to adhere to the bowels and/or other tissues. Given the numerous complaints regarding C-Qur, the FDA sent Atrium Medical Corporation a warning letter regarding their inadequate reactions to these complaints.
Along with the common complications alleged in dozens of lawsuits, there were 35 complaints regarding human hair found in the sterilized products, which prompted the FDA to issue a permanent injunction in 2015 to stop Atrium Medical Corporation from manufacturing the C-Qur device. However, before the injunction went into effect, a number of people had already been surgically implanted with the C-Qur mesh.
The U.S. Judicial Panel on Multidistrict Litigation has consolidated the lawsuits pending against Atrium Medical Corporation regarding the common allegations against the C-Qur implant. The U.S. district court in New Hampshire is slated to preside over the nearly two dozen lawsuits filed by attorneys on behalf of their clients against Atrium Medical Corporation. Most of these suits allege Atrium knew about their product’s design flaws which lead to inflammatory reactions to the product and resulted in improper surgical implantation, pain, bowel adhesions, and other injuries.
Multidistrict litigation (MDL) consolidation speeds up the process of hearing multiple lawsuits based on the same complaint or issues. Thus far, there have been no class action lawsuits filed by attorneys involving hernia mesh implants and these are the first lawsuits to be lumped together in court. Along with Atrium Medical Corporation and the others mentioned above, other manufacturers are also facing suits regarding their hernia mesh implants. Thinking about joining a class action hernia mesh lawsuit? Contact us today and we will put you in touch with a suitable attorney.
Parietex and Parietex Composite Mesh
Covidien, now knowns as Medtronic Minimally Invasive Therapies, first produced a polyester hernia mesh – the Parietex hernia mesh – in 1999. The results were not good. Many subjects experienced bowel issues, adhesions, pain, and infections as a result of this particular hernia mesh.
Eventually, the company moved on to the Parietex Composite Mesh, which was made of polyester with a collagen barrier. The idea was that the collagen barrier would prevent the polyester base from adhering the bowels. Unfortunately, the barrier failed to work, and many patients continued to report bowel issues.
Next, Covidien developed the Parietex ProGrip Mesh System: a “self-fixating” mesh system used in hernia procedures, which featured thousands of hooks designed to keep the mesh in place. However, the hooks caused victims considerable pain and injuries, and made it more difficult for doctors to remove the mesh. Many subjects required multiple surgeries to address the issues caused by the defective Parietex ProGrip.
Studies show that companies that manufacture mesh products make around $100,000,000.00 a year. It does not appear that the thousands of victims whose lives have been ruined by the hernia mesh are getting in the way of this lucrative business.
One of the first hernia mesh implants to be recalled was C.R. Bard’s Kugel hernia mesh patches. It was approved in the 1990s and has been implanted over a million times.
The implant was made of polypropylene and contained a ring around the mesh. In some cases, this ring would break. Once the ring started to break down, it would begin to shrink. The polypropylene would shrink to a size that was smaller than the size of the ring, exposing the mesh and and causing it to buckle or break and perforate the bowels or other organs.
Davol Inc., which is a subsidiary of C.R. Bard, recalled the Kugel meshes in 2005, 2006 and 2007. However, lawsuits are still pending against the hernia mesh product, including a lawsuit in Rhode Island filed against Davol Inc. by Wayne Smith, who had it implanted in 2005, prior to the first recall. Shortly after his surgery, he began to complain of abdominal pain and tenderness around the surgical site and it was recommended that he have the implant removed.
C.R. Bard and Davol Inc. attempted to have the lawsuit dismissed, claiming that the plaintiff’s claims did not satisfy the laws of Rhode Island. However, the judge presiding over the case has refused to dismiss the case.
C.R. Bard manufactures several other hernia mesh implants which have been named in lawsuits due to complications caused by their design defects. Along with Davol Inc.’s Kugel hernia mesh, C.R. Bard has also been sued over their PerFix Plug mesh implant and the 3DMax mesh implant. Both of these products have resulted in problems in the testicular area for men, causing pain or, in the PerFix Plug’s case, removal of the testicles.
C.R. Bard also manufacturers the Ventralex ST implant, which has also been named in lawsuits. It was closely modeled after the Kugel mesh design, although the Kugel mesh was recalled a decade ago. So far, the Ventralex implants have not been recalled, but there have been complaints filed by attorneys alleging severe inflammatory reactions to the product as the victim’s tissue rejected it. Make sure you check this page often to keep up with the C.R. Bard hernia mesh lawsuits.
When a surgeon repairs a hernia laparoscopically, it is likely that he will insert the mesh deep into the abdominal cavity. This surgical procedure causes the mesh to push against the bowel causing complications to arise.
While some surgeons and attorneys are aware of the pain and injuries caused by defective hernia meshes, many continue to cite unreliable and outdated studies to indicate its safety. Some lawyers will flat out refuse to take a hernia mesh case, pointing to those old studies as proof that polypropylene is safe for hernia surgeries.
Given our knowledge, we are aware that several defective hernia mesh products are not safe and have led to health issues, pain and complications. We value your health over profits, and will assist you with your hernia mesh lawsuit, should you wish to pursue legal action against your mesh implant manufacturer. Every claim by a plaintiff who has suffered an injury filed by his or her attorney constitutes a separate hernia mesh lawsuit.
In the United States, after the FDA approves a product, it can be very difficult to reverse that decision. Although victims have made clear that some hernia mesh implants can cause complications after surgery, such as bowel obstructions, severe infections, tissue necrosis, chronic pain and other issues, this alone has not been enough to motivate change.
When thousands take action, however, the regulator can be pushed to change. It can take up to ten thousand patients showing that they suffered an injury for the FDA to finally look into the possible defective nature of a product like hernia meshes.
There are over 50 different types of meshes on the market.
It is not surprising, then, that hernia meshes are often overused. While many surgeons are capable of fixing a smaller, inguinal hernia without a mesh, thousands have suffered the severe pain and/or complications associated with a hernia mesh implant that could have been avoided with surgical sutures. Other types of smaller hernias, such as those that are the result of laparoscopic surgery, generally do not require meshes either; usually, they can be repaired with additional sutures by good surgeons.
It is important to note, however, that there is a high likelihood of recurrence among subjects whose hernias are treated with additional sutures or a surgical mesh implant.
In a nutshell, the answer is yes. The Shouldice Technique for inguinal hernia treatment is a type of surgery that is used as a common alternative to surgical implantation of these potentially defective devices.
With a recurrence rate of around one percent and far less additional injuries reported, Shouldice repair is seen as the gold standard for dealing with inguinal hernias. The process involves using a patient’s own tissue to repair the hernia and requires local anesthesia and a sedative. No foreign products are introduced into the patient’s body during the surgery, eliminating the chances of perforations, adhesions, or fistulas as one own’s tissues are rarely rejected.
Many manufacturers have funded studies to show that a hernia recurrence was less likely after surgery when a hernia mesh implant was used. However, few of these studies follow up with patients years after their procedure. This means that recurrences and complications that occur later in a patient’s lifetime are not included in these studies.
Even though some studies show there is a slightly lower chance of hernia recurrence when a mesh is used during surgery, the resulting complications can be quite dangerous.
Some injuries may seem minor, such as occasional stomach cramping or abdominal pain. However, such pain can be followed by much more serious symptoms such as bowel and testicular problems, neurological issues, and /or auto-immune conditions.
For example, if the hernia mesh implanted in a subject erodes his bowel, he will require additional surgical procedures to correct the issue. He will most likely be hospitalized for weeks, he may require additional surgery such as as partial removal of local necrotic tissue or even his bowel, and he runs the risk of developing further complications down the road.
When the rate of intraperitoneal laparoscopic surgeries conducted to repair hernias increased, the rate of severe side effects caused by hernia meshes also increased. Manufacturers created hernia meshes with a coating to ensure that there was a layer that protected the patient’s bowel tissues from the polypropylene mesh after the surgery. The goal is to have the body eventually absorb the coating over a few months or years. However, as stated above, once they come in contact with human tissues, these coatings have resulted in allergic reactions or have been the cause of post-surgical complications.
The American regulatory agency seems resistant to admitting that several approved hernia mesh products are defective.
To show the lack of regard shown by the regulator on this issue, many law firms have created websites providing information related to the Parietex ProGrip lawsuits and the Parietex Composite lawsuits.
Several law firms and attorneys across the country are responsible for the large number of personal injury and defective product claims that have been filed by plaintiffs. These firms are currently investigating all of the relevant hernia mesh claims made in court.
One way to alert the regulator of injuries is to ask an attorney to file a hernia mesh lawsuit against the manufacturer of the allegedly defective product. Once a claim is filed against a manufacturer, the company is required to report the lawsuit to the FDA.
Generally, the more lawsuits that are filed, the more likely it is that the agency will take a second or third look at the medical devices and the complications surrounding them.
If the defective hernia mesh implant fails within three years after surgery, and the same surgeon who implanted the mesh also removes it, that surgeon must report that injury to the manufacturer. If surgeons continue to file these reports to manufacturers, those companies are legally obligated to inform the U.S. regulatory agency about the situation.
The FDA has posted a statement on its website regarding hernia meshes and the possible complications involved. However, the statement notes that the most serious reports that involved hernia mesh products that were later recalled – a claim most attorneys would dispute.
In 2006, the first hernia mesh product was approved for surgical implantation: Atrium Medical Corporations’s C-QUR mesh. In 2010, further mesh products were approved, despite a 2009 study showing that the C-QUR mesh increased adhesion rates and immune system responses.
Atrium Medical Corporation received a warning from the FDA in 2012 regarding their mesh product, with the agency stating concerns that many of the infection complaints had not properly addressed or documented by the manufacturer. Eventually, the FDA obtained a court injunction ordering Atrium Medical Corporation to halt its manufacturing of its mesh products.
Unfortunately, to date, no other manufacturer has been targeted by the regulator, despite plenty of research linking their respective meshes to serious injuries including obstruction, adhesion, perforation, and recurrence.
Below are several, recent hernia mesh studies and a summary of their results.
June 2017 – Study on Deterioration of Polypropylene Hernia Repair Meshes
The study attempted to investigate how hernia meshes can change within the body. The “oxidative stress at the site of implantation” can sometimes cause the implants to lose their structural integrity. This can result in stiffening or even shrinkage of the mesh, which often results in chronic pain for patients.
August 2016 – Two-Year Study on Patients Who Received a Hernia Mesh
Over 600 subjects were studied for two years after they were implanted with a mesh for hernia repair surgery. Around 31 percent of those patients suffered some type of complication within two years. These side effects included tissue necrosis, nonhealing wounds, hematoma, fistula, dehiscence, cellulitis, and other types of physical injury.
Those patients who had a preoperative MRSA+ infection on any site, such as at a urine or blood site, are at even greater risk of developing hernia mesh complications.
August 2015 – Study Indicating the Impact of MRSA+ Infection on Likelihood of Hernia Mesh Infections
768 patients went through a hernia repair procedure which included the surgical implantation of hernia mesh. Around 10 percent ended up with a hernia mesh tissue infection, while 33 percent of the subjects who had a preoperative MRSA+ infection suffered from a hernia mesh infection.
Although the mass tort against Ethicon (MDL -2782 IN RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation) was originally scheduled to start on September 2019, the first bellwether trial has been pushed to 2020. On September 23, 2019, an amended practice and procedure order by Honorable Judge Story set the first exploratory hernia mesh trial for June 22, 2020. A pre-trial conference will be held before the trial begins so that both party’s attorneys could discuss their positions, but only after the admissibility of the expert witness testimonies is decided in February 2020. As per January 2020, more than 2,000 pending lawsuits have been centralized in the MDL.
With dozens of hernia mesh lawsuits pending, it is possible that class action lawsuits could be filed, although, thus far, none have been filed. We update this post when new information is available. Please don’t hesitate to fill out the form located at the top of this page for a free case evaluation. An attorney will be ready to help you.
According to the Judicial Panel on Multidistrict Litigation, as of January 2020, there are a total of over 70,000 cases pending, including those filed against C.R. Bard, Inc., Boston Scientific Corp., and Ethicon Inc. Meanwhile, class action litigation against Atrium Medical Corporation has continued to gain traction over the last 6 months, with an average of 39 cases filed each month, compared to an average of just 24 in the previous months.
On March 8, 2018, Johnson & Johnson’s subsidiary, Ethicon Inc., was hit with a $35 million verdict in favor of the plaintiffs, Anton and Barbara Kaiser. Barbara Kaiser received a Prolift pelvic mesh implant in 2009, and started suffering from chronic, low pelvic pain shortly after her surgical procedure. The jury in the District Court for Northern Indiana found Ethicon Inc. liable for all of the damages suffered by the Ms. Kaiser since it had voluntarily underreported and withheld information related to their device’s lack of safety and effectiveness after surgical implantation.
As of this writing, no settlements have been reached in any of the active hernia mesh lawsuits.
However, in April 2017 Ethicon Inc. was ordered to pay a total of approximately $20 million in damages by a Philadelphia Jury. The jury concluded that a TVT-Secur mesh implanted in a New Jersey woman was defectively designed and caused her serious injuries.
An Ethicon Inc. spokesperson stated that the company’s attorney would appeal the decision. Yet, according to University of Richmond law professor Carl Tobias, who specializes in product liability, this would be ‘silly’, as the case represents the fifth loss in a row for Ethicon Inc. regarding its mesh products in three years’ time. For the manufacturer, this is an increasingly losing battle that continues to harm the company’s reputation.
Plaintiff Margaret Engleman said that she is proud to give a voice to all of the women who suffered her same fate. From 2007 to the present, she stated that she endured indescribable pain after the TVT-Secur mesh started to erode inside her body damaging her organs and tissues. According to her claim, her bladder problems worsened and she experienced a constant stabbing pain in her groin.