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Hernia mesh Lawsuit, Recalls, Risks and Side Effects

Hernia Mesh Lawsuits

The following hernia mesh devices are involved in multidistrict products liability litigation:

Ethicon PHYSIOMESH Flexible Composite Hernia Mesh MDL

Federal products liability cases involving Ethicon, Inc.’s Physiomesh Flexible Composite Mesh have been consolidated as multidistrict litigation (MDL) in the Northern District of Georgia. According to the courts case summary, “This litigation involves claims that a particular hernia mesh product was allegedly defectively designed, manufactured, and labeled by Ethicon, Inc. and/or Johnson & Johnson and caused personal injuries to the plaintiffs.”

As of September 17, 2018, the Ethicon PHYSIOMESH Flexible Composite MDL included 1,430 pending cases. The MDL explicitly does not include claims relating to PHYSIOMESH Open Flexible Composite Mesh.

Atrium C-Qur Mesh MDL

Since December 2016, federal products liability cases over Atrium Medical Corp.'s C-Qur Mesh have been centralized in the District of New Hampshire under the oversight of District Court Judge Landya McCafferty. As of September 13, 2018, the MDL contained over 750 active cases, with the vast majority already having had the District of New Hampshire as their venue.

CR Bard Pelvic Repair System MDL

In October 2010, by order of the Judicial Panel on Multidistrict Litigation (JPML), federal products liability cases involving CR Bard. Inc.'s Pelvic Repair System were consolidated as multidistrict litigation (MDL) in the Southern District of West Virginia. As of September 2018, the MDL contained 15,604 total cases, of which 12,029 have been closed.

Davol / CR Bard Polypropylene Hernia Mesh

On August 2, 2018, the US Judicial Panel on Multidistrict Litigation (JPML) filed a transfer order establishing multidistrict litigation (MDL) consolidating products liability claims involving polypropylene hernia repair products manufactured by Davol, Inc. and CR Bard, Inc. The order transferred the cases to the Southern District of Ohio to be overseen by Judge Edmund A. Sargus.

The JPML’s transfer order included over 50 separate cases from over 20 different United States District Courts.

Ethicon Pelvic Repair System MDL

Since 2012, the US District Court for the Southern District of West Virginia has been overseeing multidistrict litigation (MDL) relating to Ethicon Inc.’s Pelvic Repair System. On September 13, 2018, the court entered an order establishing a qualified settlement and appointing an administrator to oversee it.

While the terms of the settlement agreement remained confidential, the court named Archer Systems, LLC as administrator of the qualified settlement fund with the money itself to be held in an account at JP Morgan Chase, which will also serve as escrow agent to the fund.

As of September 2018, the Ethicon Pelvic Repair System MDL contained a staggering 40,290 total cases, with 13,056 cases having been closed.

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Ethicon Mesh Lawsuit Update 2018: Jury Finds Negligence But Deadlocks on Connection to Injuries in Philly Ethicon Mesh Case

September 28, 2018

The jury has deadlocked in the seventh Philadelphia-based trial over alleged defects to pelvic mesh manufactured and distributed by Ethicon Inc., causing the judge to declare a mistrial, Law360 reported September 24.

The case involved plaintiff Susan McFarland, who originally sued Ethicon in July 2013 over injuries allegedly caused by its TVT-O pelvic mesh, which McFarland had implanted in 2008 to treat stress urinary incontinence. However, rather than relieve her symptoms, McFarland contends that defects in the TVT-O design have caused her permanent injuries, including the inability to have sexual intercourse with her husband.

While the jury reported to Judge Michael Erdos that it was able to reach agreement that there had been negligence on the part of the defendant Ethicon, the jurors were hopelessly deadlocked when it came to whether the Ethicon’s negligence was the cause of the plaintiff’s injuries.

According to Law360, the jury initially informed Judge Erdos of the deadlock on Friday, September 21, but the judge asked the jury to reconvene for one more day of deliberations to see if its members could agree on a verdict. On Monday, the judge finally relinquishing, dismissing the panel.

“There seems no reasonable hope that a verdict of 10 jurors or more can be reached,” Judge Erdos conceded before the court prior to addressing the jurors directly. “Everyone stood by their convictions and that’s the most we can ask of you.”

Of the six previous Philadelphia-based trials over Ethicon pelvic mesh, the juries in five have sided with the plaintiffs, resulting in over $105 million in total damages.

If you or a loved one has been injured by defective surgical mesh, hernia mesh, or pelvic mesh, contact the experienced team of attorneys at today for a free consultation with a licensed attorney!


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Hernia Mesh Device Recalls

According to the US Food and Drug Administration (FDA) the following recalls, have been issued for surgical mesh devices:

TIGR Matrix Surgical Mesh
Recalling Company: Novus Scientific

Recall Initiated: July 19, 2016
Level: Class 2
Status: Terminated December 23, 2016
Reason: Additional warning and additional contraindication
Additional contraindication: Not suitable for the repair of direct inguinal hernias
Additional warning: Because TIGR Matrix Surgical Mesh is fully resorbable, it should not be used in repairs where permanent support from the mesh is required

Ventralight Composix Mesh with Echo
Recalling Company: Davol, Inc., Subs. CR Bard, Inc.

Recall Initiated: April 24, 2014
Level: Class 2
Status: Terminated December 23, 2015
Reason: “Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.”

PROCEED Surgical Mesh
Recalling Company: Ethicon, Inc.

Recall Initiated: February 19, 2014
Level: Class 2
Status: Open
Reason: “The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.”

SeriScaffold Surgical Scaffold
Recalling Company: Allergan Medical

Recall Initiated: January 8, 2013
Level: Class 2
Status: Terminated July 29, 2013
Reason: “Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured.”

Bard Soft Mesh
Recalling Company: Davol, Inc., Sub. CR Bard, Inc.

Recall Initiated: April 25, 2011
Level: Class 2
Status: Terminated October 28, 2011
Reason: “Mislabeling: complaints of product labeled as Bard Soft Mesh 4” x 6” containing Bard Soft Mesh 6” by 6”.”

Bard Ventralex
Recalling Company: Davol, Inc., Sub. CR Bard, Inc.

Recall Initiated: April 11, 2011
Level: Class 2
Status: Terminated October 27, 2011
Reason: “Mislabeled: Bard Medium Ventralex Hernia Patch 6.4cm/2.5” packaged in pre-printed carton identified for a Bard Ventralex Small Circle 4.3cm/1.7”.”

utoSuture SURGIPRO Polyproylene Mesh Clear 3” x 5” Sterile
Recalling Company: Covidien LP

Recall Initiated: December 15, 2010
Level: Class 2
Status: Terminated January 10, 2013
Reason: “Sterility compromised due to breach in sterile barrier.”

PROCEED Surgical Mesh
Recalling Company: Ethicon, Inc.

Recall Initiated: October 18, 2010
Level: Class 2
Status: Open
Reason: “There is a potential for delamination in one lot of Proceed surgical mesh.”

Bard Mesh Pre-shaped
Recalling Company: Davol, Inc., Sub. CR Bard, Inc.

Date Initiated: October 15, 2010
Level: Class 2
Status: Terminated October 27, 2011
Reason: “Mislabeled: The labeled BARD Pre-shaped code 0112700 (1.8” x 4.0”/4.5cm x 10cm), but the contents are the BARD Mesh Large Pre-shaped product code 0113700 (2.4” x 5.4”/6.0cm x 13.7cm).”

Ventrio Hernia Patch
Recalling Company: Davol, Inc., Sub. CR Bard, Inc.

Date Initiated: April 8, 2010
Level: Class 2
Status: Terminated October 27, 2011
Reason: “Mislabeled: Product labeled as Small Oval (3.1” x. 4.7”) may contain Small Circle (3.0”).”

3D Max Mesh
Recalling Company: Davol, Inc., Sub. CR Bard, Inc.

Date Initiated: December 8, 2008
Level: Class 3
Status: Terminated May 2, 2012
Reason: “Mislabeled: Product labeled as Left large, may contain Right Large.” [sic.]

PROCEED Surgical Mesh
Recalling Company: Ethicon, Inc.

Date Initiated: January 4, 2006
Level: Class 2
Status: Terminated September 28, 2006
Reason: “Lots of Proceed Surgical Mesh may delaminate from the polypropylene mesh during certain hernia repairs. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization.”

Composix Kugel Mesh X-Large Patch
Recalling Company: Davol, Inc., Sub. CR Bard, Inc.

Date Initiated: December 22, 2005
Level: Class 1
Status: Completed
Reason: “Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula.”

Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement
Recalling Company: Synovis Surgical

Recall Initiated: May 23, 2005
Level: Class 2
Status: Terminated November 17, 2005
Reason: “Device is contained in 2 pouches. The outer pouch’s seal may be compromised; this may render the exterior of the interior pouch non-sterile.”

Recalling Company: Owens & Minor Distribution, Inc.

Recall Initiated: November 3, 2003
Level: Class 2
Status: Terminated on August 3, 2011
Reason: “Counterfeit product is unapproved medical device with associated potential health hazard.”

PROLENE Polypropylene Mesh
Recalling Company: Cardinal Health

Recall Initiated: November 3, 2003
Level: Class 2
Status: Terminated on November 18, 2008
Reason: “Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, produce code PMII.”

Recalling Company: McKesson General Medical Corporation

Recall Initiated: October 31, 2003
Level: Class 2
Status: Terminated August 4, 2011
Reason: “Counterfeit product is unapproved medical device with associated potential health hazard.”

Recalling Company: Q-Med Corporation

Recall Initiated: October 30, 2003
Level: Class 2
Status: Terminated July 11, 2012
Reason: “This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark.”

Veritas Collagen Matrix
Recalling Company: Synovis Surgical

Recall Initiated: December 11, 2002
Level: Class 2
Status: Terminated May 28, 2003
Reason: “A gap in the exterior seal may lead to sterility concerns with the interior pouch.”

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Types of hernia mesh

As with many medical devices, when it comes to surgical mesh, there are a dizzying variety of options available, each with its own potential risks and benefits. When deciding which option is best for you, it can be difficult to separate the marketing from the facts, so it is important to gather as much information as possible in making your decision.

Generally, surgical meshes can be divided into three main types based on the material out of which they are made: ePTFE, Composite, or Collagen Matrix. Below are listed some of the main examples of each type (manufacturer in parentheses).


  • • DualMesh (W.L. Gore and Associates)

  • • DualMesh Emerge (W.L. Gore and Associates)

  • • DualMesh Plus (W.L. Gore and Associates)

  • • DualMesh Plus Emerge (W.L. Gore and Associates)

  • • DualMesh with Holes (W.L. Gore and Associates)

  • • DualMesh Plus with Holes (W.L. Gore and Associates)

  • • Mycromesh (W.L. Gore and Associates)

  • • Mycromesh Plus (W.L. Gore and Associates)

  • • Soft Tissue Patch (W.L. Gore and Associates)

  • • Reconix (C.R. Bard, Inc.)

  • • Dulex (C.R. Bard, Inc.)


  • • Composix (C.R. Bard, Inc.)

  • • Composix EX (C.R. Bard, Inc.)

  • • Paritex Composite (Sofradim International)

  • • Paritene Composite (Sofradim International)

  • • Supramesh (Genzyme Corporation)

  • • Glucamesh (Brennen Medical, Inc.)

  • • Glucatex 3D (Brennan Medical, Inc.)

Collagen Matrix:

  • • Surgisis ES (Cook Surgical, Inc.)

  • • Surgisis Gold (Cook Surgical, Inc.)

  • • FortaPerm (Organogenesis Inc.)

  • • FortaGen (Organogenesis Inc.)

  • • Permacol (Tissue Science Laboratories plc)

  • • Alloderm (Lifecell, Inc.)

Risks & Side Effects associated with hernia mesh

Going back over a decade, the United States Food and Drug Administration (FDA) has been receiving reports from patients complaining about side effects they attribute to their surgically installed hernia mesh. These patients’ symptoms have included serious infections, obstruction of the bowels, severe abdominal pain, and inflammation. In some cases, patients reported these symptoms as having been so intense as to require hospitalization, and many patients have required additional surgeries to address the complications arising from the implantation of the hernia mesh device.

Infection: As with any surgical procedure—particularly those involving implanting a foreign material into the human body—the installation of surgical mesh carries with it a risk of infection, which in some cases can become quite serious, even life-threatening. The risk of infection varies from individual to individual, but those with compromised immune systems—including the elderly and those suffering from additional ailments—are at an increased risk of contracting an infection and of that infection becoming serious.

The risk of infection in recipients of a surgical mesh implant is increased due to the necessity of taking immunosuppressant drugs to prevent the body’s immune system from rejecting the newly implanted material. In particular, these drugs target the body’s production of T lymphocytes, also known as T cells, which aggressively attack the foreign material.

Obstructed Bowels: According to the University of California San Francisco (UCSF) Department of Surgery, a bowel obstruction is “a blockage of the small or large intestine by something other than fecal impaction.” Obstruction of the bowels is a serious condition that can potentially require surgery.

Obstruction of the bowels can occur following so-called “mesh migration”, which takes place when surgically implanted mesh becomes dislodged from its original location. Mesh migration results from an issue relating to the materials used to affix the surgical mesh to the living tissue, which necessarily failed prematurely if the mesh became loose within the body. Like the quest for the best possible material for surgical mesh, the search for the best method for adhering surgical mesh to living tissue continues, with human patients suffering the literal pains of this all-too-slow scientific advancement.

Inflammation: According to a recently published review on surgical meshes appearing in the scientific publication Membranes, “Inflammation is the reaction of vascularized living tissue to injury and is the primary biological reaction to implanted medical devices. In the case of implanted meshes, the inflammatory response is presented in four stages that are related temporally and hierarchically.”

These four stages of post-implantation inflammation are as follows:

Stage one inflammation: Almost instantly upon implantation, surgical mesh and other prosthetics begin absorbing proteins, which triggers a series of chemical responses that attract a variety of different cell types to the site of the foreign material. The attraction of a certain kind of cell known as a neutrophil to the site of the injury is recognized as the first step of the body’s autoimmune response and the beginning of the first stage of inflammation. During this stage, neutrophils phagocytize (basically, engulf) microorganisms, often dying in the process.

Stage two (chronic) inflammation: When the body’s immune system recognizes that its initial response has failed to eliminate the foreign body and/or return the injured tissue to its original condition, a state of chronic inflammation can result. During this stage, macrophages, plasma cells, and lymphocytes all contribute to the inflammation of the affected area.

Stage three inflammation: According to Membranes, “In most cases where chronic inflammation is related to a medical device or biomaterial, the inflammation process will lead to an immune response or foreign body reaction, corresponding to the third stage of inflammation.”

The phrase “foreign body reaction” refers to a specific and serious biological response to the presence of the implanted material that varies depending the foreign object’s contours and textures, but which typically involves a combination of foreign body giant cells, macrophages, fibroblast, and capillaries, which encompass the foreign body.

Stage four inflammation: Finally, in the fourth stage of inflammation, also known as the “wound healing phase”, damaged tissue is supplanted by specialized cells that produce “extracellular matrix materials” that, in layperson’s terms, form scars around the damaged tissue.

Side Effects of Surgical Mesh

According to the FDA, the most common complications and side effects following surgical hernia repair using implanted mesh include:

  • • Abdominal Pain

  • • Infection

  • • Hernia Recurrence

  • • Adhesion

  • • Bowel Obstruction

What is a hernia?

A hernia occurs when a portion of the small intestine, a piece of fat, or some other tissue normally contained within the abdomen bulges through a weakened portion of the lower abdominal wall, in the groin region. Inguinal hernias take place at one of the two inguinal canals, which operate—in effect—as twin passageways through the lower abdominal wall, with one on each side.

The inguinal canals are of particular importance to the functioning of the male reproductive system because they carry the spermatic cords, which include a mix of blood vessels and nerves as well as the spermatic duct, responsible for transporting sperm cells from the testicles to the penis. The inguinal canals play an important role in female reproduction, as well, holding the round ligaments that support the uterus.

Hernias can be either direct or indirect. Direct hernias occur almost exclusively in adult males and happen as a result of long-term weakness of the abdominal muscles surrounding the inguinal canal. This weakness of the abdominal muscles typically occurs due to a combination of aging, stress, and strain, with men over the age of forty at a considerably greater risk for developing a direct hernia than their younger counterparts. A history of prior hernias or previous surgeries to the lower abdominal region are significant risk factors for recurrence of a direct hernia, as both are indicative of a weakened abdominal wall. Females rarely suffer from direct hernias due to the presence of the broad ligament of the uterus, a sheet of tissue that supports the female reproductive organs and also acts as an additional layer of support for the lower abdominal wall.

Indirect hernias, by contrast, occur in both sexes (though still with greater prevalence in males) and are a result of a congenital (present-since-birth) defect in the abdominal wall. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) explains how these congenital defects to the abdominal wall initially form:

“During the development of the fetus in the womb, the lining of the abdominal cavity forms and extends into the inguinal canal. In males, the spermatic cord and testicles descend out from inside the abdomen and through the abdominal lining to the scrotum through the inguinal canal. Next, the abdominal lining usually closes off the entrance to the inguinal canal a few weeks before or after birth. In females, the ovaries do not descend out from inside the abdomen, and the abdominal lining usually closes a couple of months before birth. Sometimes the lining of the abdomen does not close as it should, leaving an opening in the abdominal wall at the upper part of the inguinal canal. Fat or part of the small intestine may slide into the inguinal canal through this opening, causing a hernia. In females, the ovaries may also slide into the inguinal canal and cause a hernia.”

According to the NIDDK, these indirect hernias are the most prevalent form of hernia, occurring in 2% to 3% of male children and less than 1% of female children. This discrepancy between the sexes holds across hernias generally, with 25% of males expected to develop some form of hernia in their lifetimes, a figure that drops to only 2% for females.

While direct hernias are much more likely to occur in men over the age of forty, indirect hernias often develop at a young age, appearing as early as before the age of 1 and most frequently in patients below the age of thirty. Infants born prematurely also are at increased risk of an indirect hernia.

The Signs of a Hernia

According to the The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the following represent the most common signs associated with a hernia:

  • • Pain, discomfort, or aching in the groin area

  • • A small bulge in the skin near where the abdomen meets the thigh

  • • Weakness and/or heaviness of the body

  • • Burning sensations in groin area

  • • In males, swelling of the scrotum

What is hernia mesh?

The idea of treating a hernia by using a prosthetic material to repair the breach in the abdominal wall goes back as far at least as the 1890s, when Theodor Billroth subjected his patients to a wide variety of materials in the course of his experimentations. Unfortunately for Billroth—but even more unfortunately for his patients—none of his many efforts succeeded, all failing on account of some combination of infection, rejection, and/or recurrence of the hernia itself.

But—what with medical history being replete with examples of hard-minded pioneers being undeterred by the oftentimes horrific failures of their forebears—the experiments continued. In the 1950s, Dr. Francis Usher took on the cause, exploring the potential for modern materials such as Nylon, Orlon, Dacron, and Teflon, but rejected each in turn. Finally, Dr. Usher came across the material known as Marlex, a recently developed polyolefin material that showed incredible potential as a surgical mesh. Dr. Usher began toiling away, racing to produce a woven surgical mesh made of Marlex, and two years later his first Marlex-based prostheses were implanted, proving to be a significant advance over previous efforts. Despite this success, Dr. Usher continued to search for new materials that could provide the basis for even more effective surgical meshes, finally arriving at a knitted polypropylene, publishing the surgical guide to its installation in 1958.

Over the intervening decades, individual researchers tinkering away in their labs have been supplanted by giant multinational medical device makers boasting massive research-and-development budgets, and though the materials may have changed, the basic concepts behind—and the recurring problems with—surgical mesh have remained largely the same. And, while surgical mesh has gained widespread acceptance as one of—if not the—preeminent techniques for hernia repair and recurrence prevention, this does not mean that surgical meshes do not continue to suffer from a number of serious risks and potential complications.

As of August 2017, there were over 70 different surgical mesh products on the market, constructed from a wide variety of synthetic materials, and even some natural ones, including animal tissues. While surgical meshes have proven effective at preventing hernia recurrence by reinforcing the weakened tissue, such has come at the cost of a number of serious potential complications such as adhesion, infection, and bowel obstruction.

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