A Springs City, Tenn. resident filed a new lawsuit on Oct. 30, 2018 against C.R. Bard Inc. and Bard Davol Inc. alleging Ventralight mesh complications. The alleged Ventralight mesh complications stemmed from the plaintiff’s implantation with just one of a line of hernia repair products made by and distributed by the defendants called Ventralight ST Hernia Patch.

According to the lawsuit narrative, plaintiff Tabitha R. indicates that the Ventralight ST Hernia Patch is advertised to the professional medical community and consumers alike to be very safe and reliable as a treatment for hernias and associated organ prolapse.

Despite these promoting statements, Tabitha claims the defendants were able to get the medical device pushed through the U.S. Food and Drug Administration’s (FDA) processes without showing proof of its effectiveness or safety.

The FDA has a program known as the 510(k) review which allows medical devices and drugs to shortcut the traditionally lengthy approval process if the manufacturing company can prove that the item is substantially equivalent to a product on the market with both safety studies and market history. The Ventralight ST Hernia Patch was approved for commercial distribution through this 510(k) process on May 1, 2013.

Use of this product, according to Tabitha’s legal action, is dangerous for a good percentage of people using it because of its composition using biologically incompatible materials. Tabitha alleges patients’ immune systems often react to the composition as if it were a foreign, invading body and develop Ventralight mesh complications such as infections, and obstructions of their bowel tissue.

The Ventralight mesh complications that are related to bowel blockage are often associated with adhesions. Adhesions are a type of internal gluing secondary to scar tissue development. They are not at all uncommon after abdominal surgery, but because the mesh is allegedly implanted using minimally invasive surgical techniques, adhesion development should be very limited to non-existent.

Tabitha says she was implanted with the Ventralight ST Hernia Patch for a ventral hernia in December 2016. Despite having undergone a surgery to repair and allegedly cure a problem leading to abdominal pain, the plaintiff says she experienced Ventralight mesh complications immediately after surgery that were ongoing.

She says she had mesh-induced infections and chronic pain for the weeks following implantation until undergoing a secondary surgery to have the product removed about seven weeks later.

Tabitha says she has suffered both physical and psychological pain as a result of these Ventralight mesh complications and the end is not in sight. Her injuries have been defined as permanent, according to the lawsuit, and the lost wages and burden of medical bills are expected to be felt for some time to come.

Tabitha alleges that the company had a responsibility to run all kinds of safety tests on its mesh products prior to applying to the FDA. This is a burden that, regardless of the approval method, should be considered necessary by any drug or medical device manufacturer, she argues.

The complainant is bringing seven counts against the defendants in this case. The counts include Negligence, Breach of Express and Implied Warranty, Design and Manufacturing Defect, Failure to Warn, and Violation of Consumer Protection Laws.