Tuesday, August 20, 2019 | Updated at 2:02 PM ET

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Hernia Mesh Lawsuits Mount As Complications Continue

First Posted: Jul 26, 2019 03:19 AM EDT
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Hernia Mesh Lawsuits Mount As Complications Continue

Photo : Pixabay

Hernia mesh manufacturers face thousands of lawsuits as patients continue to face complications. Major pharmaceutical companies, including Johnson & Johnson, C.R. Bard, Gor and Atrium, have been named in the lawsuits

Plaintiffs suffer a number of complications from defective hernia mesh devices, including:

  • Bleeding

  • Abscess

  • Chronic pain or discomfort

  • Inflammation

  • Infections

  • Flu-like symptoms

  • Mesh erosion

  • Mental health issues

  • Sepsis

  • Scarring

  • Organ perforations

  • Autoimmune diseases

  • Bowel obstruction and constipation

  • Fistulas

  • Loss of teeth

Some complications may start off as minor issues, such as abdominal cramping or pain. However, they often progress into more painful and serious conditions over time, such as bowel obstruction and testicular problems. 

The Food and Drug Administration (FDA) allowed hernia mesh manufacturers to use the 510(k) clearance process to get their products to market. The fast-track program can rush products onto the market before they've been rigorously tested. 

Hernia mesh is used in more than one million hernia repairs in the United States, accounting for nearly 90% of all hernia repairs. The device is implanted in patients with weakened tissues to repair a hernia.

Hernias occur when organs burst through weak cavity walls. Hernia mesh implants have been used to repair a variety of hernias, including abdominal, femoral, hiatal, inguinal, incisional, and umbilical.

A report from the BBC estimates that between 68,000 and 170,000 patients in the UK are at risk for serious complications related to hernia mesh implants. In the U.S., more than 100,000 hernia mesh devices are implanted. 

In 2014, the FDA announced several recalls of hernia mesh devices, citing a variety of issues from poor performance to adverse events and packaging errors. Ethicon Inc., C.R. Bard and Atrium Medical Corporation were targeted in the recalls.

One of the first implants to be recalled was C.R. Bard's Kugel mesh patch. The implant was approved in the 1990s and has been implanted more than one million times. The implant, made of polypropylene, had a ring around the mesh. Over time, the ring would break down and shrink, causing it to buckle or break. When this occurred, the mesh would become exposed, and the ring could perforate the bowels or other organs. 

Many hernia mesh manufacturers are facing lawsuits over their allegedly defective implants. 

In May of 2019, a jury returned an $80 million verdict in favor of the plaintiff in a lawsuit against Johnson & Johnson's subsidiary Ethicon. That award included $30 million in compensatory damages and $50 million in punitive damages. 

Atrium is also facing several lawsuits related to their C-Qur product. This hernia mesh device was also brought to the market using the 501(k) fast-track approval program, and was approved by the FDA in 2005. Many of the lawsuits claim that the product causes allergic reactions, as the polypropylene material is coated with fish oil.

Other plaintiffs claim that C-Qur adhered to their bowels, causing them to twist or perforate. Other complaints claimed that human hair was found in the sterilized products. These claims forced the FDA to order Atrium to stop manufacturing their C-Qur device. A number of patients received the implanted device before the FDA intervened.

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