Hernia Mesh

Manufacturer 

 

Ethicon                                                             $339.57 Billion
Johnson & Johnson  
Physiomesh, Proceed, Prolene
Prolene 3D
 
Atrium                                                               $24.72 Billion
Maquet / Getinge Group 
C-Qur
 
Bard Davol                                                        $61.49 Billion
Becton Dickinson 
Kugel, 3D Max, Perfix, Ventralex ST
Composix, Ventralex, Composix E/X
Ventrio, Ventrio ST, Marlex
CK Parastomal Patch, Sepramesh
 
Covidien                                                            $107.58 Billion
Medtronic  
Parietex Composite, Surgipro
Parietex Plug and Patch

 

FDA Approval 

 

Various Approval Dates

 

MDL Information 

 

Physiomesh Flexible Composite             MDL 2782 (Northern District of Georgia)
Atrium Medical Corp. C-Qur                     MDL 2753 (District of New Hampshire)
Bard Davol                                                   MDL 2846 (Southern District of Ohio)
Covidien Medtronic                                   Only 12 suits filed federally, MA & MN state
  court filings

Background

According to the FDA, hernias are very common in the United States, with more than one million procedures performed each year.  Approximately 800,000 are to repair inguinal hernias, and the rest are for other types of hernias.
 
 
According to information from June 2020 Mass Torts seminar:
 
 
Bard (BD) Hernia Mesh – There are 21 different brands of Bard hernia mesh involved in the litigation.  One of these, Bard Soft Mesh, plaintiffs do not want filed.  Bard product brands not included are Phasix, Dulex, Curasoft and Biologics.  The first trial (defense pick) is scheduled for September 29, 2020, and two plaintiff’s trials are to commence shortly thereafter.  Bard (BD) represents approximately 65% of the cases.
 
 
Ethicon Hernia Mesh – Consisting of approximately 15% of the cases, Proceed is the brand of focus, and PHS (Prolene Hernia System) is being consolidated in MCL (Multi-County Litigation (MCL-633).  Plaintiffs do not want Prolene Flat or Soft mesh, or Ultra Pro filed.  One interesting item is that apparently, Ethicon marketed these products to doctors with the understanding that the suture application used on the mesh would protect against adhesion for 30 days.  This appears to be false, with at most a protection of 3-5 days, which really offers no protection against adhesion.
Atrium C-Qur Hernia Mesh – These cases represent approximately 3% of the cases.  It has been reported that the manufacturer has already set aside $400 million to settle these cases.
 
Covidien Medtronic Hernia Mesh – Representing approximately 15% of the cases, the manufacturer moved to have these cases consolidated in NY federal court.  However, because only about 12 cases have been filed in 3 years, the ruling came down against consolidation.  Plaintiffs are filing cases in MA and MN state courts.

 

Treatment / Use

 
Surgical mesh is a medical device that is used to provide additional support to weakened or damaged tissue. The majority of surgical mesh devices currently available for use are constructed from synthetic materials or animal tissue.
Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be absorbable, non-absorbable or a combination of absorbable and non-absorbable materials.
 
 
Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement to the repaired hernia.
Absorbable mesh will degrade and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair.

Injuries / Complications / Concerns

 
Based on FDA’s analysis of medical device adverse event reports and of peer-reviewed, scientific literature, the most common adverse events for all surgical repair of hernias—with or without mesh—are pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation).
 
 
The most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).
 
 
In 2016, after reports were published regarding Ethicon’s Physiomesh product failures, Ethicon issued a worldwide recall on the product.  Ethicon is not alone, as there are numerous manufacturers whose products have been linked to significant injuries and the need for revisions including Bard, Atrium and Covidien/Medtronic.
 
 
In addition to recurrence, other injuries or problems include pain, infection, adhesion, intestinal blockage, migration, mesh shrinkage or contraction, revision surgery, bowel perforation, mesh erosion and nearby organ damage or failure.

Information on the Topic of Hernia Mesh

 

New Jersey Ethicon Hernia Mesh Litigation (2020)

https://www.wilentz.com/ethiconmeshnj

 

Bard Hernia Mesh MDL Court Orders and Forms (2020)

https://www.levinlaw.com/bard-mdl

 

Covidien Hernia Mesh Suits Will Proceed Without Federal MDL (8-7-2020)

https://news.bloomberglaw.com/product-liability-and-toxics-law/covidien-hernia-mesh-suits-will-proceed-without-federal-mdl

 

Bard Hernia Mesh Design Flaw, Warning Claims Cleared for Trial (9-2-2020)

https://news.bloomberglaw.com/product-liability-and-toxics-law/bard-hernia-mesh-design-flaw-warning-claims-cleared-for-trial

 

Complications from Hernia Mesh (5-15-2019)

https://mednews365.com/complications-from-hernia-mesh/

 

Hernia Mesh Concerns Grow among Men as More Patients Report Surgery Complications (12-1-2018)

https://www.abc.net.au/news/2018-12-02/hernia-mesh-concerns-grow-among-men-surgery-complications/10570182

Hernia Mesh Complications may have Affected up to 170,000 Patients, Investigation Finds (9-27-2018)

https://www.bmj.com/content/362/bmj.k4104

 

Hernia Mesh Complications Could Affect 100,000 as MPs Warn of ‘Another Scandal’, Analysis Claims (9-26-2018)

https://www.independent.co.uk/news/health/hernia-mesh-implant-vagina-pain-symptoms-wheelchair-victoria-derbyshire-surgery-a8555396.html

 

Concern Grows Over Hernia Mesh as More Patients Share Post-Surgery Horror Stories (9-14-2018)

https://www.abc.net.au/news/2018-09-14/hernia-mesh-patients-speak-out-about-horrendous-outcomes/10242004

 

Study Finds Mixed Results for Use of Mesh for Hernia Repair (10-17-2016)

https://media.jamanetwork.com/news-item/study-finds-mixed-results-for-use-of-mesh-for-hernia-repair/

 

Outcomes of Bridging Versus Mesh Augmentation in Laparoscopic Repair of Small and Medium Midline Ventral Hernias (6-10-2016)

https://link.springer.com/article/10.1007%2Fs00464-016-4984-9

Ethicon Physiomesh Flexible Composit Mesh – Hazard Alert – Higher Rate of Recurrence / Reoperation (6-9-2016)

https://www.tga.gov.au/alert/ethicon-physiomesh-flexible-composite-mesh

 

Ethicon – Urgent: Medical Device Removal – Ethicon Physiomesh Flexible Composite Mesh (5-27-2016)

http://www.hsa.gov.sg/content/dam/HSA/HPRG/Medical_Devices/Updates_and_Safety_reporting/Field_Safety_Corrective_Action/FSN/2016/May/HSA%206004101-002-16-22_35%20FSN.pdf

 

Comparison of Two Different Concepts of Mesh and Fixation Technique in Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial

(3-30-2016)

https://www.ncbi.nlm.nih.gov/pubmed/26139491

 

Preliminary Results of Surgical and Quality of Life Outcomes of Physiomesh in an International, Prospective Study (12-22-2012)

https://www.ncbi.nlm.nih.gov/pubmed/23292674

Retrospective Study on the Use of a Composite Mesh (Physiomesh) in Laparoscopic Ventral Hernia Repair (12-22-2012)

https://www.ncbi.nlm.nih.gov/pubmed/23225592

 

Ethicon Physiomesh 510(k) Approval Letter (4-9-2010)

https://www.accessdata.fda.gov/cdrh_docs/pdf9/K093932.pdf

 

Atrium C-Qur 510(k) Approval Letter (4-16-2008)

https://www.accessdata.fda.gov/cdrh_docs/pdf8/K080688.pdf

 

Inguinal hernia repair with the Kugel patch (1-2005)

https://www.ncbi.nlm.nih.gov/pubmed/15740516