|
Bard expands Kugel hernia patch recall |
|
Friday, 24 March 2006 |
|
C.R. Bard, Inc. and the FDA have announced an expansion of the hernia patch recall first issued in December 2005.
The expanded recall covers all lot numbers of the extra large and oval models of the Composix Kugel mesh patch, as well as some lot numbers of the large oval and large circle versions of the patch. The decision to expand the earlier hernia patch recall was made after Davol, Inc., a subsidiary of Bard, learned of several additional cases of breaks in the “memory-recoil ring” which surrounds the Kugel hernia patch. These broken patches have led to complications in some patients, including cases of bowel perforation, bowel obstruction, chronic enteric fistulas and at least one death. As part of the hernia patch recall, Bard has sent a letter to distributors of the Kugel mesh patch alerting them to the specific patch models which have been recalled and warning them of the risk of injury faced by patients who receive the device. An additional letter has been sent to doctors directing them to stop implanting the devices involved in the hernia patch recall and return them to the company.
The first hernia patch recall was issued in December 2005 and later expanded in January 2006 to cover additional versions of the Kugel mesh hernia patch. Initially, Davol had believed that the broken memory-recoil rings were caused by doctor error and not defects in the patch itself. However, when tests conducted by the company in December 2005 revealed a manufacturing defect in the larger models of the Kugel mesh patch, it was forced to issue the first hernia patch recall.
The FDA has advised patients who received one of the recalled hernia patches to seek medical attention immediately if they experience abdominal pain, fever or tenderness in the area where the patch was implanted. The agency said that these symptoms could indicate a break in the hernia patch and could lead to serious injury or death if left untreated. |