Lawsuit: Ventralex Hernia Mesh Caused Severe Complications
A Florida woman is suing the makers of the Ventralex hernia mesh device, alleging that a manufacturing defect caused her to suffer serious and severe post-surgical complications.
Latoya D. filed the product liability lawsuit on Oct. 13 in federal court in the Southern District of Florida. She accuses New Jersey-based medical device maker C.R. Bard and its subsidiary, Davol, of manufacturing a hernia mesh device which carries an unreasonable risk of danger and injury.
Latoya joins plaintiffs across the country who have filed lawsuits against hernia mesh manufacturers. The most common complaints, according to the Washington D.C.-based medical watchdog organization Drug Watch, are “severe medical complications, such as persistent pain, mesh migration, and bowel obstruction or perforation.”
Drug Watch also reports that the FDA has received hundreds of reports of adverse events filed by doctors, patients and representatives of the companies that made the mesh linked with complications.
In Latoya’s case, she accuses the Ventralex hernia mesh implanted in her body during hernia repair surgery in July 2015 of obstructing her bowels almost immediately.
Her doctors ultimately learned that the device suffered a “technical failure,” resulting in a “large ventral hernia that contained multiple loops of her bowel.”
According to the suit, Latoya required a second surgery to reverse the complications as well as plastic surgery to fix her damaged abdomen. There will likely be future adverse effects caused by the Ventralex hernia mesh, the complaint continues, that will require additional treatment and surgeries to remove the hernia mesh patch.
Twice in 2011, Davol recalled the Bard Ventralex Hernia Patches due to labeling mix-ups.
On April 11, 2011, a Class 2 Device Recall was issued for a specific lot of the Hernia Patch Medium Circle with Strap, a self-expanding, non-absorbable, sterile prosthesis used in various types of hernia repairs requiring reinforcement with a non-absorbable support material.
Davol priority overnighted an urgent medical device recall letter to all affected customers, notifying them of the issue and what action to take.
Six months later, on Oct. 4, 2011, the manufacturer issued another urgent medical device recall letter for its Bard Ventralex ST Medium Circle with Strap Hernia Patch because the products had been packaged in a pre-printed carton identified for a Bard Ventralex ST Large Circle.
That recalled Ventralex hernia mesh was designed for use in “the reconstruction of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair hernias and deficiencies caused by trocars,” according to the FDA.
A Class 2 device recall, according to medical device consulting firm C3, indicates “a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems.”
In addition to Davol and Bard, Atrium Medical Corporation and Ethicon have also recalled some of their hernia mesh devices. And the FDA in 2014 issued a Safety Communication warning of adverse events tied to the medical devices.
If you’ve suffered injuries because of a defective hernia mesh, the attorneys at McDonald Worley can help you recover financial compensation to cover medical bills as well as pain and suffering. Call today for a FREE case evaluation.