The Bard® Crurasoft™ Hernia Patch Recoil Ring May Break and Cause Pain, Infection and Other Complications
What’s the problem?
The CruraSoft Patch is a new soft tissue repair product that features a dual-sided CruraSoft Patch with specially designed PTFE mesh on one side to reinforce soft tissue. On the other side, a ePTFE patch minimizes adhesions to the prosthesis. The CruraSoft patch is designed specifically for repair of the hiatal defect during laparo-scopic fundoplications and paraesophageal hernia procedures.
Since 2005, reports of similar hernia patch defects surfaced, posing potentially life-threatening risks to the thousands of Americans who had been implanted with the devices. According to various reports, the product, which consists of a “memory recoil ring” that opens once the patch has been inserted, can break and cause organ punctures and fistulas—abnormal passageways between intestinal organs.
In December 2005, the device maker issued a recall after it had learned of the serious product defects. Several months later, in March 2006, after 31 more ring breaks were reported—20 of which caused patient injury—the recall was expanded to include several additional products and lot numbers including the Bard large oval patches, the extra large oval patches, and the large circle patches.
Hernia mesh patch defects can lead to serious, life threatening injuries including:
- Bowl perforation
- Bowel obstruction
- Chronic intestinal fistulae
- Serious infection
In addition to patch recalls, the FDA recalled some of the company’s Salute devices and warned that Davol was in serious violation of the law and that they could take further regulatory steps without notice, including inventory seizure, injunctions preventing product sale, or monetary penalties. In all, Kugel Mesh Hernia Patches have been recalled three times by the FDA who received nearly 100 reports of problems related to the patch, several involving death.