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A California woman indicates that she has been left with painful problems after hernia repair, due to complications associated with the failure of both an Ethicon Proceed and Bart Ventrio patch.
The complaint (PDF) was filed by Frances Ramirez in the U.S. District Court for the District of Rhode Island on April 1, indicating that the manufacturers Davol, Inc., C.R. Bard, Inc., Johnson & Johnson, and it’s Ethicon subsidiary sold defective hernia mesh products, which pose an unreasonable risk of harm to the body.
Ramirez indicates that she underwent an incisional hernia repair procedure in September 2009, at which time an Ethicon Proceed hernia mesh product was implanted. However, less than a year later, she had to undergo an additional surgery, during which the surgeon had a difficult time even locating the mesh due to a large amount of granulated tissue which had developed around the mesh.
As a result of granulated tissue, bowel adhesions and other issues, Ramirez required a number of additional surgeries. In August 2011, she again had procedure due to a recurrent hernia, at which time she was implanted with a Bard Ventrio, and the Ethicon Proceed patch was removed at that time. However, in July 2014, she underwent a hysterectomy, at which time the surgeon discovered an extensive enterolysis of small bowel from the Bard Ventrio mesh, and she again had to have the hernia mesh removed in April 2016.
The lawsuit indicates that neither Ramirez nor her surgeons were aware of the hernia mesh problems associated with both of the products.
“Defendants marketed the Mesh Products to the medical community and to patients as safe, effective, reliable, medical devices for the treatment of hernia repair, and as safer and more effective as compared to the traditional products and procedures for treatment, and other competing mesh products,” the lawsuit states. “Defendants did not undergo pre-market approval for the Mesh Products and are, therefore, prohibited by the FDA from asserting superiority claims.”
The case joins a growing number of similar Ethicon hernia mesh lawsuits pending in courts nationwide, most of which involve problems with the previously recalled Physiomesh product, which is another multi-layer polypropylene hernia patch that was removed from the market after it was linked to reports of problems.
The lawsuit also joins hundreds of other Bard hernia mesh lawsuits, each involving similar allegations that plaintiffs experienced painful complications that were caused by design defects associated with Bard Ventrio, Bard Ventralex, Bard Perfix, Bard Composix and other polypropylene products sold in recent years.
Given similar questions of fact and law raised in the complaints, all federal Bard hernia mesh claims have been centralized before U.S. District Judge Edmund A. Sargus in the Southern District of Ohio, for coordinated discovery and pretrial proceedings as part of an MDL, or multidistrict litigation, which will include a series of three “bellwether” trials that are expected to being next year to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the cases.