A Class 1 Recall for a Ventral Hernia Repair Device
Bard Composix Kugel Mesh Patches recalled. The US Food and Drug Administration (FDA) and Davol, Inc (a subsidiary of C.R. Bard, Inc), have notified healthcare professionals regarding the expansion of a class 1 recall for a ventral hernia repair device (Bard Composix Kugel Mesh Patch) to include all lots of the oval “midline” size (product code 0010209), and lots manufactured before 2004 of the large oval (0010202) and large circle (0010204) products. The recall previously affected only the extra-large oval patch.
The recall is due to the potential for breakage of the “memory recoil ring” under the stress of placement into the intraabdominal space, leading to bowel perforation and/or chronic enteric fistulae, according to an alert sent yesterday from MedWatch, the FDA’s safety information and adverse event reporting program.
Surgeons and hospitals are advised to cease using the products with codes and lots affected by the recall and to return unused units to the company.
Patients who have received one of the recalled devices should seek immediate medical attention if they experience symptoms such as unexplained or persistent abdominal pain, fever, tenderness at the implant site, or other unusual symptoms potentially related to ring breakage.
Repair of ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery
Further information for customers is available by contacting the company by phone at 1-800-FOR-BARD (1-800-367-2273) or by e-mail to bard.helpline@crbard.com. Physicians may contact the company’s medical services and support division by phone at 1-800-227-3357 or e-mail to medical.services@crbard.com. Additional information regarding patient management is also available online at http://www.davol.com/HTMLFiles/hernia/recall.htm.
The device is indicated for the repair of ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The “memory recoil ring” allows it to spring open and lie flat behind the defect after having been folded for insertion through a small incision.
Healthcare professionals are encouraged to report adverse events related to use of the ventral hernia repair patches to the FDA’s MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
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