A plaintiff, Debra W., recently filed a Physiomesh complications lawsuit in Georgia federal court against the manufacturers Ethicon Inc., and Johnson & Johnson company.

According to the Physiomesh complications lawsuit, Debra is a resident and citizen of the state of Arizona. She was implanted with the Physiomesh in August 2011. After she was implanted with the device, Debra alleges that she later had to be hospitalized at St. Joseph’s Hospital and Medical Center, located in Phoenix, Ariz. due to serious Physiomesh complications.

The defendants face the following counts brought forth by the plaintiff: 1) Strict Product Liability- Defective Design; 2) Strict Product Liability- Failure to Warn; 3) Strict Product Liability- Manufacturing Defect; 4) Negligence; 5) Gross Negligence; 6) Punitive Damages; 7) Discovery Rule, Equitable Tolling/Estoppel.  The Physiomesh complications lawsuit alleges that the “Defendants impliedly warranted their product to be of merchantable quality, safe, and fit for its intended use.”

Physiomesh Devices

The U.S. Food and Drug Administration (FDA) approved Ethicon’s Physiomesh hernia repair mesh in March 2010. The Physiomesh device is also known as the Physiomesh Flexible Composite Mesh. Ethicon marketed the Physiomesh device as “sterile, low profile, flexible composite mesh designed for repair of hernias and other fascial deficiencies.”

The FDA approval for Ethicon’s Physiomesh went through a fast-track process, known as the 510(k) process which grants companies such as Ethicon a faster approval if they can illustrate that their product is similar to a product that is already on the market. This fast-track process does not require new products to undergo full testing and research requirements. The product quickly gained popularity once it received FDA approval.

Unfortunately, there are many serious adverse side effects and complications associated with Ethicon’s Physiomesh. These adverse side effects and complications include chronic pain, hernia recurrence, rejection of the mesh, infection, device migration, scarring, inflammation, organ adhesion, erosion, tissue and nerve damage, and death.

Once the mesh was on the market, medical professionals began to notice a high failure rate associated with Physiomesh devices.  In May 2016, Ethicon decided to withdraw its Physiomesh product from the market.  Ethicon blamed the high failure rate on a variety of potential factors.  Some of these factors included patient selection and medical professional’s instructions.

Filing a Physiomesh Complications Lawsuit

Physiomesh complications lawsuits allege that the manufacturer, Ethicon, failed to sufficiently and adequately test their product for adverse effects and complications. Plaintiffs assert that the company failed to warn consumers of the adverse effects that are associated with the product.

It has also been alleged in various Physiomesh complications complaints that the company placed profit and revenue over consumer and patient safety.  Plaintiffs who file Physiomesh lawsuits often seek to recover compensation for past and future medical bills.  They may also be compensated for the pain and suffering they experienced due to adverse side effects from the medical device.

The Physiomesh Complications Lawsuit is Case No. 1:17-cv-04081-RWS, in the U.S. District Court for the Northern District of Georgia, Atlanta Division.