Composix Mesh Hernia Patch Recall - Frequently Asked Questions
Who is Affected By the Bard Composix Mesh Patch Recall?
Those who have had surgery in the last few years may be at risk for serious complications if the Bard Composix Kugel Mesh Patch was used in their operation. The patch initially was recalled on December 22, 2005, but the recall was expanded on January 24, 2007 to include additional product codes and lot numbers.
What is the Bard Composix Mesh Patch?
The Bard Composix Kugel Mesh Patch is used in the repair of ventral (incisional) hernias that are caused by the thinning or stretching of scar tissue that is a result of surgery. The patch is put into place behind the hernia through a small incision and then held open by a "memory recoil ring" that causes the patch to stay folded while it is inserted but then allows the patch to open fully once inserted.
Why Is the Bard Composix Mesh Patch Bring Recalled?
The "memory recoil ring" used in the Bard Composix Mesh Patch can break if placed under too much stress in the intra-abdominal space. Breakage can cause bowel perforations and/or chronic intestinal fistulae.
What Products have been recalled?
Products recalled include: the Bard Composix Kugel Extra Large Oval 8.7" x 10.7", product code 0010206; the Bard Composix Kugel Extra Large Oval 10.8" x 13.7", product code 0010207; the Bard Composix Kugel Extra Large Oval 7.7" x 9.7", product code 0010208; the Bard Composix Kugel Oval 6.3" x 12.3", product code 0010209; the Bard Composix Kugel Large Oval 5.4" x 7.0", product code 0010202; the Bard Composix Kugel Large Circle 4.5", product code 0010204.
Who Should Those Affected by the Recall Contact?
Those who have had a recalled patch implanted should contact a doctor if they experience symptoms that might be a result of ring breakage. Such symptoms include unexplained or persistent abdominal pain, fever, sensitivity at the implant site, or anything else that could be abnormal.
Are These Patches Still Being Used?
Davol, Inc., a subsidiary of C.R. Bard, sent notices to health care professionals and distributors saying that the most recent recall of Bard Composix Kugel Large Oval and Large Circle Patches had been extended to product codes 0010202 and 0010204 on January 10, 2007. Hospitals were advised to return unused product to the company and surgeons were instructed not to use the patches. Davol also has withdraw lots manufactured between October 2005 and October 2006 with lot numbers between 0010202 and 0010204.
Who Can Be Contacted for More Information?
Customers can contact Davol Customer Service at 1-800-531-4124. Physicians can reach Bard's Medical Services and Support Department at 1-800-562-0027 or speak with the Bard Medical Director at 1-908-277-8306.