Johnson & Johnson’s Ethicon subsidiary has recently issued a worldwide market withdrawal of its hernia mesh medical device after injury reports indicate a high rate of severe side effects and need for revision surgery.

According to the company, it is unknown why Ethicon hernia mesh is susceptible to device failure. The company believes the problem may be linked to “patient factors” and how doctors may be implanting the hernia mesh products. The Ethicon hernia mesh market withdrawal was announced recently in May 2016, and was sent to doctors and hospitals across the planet.

With the FDA classifying the Ethicon hernia mesh as a “market withdrawal,” Johnson & Johnson is requiring doctors and hospitals to return unexpired hernia mesh products for a refund. The Ethicon hernia mesh products affected by the market withdrawal includes the Ethicon Physiomesh Composite Mesh product line:

• PHY0715R
• PHY1015V
• PHY1515Q
• PHY1520R
• PHY1520V
• PHY2025V
• PHY2030R
• PHY2535V
• PHY3035R
• PHY3050R

It is important to note that the Ethicon hernia mesh market withdrawal does not apply to the Ethicon Physiomesh Open Flexible Composite Mesh or other Ethicon mesh products.

Overview of Ethicon Hernia Mesh Problems

Ethicon hernia mesh is a plastic or polypropylene mesh material which can be used for abdominal and groin hernia repair.

It is important to note that Ethicon hernia mesh is made from the same material as the company’s transvaginal mesh products, which have also been linked to numerous complications. However, Ethicon added an absorbent film coating to each side of the hernia mesh, which was meant to lower chances of mesh complications.

The Ethicon hernia mesh market withdrawal was issued after German and Danish registries found high rates of device failure. The data came from the Herniamed German Registry and Danish Hernia Database, which found high rates of recurrence and revision surgery soon after the patients had the devices implanted.

According to the FDA public warning, “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. Consequently, Ethicon have [sic] 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.”

Hernia mesh has been on the market for over 50 years, but the concern of hernia mesh has become widespread throughout the United States. Patients who received Ethicon hernia mesh should be aware of any potential complications, along with symptoms indicating mesh infection including:

• Inflammation
• Pain in groin or abdominal area
• Flu-like symptoms (especially nausea and vomiting)

Patients who experience problems with Ethicon hernia mesh may be able to file legal action against the manufacturing company. Potential claimants should contact an experienced medical device lawyer to determine eligibility for a hernia mesh lawsuit.