Hernia Mesh
Product Failure

Surgical hernia mesh is used as a patch to support damaged and weakened tissues, or hernias. Its main purpose is to provide scaffolding so the tissue can regrow and strengthen the weakened area. Scientific studies have recently begun to conclude that certain models of hernia mesh products have a tendency to fail at higher than acceptable rates. These hernia mesh failures can be extremely damaging and involve migration of the hernia product into other areas of the body, including, the bowel. Mesh failures can also cause dangerous infection. Oftentimes, the only way to address mesh failure is to have an invasive revision surgery to remove the failed and damaging mesh.

GoldenbergLaw is currently taking cases of clients who experienced injuries, including a required revision surgery, because of complications caused by defective hernia mesh devices such as Ethicon’s Physiomesh Flexible Composite Mesh and Atrium’s C-QUR surgical hernia meshes, among others. Numerous hernia mesh devices have been identified as problematic, leading to revision surgery and revision surgery complications.

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Case Quick Facts

The Problem

Hernia mesh should be designed in a way so that it will easily incorporate into the body to repair the problem hernia. Appropriate mesh designs require the right materials so as to avoid adverse body reactions as well as proper shape design to assist in incorporation into the hernia. When the right design components are not implemented, dangerous mesh failures can occur.

When hernia mesh is defective and fails, it can do so in various ways. Dangerous hernia mesh failures often involve a failure to integrate properly into the weakened tissue or hernia resulting in migration to another part of the body. Certain hernia meshes that are made of improper materials can also cause an adverse reaction in the body, resulting in serious and life-threatening infections.

When mesh migrates to a different area of the body than intended, it can cause serious injuries to the patient, including, bowel obstruction, bowel perforation, adhesions, and the need for an invasive surgery to remove the problem mesh. Further, when the mesh is composed of a material that causes an adverse reaction in the body, an infection can result that necessitates immediate antibacterial medical care as well as invasive surgeries.

The Injuries

The most common problems associated with hernia mesh product failure surgery are:

  • Infection
  • Intestinal fistula
  • Hernia recurrence
  • Adhesion (tissues stick together that aren’t supposed to)
  • Bowel obstruction
  • Tissue or organ perforation
  • Intestinal blockage
  • Mesh migration
  • Mesh shrinkage
  • Seroma (fluid buildup at the surgical site)
  • Revision surgery

According to the FDA’s analysis of adverse medical event reports, recalled mesh products were the main cause of bowel perforation and obstruction complications.

The Defendant(s)

GoldenbergLaw is investigating the following Ethicon products:

  • Physiomesh
  • Proceed Surgical Mesh
  • Proceed Ventral Patch
  • Prolene Hernia System
  • Prolene 3D Patch

GoldenbergLaw is investigating the following mesh models made by Atrium:

  • C-Qur Edge
  • C-Qur V-Patch
  • C-Qur Tacshield
  • C-Qur Mosaic

Bard Davol, Inc.
Bard makes several mesh products, however, we are currently investigating the following mesh products made by Bard:

  • Composix and E/X (E/X version made from Marlex mesh)
  • Modified Kugel
  • Perfix Plug
  • Sepramesh
  • SpermaTex
  • Visilex
  • 3D Max (made from Marlex mesh)
  • Ventralex or Ventralex ST Hernia Mesh
  • Ventrio or Ventio ST
  • Ventralight ST
  • Perfix Light
  • 3D Max Light
  • Composix L/P

GoldenbergLaw is currently investigating the Parietex hernia mesh made by Covidien.

GoldenbergLaw Can Help

GoldenbergLaw is currently investigating hernia mesh failure cases involving the above-noted product types. If you need a hernia mesh lawyer, we have the experience to help you out. Reach out for a free consultation

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What is a Revision Surgery?

Revision Surgery Following Hernia Mesh Failure
If your hernia mesh fails to work as intended, you might need revision surgery. A revision surgery follows the initial mesh implant surgery. Although a second surgery can be common among hernia mesh patients, the purpose of a revision surgery is to fix injuries and problems caused by the failing hernia mesh product.

The revision surgery of recalled mesh products is an unpleasant process. The surgeon has to open up the abdominal area and/or groin area in order to cut each identifiable piece of mesh away from the organ and surrounding tissue. All of this is very painful and requires a longer recovery period than the initial surgery in most cases.

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Defective Hernia Mesh Products to Highlight

Physiomesh Flexible Composite Mesh
This is a hernia mesh product created with polypropylene (plastic) filaments that are woven and then laminated with monocryl – an absorbable coating that prevents the mesh from sticking to surrounding tissue. The monocryl coating is a nonporous material which means it does not lend to quick adherence to the hernia, but instead can cause migration to other parts of the body. When migration occurs, the mesh may adhere to the bowel or other organs, causing serious pain and dangerous medical conditions. The mesh is also made up of weak materials. This has allowed the hernia to break through the mesh, resulting in hernia recurrence and required revision surgery.

Physiomesh is manufactured by Ethicon. The product was given FDA 510(k) clearance in April 2010. The product launched in October 2010. It was eventually withdrawn from the market in May 2016 after patients began reporting serious injuries from the product.

C-QUR Hernia Meshes
C-QUR mesh is manufactured by Atrium. The design combines polypropylene mesh with an all-natural Omega 3 gel coating. The gel coating is derived from highly purified pharmaceutical-grade fish oil.

The FDA conducted several investigations into Atrium and eventually sued Atrium in 2015. A recall has not yet been issued. Specifically, in 2011, the FDA sent a warning letter to Atrium noting that the company was failing to address multiple complaints related to infections associated with C-QUR hernia mesh. Atrium was also in trouble with the FDA for failing to control temperature in the manufacturing process. In 2013, there was a class II recall of the C-QUR Edge mesh because the Omega 3 fatty acid coating could adhere to the inner packaging liner due to exposure to high humidity. This affected 1,501 devices. In 2015, the FDA sued Atrium and issued an injunction, stopping the manufacture and distribution of the C-QUR hernia mesh at the Atrium Hudson facility.

Why Choose GoldenbergLaw?

GoldenbergLaw has a highly experienced team of lawyers that has experience with similar drug and medical cases. If you find yourself in need of a hernia mesh lawyer, look no further than GoldenbergLaw. Our experience with similar cases makes us the team to trust to make sure that your case is handled seriously and carefully.

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