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" |
| PC#0010204 |
Bard Composix Kugel |
Large Circle |
4.5" |
Motley Rice LLC is currently investigating cases involving injuries related to Composix Kugel Mesh Patches. For more information, please contact Rhett Klok (rklok@motleyrice.com).
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Please contact us with any questions or if you'd like to explore your legal rights.
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