Bard Composix Kugel Mesh Hernia Patch Maker Davol Inc. in 'Serious Violation' Warns FDAJun 12, 2007 | Parker Waichman LLP
Not long after expanding the recall of the Bard Composix Kugel Mesh Patch, the FDA issued a warning letter to Davol Inc., the patch’s manufacturer, citing serious regulatory problems with quality assurance systems used in the manufacture of the Kugel patches, as well as its Salute Reusable Fixation devices. The letter, which was dated April 24, 2007, came after the FDA conducted an inspection of the company’s Cranston, Rhode Island headquarters. The inspection took place from January 23 through March 13, 2007.
Problems with the Kugel Hernia Mesh patches first came to light in 2005. At that time, the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch because the memo recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. A Class I recall means that the recalled product poses a serious danger to patients still using it. The FDA warned doctors to quite using the patch. The FDA also warned patients who received the patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. In April 2006, the patch Class I recall was expanded to the “mid-line” size of the patch. The recall was expanded for a third time in February of 2007 to include the large size patch.
The FDA issues warning letters when an inspection finds serious problems in the methods, facilities and controls used in the manufacture, storage, packing or installation of a company’s products. During its inspection, the FDA found a number of problems at the Davol headquarters, but the most troubling were problems found with the system the company uses to track complaints. The letter states that the facility lacked procedures to handle everything from complaint investigation to the determination of actual recall actions. The FDA said that the lack of these procedures where to blame for Davol’s delays in dealing with the Kugal Patch’s problems.
The FDA letter also cited problems with the company’s manufacture of its Salute Reusable Fixation devices. This device is used for attaching mesh in laparoscopic and open hernia repair and pelvic floor reconstruction. During its inspection, the FDA found no documentation that any testing was performed to ensure that the Salute device met the company’s own specifications. The FDA recalled some of these devices in December, 2006.
The FDA letter stated that the problems found during its inspection could be symptomatic of serious underlying problems in the company’s quality assurance system. The FDA ordered Davol to investigate and promptly correct the quality procedures. The FDA also warned that Davol was in serious violation of the law, and as a result, the FDA could take further regulatory steps against the company without notice. These steps could include seizure of product inventories, court injunctions preventing Davol from selling its products, or monetary penalties.