Johnson & Johnson is facing a new Physiomesh lawsuit from a Georgia man, alleging serious hernia mesh complications. The Physiomesh lawsuit claims issues with the hernia mesh compounded the claimant’s medical condition, and that the product’s warning label did not contain any language indicating serious side effects.

According to the Physiomesh lawsuit, plaintiff William P. had had opted for Johnson & Johnson’s Physiomesh product for his hernia repair. William had undergone hernia repair surgery using the Physiomesh hernia mesh product after reviewing the company’s marketing materials.

Not long after his initial hernia mesh implant surgery, William reportedly experienced painful side effects and had to see his physician. William had to undergo revision surgery, which revealed that the Physiomesh product had caused a tear and a two centimeter hole.

The Physiomesh product was explanted and replaced, with William still reportedly experiencing severe abdominal pain that interferes with his daily life. William says he will continue to need follow up care, and may have to undergo additional surgeries to repair the injuries.

Overview of Physiomesh Lawsuit

William opted to file the Physiomesh lawsuit after discovering Johnson & Johnson may have known of the device’s defective nature. Johnson & Johnson recalled the Physiomesh product from the market in May 2016, due to reports of serious hernia mesh complications.

The Physiomesh lawsuit states that Johnson & Johnson describes the Physiomesh product as “sterile, low profile, flexible composite mesh designed for repair of hernias and other fascial deficiencies.” It is important to note that the Physiomesh product is held together by two undyed polygelcaprone-25 films, which is not used in any other hernia mesh products.

However this product’s coating may have been a contributing cause to the hernia mesh complications William allegedly experienced. The hernia mesh difficulties William and other patients have experienced include: debilitating pain, swelling, adhesion, obstructions, mesh migration, hernia recurrence, bacterial infections, and other serious injuries.

Hernia mesh has been on the market for over 50 years, but defective hernia mesh products can potentially cause patients more harm than good.

The Physiomesh Flexible Composite Mesh device was approved by the FDA in March 2010, which was approved through the agency’s 510(k) approval program. Under this policy a medical product can be approved to go to market without thorough preclinical studies if the product is substantially similar to another product already on the market. However this may prevent a product from undergoing a full prior to being released onto the market.

William alleges a more thorough review would have prevented an unreasonably dangerous hernia mesh product from hitting the market, which ultimately would have prevented patient injuries. In William’s Physiomesh lawsuit, he alleges the device carries unreasonable risk and that the company made no effort to notify him or his physicians.

William states that he never would have opted for the Physiomesh hernia mesh if he had been aware of the potential complications. William is filing this Physiomesh lawsuit on multiple counts of negligence and failure to warn.

This Physiomesh Lawsuit is Case No. 5:17-cv-00239-CAR, in the U.S. District Court of Middle Georgia, Macon Division.