A Missouri woman who says she developed severe adhesions due to an allegedly defective Ventralex ST implant has filed a new hernia mesh lawsuit against C.R. Bard, Inc. and its Davol, Inc. subsidiary.
The Bard Ventralex ST Hernia Mesh Patch is constructed of a plastic-like material called polypropylene that has been coated with Davol’s Sepra Technology (ST), a bioresorbable, chemically modified sodium hyalurnate, carboxymethylcellulose, and polyethylene glycol-based hydrogel. The coating is designed to keep tissues from adhering to the hernia mesh before it is eventually absorbed and excreted by the body.
Like many similar devices, Ventralex ST mesh was cleared for sale via the U.S. Food & Drug Administration’s (FDA) 510 (K) program, which allowed Bard and Davol to avoid conducting human clinical trials before the implant came to market.
According to a complaint filed in the U.S. District Court, Western District of Missouri, on February 14th, Rebecca Eli was implanted with the Bard Ventralex ST Hernia Patch in October 2013 during surgery to repair an incisional hernia. (Case No. 4:18-cv-00116-HFS)
The device subsequently failed, forcing her to undergo hernia mesh revision surgery in April 2014. At that time, her doctor discovered that there was significant adhesion formation in the abdomen. Eli’s complaint asserts that her ongoing hernia mesh complications will likely require multiple additional surgeries in the future.
Among other things, Eli alleges that the ST coating prevents fluid escape, which causes seroma formation that may potentially result in infection, abscess formation and other complications.
“As a result of the defective design and/or manufacture of the ST Bard Mesh, there was an unreasonable risk of severe adverse reactions to the mesh or mesh components including: chronic pain; recurrence of hernia; foreign body response; rejection; infection; scarification; improper wound healing; excessive and chronic inflammation; allergic reaction; adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma formation; nerve damage; tumor formation; cancer; tissue damage and/or death; and other complications,” the complaint states.
C.R. Bard and Davol are among several hernia mesh manufacturers hit with product liability lawsuits in recent months.
Johnson & Johnson and its Ethicon, Inc. subsidiary are currently named defendants in more than 400 hernia mesh lawsuits, following a worldwide market withdrawal of certain Physiomesh Flexible Composite mesh implants in March 2016. The majority of those hernia mesh cases have been centralized in a multidistrict litigation now underway in the U.S. District Court, Northern District of Georgia.
A multidistrict litigation has also been established in the U.S. District Court, District of New Hampshire, for product liability claims involving Atrium Medical’s C-Qur hernia mesh implant.