Hernia Mesh Lawsuit. Who qualifies in 2023?

About Hernia Mesh Implants

Although many are under the impression that the Food and Drug Administration (FDA) requires medical device manufacturers to undergo rigorous tests prior to obtaining approval for their product, this is not the case for the hernia mesh device.

In fact, 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 thousands of defective hernia mesh products which led to severe complications in many patients that even required revision surgery to fix.

On this page, we explain everything about the hernia mesh medical device, from common complications to which companies are under fire to trial dates for lawsuits in 2023 and beyond. This information is provided to help you answer the question you might be asking yourself or you might possibly ask a hernia mesh attorney in the future: do I qualify for compensation?

Why is Hernia Mesh Used?

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.

Doctors started using the hernia mesh medical device because of the idea that it would lower the chances of a hernia coming back, a condition known as hernia recurrence.

Unfortunately, due to fast-tracking surgical hernia mesh implants, we still cannot call hernia recurrence a thing of the past. Many of these implants have also been known to fail due to design defects, leading to severe complications that ultimately resulted in a revision surgery for countless patients.

Hernia Mesh Injuries & Complications

Many hernia mesh patients who have undergone surgery to fix their hernias with the use of surgical hernia mesh implants have also reported numerous side effects.

The use of a defective hernia mesh device can result in a plethora of injuries, including:

• Adhesions
• Bowel obstruction
• Abdominal pain
• Bowel perforation
• Infections
• Mesh migration
• Autoimmune diseases
• Neurological problems
• Fistula formation
• Pain during sexual intercourse
• Chronic pain
• Mesh failure
• Recurrent hernia
• Hernia mesh revision surgery

The majority of hernia surgeries make use of synthetic mesh. However, the polypropylene mesh, a kind of synthetic mesh, has been known to cause more problems for patients, including allergies and mesh rejection.

Hernia Mesh Recalls

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.

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 recalls with reasons ranging from poor performance to packaging errors to adverse events. Companies targeted by the FDA included C.R. Bard, Ethicon Inc., and Atrium Medical Corporation.

Hernia Mesh Lawsuits

Ethicon Inc.’s Physiomesh and Proceed Surgical Mesh Lawsuits

Ethicon Inc. recalled its Physiomesh product in the United States in May 2016 after the implant was linked to several cases of hernia recurrence and revision surgery. 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 in bladder slings and transvaginal mesh. Both of which have resulted in thousands of lawsuits.

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, who alleged that she suffered bowel adhesions that required surgery due to Physiomesh. Now that the doctor reported that removal of all the adhesions is no longer possible, she could suffer from permanent complications.

Still, 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 and we will help you find the right hernia mesh lawyer.

Covidien/Medtronic Minimally Invasive Therapies’ Parietex Composite and Parietex ProGrip Mesh

Parietex and Parietex Composite Mesh

Covidien, now known as Medtronic Minimally Invasive Therapies, first used polyester instead of polypropylene in a surgical mesh device. The company’s Parietex hernia mesh product was brought to the market 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.

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.

C.R. Bard Hernia Mesh Lawsuits

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 this happens, the polypropylene would shrink to a size that was smaller than the size of the ring, exposing the mesh and and causing it to break and perforate the bowels or other organs.

Hernia mesh manufacturer Davol Inc., a subsidiary of C.R. Bard, recalled the Kugel meshes in 2005, 2006, and 2007. However, lawsuits are still pending against the surgical mesh, including a lawsuit in Rhode Island filed 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 for him to undergo mesh removal.

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. These are the PerFix Plug, 3DMax, and Ventralex ST mesh implants. Make sure you check this page often to keep up with the C.R. Bard hernia mesh lawsuits.

How Can Patients Report Hernia Mesh Complications to the Food and Drug Administration?

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. Generally, the more lawsuits that are filed, the more likely it is that the agency will take notice of the complications related to the medical device.

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.

What is the Food and Drug Administration’s Current Stance on Hernia Meshes?

Although the FDA has posted a statement on its website regarding hernia meshes and the possible complications involved, the American regulatory agency seems resistant to admitting that several approved hernia mesh products are defective.

The statement notes that the most serious reports that involved hernia mesh products were later recalled – a claim most attorneys would dispute.

Moreover, after sending a warning to Atrium Medical Corporation in 2012 regarding complaints against their mesh product and eventually putting a stop to the device’s production, the FDA has not targeted any other hernia mesh manufacturer after that.

This, despite plenty of research linking defective meshes to serious injuries, complications, and additional surgery.

What is the Scientific Community Saying About Hernia Meshes?

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, often causing chronic pain in 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, fistula, dehiscence, cellulitis, and other types of physical injury.

Patients who had a preoperative MRSA+ infection on any site are at an even greater risk of developing 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.

• Sources

  1. Medical News Today: Types and treatments for hernia

  2. WebMD: Understanding Hernia Basics

  3. FDA.gov: Hernia Surgical Mesh Implants

  4. BBC: Hernia mesh complications ‘affect more than 100,000’

  5. Gutresolution: Hernia Mesh – A Story of Deception, Tragedy and Hope

  6. FDA.gov: Recalls, Corrections and Removals (Devices)

  7. Massdevice: J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh

  8. Ethicon: ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device

  9. FDA.gov: 510(K) SUMMARY

  10. Pacermonitor: Quinn v. Ethicon, Inc. et al

  11. Masstortnexus: Documents – Physiomesh Complaint Huff vs Ethicon

  12. Pubmed: In vitro study on the deterioration of polypropylene hernia repair meshes.

  13. Pubmed: Evaluation of long-term surgical site occurrences in ventral hernia repair: implications of preoperative site independent MRSA infection.

  14. Pubmed: Previous Methicillin-Resistant Staphylococcus aureus Infection Independent of Body Site Increases Odds of Surgical Site Infection after Ventral Hernia Repair.