Abdominal wall hernias often require surgical correction. A surgeon can typically repair a hernia using surgical mesh. Many of the synthetic hernia mesh products marketed since the year 2005 to the present were rushed to the market using the FDA’s 510k clearance process and were manufactured and marketed with little to no studies as to the safety of the device. Typical problems of hernia mesh inside the body are shrinkage of the mesh and infection, organ damage, obstructions, hernia recurrence, any of which could require a hernia revision surgery.
A 2016 review estimated that doctors performed 20 million hernia surgeries worldwide every year. It found that hernia repairs created a $48 billion revenue stream in the U.S. alone. About 9 out of every 10 of U.S. hernia repairs use hernia mesh.
About Hernia Mesh Litigation
- The latest research shows that roughly one million hernia repair surgeries are performed each year in the United States
- Hernia mesh is made from synthetic material, like polypropylene, and is used in abdominal surgical procedures to provide stabilization to the repaired area. This type of mesh product is used in around 90% of the cases.
- Hernia mesh plaintiffs commonly suffer from bleeding, sepsis, scarring, mesh erosion, infection, chronic pain, perforation, bowel obstruction and a variety of other health complications.
- C.R. Bard is one of the largest hernia mesh manufacturers in the U.S. Davol, Inc. is a division within Bard that produces hernia mesh and certain other medical devices. Bard / Davol hernia mesh brands are among the most widely-used products of their kind.
- Complications from the mesh include adhesion (mesh sticking to internal organs), inflammatory and allergic responses, mesh rejection, and mesh migration (i.e. mesh moved in body).
- The current Bard MDL (Multidistrict Litigation) has 12 bellwether cases—-six chosen by plaintiffs and six chosen by the defendants. But as discovery moves forward the bellwether pool will shrink to six cases.
- No one can say what the expected total settlement offer will look like. In 2010, C.R. Bard agreed to pay $184 million, with an average hernia mesh settlement value of $92K. That said, commentators seem to think an offer for the current MDL cases will be higher because hernia mesh plaintiffs who have recently tried their cases have done well:
In September 2017, a Philadelphia jury awarded $57.1 million to a woman who suffered chronic pain and incontinence due to erosion of her Ethicon pelvic mesh implant, requiring three surgeries to remove.
In March 2018, a couple in Indiana sued Ethicon (a J&J brand), and the jury awarded $10 million in physical damages and $25 million in punitive.
- If no settlement is reached, the plaintiffs may have their case transferred back to their home state to be worked up for trial (the Lexecon right after Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998)).
Hernia Mesh Manufacturers
Hernia mesh manufacturers produce more than 70 different brands of mesh. A handful of companies dominate the U.S. market. Hernia mesh is part of a $48 billion industry that drives other medical device sales per the FDA and DrugWatch. Hernia mesh manufacturers range from giant, well-established companies to small start-ups. Mesh manufacturers use different materials in different products. These materials can provide different benefits. But they can also present different risks.
A 2017 study identified more than 70 different types of hernia mesh on the market. While there is a long list of companies that produce hernia mesh, a handful of them dominate the U.S. market.
Major Manufacturers Producing Hernia Mesh Include:
- Atrium Medical
- B. Braun Melsungen, AG
- C.R. Bard
- Gore Medical
- LifeCell Corporation
Atrium Medical Corporation
The C-QUR product line may be Atrium’s best known hernia mesh. A fish oil-derived coating covers the plastic mesh. The coating creates a barrier to prevent adhesions. A patient’s body absorbs the coating over time. Atrium Medical Hernia Mesh Brands
- Prolite Ultra
Atrium recalled several C-QUR hernia mesh products in 2013 due to improper packaging. The recall included more than 145,000 units. Atrium manufactures and distributes products to over 60 countries. The company has home offices in New Hampshire. It also has offices in The Netherlands, Australia and Germany.
Bard Medical specializes in disease management. It makes several different types of hernia mesh including Composix Kugel meshes. Bard recalled several of its Kugel hernia mesh products starting in 2005. The devices caused perforations and other internal injuries. Bard faced more than 2,600 lawsuits over its Kugel patches. It settled them for $184 million in 2011.
Bard Hernia Mesh Brands
- AlloMaxBard Soft Mesh
- Bard Mesh Sheets
- MK Patch
- PerFix Plug
- Phasix Mesh
- Sepramesh IP Composite
- XenMatrix Surgical Graft
B. Braun Melsungen, AG
Braun is a German company with U.S. offices in Pennsylvania. The company designed Omyra hernia mesh to prevent adhesion. It is the first single-layer, non-coated mesh of its kind. Braun is the 13th largest medical device manufacturer in the world. The company began as a pharmacy in Melsungen, Germany, in 1839.
Braun Hernia Mesh Brands
Ethicon pulled its Physiomesh Flexible Composite hernia mesh off the market in 2016. The company cited higher than expected failure rates for the market withdrawal. It continued to manufacture other Physiomesh products. Ethicon has recalled more than 18,000 units of its Proceed hernia mesh since 2005. The company said packaging or other problems caused the mesh to lose its coating. This could allow adhesions between the mesh and internal organs. Ethicon began manufacturing sutures and other wound closure devices in 1887. It has been a Johnson & Johnson subsidiary since 1949. Johnson & Johnson is the world’s largest medical products company.
Ethicon Hernia Mesh Brands
- FlexHD Structural
- Ultrapure Advanced
- XCM Biologic
Gore Medical manufactures implantable devices and membranes used in medical devices. Gore’s Dual mesh is the first hernia mesh with dual surface material. People have reported injuries associated with Dual mesh to the U.S. Food and Drug Administration. Gore Medical is a subsidiary of W.L. Gore and Associates based in New Jersey. The parent company specializes in synthetic fiber products. It is best known for its waterproof and breathable Gore-Tex fabrics. Gore Medical even manufactures a Gore-Tex line of mesh.
Gore Medical Hernia Mesh Brands
- Gore-Tex Soft Tissue Patch
LifeCell is an Allergan subsidiary based in New Jersey. It manufactures tissue repair products for reconstructive, urogynecologic and orthopedic surgeries. Allergan acquired the company in 2017 for $2.9 billion. LifeCell manufactures biologic mesh including Alloderm and Strattice hernia meshes. Strattice’s design allows fluid to flow through the mesh after implantation. The FDA has received reports blaming Strattice for patient injuries.
LifeCell Hernia Mesh Brands
- Alloderm Select
Medtronic manufactures a handful of different meshes for hernia repair. It developed ProGrip Self-Fixating Mesh for minimally-invasive surgery. The mesh does not need tacks to hold it in place. Medtronic’s headquarters are in Dublin, Ireland, and Fridley, Minnesota. It started as a medical equipment repair shop in 1949. Medtronic’s big breakthrough came when it developed a wearable, battery-powered pacemaker. Today, Medtronic has nearly 400 facilities and offices in 160 countries.
Medtronic Hernia Mesh Brands
The foregoing information can be found from the FDA and DrugWatch.