Hernia Mesh Manufacturers

Hernia mesh manufacturers range in size from small startups to global conglomerates. A 2021 report by DelveInsight, a market research firm that supports pharma companies, valued the global hernia mesh market at approximately $4 billion. Projections expect it to grow to $5.38 billion by 2028.

A primary reason for the growth is that hernia mesh is still considered the gold standard in hernia treatment today. The mesh’s flexibility allows doctors to perform laparoscopic surgery for hernia repairs, and it’s considered generally safe. However, serious complications have been linked to these medical devices.

Plaintiffs have filed hernia mesh lawsuits across the U.S. as a result of serious injury linked to hernia mesh and alleged negligence on the part of manufacturers. Individual suits as well as multidistrict litigation name a number of the largest hernia mesh makers as defendants.

The number of cases against hernia mesh manufacturers increased so significantly, and the injury claims were similar enough, that the courts approved consolidating them into MDLs. As of mid-October 2023, the top four manufacturers have 24,820 hernia mesh lawsuits pending in MDLs.

While a 2022 study that followed 100 patients for 10 years after a ventral abdominal hernia repair found no recurrence after three years, about 10% of people experienced a hernia recurrence after about eight years. Two people had a central breakdown of the mesh near the seven-year mark.

In addition to recurrence, lawsuits claim other serious complications. These include adhesion, bleeding, bowel obstruction, infection, mesh migration and perforation.

Atrium Medical Corporation is a medical supply company based in New Hampshire. It started in 1981 and now operates in more than 60 countries. In 2011, the Getinge Group acquired Atrium, which is now part of Maquet, a subsidiary of the Getinge Group that focuses on cardiovascular surgical products.

Atrium recalled several C-Qur hernia mesh products in 2013 because of improper packaging. In all, the company issued four hernia mesh recalls that included more than 145,000 units. About 3,340 pending lawsuits name C-Qur hernia mesh products as of mid-October 2023.

Bard Davol specializes in disease management. It also makes more than a dozen hernia mesh products. Becton, Dickinson and Company acquired Bard Davol in 2017. The company now operates as a subsidiary of BD.

Bard faced more than 2,600 hernia mesh lawsuits over its Kugel patches. In 2011 the company settled the claims for $184 million.

Bard Davol is defending other lawsuits related to its polypropylene hernia mesh products. Bard recalled hernia mesh recalls several of its Kugel hernia mesh products, starting in 2005, because the devices caused perforations and other internal injuries. Bard no longer makes these mesh products.

Covidien is a medical equipment and supply manufacturer founded in Ireland in 1967. In addition to hernia mesh, it also manufactures airway and ventilation products, oximetry and monitoring products and other medical devices.

Covidien recalled Parietex Composite Parastomal Mesh in October 2018 because of a higher-than-average failure rate. It ended the recall in May 2020.

Medtronic, the first company to develop and manufacture a hernia mesh product that can be implanted without tacks, now owns Covidien. Both companies’ hernia mesh product lines remain in production.

Ethicon started manufacturing sutures and other wound closure devices in 1887. It has been a Johnson & Johnson subsidiary since 1949.

Ethicon pulled its Physiomesh Flexible Composite hernia mesh off the market in 2016, citing higher-than-expected hernia mesh failure rates. The company continues to make and market other mesh products.

Between 2005 and 2014, Ethicon recalled more than 18,000 units of Proceed hernia mesh. The company said packaging and other problems caused the mesh to lose its coating. A lack of coating could allow adhesion between the mesh and internal organs.

Ethicon and Bard Davol Funded Hernia Research

Johnson & Johnson and Bard, two of the largest hernia mesh manufacturers, funded development of new international hernia surgery guidelines in 2018. These recommendations favor the use of mesh implant procedures over tissue-only surgeries, instructing doctors to discuss hernia mesh alternatives with patients only after explaining the results of mesh surgeries.

Some surgeons who favor nonmesh or pure-tissue repair have spoken out about the mesh industry’s funding of the 2018 guidelines. Dr. Robert Bendavid of the University of Toronto and the Shouldice Hernia Hospital told Drugwatch the 2018 guidelines “virtually eliminated pure-tissue repairs.”

The 2018 guidelines were later modified. The new guidelines recommend mesh use only for patients with a high risk of incisional hernia.

Of the authors and editors of the guidelines, 50 disclosed receiving grants from Ethicon, Bard Davol or both. Additionally, 15 also received money from other companies that make hernia mesh-related devices. Other companies that funded research include Applied Medical, Cook Medical, FEG/Dynamesh, Gore Medical, Insightra, Medtronic, Olympus and Stryker.

A handful of other medical supply companies make hernia mesh products for the U.S. market. These companies may not have the market presence of companies like Ethicon and Bard Davol, but surgeons use their mesh in surgeries every day.

Among the other manufacturers are Braun Melsungen, AG (B. Braun), Gore Medical and LifeCell Corporation. Several of these companies have introduced hernia mesh innovations to the market, such as Braun Melsungen, which was the first hernia mesh manufacturer to design a single-layer, noncoated mesh to prevent adhesion.

B. Braun Melsungen AG

Searches for hernia mesh and B. Braun Melsungen AG’s line of surgical mesh products on its U.S. website currently don’t yield results. Its global website, however, lists a number of hernia mesh products as available.

The company is the 13th largest medical device manufacturer in the world. It started as a pharmacy in Melsungen, Germany, in 1839 and has offices across the globe, including a medical division in Pennsylvania.

Gore Medical

Gore Medical is a subsidiary of W.L. Gore and Associates, which makes implantable devices and membranes used in medical devices. The company is best known for its waterproof and breathable Gore-Tex fabrics but also produces Gore-Tex mesh.

Gore’s Dualmesh is the first hernia mesh with dual surface material. People have reported injuries associated with Dualmesh to the U.S. Food and Drug Administration.

LifeCell Corporation

LifeCell produces tissue repair products for reconstructive, urogynecologic and orthopedic surgeries. The FDA has received reports linking LifeCell’s Strattice hernia mesh to injuries to surgical patients.

Allergan acquired LifeCell in 2017. Allergan is a competitor in the biotech manufacturing industry.