Virginia Hospitals Admit Implanting Defective Kugel Mesh Patch in Seven Patients
A Virginia Hospital system, Sentara, admitted this week that they implanted seven patients with the defective Kugel Mesh Hernia Patch after the FDA issued a Class I recall for the defective patches. The story broke when a Virginia Beach woman, Judith Coyne, called a local news station making a claim that the Sentara Virginia Beach General used the recalled product in her surgery. She complained that she was experiencing excruciating pain and that no one would believe her that the patch was the problem. On Tuesday the hospital admitted the error and now have confirmed that six others were also implanted with the product subsequent to the FDA's recall.
When first contacted, a Sentara spokesperson said the Kugel Mesh made by Davol Incorporated was not the same lot number as the one recalled, but late Tuesday afternoon Sentara released this statement: "Based on additional research that we conducted today...We learned that the hernia mesh patch used on Ms. Coyne was indeed part of the product recall. We regret the information we had yesterday was incorrect. We have contacted Ms. Coyne's surgeon and requested that he conduct a follow up examination and evaluation so that we can provide any assistance possible to address her pain issues."
The product was recalled six months prior to Coyne's surgery after is was discoveruddy that the memory recoil ring that allows the patch to expand after being inserted into the hernia. The defective patches have been linked to serious injuries and death. The hospital says that they will notify all of the patients that were implanted with the defective products and do all that they can to resolve the issue.
Originally posted at InjuryBoard by Scott Kappes