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 mistake and now have confirmed that six others were also implanted
with the product subsequent to the FDA’s recall.
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 discovered 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.