Hernia Mesh Recall Update

According to the U.S. Food and Drug Administration (FDA), approximately one million people in the United States undergo hernia repair surgery each year. A hernia develops when fatty tissue, part of the intestines, or another organ protrudes through an area where muscles have weakened. The purpose of hernia mesh devices is to strengthen the weak muscles and keep the tissue in place.

Doctors have long recommended that patients with bothersome hernia symptoms undergo minimally invasive hernia repair surgery where a surgeon implants a hernia mesh medical device. Unfortunately, some patients have developed serious complications due to hernia mesh products. Some of the most common serious complications include:

  • Abdominal bleeding
  • Adhesion of scar tissue
  • Blockage of the intestines
  • Bowel obstruction
  • Bowel perforation
  • Chronic pain
  • Fistulas between organs, in the bloodstream, or in the intestines
  • Hernia recurrence
  • Infection at the surgical site
  • Migration when a piece of surgical mesh breaks off and travels to another part of the body
  • Perforation of organs
  • Revision surgery or other additional surgery
  • Seroma, which is a buildup of fluid at the hernia site
  • Severe pain

The FDA has received several adverse event notifications, leading to the voluntary recall of hundreds of thousands of hernia mesh products since 2005. Hernia mesh manufacturers most often involved in FDA actions and hernia mesh lawsuits include:

  • Atrium Medical Corporation (also known as Getinge Group and Maquet): C-QUR Edge Mesh V-Patch, C-QUR Lite Mesh V-Patch, C-QUR V-Patch, C-QUR Mesh, C-QUR OVT mesh, C-QUR RPM mesh, C-QUR Tacshield, and C-QUR Mosaic
  • C.R. Bard: 3D max mesh, Composite E/X mesh, Kugel hernia mesh, PerFix mesh, Sepramesh IP composite mesh, Ventralex hernia patch, Ventralex ST hernia mesh, and Ventralex hernia patch
  • Covidien (also known as Medtronic) Parietex surgical mesh, Parietex ProGrip mesh, and Parietex composite mesh
  • Johnson & Johnson: Ethicon Proceed surgical mesh, Ethicon Physiomesh flexible composite mesh, and Prolite Hernia System

The biggest reason for recalled mesh products is the higher than normal rate of serious complications, the need for revision surgery, and the need for other additional surgeries. Additional reasons cited include improper packaging, missing laminate coating on mesh devices that can lead to adhesion, and breaking of the medical device ring causing fistulas and bowel perforation.

History of Hernia Mesh Recalls and Legal Actions

The mesh manufacturer C.R. Bard was the first to face a recall between 2005 and 2007 with its Kugel hernia mesh. The FDA recall notice stated that this C.R. Bard recalled mesh had an unacceptably high amount of breakage that caused fistulas or bowel perforation.

In 2012, the FDA sent warning letters to the Atrium Medical Corporation requiring the mesh manufacturer to address known issues with the medical device such as infections. The FDA also noted that Atrium failed to produce an adequately sterile environment for medical device manufacturing. When Atrium did not respond to the FDA’s letter, the FDA issued a Class 2 recall on each of its C-QUR hernia mesh products listed above, including hernia patches.

The FDA filed a hernia mesh lawsuit against the Atrium Medical Corporation in 2015 for an unacceptable quality control process at its New Hampshire plant. The FDA-initiated lawsuit entirely shut down the production of all C-QUR hernia mesh products for a short time.

The Johnson & Johnson division of Ethicon announced a voluntary market withdrawal of its physiomesh in 2016 after the FDA determined it had violated safety protocols. Another reason Johnson & Johnson took this action was that several medical research studies indicated an abnormally high rate of hernia recurrence and other significant hernia mesh complications.

By spring 2020, thousands of people filed lawsuits against hernia mesh manufacturers for the serious complications they experienced after hernia mesh implantation surgery. Because of the significant number of people harmed by this defective product, most hernia mesh lawsuits now fall into one of two classifications. The first is the Atrium Medical Corporation C-QUR Mesh Product Multidistrict Litigation (MDL) 2782. The other is the Ethicon Physiomesh Flexible Composite Hernia Mesh Products MDL 2753.

The term multidistrict litigation refers to a process implemented by the United States District Court System to centralize defective product lawsuits involving thousands of people. Each hernia mesh lawsuit remains a separate legal entity, but actions such as the discovery of evidence, depositions, and legal decisions become part of the same pretrial hearing.

An MDL differs from a class-action lawsuit, which we will review in greater detail during your free case evaluation. Groups of people who experienced serious complications after hernia repair surgery have joined class-action lawsuits against hernia mesh manufacturers in addition to MDL actions.

Is Your Hernia Mesh Product Part of a Medical Device Recall?

Please do not panic if you see the brand of hernia mesh product used in your hernia repair surgery on the above lists. Some people never experience complications from a defective medical device and do not need to take further action.

However, you should schedule an appointment with your doctor as soon as possible if you have symptoms such as severe pain, chronic pain, nausea, vomiting, and any unexpected side effects after hernia repair surgery. This is true whether your medical device is part of a nationwide hernia mesh recall or not. Your doctor will discuss additional treatment options with you, including revision surgery.

You have the legal right to file a hernia mesh lawsuit if you can prove that the defective product or possibly the surgeon’s implantation methods caused your serious complications. You must initiate your lawsuit before the statute of limitations expires in your state.

The typical statute of limitations is two or three years, but some states allow people with serious complications from a medical device up to six years to initiate a claim. We recommend scheduling your free case evaluation with Hill & Ponton Disability Attorneys as soon as possible to give us the maximum amount of time to prepare and present your hernia patch or hernia mesh lawsuit.

Do You Qualify for a Hernia Mesh Lawsuit?

Whether you suffer from chronic pain, required additional surgery to correct a bowel obstruction, developed fistulas, or deal with other serious complications of hernia mesh implants, Hill & Ponton is here to help. We invite you to contact our law firm to request a free case evaluation today.