Recalled Bard Composix Kugel Mesh Hernia Patch Given to Patients at Virginia Hospitals
June 5, 2008
Seven patients at two Virginia hospitals were mistakenly implanted with recalled Bard Composix Kugel Mesh Hernia Patches during the first half of 2007. The accidental implants occurred at Sentara Virginia Beach General Hospital and Sentara Leigh Hospital, both of which are owned by Sentara Health Systems.
Judith Coyne, one of the patients who received a defective Kugel Mesh Hernia Patch, says she has been in excruciating pain since her hernia surgery and fears her life may be in danger. Although the recalled hernia patch inside her could be life-threatening, doctors to remove it. Doctors say that the mesh is stuck to Judith’s organs and that removing it could kill her.
When it was first introduced in 1997, the Kugel Mesh Hernia Patch revolutionized hernia repair surgery. By 2005, however, the FDA was receiving more and more complaints about the Kugel Mesh Hernia Patch. The complaints were so alarming that in December 2005, the FDA issued a Class I recall of the X-Large Bard Composix Kugel Mesh Hernia Patch. As it turns out, the plastic recoil ring that opens the patch could break inside the body, causing bowel perforations, bowel obstruction, internal bleeding, or even death.
In March 2006, the Kugel Mesh Hernia Patch Recall was expanded to include additional lot numbers and sizes, and in January 2007, the recall was expanded again. Apparently, patients at the Virginia hospitals were implanted with Kugel Mesh Hernia Patches recalled in January 2007. Doctors believe that the recalled hernia patches were inadvertently used because the recall occurred in stages, making it confusing. Sentara Health Systems was unaware that recalled Kugel Mesh Hernia Patches were being used at its hospitals until Judith Coyne told her story to WAVY News 10, a Virginia news station. By using the product code and lot number, Judith Coyne had determined that she was implanted with a recalled hernia patch in June 2007, six months after the final Kugel Mesh Hernia Patch recall was issued.
Sentara is in the process of notifying all of the patients who received the recalled Kugel Mesh Hernia Patch. Anyone with questions can call the health system at 1-800-SENTARA, weeknights until 11:30 p.m. Also, anyone who has suffered injuries related to a Kugel Mesh Hernia Patch, even if the patch has not been recalled, should contact us today for a free and confidential case review.