At the urging of the U.S. Food and Drug Administration, Davol Inc. expanded its voluntary recall of specific lots of Bard Composix Kugel Large Oval and Large Circle Patches in January 2007. The patches, which have been used in a number of hernia repair surgeries, have been known to cause serious complications in patients.
The patches were designed to repair ventral (incisional) hernias that occur when post-surgery scar tissue is stretched. After the hernia operation, the patch is held open by a ?memory recoil ring? that allows the patch to be folded so it can be inserted through a small incision behind the affected area. Once in place, that memory ring allows the patch to spring open and lay flat.
However, the patches were recalled because certain lot numbers with the recoil ring would break under the stress of placement, which could lead to tears in the bowel or cause problems with the intestines and other organs. Problems reported by Davol include:
- Broken ring migrated into or through abdominal wall with associated infection
- Ring migration into vagina
- Bowel perforation
- Bowel obstruction
- Death from septic shock
- Consumptive coagulopathy and acute myocardial infarction
This latest recall expands on two previous recalls of similar defective medical devices: In December 2005 and January 2006, the Extra Large Patches were recalled, and in March 2006 the Large Patches were recalled.
The latest recall demands that use of the Large Oval and Large Circle be immediately discontinued because they have the same component design as the previously recalled patches. The FDA notice lists the following product codes that were to be immediately withdrawn from the market:
- Product Code: 0010202, Bard® Composix® Kugel® Large Oval, 5.4″ x 7.0″
- Product Code: 0010204, Bard® Composix® Kugel® Large Circle, 4.5″
Anyone who has had hernia surgery since 2005 may be at risk of serious physical injury or death. The FDA has advised patients who have received this device to seek medical attention immediately if abdominal pain, fever, tenderness at the implant site or other unusual symptoms occur. The FDA also has instructed surgeons and hospitals to immediately stop using the recalled products and return the unused patches to the company.
The law firm of Hardison & Cochran is representing patients and families who have been harmed by Bard Composix Kugel Mesh patches.
Contact our Raleigh defective medical device attorneys to learn about your legal rights and options in bringing a product liability lawsuit for the injuries you sustained as a result of using this hernia patch.