Kugel Mesh Manufacturer Receives FDA Warning Letter

Rockville, MDBased on all the problems patients have experienced with the Kugel Mesh hernia patch it should come as no surprise that the maker of the patch, C.R. Bard, recently received a warning letter concerning its plant in Puerto Rico. Of course, that is the plant at which the Kugel Mesh patches are manufactured.

The letter, dated July 22, 2008, notes inspections at the plant that took place between November 20, 2007 and February 13, 2008, found numerous violations of Good Manufacturing Practice requirements. The FDA warned C.R. Bard about problems such as not ensuring their products conformed to design requirements, not identifying products with quality issues and consumer complaints about mix-ups and mislabeled products. For example, some Bard Modified Kugel Patches were labeled as medium size when they were actually small size.

The FDA notes in its letter that violations at the plant could raise questions about the safety of some of C.R. Bard's medical products. So far, there has been no indication from the FDA that the various recalls of Kugel Mesh hernia patches are related to violations found at the plant. However, that likely comes as little relief to patients who have suffered serious complications after the patches were implanted. Those complications include chronic enteric fistulae and bowel perforations.

In its letter, the FDA states:

"We have reviewed your responses [to safety issues] and have concluded that they are inadequate. Your firm has repeatedly distributed products that were mislabeled, and it seems that you do not appreciate the criticality of your mislabeling issues. This is evidenced by your failure to take appropriate action with respect to distributed products that you confirmed were mislabeled after investigating complaints that you received regarding the products. We find your lack of action highly objectionable because your mislabeled products do not have the identity that they represent to possess. We also find your medical evaluations related to these incidents are inadequate because you rely on the user to identify that the wrong device has been supplied."

Essentially, C.R. Bard left it up to the user to determine that the mesh inside the box was not the mesh advertised outside the box, rather than warning users that an error had occurred.

Furthermore, the FDA writes, "We are very concerned by your continual practice of failing to extend investigations and corrective actions to your distributed products." Finally, the FDA notes that although C.R. Bard established a threshold of 20 complaints per month, after which corrective and preventative actions should have been taken, the firm received 25 complaints about Davol Mesh products in March 2007, and 32 complaints in April 2007. However, the company did not initiate corrective and preventative actions until July 24, 2007, after the 20 complaint threshold was exceeded in June 2007. That's at least 3 months of extra surgeries that were allowed to occur because of a delay in initiating corrective actions.

Initially, C.R. Bard blamed problems with the mesh patches on improper placement techniques, essentially blaming doctors for problems with the patches. However, given the safety violations at the Puerto Rico plant and the warnings from the FDA, it is not far-fetched that the problem is with the device rather than being the fault of the surgeon. Of course, either way, the patient is the one who has to live with the complications—the pain caused by an infected mesh patch, the repeated surgeries to try to fix the problem and the possible loss of part of the intestines, where the mesh has fused with the tissue.

C.R. Bard currently faces thousands of lawsuits related to its Kugel Mesh hernia patches, alleging the company did not adequately warn patients about the risks associated with the patch.