Specific lot numbers of the Composix® Kugel® Mesh Patches, used to repair ventral (incisional) hernias caused by thinning and stretching of scar tissue post-surgery, were recently recalled by manufacturer Davol, Inc., a subsidiary of C.R. Bard, Inc. The recall occurred after it was discovered that the "memory recoil ring," which opens the patch, can break under the stress of placement in the intra-abdominal space. This can lead to serious intestinal conditions such as bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
Affected lots were recalled between December 2005 and March 2006. In March, the FDA sent a recall letter to physicians and patients advising patients implanted with one of the recalled lot numbers to seek immediate medical attention if they experience persistent or unexplained abdominal pain, fever, tenderness at the implant site, or other related symptoms. Patients should also contact their physician, if they have not done so, for further evaluation.
This recall is product code- and lot-specific and applies to the large sized patches. The specific Product Codes and Descriptions recalled at this time are:
(Recalled December 2005 and January 2006)
PC# 0010206 Bard Composix® Kugel® Extra Large Oval 8.7" x 10.7"
PC#0010207 Bard Composix® Kugel® Extra Large Oval 10.8" x 13.7"
PC#0010208 Bard Composix® Kugel® Extra Large Oval 7.7" x 9.7"
(Recalled March, 2006)
PC#0010209 Bard Composix® Kugel® Oval 6.3" x 12.3"
PC#0010202 Bard Composix® Kugel® Large Oval 5.4" x 7"
Our firm is currently investigating cases involving injuries related to Composix® Kugel® Mesh Patches.
You may contact us at email@example.com or call 973.696.7900 or complete our on line form: http://www.gelmans.com/FrontEnd/Cases/submit_case.asp
FDA Recall Notice: Down load the PDF file to the left