Last Updated September 5, 2020

Right now, surgical mesh products manufactured by Johnson & Johnson subsidiary, Ethicon, as well as Atrium, and Davol/C.R. Bard are the focus of multidistrict litigation (MDL), including hernia mesh lawsuits, in federal courts in Georgia, New Hampshire, and Ohio alleging that these products were defectively designed and manufactured.  These products were all cleared by the U.S. Food and Drug Administration’s (FDA) fast-track “510(k) Clearance” process, bypassing the rigorous testing and research required of other devices prior to implantation in human beings.  The Plaintiffs in these actions seek compensation for the injuries, pain, suffering, and other losses caused by mesh products implanted in their bodies.

Historic Mesh Lawsuits and Recalls

Davol Kugel Mesh Recall and Settlement

Starting in 2005, C.R. Bard subsidiary, Davol, initiated a large-scale recall of its Composix Kugel mesh patch line following increasing reports of complications and painful revision surgeries in patients where it was used.  This was followed by a 2007 recall covering nearly 100,000 Composix Kugel mesh devices and FDA reports which suggested that the device’s memory ring had caused serious injury and even death in some patients.  Finally, the FDA was prompted to issue a Class I recall for the Composix Kugel mesh, it’s highest recall level, due to the hazards it posed to the general public.  As lawsuits naming Davol and C.R. Bard began to surface; they were eventually consolidated into an MDL in 2010.  After a jury awarded Christopher Thorpe and Laure Thorpe $1.3 million in damages and $200,000 for loss of consortium, Davol’s parent company, C.R. Bard, elected to settle approximately 2,600 lawsuits for $184 million. 

Atrium C-Qur Recall

In 2012, the FDA issued a warning to Atrium, the manufacturer of the C-Qur mesh product line as a consequence of its failure to address infection and sterility issues.  These issues stemmed in large part from the poor hygiene standards in Atrium’s manufacturing processes and environment.  Despite the warning letter from the FDA, Atrium still did nothing to remediate the problems it was having with C-Qur’s manufacturing and the FDA took the additional steps of issuing a Class II recall and filing a lawsuit naming Atrium for its poor quality control and manufacturing processes.

Ethicon/Johnson & Johnson Physiomesh Recall

After reviewing a spate of studies that pointed to higher-than-normal rates of revision surgeries and complications, Ethicon voluntarily recalled its Physiomesh products in 2016.

Current Mesh Lawsuits

Multidistrict Litigation

As of September 2020, three mesh manufacturers:

• Ethicon (Johnson & Johnson)
• Atrium Medical
• Davol (C.R. Bard)

…are embroiled in large-scale multidistrict litigation involving some 8,598 cases concerning their best-selling mesh products.  At this time, none of the cases have gone to trial.  Alongside these MDLs are pending individual lawsuits pending in state court from similar issues associated with mesh devices manufactured by Gore and Covidien (Medtronic).

Manufacturer	Products/Brands
Atrium Medical	C-Qur Mesh, C-Qur Tac Shield, C-Qur V-Patch, C-Qur Edge, C-Qur Lite Mesh V-Patch, C-Qur Edge Mesh V-Patch, C-Qur V-Patch Mesh, C-Qur OVT Mesh, C-Qur RPM Mesh, C-Qur Mosaic, C-Qur FX, C-Qur CentriFX
Davol (C.R. Bard)	Composix Kugel Mesh, Composix E/X Mesh, Composix L/P Mesh, Perfix Plug, 3DMax, Sepramesh IP Composite, Ventralex Hernia Patch, Ventralex ST Hernia Patch, Ventrio Hernia Patch, Ventrio ST Hernia Patch, Visilex, Marlex, Spermatex
Covidien (Medtronic)	Paritex Composite Mesh, Surgipro Mesh, Monofilament Mesh, Composite Mesh, Optimized Composite Mesh, ProGrip Self-Fixating Mesh, Parietex Plug and Patch System, Symbotex Composite Mesh
Gore	DualMesh, DualMesh Plus
Ethicon (Johnson & Johnson)	Physiomesh, Prolene Plug, Prolene PHS, Proceed Surgical Mesh, Prolene 3D Patch, Ultrapro Lightweight Mesh

In re: Ethicon Physiomesh Hernia Mesh (MDL-2782)

Ethicon is a business unit of the multi-billion dollar global drug and device behemoth, Johnson & Johnson.  Ethicon was tasked within Johnson & Johnson, with the development, promotion, marketing, testing, training, distribution, and sale of a range of hernia repair mesh products.  Among the devices manufactured, marketed, and sold by Ethicon is Physiomesh, a product commonly used as a tool to remediate hernias.  Physiomesh has a unique design incorporating five (5) layers: two layers of poliglecaprone-25 (“Monocryl”) film covering two underlying layers of polydioxanone film (“PDS”), which in turncoat a polypropylene mesh.  Patients who have filed claims against Ethicon allege that this multi-layer coating caused an intense inflammation in the body as well as the migration of the device to surrounding tissue.  These patients frequently were later subjected to painful and invasive revision surgeries to remove the Physiomesh and repair hernia damage.

In re: Atrium Medical Corp. C-Qur Mesh (MDL -2753)

Atrium Medical Corporation is a pharmaceutical and medical device company with its global headquarters in Merrimack, New Hampshire.  Over several years, Atrium has manufactured and marketed the C-Qur line of mesh products for hernia repair.  In 1993, Atrium began selling hernia mesh under the name ProLite and ProLite Ultra.  These polypropylene mesh devices as well as subsequent devices, culminating with the advent of the C-Qur line in 2006, were all approved for implantation through the FDA’s 510(k) “clearance” process.  Patients implanted with the C-Qur polypropylene mesh allege in court filings that the mesh is biologically incompatible with human tissue and promotes an inflammatory immune response in large populations of implantees.  Additionally, the Atrium C-Qur mesh line incorporates Omega 3 Fatty Acid Fish Oil (“O3FA”) as a barrier coating on the mesh, which patients believe also triggers a dramatic auto-immune response.  C-Qur implantees state that as a consequence of their being implanted with the device, they have experienced chronic pain and misery, as well as been subjected to painful follow-up hernia surgeries and revisions.

In re: Davol/C.R. Bard, Inc. Polypropylene Mesh (MDL-2846)

Davol is a subsidiary of global medical device manufacturer, C.R. Bard and is responsible for the marketing, development and manufacture of the Kugel Mesh and Ventralex Mesh Patch products (among others).  In litigation, patients implanted with Davol mesh devices allege that Davol knew, or should have known, that its mesh product lines were not properly tested, manufactured, inspected, packaged or labeled and that they have the potential to cause injury to implantees, such as: adhesion; bowel obstruction; migration; malfunction of the memory recoil ring; oxidation; folding over; crumpling; wadding up; hardening; separation; tearing or splitting.  Patients assert that because of these defects in the Davol mesh line, they have been subjected to intense pain and suffering from injuries as well as additional surgeries for revision and hernia repair.

Individual and State Court Mesh Lawsuits

Not all mesh lawsuits involve participation in MDL.  There are other individual cases filed in state and federal court across the United States naming other mesh manufacturers such as: Gore concerning its Gore-Tex DualMesh product; and Covidien/Medtronic over issues with the Parietex mesh.

Hernia Mesh Injury Claims

Joanne Quinn

In May 2014, Ms. Quinn was treated at a hospital in Melbourne, Florida, for the repair of an incisional hernia and was implanted with Ethicon’s Physiomesh product.  Following her implantation with Physiomesh, Ms. Quinn’s condition worsened and she suffered persistent abdominal pain and bowel obstruction issues.  Over a year later, she underwent a painful two-hour revision and removal surgery.  Due to the extensive adhesions to her abdomen and bowels, surgeons were only able to remove part of the mesh causing her pain.

Daniel Hicks

In 2012, Mr. Hicks underwent surgery to repair an umbilical hernia and was implanted with the Atrium C-Qur mesh.  In February 2015, he started to feel severe pain and a burning sensation in his abdomen accompanied with nausea and vomiting that became markedly worse after eating.  Additionally, Mr. Hicks suffered with a constant burning sensation in the area near where his mesh was implanted when he coughed or bent over.  A CT scan revealed severe inflammation in the soft tissue of his abdominal wall and Mr. Hicks underwent invasive revision surgery and bowel resection.  During the procedure, his surgeon noted that Mr. Hick’s bowel was partially disrupted due to mesh adhesion.  The mesh could only be removed following removal of a small section of Mr. Hick’s bowel.  Following surgery, his pain only worsened and he underwent a second exploratory surgical procedure which revealed necrosis in his bowel along with inflammation where the mesh had embedded.  Despite the efforts to remove the mesh surgically, Mr. Hicks continues to suffer with abdominal and back pain.

Terry Hansen

Mr. Hansen was hospitalized and underwent surgery for inguinal hernia repair in October 2013 and during the procedure was implanted a Davol PerFix Plug to affect a repair.  In 2017, he underwent surgery to remove the PerFix Plug and his doctor noticed that the mesh had become wrapped around cord structures and was sitting within the inguinal canal.  He attempted to remove all of the mesh but due to the nature of its location and attachment to surrounding tissue, was only able to remove part of the mesh implant.  Mr. Hansen continues to suffer from severe pain associated with the area where the PerFix Plug was implanted.

What Is Involved with a Hernia Mesh Lawsuit?

If you were implanted with a hernia mesh product and you are now experiencing pain and/or having to undergo invasive revision or removal surgery, you may be interested to explore your options for receiving compensation for suffering and medical expenses.  Some things to consider before going down the path to possible litigation:

Which Mesh Device Is Your Implant?

There are several mesh product manufacturers around the world.  Not all of them are associated with the same issues and complications.  Accordingly, it is very important from the outset to know which device and which manufacturer were behind your implant procedure.

Was Your Mesh Device the Subject of a Recall?

Some mesh devices have been recalled either voluntarily by the manufacturer, or by the action of the FDA.  A recall is typically an indication that a mesh device may be unsafe.

What Are the Nature of the Injuries You Have Suffered or Are Suffering?

If you are suffering with complications, pain and injuries that impact your enjoyment and quality of life, those things will be important to establish as part of any claim.  Furthermore, if you are being treated for complications or have undergone or are planning to undergo additional surgeries to address them, records of your treatment and physician recommendations will be important to assess.

When Were You Implanted and When Were Your Follow-Up Surgeries?

Hernia mesh lawsuits are subject to different statutes of limitation in each state.  These rules limit the time you have to file a lawsuit following the date when you first learned of your injuries.  It will be important for you to have records establishing the date of the original device implant procedure as well as any follow-up surgeries are undertaken to address issues stemming from your mesh implant.  Additionally, any records showing when you first learned of your mesh-related injuries will be of vital importance.

In the end, anyone suffering with a defective hernia mesh device that wishes to consider the potential for a legal claim will need to contact an experienced attorney to evaluate these issues and more before making a decision whether to proceed.  Speaking with an attorney is free and the initial consultation does not impose any obligations.