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According to allegations raised in a product liability lawsuit filed last month against C.R. Bard and it’s Davol, Inc. subsidiary, complications with Marlex hernia mesh caused a Pennsylvania woman to suffer severe and permanent injuries, resulting in the need for emergency surgery to remove the product from her body.
The complaint (PDF) was filed by Caroline Ideluca in the U.S. District Court for the Western District of Pennsylvania, indicating that Marlex Mesh used during a 2003 incisional hernia repair was defectively manufactured, defectively designed and unreasonably dangerous.
Marlex Mesh was used during Ideluca’s hernia surgery, and more than 10 years later the product caused her to develop severe abdominal pain, nausea and vomiting, requiring treatment at a hospital emergency room. In November 2015, a CT Scan revealed that Ideluca was suffering from a small bowel obstruction and incarcerated incisional hernia, requiring an exploratory laparoscopy. During the procedure, doctors noted that the Marlex Mesh was “densly adhered” to the bowel, requiring complex removal of the hernia mesh and a bowel resection.
It was not until after her hernia mesh explant surgery that Ideluca discovered there were problems with Marlex Mesh, which was recalled by the manufacturer in January 2008. However, according to allegations raised in the lawsuit, Bard and Davol were knew about the risk of Marlex Mesh complications long before that, but provided incomplete and insufficient information to Ideluca’s physicians about the safety of their product and aftercare required for patients implanted with Marlex Mesh.
“Defendants were aware of hundreds of reports from patients who had had Marlex Mesh implanted which subsequently caused complications and eventual excision of the Marlex Mesh in most instances,” Ideluca’s lawsuit states. “The Marlex Mesh manufactured by Defendants had numerous defects which created a high risk of unreasonable and dangerous injuries and side effects with severe permanent adverse health consequences.”
Hernia Mesh Litigation
Ideluca’s case joins a growing number of hernia mesh lawsuits filed in recent months design defects associated with several different widely used surgical repair products.
While problems with the Marlex Mesh was discovered more than 10 years ago, many individuals who received this product during a hernia repair remain unaware of the high risk of complications.
Other widely used hernia repair products introduced in more recent years have also been identified in recent lawsuits, including the Atrium C-Qur patch and Ethicon Physiomesh, the latter of which was removed from the market last year amid reports of hernia mesh complications.
The Atrium C-Qur, pronounced “Secure”, was approved by the FDA in March 2006, featuring a polypropylene mesh with an outer coating of gel made from 3 fatty acids. However, this design has been linked to reports of severe infections, allergic reactions and other problems.
Ethicon Physiomesh was introduced in March 2010, featuring a unique, multilayered design that was intended to improve performance. However, amid a high number of failures, an Ethicon Physiomesh recall was issued in May 2016, removing the product from the market worldwide. While the action was classified as a “market withdrawal” in the United States, the manufacturer has indicated that it will not be returning the product to the market.
Most of the current cases filed in courts nationwide involve Atrium C-Qur lawsuits or Ethicon Physiomesh lawsuits. However, new cases involving problems with Marlex Mesh and other recalled Bard hernia repair products continue to be filed as well.