Bard Composix Kugel Mesh Hernia Rupture
The Bard Composix Kugel Mesh Hernia Repair Patch (Bard-Kugel Patch) is a medical device implanted in those patients suffering from painful hernias followed by surgical hernia repair. The mesh patch is designed to ease the recovery process associated with a hernia and allow for a quicker, more efficient surgical repair procedure. Unfortunately, the mesh patch was recalled in 2005 and 2007 after parts of the patch were rupturing inside patients, leading to painful side effects and subsequent surgeries. Patients having already received the patch are urged to closely monitor their health and report any abnormalities to their physicians right away.
The Bard-Kugel Patch remains on the market despite the FDA’s reclassification of the device to Class I, meaning its defects could render it potentially dangerous to consumers and it must be closely watched, monitored and tested. The patch is implanted through a small incision and is designed for use in an open, tension-free, preperitoneal inguinal hernia repair technique. The patch is also intended to prevent against future hernias and its memory-recoil feature is designed to ensure it does not lose its shape once implanted in patients.
The Bard-Kugel Patch has a history of defective memory recoil rings. The memory recoil rings are susceptible to breaking and causing bowel perforations and chronic intestinal fistulae. Patients suffering from these conditions will experience high fever, abdominal pain and tenderness at the implant site. Physicians having evaluated the condition believe that the Bard-Kugel Patch may rupture due to its large size in a relatively small and compact area.
As more patients reported difficulty with the Bard-Kugel Patch, the FDA issued an immediate recall in 2005 and again in 2007. In addition, the FDA has commented that no Bard-Kugel patches should be used if manufactured within that time span and all should be discarded or returned. The Bard-Kugel Patch remains on the market as an option for hernia patients but maintains its Class I status as a potentially dangerous medical device.
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