Florida Woman Files Vaginal Lawsuit Due to Repeated Revision Surgeries

On November 8, 2012, a vaginal mesh lawyer filed a lawsuit on behalf of a Florida woman who claims that the vaginal mesh products manufactured by Davol, Inc. caused her serious injuries that made four corrective surgeries necessary.

Davol, Inc. is a subsidiary of C.R. Bard.

The case was originally filed in the Circuit Court of the Seventh Judicial Court, in and for Volusia County, but at the request of the defendants, the case was removed to federal court on December 17, 2012. It is now moving forward in the U.S. District Court, Middle District of Florida and has been tagged for possible transfer to the Davol MDL located in Rhode Island.

She claims to have had extensive hospitalizations as well as suffering from disability, disfigurement, loss of capacity for the enjoyment of life, and mental anguish. In addition, she expects to suffer from continued losses in the future.

Plaintiff undergoes multiple corrective surgeries following mesh implantation

The company’s website states that the Bard Ventralex Patch is used to fix small umbilical hernias. The intent of tissue ingrowth into the polypropylene mesh and deep implantation of the prosthetic is for a strong repair and reduce the possibility of recurrence of the initial problem.

The plaintiff received the Bard Ventralex Mesh Patch on March 29, 2009 and began to suffer from complications from the device. She felt pain at the surgical site and, on July 29, 2009, had the Surgipro Mesh Patch implanted. This mesh product is utilized to repair hernias. On August 14, 2009, the staples were removed in still another surgical procedure, but she continued to suffer problems. She then had another procedure on March 12, 2010 in order to remove the Bard Ventralex Mesh patch.

Still another surgery was performed in January of 2012 to remove the Surgipro mesh. On July 9, 2012, she had surgery to remove scar tissue from the surgical site.

Vaginal mesh device recalled by manufacturer

The Bard Ventralex is also known as the “Kugel Hernia Patch” and in December of 2005, Davol implemented a vaginal mesh recall of the Composix Kugel Mesh after it was found that the portion that opens the patch—the memory recall ring—could break under stress of placement in the intra-abdominal space. The recall notice was updated to include additional product codes and lot numbers between December 2005 and January 2007.

The case notes that the Bard Ventralex Mesh Patch was defective and has been recalled by the manufacturer.

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Post-marketing research shows risks of Bard Ventralex Mesh Patch

This surgical mesh device consists of two components including a polypropylene layer meant to adhere to the abdominal wall; and an expanded Polytetrafluoroethylene (ePFTE) layer that is designed to minimize tissue attachment to the patch.

In post-marketing reports, the ePFTE layer can directly lead to bowel obstruction, the formation of fistulas, and adhesions infections. A danger of causing an intense inflammatory reaction in the body was also found with the polypropylene layer. This can cause a separation and migration of the patch, shrinkage, and heavy scar formation.