Hernia Mesh

Background

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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.

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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.

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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.

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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.