Ethicon Physiomesh Recall Issued Amid High Revision Rates

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Irvin Jackson

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Johnson & Johnson’s Ethicon unit has removed a popular hernia repair mesh product from the market worldwide, after it was linked to a high rate of problems and revisions, and the manufacturer failed to identify what is causing the complications.

The Ethicon Physiomesh recall was issued in several countries, and announced last month in an Urgent Field Safety Notice sent to operating room managers, materials management personnel and surgical chiefs at hospitals worldwide.

While the FDA has classified the action as a “Market Withdrawal”, the manufacturer is requiring medical providers to return unexpired products and indicates that Ethicon Physiomesh Composite Mesh will not be returned to the market.

Hernia Mesh Lawsuits

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Hernia mesh lawsuits are being filed against Bard, Atrium, Covidien and several other hernia mesh manufacturers over mesh failures resulting in injuries and additional surgery.

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Is there a hernia mesh lawsuit? Find out if you qualify for a hernia mesh lawsuit settlement payout.
Is there a hernia mesh lawsuit? Find out if you qualify for a hernia mesh lawsuit settlement payout.

Hernia Mesh Lawsuits

Did you or a loved one receive a hernia mesh?

Hernia mesh lawsuits are being filed against Bard, Atrium, Covidien and several other hernia mesh manufacturers over mesh failures resulting in injuries and additional surgery.

Learn More
SEE IF YOU QUALIFY FOR COMPENSATION

The notice lists product codes for Ethicon Physiomesh Flexible Composite Mesh impacted by the recall, which was issued after an analysis of unpublished data found that the products have higher than average recurrence and reoperation rates following laparoscopic ventral hernia repair. The data came from the Herniamed German Registry and the Danish Hernia Database (DHDB).

“Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors,” the field notice warns. “Consequently, Ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ETHICON PHYSIOMESH Composite Mesh from the global market.”

The action affects the Ethicon Physiomesh Composite Mesh product line. The product codes affected include PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, PHY2030R, PHY2535V, PHY3035R, and PHY3050R. The mesh products came in square, oval and rectangle shapes. The recall does not affect the Ethicon Physiomesh Open Flexible Composite Mesh device or other Ethicon mesh products.

Ethicon is calling on its customers to examine their inventories to determine if they have affected mesh products, and to complete a Business Reply Form attached to the field notice even if they do not have the product being recalled. The company indicates that customers are required to return the recalled, unexpired Ethicon Physiomesh devices immediately. It is only reimbursing those who return unexpired mesh products by September 16, 2016.

Irvin Jackson
Written by: Irvin Jackson

Senior Legal Journalist & Contributing Editor

Irvin Jackson is a senior investigative reporter at AboutLawsuits.com with more than 30 years of experience covering mass tort litigation, environmental policy, and consumer safety. He previously served as Associate Editor at Inside the EPA and contributes original reporting on product liability lawsuits, regulatory failures, and nationwide litigation trends.

Tags: Ethicon, Hernia Mesh, Johnson & Johnson, Medical Device Recall
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2 Comments

susie
I had the hernia surgery in January 2013, by June I had developed a lump in my throat, I now have Hashimoto’s thyroiditis (an autoimmune disease.) Did the mesh cause this?
Jennifer
This product was used during my surgeries (I had 2 surgeries in September 2015) and have had daily pain since then as well as increasing nausea for the last couple of months. I found out yesterday about this recall in a letter from my surgeon. I was assured by my doctors that there would be no medical issues with this product and that it was “not like the others…”

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