Composix / Ventralex Kugel Mesh Patch
California Composix Kugel Mesh Patch Recall Attorney » Recall Law Firm » Pharmaceutical Injury
The Composix Kugel Mesh Patches, used to repair ventral (incisional) hernias caused by thinning and stretching of scar tissue post-surgery, have recently been recalled by the manufacturer Davol, Inc., a subsidiary of C.R. Bard, Inc. The recall began after it was found that the "memory recoil ring," which opens the patch, can break under stress due to its 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). Specific lot numbers were recalled.
The recalled lots were between December 2005 and March 2006.
In March 2006, the FDA sent a recall letter to physicians and patients to advise patients that if they had been 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 such problems.
This recall is product code- and lot-specific and applies to large sized patches. The specific Product Codes and Descriptions recalled are:
- (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"
- (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"
The Law Offices of Nadrich & Cohen, are currently investigating cases involving injuries due to the Composix Kugel Mesh Patches. If you or a loved one was injured due to the Patch contact us immediately to discuss your case with an experienced pharmaceutical litigation attorney.