Kugel Hernia Patch Manufacturer Cited for Violations at Puerto Rico Plant

The FDA released a warning letter yesterday that was sent to C.R. Bard, Inc. regarding “adulterated” medical products manufactured at their plant in Puerto Rico, which is where the company manufactures the Kugel Hernia Patch mesh that has been the subject of thousands of lawsuits in the United States.

Inspections at the plant between November 20, 2007 and February 13, 2008, revealed a number of violations of Good Manufacturing Practice requirements of federal regulations.

The company was warned about a number of problems, such as failing to make sure that products made conform to their design requirements, failing to identify products with quality issues and other violations which could raise questions about the safety of medical products made at the plant.

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The FDA letter, which was dated July 22, 2008, also indicates that C.R. Bard received a number of consumer complaints during 2006 and 2007 involving mix-ups and mislabeled products. In one case, the FDA states that Bard sold “Bard Modified Kugel Patch” products labeled both on the box and the sterilized pack as medium, even though they were the small size.

“We are very concerned by your continual practice of failing to extend investigations and corrective actions to your distributed products,” wrote Maridalia Torres, the FDA San Juan District Director in the letter sent to John Weiland, the President and CEO of C.R. Bard, Inc.

C.R. Bard has issued three separate Kugel Hernia Patch recalls since 2005, even though there is no indication that the violations cited in the warning letter have anything to do with the design defects that prompted the recalls.

Bard also faces over 2,000 Kugel Hernia Patch lawsuits filed by patients who suffered serious internal injuries after hernia surgery, such as bowel perforations, chronic intestinal fistula and death.

The Bard plant in Humacao, Puerto Rico was constructed in 2003. According to the company’s website, they manufacture a variety of products at the plant, including Davol hernia mesh products like the Kugel patch; grafts, fabrics, shunts and the Vacora Biopsy System for Bard Peripheral Vascular; catheters and feeding devices for Bard Access Systems, and Tegress T bulking agent for Bard Urological Division.


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