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Physiomesh / Hernia Mesh Linked to High Recurrence and Additional Surgeries

Physiomesh / Hernia Mesh Lawsuit

As much as 10% of the population develops some type of a hernia throughout their lifetime. As a result, hernia repair is on the of most common types of surgeries performed in the United States. Hernia mesh, a type of surgical mesh, is commonly used in hernia repair surgery to both strengthen the repair and reduce the rate of recurrence. However, complications as a result of the hernia mesh have caused further issues often resulting in corrective surgery. Hernia mesh lawsuits have been filed as a result of complications that have resulted from the mesh devices.

Litigation Updates

Thousands of Cases Filed, Trial Preparations are Continuing

September 2018 - The cases are filed in the United States District Court for the Northern District of Georgia in front of Judge Richard W. Story.  There are thousands of cases which have been filed and consolidated in front of Judge Story.

In order to proceed in an organized manner, the Court entered an order in January 2018 which created an initial group of 34 cases to prepare for trial. Unfortunately, none of the TorHoerman Law cases are in this initial group. This initial group of cases was supposed to be narrowed down to 10 by December 1, 2018, with a scheduled first trial for September 16, 2019.  However, the Judge recently issued an order pushing all deadlines out 75 days.

We expect that Judge Story will create a second group of cases to be worked up for trial in early 2019 and are hopeful that one or more of our cases will be included in the group.

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Trial Date Set for Ethicon Physiomesh Flexible Composite Hernia Mesh

January 2018 – 469 lawsuits regarding Ethicon's Physiomesh Flexible Composite Hernia Mesh are pending in Georgia Northern District Court. A trial date has been set for September 16, 2019.

Lawsuits Filed Against Manufacturers of C-Qur and Physiomesh

August 31, 2017 - There are currently two separate multidistrict litigations (MDL) open against manufacturers of hernia mesh surgical devices.

In the U.S. District Court of the Northern District of Georgia, MDL 2782 has been created for claims against Johnson & Johnson subsidiary, Ethicon, for its Physiomesh product.

MDL 2782 was formed in June 2017, following Ethicon's worldwide market recall of Physiomesh products in May 2016. The MDL consolidated the initial 18 cases into the Northern District of George Federal Court. There are currently 92 Physiomesh lawsuits now pending in the federal MDL.

The worldwide Physiomesh recall came as a result of unpublished data from multiple European hernia registries, which showed a correlation between Physiomesh and higher than average recurrence and revision rates, as compared to other laparoscopic ventral hernia meshes. 

Ethicon did not cite a specific component of their product that caused the defect. According to Physiomesh's recall notice, the withdrawn patches will not be returning to the market.

In the U.S. District Court of New Hampshire, MDL 2753 has been created for claims against Atrium for its C-Qur Mesh product.

While the FDA has not yet recalled C-Qur mesh, the FDA has conducted multiple investigations into the potential consumer risks of C-Qur mesh, as well as the business practices of the product manufacturer, Atrium.

In 2015, the FDA filed a lawsuit against Atrium, claiming the manufacturer had introduced adulterated medical devices into the market.

FDA investigations into C-Qur mesh have opened inquiries into the potential dangers posed to consumers. While C-Qur is advertised as unlikely to create scar tissue or fuse with muscle tissue, there have been a large number adverse events reported by consumers — including allergic reactions, inflammation, bowel obstruction, infection, and a tendency to fuse with abdominal muscle tissue. These alleged medical issues were the basis for a number of healthcare professionals and hospitals to discontinue using C-Qur.

Since the FDA's investigation into Atrium, there have been more than three-dozen cases filed across 26 district courts. Plaintiff's allegations range from adverse effects caused by C-Qur mesh to Atrium's failure to properly warn consumers of the potential dangers involved with C-Qur. In December 2016, MDL 2753 was created in the Federal District Court of New Hampshire. The MDL consolidated the growing number of C-Qur hernia mesh lawsuits into a single district court.

In an effort to promote judicial efficiency and eliminate delays associated with the transfer of lawsuits from other federal jurisdictions, the courts are now permitting plaintiffs to file directly in both MDL 2782 & MDL 2753.

At the moment, both MDL's are at a standstill as the court's go through pretrial judicial proceedings.

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Ethicon Physiomesh Flexible Composite Hernia Mesh MDL Established

June 1, 2017 – A multidistrict litigation regarding Ethicon's Physiomesh Flexible Composite Hernia Mesh is established.

Atrium C-Qur Lawsuits Consolidated

Dec. 8, 2016 –Atrium C-Qur lawsuits are consolidated into multi-district litigations in the federal court for New Hampshire, docketing the case as MDL No. 2753.

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What is Physiomesh/Hernia Mesh?

Since the 1970’s, the implantable mesh has been used in surgeries to repair a hernia in the abdominal wall.

According to the FDA, “A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. Hernias often occur in the abdominal wall.” More than 1 million hernia repairs occur in the United States per year.

Hernias often have a high rate of reoccurrence so surgeons use hernia mesh to strengthen the repair and reduce the rate of reoccurrence. However, adverse events reported to the FDA such as bowel perforation and obstruction complications, or even hernia recurrences, generally required surgical procedures to correct the issues.

There are four types of surgeries used to repair hernias:

  • Laparoscopic extraperitoneal repair
  • Laparoscopic transabdominal preperitoneal patch repair
  • Open tension-free mesh repair
  • Open primary tissue approximation repair

The first three all require the use of surgical mesh to repair a hernia. The hernia meshes implanted to repair a hernia can vary by brand and type. The four most common types of hernia mesh products are:

  • Atrium
    • C-Qur
  • Ethicon
    • Ethicon Physiomesh Composite Mesh
      • Johnson & Johnson issued a voluntary hernia mesh recall of the products in 2016.
    • Ethicon Physiomesh Open Flexible Composite Mesh Device
  • Covidien/Medtronic
    • Parietex, Parietex ProGrip, Parietex Composite Ventral Patch, Parietex Parastomal Mesh, Parietex Optimized Composite Mesh (PCO), and Symbotex Composite Mesh
  • C.R. Bard
    • SepraMesh, Ventralex, Bard 3D Max, Kugel, Kugel Composix Mesh, PerFix Plug, Ventrio, Ventrio ST, Composix E/X Mesh, Visilex, and Spermatix

Although Ethicon’s Physiomesh Composite Mesh product was voluntarily recalled in 2016 by Johnson & Johnson, all other products are currently still available for hernia mesh repairs in the United States.

If you feel you were injured as a result of hernia mesh, report your adverse side effects to the FDA.

 

Adverse Side Effects of Hernia Mesh Reported to the FDA

According to the FDA, adverse side effects following hernia repair with mesh are:

  • Pain
  • Infection
  • Hernia Recurrence
  • Adhesion
  • Bowel perforations and/or obstruction
  • Mesh migration
  • Mesh shrinkage

 

Injuries We’re Pursuing in a Hernia Mesh Lawsuit

Hernia mesh side effects vary by on a case by case basis. However, we are accepting cases for a hernia mesh lawsuit for those individuals who:

  • Had a hernia mesh implanted after 2006.
  • Had at least one revision surgery or impending revision surgery.
  • Are not able to undergo revision surgery because it would be too difficult.

TorHoerman Law is currently not accepting cases for those individuals who have an autoimmune disease or suffered from a hiatal hernia.

 

Contact TorHoerman Law Hernia Mesh Lawsuit Lawyers

TorHoerman Law believes in helping those injured through no fault of their own. If you believe you suffered a personal injury as a result of a hernia mesh product, contact our law firm for a free, no-obligation consultation.

 

Other Types of Mesh

Although mesh products are used to repair hernia’s, similar types of products, referred to as transvaginal mesh, are also used repair weakened or damaged tissues in the instance an individual is suffering from pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

Did you suffer adverse side effects as a result of transvaginal mesh? Contact our transvaginal mesh lawyers today.

Timeline

Urgent Field Safety Notice Issued

May 25, 2016 – Johnson & Johnson issued an "Urgent Field Safety Notice" to warn of the higher instances of reoccurrence or reoperation as a result of the Ethicon Physiomesh Composite Mesh. All unused products were also voluntarily recalled.

+ - References

Balentine, Jerry R. "What Is a Hernia? Symptoms (Pain), Types & Surgery." EMedicineHealth, 21 Nov. 2017, www.emedicinehealth.com/hernia_faqs/article_em.htm.

"Ethicon Physiomesh Flexible Composite Mesh." Therapeutic Goods Administration (TGA), Australian Government Department of Health, 9 June 2016, www.tga.gov.au/alert/ethicon-physiomesh-flexible-composite-mesh.

"Hernia Mesh Lawsuit - Learn Instantly If You Qualify." TruLaw, trulaw.com/physiomesh-lawsuits/.

"Hernia Surgical Mesh Implants." U.S. Food and Drug Administration Home Page, U.S. Department of Health and Human Services, www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm.

http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2753-Initial_Transfer-12-16.pdf

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