A consumer recently filed a hernia mesh lawsuit, alleging that the mesh product used in her surgery was defective and caused serious health problems.

Plaintiff Maria C. and her husband Carl C. recently filed a hernia mesh lawsuit against C.R. Bard Inc. and Bard Davol Inc., claiming that the mesh product used in her hernia repair was defective and caused adverse health effects.

In August 2014, Maria says she underwent surgery to repair her ventral hernia during which the defendants’ Ventralight hernia patch was used. After her surgery, Maria says she began to experience side effects as a result of the mesh used during the procedure. Her side effects included chronic pain, infections, and fissures.

In August 2016, the debilitating side effects caused her to have additional surgery to remove the mesh, the complaint alleges.

The Ventralight is one of many mesh products sold by the defendants. These mesh products are used for the surgical repair of hernias–although they may accomplish this at a price, according to the hernia mesh lawsuit. Maria claims that the design of the mesh caused her to have an adverse reaction which in turn caused her debilitating side effects.

“The Product was made of materials which are biologically incompatible with human tissue and react negatively and sometimes dangerously with a large number of those on whom it is used,” the hernia mesh lawsuit claims. “Defendant knew or should have known that their Product was unreasonably harmful.”

Scientific evidence points to the potentially dangerous nature of mesh products. In April 2016, the FDA published an article regarding hernia mesh products. According to the hernia mesh lawsuit, the FDA identified numerous common side effects associated with mesh products including “pain, infection, hernia recurrence, adhesion and bowel obstruction”. Other complications include mesh migration and mesh shrinkage.

Maria argues that the defendants knew or should have known that their products were defective but continued to sell them to turn a profit.

“Defendant negligently failed to warn or instruct the Plaintiff and/or [her] health care providers of the full extent of the risks and hazards known to exist with use of the mesh in a manner commensurate with the exercise of reasonable care,” the hernia mesh lawsuit claims.

Maria claims that the defective product was approved through the FDA’s 501(k) process, which allegedly allowed it to be released despite being defective. The 501(k) review is a fast track approval process which requires manufacturers to show that their device is similar enough to a pre-approved product to avoid clinical testing. Although this process allows devices to be approved sooner, it requires no testing of a new medical device before it is released onto the market, which opens up the possibility for defective products to be released.

As a result of the defendants’ alleged negligence, Maria says she sustained mental and physical pain and suffering, mental anguish, permanent injury, cost of medical treatment, economic loss, loss of income, and damage to her relationship with her husband Carl. The hernia mesh lawsuit seeks damages in excess of $75,000 in addition to interest, court costs, and attorneys’ fees.

The Hernia Mesh Lawsuit is Case No. 2:18-cv-13242-KM-MAH in the United States District Court for the District of New Jersey.