April 3, 2006 — The US Food and Drug Administration (FDA) and Davol, Inc. have notified healthcare professionals regarding the expansion of a class 1 recall for a ventral hernia repair device to include all lots of the oval “midline” size, and lots manufactured before 2004 of the large oval and large circle 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 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. These symptoms are often taken much more lightly than they probably should be. Patients should not ignore them and listen to the doctors.
Proper testing of this device by the manufacturer would have revealed the defects with the device and saved many of these patients from multiple additional surgeries, complications and a lifetime of pain.
For further information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.