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Many hernia mesh implants have led to serious complications. Some of them were put on the market before the products were thoroughly tested.
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Even though the Food and Drug Administration must give medical device manufacturer’s approval before they can put their products on the market, they don’t always go through rigorous testing. The FDA allowed hernia mesh manufacturers to put their products on the market using the 510(k) clearance process, which is a fast-track program. Unfortunately, this process allowed defective hernia mesh products onto to the market, which led to complications in many patients which led to Hernia Mesh lawsuits.
On this page we explain everything from complications to which companies are under fire to trial dates for lawsuits in 2017 and beyond. This all leads to the question you might be asking yourself when you have been injured and found this article: Do I qualify for compensation?
Hernias occur when there is weakness in the stomach wall which allows tissue or part of the intestine to poke through the weak area. Along with abdominal or umbilical hernias, there are many other types which surgeons can repair by either stitching them to enclose the 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 these types of hernias:
Inguinal hernias are the most common type of hernias and incisional hernias are the second most common type. Unfortunately, due to fast-tracking hernia surgical mesh products, many of them have failed due to design defects, leading to serious complications.
There have been many complications reported by patients who’ve had hernia mesh applied during a hernia repair. Some of the more common complications linked to the implants are:
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 them to adhere to those organs and cause multiple complications. Some of the manufacturers have taken their hernia mesh implants off the market, including Ethicon, who made the Physiomesh hernia mesh implant.
Every year, more than 100,000 hernia mesh devices are implanted in the US alone. Until today, many hernia meshes have not been recalled by the FDA. Below a little more on the recalls that did take place.
In 2014, the Food & Drug Administration announced a number of Mesh recalls and started warning the public about the device. The nature of the recalls differed from poor performance, to packaging errors to adverse events. Companies targeted by the FDA included Bard (potential hazard of breaking ring, leading to bowel perforation among other complications), Ethicon (potential hazard of losing laminate coating), and Atrium (improper packaging).
The first recall was actually issued by the FDA in late 2005, to Bard Davol. The recall was extended in 2006 and extended again in 2007.
Ethicon, the manufacturer of Physiomesh, recalled the product in May of 2016 after the implant was linked to several hernia recurrences and revision surgeries. Along with recalls in the United States, Johnson and Johnson, Ethicon’s parent company, Physiomesh was also been recalled in Europe and Australia due to complications.
Like most hernia mesh implants, Physiomesh is made from polypropylene, which has also been used to make bladder slings and transvaginal mesh, both of which had resulted in thousands of lawsuits. The only difference in the hernia mesh is the company used an absorbable on each side of the polypropylene material. This product used the FDA’s 501(k) fast-track clearance procedure to get their product on the market.
There have been several lawsuits filed involving the mesh product, including a suit filed in September 2016 by a Florida woman, Joann Quinn. The lawsuit alleges the mesh used on her caused bowel and abdominal adhesions and she had to undergo surgery to remove them. However, the doctor reported he couldn’t remove all the adhesions and Ms. Quinn could suffer from pain and further complications for the rest of her life.
Hundreds of documents have been submitted by physicians to the FDA and Johnson & Johnson about the defective nature of the Proceed hernia mesh. Ethicon even admitted they had no idea why the Physiomesh is defective. They did not even know how they could limit complications for those patients who already had the Ethicon inserted in their body.
The first trial against Ethicon and their Physiomesh product has been set for 2018. The lawsuit brought by a patient, Matthew Huff, alleges the product caused him to have multiple complications after it was implanted during his 2013 hernia surgery. It was thefirst lawsuit filed against Physiomesh and it alleges when Huff went to the hospital complaining of chills, fever, nausea and severe pain, doctors found an infection had developed around the implant.
The infection had caused several abscesses and a fistula to develop, for which he needed surgery. A trial for the lawsuit was originally set for July 31, 2017, but both sides wanted more time to prepare due to the complexities of the issues involved in the case. Subsequent to Huff’s lawsuit, several others have been filed against Ethicon alleging complications due to their product’s design.
Another company, Atrium Medical Corporation, is also facing multiple lawsuits involving their hernia mesh product called C-Qur. The product was approved by the FDA in 2005 after it had also used the fast-track procedure 501(k). Many of the lawsuits allege Atrium’s hernia mesh product caused allergic reactions because the polypropylene material is coated with fish oil.
Allergic reactions are not the only issues with this product as there have been other complaints regarding it adhering to bowels, which caused them to twist or causing the bowel to become perforated. Some lawsuits also said the fish oil coating peeled off, causing the adherence of the mesh against the bowel and other tissues. The FDA had sent Atrium a warning letter regarding their inadequate reactions to complaints about the C-Qur product causing infections.
Along with the complications alleged in dozens of lawsuits, there were also 35 complaints about human hair being found in the sterilized products, which prompted the FDA to issue a permanent injunction in 2015 to stop Atrium from manufacturing the C-Qur device. However, before the injunction went into effect, several patients had already undergone surgery and had the hernia mesh implanted.
With dozens of lawsuits pending against Atrium Medical regarding the C-Qur implant, the lawsuits have been consolidated by the US Judicial Panel on Multidistrict Litigation. The US District court in New Hampshire is slated to preside over nearly two dozen of the lawsuits against Atrium. 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 implantation, bowel adhesions and other complications.
Multidistrict litigation simply speeds the process of hearing multiple lawsuits based on the same complaint or questions. So far, no class actions have been filed involving hernia mesh implants and these are the first suits to be lumped together in court. Along with Atrium and Ethicon, there are other manufacturers facing suits regarding their hernia mesh implants as well.
Covidien first produced a polyester hernia mesh – the Parietex hernia mesh – in 1999 and the results were not good. Many patients experienced issues with their bowels along with adhesions and infection.
Eventually, the company moved on to the Parietex Composite Mesh, which was made of polyester and a collagen barrier. The idea was to ensure the collagen barrier would stop the polyester base from adhering the bowel. The idea did not work with many patients still reporting bowel issues.
One of the “self-fixating” mesh systems used in hernia procedures, the Parietex ProGrip is known for causing serious complications. Many patients had to go through multiple surgeries, because they were required to remove the issues caused by the ProGrip.
The mesh features thousands of hooks designed to keep that mesh in place. However, the hooks just ended up causing patients a lot of pain, and they made it harder for doctors to remove the hernia mesh from patients’ bodies.
Studies show that around $100,000,000 a year is made by companies that manufacture mesh products. It does not appear that the thousands of patients whose lives are 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 it was implanted over a million times. Unlike other hernia mesh implants, it contained a ring which would break after implantation and cause bowel and other organ perforations.
However, it was also made from polypropylene, which caused its share of complications as well. The ring was implanted in the mesh, which once implanted started to break down and, as it did, it began to shrink. The polypropylene would shrink smaller than the size of the ring, exposing it and causing it to buckle or break and perforate bowels or other organs.
Davol, which is a subsidiary of Bard, recalled the Kugel devices in 2005, 2006 and 2007. However, there are still lawsuits pending against the hernia mesh product, including a lawsuit in Rhode Island filed against Davol by a man, Wayne Smith, who had it implanted in 2005, prior to it being recalled. Shortly after his surgery, he began to complain of abdominal pain and tenderness around the surgical site and it was recommended he have the implant removed.
C.R. Bard and Davol attempted to have the lawsuit dismissed, citing the plaintiff’s claims didn’t satisfy the laws of Rhode Island. However, the judge presiding over the case refused to allow it to be dismissed and the lawsuit against the manufacturer is being allowed to go forward.
The CR Bard corporation manufactures several other hernia mesh implants which have been named in lawsuits because of complications due to their design defects. Along with Davol’s Kugel hernia mesh, they have also been sued over 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, some testicles had to be removed.
Bard also owns the Ventralex ST implant, which has also been named in lawsuits. It was closely modeled after the Kugel mesh design, even though the Kugel mesh was recalled a decade ago. So far, the Ventralex implants have not been recalled, but there have been complaints filed against them alleging severe inflammatory reactions to the product.
If a surgeon repaired a hernia laparoscopically, it is likely they inserted the mesh deep into the abdominal cavity. This causes the mesh to push against the bowel which is when complications arise.
While some surgeons and lawyers are aware of the complications from hernia mesh, 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 was safe for hernia operations.
Every claim by a patient who suffered complications as a result of a hernia mesh constitutes a separate lawsuit.
The problem in the United States is that after a product is approved, it can be very difficult to overturn that decision.
After the FDA initially approved hernia meshes, some complications from patients are not enough to change the tune.
Even if those complications involve bowel obstructions, severe infections and other issues, the FDA may not take action.
It is only when thousands take action that something can change. It can take up to ten thousand patients showing they suffered complications for the FDA to finally look into the possible defective nature of a product like hernia meshes.
Hernia meshes are often overused. Instead of a surgeon using their skill to deal with a smaller inguinal hernia, they use a mesh. Thousands have suffered the severe pain associated with a hernia mesh that could have been avoided with surgical sutures.
Be aware though, that there is a high likelihood a recurrence among patients who were treated with sutures or a mesh.
There are over 50 different types of meshes on the market from which a surgeon can choose in order to repair a hernia.
Other types of smaller hernias, such as those that are the result of laparoscopic surgery, do not need to be repaired with hernias. They can be repaired with sutures by good surgeons.
With a recurrence rate of around one percent, Shouldice repair is seen as the gold standard for
dealing with inguinal hernia problems. The process involves local anesthesia, pain meds, sutures and
some type of sedative. Nothing more is required to treat the patient.
We do know that many manufacturers have funded studies to show that a hernia recurrence was less likely when using a hernia mesh.
The problem is that many recurrences and complications to the hernia that are suffered by patients ten years later are not studied.
Even though studies show there is a slightly lower chance of hernia recurrence after a mesh is used, the procedures are dangerous. There are far too many serious health risks and side effects these meshes are causing patients.
Some complications may seem innocuous, such as a bit of stomach cramping or abdominal pain. But such pain is usually followed by serious symptoms which can include bowel and testicular problems, neurological issues, auto-immune conditions.
If the hernia mesh erodes the bowel, patients require many surgeries to correct the issue. They are hospitalized for weeks, their bowel may even be partially removed, and they can develop other complications down the road.
When the rate of intraperitoneal laparoscopic surgeries to repair the hernia increased, the severe complications caused by the hernia meshes also went up. The coatings were created to ensure there was a layer that protected the patient’s bowel from the polypropylene mesh. The goal is to have the body eventually absorb the coating over a few months or years.
The Hollis Law Firm is responsible for many of the hernia mesh lawsuits that have been filed by patients. Now they are investigating all the relevant hernia mesh claims made by patients and physicians.
To show the public the lack of regard shown by the FDA on this issue, the Hollis Law Firm created pages for the Parietex ProGrip lawsuit, and another one for the Parietex Composite lawsuit.
The first method to alert the FDA to this issue is by patients filing a hernia mesh lawsuit against the manufacturer of the product used. When the manufacturer is told about the hernia mesh lawsuit, they have to report that to the FDA, which alerts the organization to what is going on.
While it is not always the case, the more lawsuits that are filed, the more likely the FDA will take a second or third look at hernia meshes and the complications surrounding them.
The FDA has a statement on their website regarding hernia meshes and their complications. However, the statement states that most adverse event reports to the FDA were regarding mesh products that were later recalled – a claim most lawyers and patients would dispute.
The FDA first approved a mesh product in 2006 – Atrium’s C-QUR mesh product. In 2010, further products were approved, despite a 2009 study showing the C-QUR mesh increased adhesion rates and immune system responses.
Atrium Medical received a warning from the FDA in 2012 regarding their mesh, with the organization stating that many infection complaints were not properly addressed or documented. Eventually, the FDA got a court injunction against Atrium to halt its manufacturing.
Unfortunately, no other manufacturer has been targeted, despite plenty of research linking their meshes to serious complications including obstruction, adhesion, perforation and recurrence.
If there is a failure of the hernia mesh within a few years and the same surgeon takes it out, the surgeon will report that complication to the manufacture. If surgeons continue to file these reports of complications to manufacturers, those companies are legally obligated to let the FDA know about the situation.
Here are some hernia mesh studies from the past few years, and a summary of their results.
June 2017 – Study on Polypropylene Hernia Repair Meshes Deteriorating
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 is what often results in chronic pain for patients.
August 2016 – Two-Year Study on Patients Who Received a Hernia Mesh
Over 600 patients were studied for two years after they were given a mesh for hernia repair. Around 31 percent of those patients suffered some type of complication within two years. These complications included necrosis, nonhealing wounds, hematoma, fistula, dehiscence and cellulitis.
Those patients who had a preoperative MRSA+ infection on any site, such as 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 Hernia Mesh Infection Likelihood
768 patients went through the hernia repair procedure of having a mesh put into their body. Around 10 percent had a hernia mesh infection, while 33 percent of the patients who had a preoperative MRSA+ infection had a hernia mesh infection.
With dozens of Hernia Mesh lawsuits pending, it is possible class action lawsuits could be filed, but so far none have yet been scheduled.
Only one trial date has been set so far for 2018, but more trials could be set soon. We’ve updated this post on January 8, 2018 so keep checking this page to stay updated. Of course, don’t hesitate to fill out the form on top of this page for a free case evaluation.
At the moment of writing (last update January 20th 2018) the year is still young and we haven’t seen any settlements yet. Last year we did: In April 2017 Ethicon (a Johnson & Johnson subsidiary) was ordered to pay $20 million in damages by a Philadelphia Jury. They concluded that a TVT-Secur mesh from a New Jersey woman was defectively designed and caused injuries.
An Ethicon spokespersion told the press that the company would appeal the decision, but according to Product liability law professor Carl Tobias this would be ‘silly’, seeing the case was the fifth big loss over the mesh products in 3 years time.
Plaintiff Margaret Engleman said that she is happy she could be a voice for other women in an email statement. It has been a nightmare for her when her TVT-Secur mesh eroded in her body after it was placed in 2007. According to court filings this caused ‘sharp stabbing pain’ and exacerbated her bladder problems.