FDA sends Kugel Mesh maker warning letter

On April 24, 2007 the Food and Drug Administration (FDA) sent Davol, Inc. a letter outlining five “serious regulatory problems” in its production of the Composix Kugel Mesh Patches, and handling of the subsequent recall. These patches, designed to cover and help heal hernias, were found to be defective. Tiny welds along the patch’s spring wire were failing, causing perforations and internal bleeding. This could lead to serious complications including blockages and infections requiring more surgery to correct. And, as a Class I recall, in extreme situations the defective patches could lead to death.

The warning letter was sent after an FDA investigation of Davol’s manufacturing plant in Cranston, RI between Jan. 23 and March 13, 2007.

Davol first announced a recall in December 2005, affecting its Extra Large Composix Kugel Mesh Patches produced before January 2004. However two subsequent recalls expanded the affected products to all sizes of patches, and expanded the production time to October 2006. This was the first regulatory problem that the FDA cited in the Warning Letter, noting that the initial recall should have been made to include all possible defective products right from the start.

The warning letter also noted that although this was not an “all-inclusive list of deficiencies” that the company or its products may suffer from.

“The specific violations noted in this letter… may be symptomatic of serious underlying problems in your establishment's quality system,” the FDA stated in the letter. “You are responsible for investigating and determining the causes of the violations identified by the FDA.”

Neither Davol nor its parent company C.R. Bard, Inc. responded publicly to these charges or indicated how it would correct the problems mentioned about production and safety monitoring of its Kugel Mesh patches. The FDA gave the company 15 days to reply with a description of how it corrected the mentioned problems, and what steps the company took to ensure it didn’t happen again.

If you or a loved one has suffered further injury because of a defective Kugel Mesh patch, you could be facing additional medical bills and lost wages.A Jim S. Adler & Associates personal injury attorney may be able to get you the settlement you deserve to cover all your monetary losses, and get you compensation for your pain and suffering. Contact Jim S. Adler & Associates by phone right now, or fill out the form on this page with the details of your Kugel Mesh injury for a free case review.

Kugel Hernia Mesh Patches Lawyer | Many not aware that Kugel Mesh was source of problem | Bard Composix Kugel Mesh Patch redesigned | FDA updates Kugel Mesh Hernia Patch recall |Thousands of patients affected by hernia patch recall