Davol Patch Recall

Davol Patch Recall

The Davol Patch is a medical device that has been widely used to provide internal support for a surgical hernia repair. Instances of product failure after surgical implants have led to two waves of Davol Patch recall. In December of 2005, the initial Davol Patch recall was issued for the Bard Composix Kugel Mesh X-Large Patch Oval, manufactured by Davol. In March of 2006 Davol sent notice to hospitals and surgeons that product failure had been documented for other sizes and shapes of the product and the Davol Patch recall was expanded to include those additional hernia mesh patch designs.

Also in 2006, the first lawsuit following the Davol Patch recall was filed, specifically with regard to the failure of Davol’s Kugel Mesh Patch. As with all legal action taken following the Davol Patch recall, this suit stated that the plastic ring encircling the mesh breaks and creates sharp plastic open ends which can perforate internal organs or intestines.

In January of 2007 the Davol Patch recall was extended and once again expanded to include additional products, which again were showing signs of failure in the plastic mesh ring. The component design which precipitated all of the Davol Patch recalls is this plastic ring which has sufficient flex that it can be folded, placed behind the herniated area during surgery, and then will spring back to its original shape. The ring is welded at one point to close the circle, and it is this weld that has consistently given way and created dangerous plastic points that can scar or perforate organs near the hernia.