The makers of the Ethicon Physiomesh face a hernia repair lawsuit filed by a man alleging that he suffered severe adverse effects following the product’s implantation.

Plaintiff Christopher C. has filed the hernia repair lawsuit in Georgia federal court, joining a growing multidistrict litigation (MDL) against the company. The hernia repair lawsuit was filed on March 30, 2018.

According to the hernia repair lawsuit, Christopher is a resident of the state of Texas. Christopher says that he was implanted with the Physiomesh on Nov. 1, 2013 at Baptist Orange Hospital located in Orange, Texas.

The hernia repair lawsuit was filed on multiple counts including defective design, failure to warn, manufacturing defect, negligence, violation of consumer protection laws, gross negligence and punitive damages, among others.

Christopher demands a trial by jury.

Overview: Hernia Repair Lawsuit

Patients who have been implanted with a Physiomesh have reported the following injuries and problems:

• Infection
• Mesh migration
• Mesh shrinkage
• Organ damage
• Nerve damage
• Recurring hernia
• Bleeding
• Pain
• Swelling and redness
• Internal scar tissue
• Mesh distortion
• Required revision surgery
• Seromas (fluid build-up)

Hernia repair lawsuits filed against Ethicon claim that the company knew about the adverse side effects and complications associated with the product but failed to provide sufficient and adequate warnings on the product’s labeling and related product material.

Hernia repair lawsuits are only increasing in number, and plaintiffs have since combined all federally-filed cases into a single MDL.

The Ethicon Physiomesh was approved by the U.S. Food and Drug Administration (FDA) on April 9, 2010. However, the device was approved through the FDA’s fast-track 510(k) approval program that grants approval for medical devices if the manufacturer can prove that the device is like one that is already on the market.

As a result, plaitniffs claim, Ethicon performed no clinical trials to demonstrate the product’s safety and efficacy.

Hernia mesh is implanted in patients to repair ventral (abdominal) hernias. It is made up of a kind of netting that is composed of polypropylene material. The product, known as a “hernia patch,” is used by surgeons to stabilize weakened muscles and tissues that surround a hernia bulge.

The hernia patch is a piece of netting composed of non-absorbable plastic filaments which become laminated between two layers of Monocryl (poliglecaprone). This material helps decrease inflammation risks and increases the healing rate.

A hernia does not usually cause problematic symptoms right away. Complications may become visible as soon as a “bulge” under the skin appears. A hernia is commonly found in the abdomen, but may also appear in other areas such as the groin.

Risk factors include overexertion, smoking, and being overweight. Added pressure, such as excess pressure during constipation, sneezing, persistent coughing and diarrhea, can all increase the risks for hernia development.

A number of studies have linked hernia mesh to serious complications, including a study published in the journal Surgical Endoscopy. After comparing patients who had been implanted with either a Physiomesh and Ventralight ST mesh, they observed a significantly higher pain rate in those implanted with the Physiomesh after three months.

The Hernia Repair Lawsuit is Case No. 1:18-cv-01371-RWS, in the U.S. District Court for the Northern District of Georgia, Atlanta Division.