Kugel Mesh Attorneys

Kugel Mesh Hernia Patch Finally Recalled

Many patients have suffered a great deal since getting their Kugel Mesh Hernia patch. Now both consumers and medical professionals know about this faulty implant device, but this discovery was pretty late in the game. The recall was announced by the Food and Drug Administration (FDA) at the end of the year in 2005. It was in 2002 that Davol, the manufacturer of the patch, came out with one of the largest sized patches. Not too long after, records showed that Davol was receiving complaints about the patch, but they felt that they were just too few compared to the number of patches sold. They also felt the groups of complaints were too random to show any significance. By June of 2005, Davol began to receive enough complaints to know that there is something wrong with the patch.

The Kugel Mesh hernia patch is made up of two pieces of mesh and a flexible ring. When implanted, it is bent to rest on the side of the hernia. The patch then springs back to its original shape and allows the tissue to grow onto the patch, thereby taking care of the hernia. The recall was initiated because doctors discovered that the patch was becoming dislocated or even breaking. This of course caused major medical issues for patients. Patients developed severe infections, had issues with bowel obstructions and many other severe problems.

The issue is not just that this patch was recalled, it was the lack of organization that caused such a delay for Davol to recall its product. When it comes to recalling an implanted medical device, it is vital that a recall is determined quickly and announced publicly. When the patch drew scrutiny from the FDA, officials actually visited Davol headquarters in early 2006. They found that there was a range of issues including significant holes in their complaint tracking system. Complaints about their products came in and were categorized incorrectly, just one problem that was found by the FDA.

We can be satisfied with the fact that the Kugel Mesh hernia patch was finally recalled, but we cannot forget about the patients that still have the recalled models in their bodies or the patients that suffer the effects of having the patch in their body at one time. If you have suffered any injuries from your patch implant, contact an attorney from Williams Kherkher. They will sit with you for a free consultation to assess your case and advise you on your best next legal steps.