Hernia Mesh Complications


Updated 7/30/2017

Surgical mesh is becoming increasing prevalent in hernia repair procedures. Evidence has shown that when implanted correctly,  and when the product functions as intended, surgical mesh can provide structure to the abdominal wall and prevent hernia reoccurrence in patients. Unfortunately, what we're seeing today is an alarming number of hernia mesh complications where the outcomes are much less favorable. Why is this the case?

The fact is that many of the mesh products on the market today are just not suitable for permanent fixation inside the human body which exactly how they are used. Over time the mesh fuses with internal tissue sealing and reinforcing the abdominal wall near the damaged area. This is how the mesh is designed to function. Patients usually encounter issues when there is unintended fusion between the mesh and internal organs. In other instances, serious infection  occurs at the attachment site or there is bowel obstruction. Each of these complications can leave the patient in severe pain and often requires additional surgery to correct.

Those afflicted by these products may miss time from work, and may end up with thousands of dollars of medical debt. In the worst cases,  lives of family and friends are lost as a consequence of the use of these faulty patches. If you or a loved one has suffered injury due to a defective hernia mesh patch, it's important that you contact a qualified lawyer immediately. You may be entitled to pursue a legal case against those responsible for your injury or loss. If you hesitate to take action, your statute of limitations could expire, leaving you with no way to fight back or receive financial compensation for your suffering.


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Below are some of the most common hernia mesh complications according to patients.

Infections

Infections originate near the operation site and spread throughout the body

Bowel Obstruction

Bowel obstruction leading to severe abdominal pain

Abdominal Pain

This could be a result of fusion between the bowel and the surgical mesh

Neurological Damage

Some patients have experienced unnatural neurological symptoms

Adhesion

Adhesion to vital organs or tissue can occur

Seroma

Seromas are pockets of fluid that develop around the mesh site

Dental Issues

Dental problems such as loss of teeth have been reported

Leg & Groin Pain

Pain around the leg and groin are common. Even testicular pain

Fever

Fever and high temperature can be prevalent. Most likely due to autoimmune response

 

  Cases & Settlement Amounts

updated 3/28/17

We now know there are many types of hernia mesh complications. Because of these complications, we have seen a multitude of lawsuits filed against manufacturers. There are a number of current cases and pending settlements. We suspect that this number will rise exponentially over the next few years given the widespread use of surgical mesh in hernia repair.  Here are some of the recent cases and settlement amounts.


 

2011 Thorpe vs. Davol Inc.

Christopher Thorpe filed a case against Davol/C.R. Bard in 2011.  His case was part of a collection of cases handled by the Judicial Panel on Multi-district Litigation and was ultimately transferred to the United States District Court of the District of Rhode Island.  This case, and subsequent trial, was the second of four bellwether trials (A bellwether trial is  a case where the court and involved parties test their arguments in hopes of proceeding with a larger litigation).

Christopher had two different doctors testify on his behalf providing sufficient scientific evidence to the jury. In response Davol filed a motion to exclude these testimonies from the record however, Judge Mary M. Lisi denied this action. Judge Lisi ruled that both doctors had sufficient medical experience and education and provided conclusion based on scientific evidence.

Davol also filed a motion for judgment as a matter of law in regards to the claim of deficient design. This was also denied based on evidence provided. The judge ruled that evidence provided could lead a jury to find the manufacturer negligent in their design of the patch knowing that safer alternatives existed.

Christopher and his family were ultimately compensated for his injuries and was awarded $1.5 million.

 2011 Bard Settlement

Shortly after Thorpe's settlement, Bard & Davol agreed to settle with  2000+ patients that were part of the multi-district litigation mentioned above. This class action suit claimed faulty memory coil inside the Bard Kugel patch. The hernia mesh manufacturer disclosed the information in a U.S. Securities and Exchange Commission filing stating that they reached agreement in principle with multiple plaintiffs.  While Bard never admitted any sort of liability, they did ultimately pay the plaintiffs a total of $184 million dollars.

 2014 Kugel & Ventralex

In 2014, the Ontario Superior Court of Justice approved a large settlement agreement for individuals that were part of a national class action lawsuit. This litigation again targeted patients expressing hernia mesh complications from Bard's Kugel and Ventralex products.

hernia mesh settlements
Manufacturers are paying out millions in settlements.

These products contain a patented design that features a memory coil core. This spring-loaded ring along with polypropylene material have both cause serious issues once implanted in patients. The plaintiffs pointed to this faulty design and attributed it to many of their medical recent complications such as

bowel obstruction and perforations. Of course, Bard denied any negligence or wrongdoing on their end. The court also never took a firm position in the case.

Bard ultimately agreed to pay a total sum of $1,375,000.00 to settle the claims from both primary and derivative claimants. Please visit our news blog for more up-to-date news regarding kugel mesh settlement amounts.

Although there are no official FDA recalls, cases are beginning to mount against Bard's 3D Max product.

More about the Bard Kugel Patch

The Kugel patch is a well know product. Not for a good reason. Recently the FDA has encouraged anyone who has received a Bard Composix Kugel Mesh Patch to seek medical attention immediately. The hernia patch malfunction has been associated with persistent abdominal pain, fever, tenderness at the implant site and several other unusual symptoms. Currently the products included in recall are:

  • Bard® Composix® Kugel® Large Sized Patch Class I Recall and Market Withdrawal
  • Product Code: 0010202, Bard® Composix® Kugel® Large Oval, 5.4" x 7.0"
  • Product Code: 0010204, Bard® Composix® Kugel® Large Circle, 4.5"

This patch is a device intended to repair ventral hernias. The Bard Composix Kugel Mesh patch is placed behind the hernia during surgery and is held open by a memory recoil ring. Unfortunately, the memory recoil ring had a tendency to break, which can lead to bowel perforations and/or chronic intestinal fistulae. This was the defective part of the hernia patch that caused it to be recalled three times.

For a brief history lesson, the problems with the Kugel mesh didn't come to light until 2001 when reports of its failure after implantation started appearing. Some of those spotted the same common complications included bowel obstructions, due to the memory coil ring.  Other reported complications with the patch itself were also being reported. Surgeons were discovering patches that were folded, shriveled, buckled and curled. Obviously this wasn't the intended result.

The patch was recalled in 2005 and physicians were asked not to use certain lots. The rationale was due to the high risk of coil breakage leading to dangerous injuries in patient's organs and tissues. Eventually this progressed into  a successive Class 1 Food and Drug Administration recall, which is considered to be very serious. The scary fact is these particular patches are used in over 700,000 hernia fix surgeries every year. While it is still unknown how many people will be affected by this potentially dangerous patch, it is very clear the product presents a present danger to thousands of people worldwide.

 2016 Atrium Medical - C-Qur

In December 2016, the Judicial Panel on Multi-District Litigation made the decision to consolidate 21 federal lawsuits involving Atrium C-Qur patches. Judge Landya B. McCafferty from the district of New Hampshire  will preside over the pending litigation.

The decision was unanimous among plaintiffs to have the case transferred to New Hampshire. The manufacturer, Atrium Medical, also happens to reside there. The litigation centers on the Omega-3 coating built into the C-Qur patch. Mainly it’s defectiveness and potential to cause allergic reactions, infections and bowel obstruction.  Any additional cases within the state will automatically be transferred to the current litigation. We certainly expect this number to grow exponentially before a  final ruling is made.

[More info on Atrium mesh recalls]

 

 2016 Ethicon Physiomesh

As we already know, Ethicon voluntary pulled their Physiomesh product from the market in 2016 indicating that it led to higher rates of reoccurrence and other hernia mesh complications. In fact, two separate studies conducted in both Denmark and Germany supported this claim.

The first Physiomesh case was initiated by Matthew Huff who was implanted with the device in 2013. Matthew began suffering from severe abdominal pain and fever a few years later. He was eventually diagnosed with an infection and treated for an intestinal fistula. These are both very common complications that originate from hernia mesh.

According to court documents trial will begin on 1/22/2018  in the Southern District of Illinois. Judge J. Phil Gilbert is set to preside over the case. You read more details here.

We're also reporting an alarming number of issues with the Ethicon Proceed Patch. Click the link to read more.

Please see our news blog for an updated list of  hernia mesh complications and cases. You can also read up on the latest hernia mesh lawsuit settlement amounts.

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Published By: The Mesh Attorney

Author, creator and expert on hernia mesh related injuries, case and settlements.