Unsafe Drugs: Hernia Mesh Patch Recall

The Food and Drug Administration announced that it has upgraded the recall of the Bard Composix Kugel Mesh Hernia Patch to "class 1" because the patches can cause death or serious health problems. Patients using the device should seek medical attention if they have symptoms such as unexplained or persistent abdominal pain, fever, tenderness at the implant site, or other unexplained side effects. Patients who underwent surgery that used mesh patches are advised to contact their hernia surgeons or the hospital where their hernia surgery took place to find out if the Composix Hernia patch was used in their surgery.

Hernia Mesh Patch Recall - FDA Warns of Death and Serious Health Problems

The Composix Kugel Mesh Patch is used to repair ventral hernias caused by thinning or stretching of scar tissue that occurs after surgery. The patch is held open by a "memory recoil ring" that allows the patch to be folded for insertion and it then will later open and lay flat once surgery is completed. Johnson Law Firm Attorney Steven Johnson said of the patch: "Adequate testing of this device by the manufacturer would have revealed the defects with the device and saved many of these patients from multiple additional surgeries, complications and a lifetime of pain."