Legal experts are calling out to consumers who were affected by hernia mesh infection and had to undergo revision surgery due the complications.

Hernia mesh has been used for over 50 years for hernia repair, however numerous patients have complained that certain hernia mesh products are not made well and may lead to further complications.

Recently in May 2016, Johnson & Johnson and subsidiary Ethicon Inc. issued a market withdrawal of their hernia mesh product Physiomesh Flexible Composite Mesh due to reports of high revision surgery rates.

These revision surgeries were allegedly due to hernia mesh infection, which caused numerous complications to patients with most requiring revision surgery.

The Physiomesh Flexible Composite Mesh was approved by the FDA in March 2010, through the agency’s 510(K) program. If approved by this FDA program, a medical product can enter the market much faster than the standard FDA approval process.

As long as the product demonstrates that it works at a greater or equivalent level than an already released product, the new product can then be approved. While this is standard procedure, many consumers and medical experts complain that these products are not properly evaluated when released into the market.

When the Physiomesh hernia mesh was released, the product became very popular for hernia repair soon after its release, but reports of hernia mesh infection soon followed.

Overview of Hernia Mesh Infection Complications

The overwhelming number of revision surgeries allegedly needed from hernia mesh infection complications eventually resulted in the company issuing a market withdrawal of the Physiomesh Flexible Composite Mesh.

Signs of hernia mesh infection include:

• Inflammation: While inflammation naturally occurs in hernia repair to assure the mesh stays tightly bonded in the body, the inflammation sometimes grows beyond the mesh, which can lead to infection. Hernia mesh inflammation can lead to abdominal pain.
• Healing Difficulty: Infected hernia mesh infections may prevent the incision from healing, which in turn prevents the hernia from properly healing. Hernia mesh infection can also lead to fluid build up and form a seroma, which is very painful and prevents the hernia repair from fully healing.
• Incision Site is Warm: Infections automatically generate heat, so if the infection site is warm it is likely to indicate hernia mesh infection.
• Flu Like Symptoms: Along with fever, flu like symptoms will occur soon after the hernia mesh infection.
• Dental Problems: It has been observed patients suffering from hernia mesh infection, may experience tooth decay. Patients may also experience their teeth to chip, and even fall out.

It is important to note that hernia mesh infection can potentially evolve into a biofilm, which is an organized colony of bacteria. These bacteria clusters are highly resistant to antibiotics, and often compound the patient’s condition. Due to this complication, the hernia mesh needs to be removed to prevent further complications.

The company did not specifically state the reasons behind the withdrawal or the high failure rate patients were reporting. The company suggested it could be related to a variety of factors including: hernia mesh design, the physician’s institutions, and patient selection.

Patients who have experienced Physiomesh hernia mesh infection may be able to file legal action against Ethicon Inc. for failing to warn them against potential complications. Potential claimants should contact a specialized lawyer to determine eligibility for filing a hernia mesh infection lawsuit.