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A composite mesh frequently used in hernia surgery is failing in far too many patients. Physiomesh, rushed to market before undergoing standard FDA approval, is creating dangerous side effects, including complete hernia surgery revision, and even death. If you believe you have suffered due to the negligent use of Physiomesh, it is critical that you contact a hernia mesh attorney immediately.

Physiomesh manufacturer Ethicon is now being held accountable by suffering patients and their lawyers around the country. An experienced Physiomesh lawyer will be able to gather all the necessary evidence to begin mounting a strong case against the use of defective medical devices in hospitals, striving to achieve a successful outcome.

Defining Physiomesh

Physiomesh one of three types of surgical mesh used in hernia repair. This medical-grade composite mesh was designed to support and separate tissue during abdominal hernia surgery around the bowel or belly button. The Physiomesh hernia patch is made of flexible plastic fibers woven into a fabric and sandwiched between a thick polymer coating intended to prevent inflammation and adhesions.

Use During Surgery

This form of mesh is typically used in less-invasive laparoscopic surgery. During the procedure, the abdomen is inflated to apply Physiomesh over a hernia, one side against the intestines and the other tacked or sutured on the abdominal wall to secure it. The mesh patch is supposed to act as a barrier from internal organs, preventing adhesions while promoting growth into the abdominal wall for permanent repair.

Danger of Physiomesh

As the abdomen is deflated, Physiomesh changes shape and can shorten, crease, wrinkle and crack. Additionally, the polymer coating or cushion barrier can disappear within 6 to 8 months, causing the plastic-based fabric to grow directly, dangerously into the intestines, leading to dense adhesions, pain, bowel obstruction, fluid buildup and other complications.

About 50 percent of Physiomesh patients require revision surgery, which can also be risky due to the deeply intertwined mesh.

Origin of Physiomesh

Ethicon’s Physiomesh Flexible Composite Mesh has been on the U.S. market since 2010, with a 501(k) application. That means the FDA allowed it to be sold without significant safety studies because it was deemed comparable to other hernia mesh patches on the market.

Even during preclinical and animal studies, Physiomesh raised some red flags because of observed mesh shrinkage and migration, as well as adhesions, chronic body reaction, and inflammation. No full clinical trials were performed on Physiomesh prior to release.

After seeing increased side effects related to Physiomesh, supported by two studies in Europe showing higher hernia re-occurrence and revision for Physiomesh when compared to other mesh products used in laparoscopic hernia surgery, Johnson & Johnson voluntarily withdrew the product worldwide in 2016.

Contacting a Physiomesh Attorney

A hernia mesh lawyer at one of Whitley Law Firm’s offices throughout North Carolina can assist you in bringing forward a case. Attorney’s work with clients across the country to gather details and review facts to determine whether or not to proceed with a case against the manufacturer of Physiomesh, or any other recalled hernia mesh devices.

The first Physiomesh jury trial goes before a judge in Illinois later this month. There is no reason to wait. A hernia mesh attorney will perform a complimentary case evaluation to see if you may be entitled to future compensation.