Kugel Mesh Hernia Repair Medical Patches
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On December 22, 2005 the FDA issued an immediate recall of the Kugel Mesh Hernia Repair Patches and updated the list on March 31, 2006 and again updated the list on January 24, 2007. The Kugel Mesh Patch is a medical patch used to repair ventral (incisional) hernias, was recalled because the "memory recoil ring" that opens the Mesh Patch can break in the intra-abdominal (inside the belly area) space, which can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs). The patch can cause or lead to serious infection due to migration of a broken memory coil ring. A broken Coil Ring can require additional surgeries to repair a perforation caused by a broken ring and some cases can cause death.
The FDA has advised patients who received this medical device to seek medical attention immediately if abdominal pain, fever, tenderness at the implant site or other unusual symptoms occur.
The FDA has also instructed surgeons and hospitals to immediately stop using the recalled products and return the unused patches to the company.
If you or a loved one has had hernia surgery and received a Bard Composix Kugel Mesh Patch, call us at 1-800-862-1260 for more information.
The Bard Kugel Hernia Patch has received an FDA recall on December 22nd, 2005 after a documented pattern indicated that a defective "memory recoil ring" within the device is causing complications. It has now been determined that a manufacturing defect occurred where the ring could potentially lead to rupture, causing bowel perforations and / or chronic intestinal fistulae. Symptoms associated with ring breakage may include chronic abdominal pain, prolonged fever, or tenderness at the implant site. The initial recall involved devices with lot numbers containing the letter M, N, O, or P as the fourth character. A second FDA hernia patch recall was issued in March of 2006 for Kugel Oval, Large Oval and Large Circle Hernia Patches. This second recall was also related to the potential rupture of the "memory recoil ring," though this was specifically related to the size of the implant rather than the manner in which it was implanted.
The FDA suggested that hospitals immediately suspend use of all affected Bard Kugel Hernia Patches. Affected patches should be returned to Davol Inc. for examination to help determine the extent of the defect. In cooperation with the FDA recall, Davol, Inc. contacted its patients on December 27th, 2005 warning them of the possible defect and alerting them to the hernia patch recall. Patients implanted with an affected hernia device were advised to seek medical attention immediately to determine the best course of action.
IF YOU OR A LOVED ON HAS UNDERGONE SURGERY AND A KUGEL MESH PATCH WAS USE IN THE PROCEDURE - CALL OUR LAW FIRM DAY OR NIGHT AT 1-800-862-1260. THE CALL IS FREE AND THE CONSULTATION IS FREE. CALL US WE CAN HELP.