A Class 1 recall means that the recalled device could potentially cause serious injuries, pain, and possibly even death.
The recall was announced after Davol Inc, a subsidiary of CR Bard, learned of 31 ring breaks, 20 of which involved injury to the patient. Injuries included the broken memory ring migrating through the patient's abdominal wall, bowel perforation, and bowel obstruction. One patient died after developing septic shock and acute myocardial infarction from surgery to repair damage caused by the memory ring.In announcing the recall the FDA noted that any unused units of the recalled Kugel Mesh patches should be returned to the company.
An initial recall was announced on December 27, 2005, when the Kugel Mesh manufacturer notified US customers of the problems with the devices. At that time, 32,000 units had been sold worldwide.
On March 24, 2006, the manufacturer then expanded its recall to include extra-large sizes and oval products. Surgeons were told to immediately stop using the recalled products.
If you have had a Kugel Mesh Patch implanted and notice severe pain, nausea, vomiting, fever, tenderness or a bulge at the site of the surgery, or any other unexplained symptoms, you must seek medical attention immediately.