Davol Inc., the maker of the Kugel Mesh Hernia Patch, was the subject of a Food and Drug Administration (FDA) warning letter as a result of a recall of the device. The letter, which followed an inspection of Davol’s Rhode Island headquarters, provides insight into the company’s shoddy quality assurance systems that allowed problems with the Kugel Mesh Hernia Patch to continue for some time.
When it was first introduced, the Kugel Mesh Hernia Patch was heralded as an innovation in hernia treatment. Unfortunately, by 2005, the FDA was receiving more and more reports of failure with the Kugel Patch. The reports were so alarming that the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. Apparently, the 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. By February 2007, the Kugel Patch recall had been expanded twice to several other sizes of the device.
An FDA warning letter is serious business. They are only issued 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 FDA found that Davol did not have an adequate system to handle everything from complaint investigation to the determination of actual recall actions. What’s more, the FDA blamed these inadequacies for Davol’s delays in dealing with the Kugal Patch’s problems.
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 threatened further regulatory steps against the company without notice. These steps could include fines, seizure of product inventories, court injunctions preventing Davol from selling its products.
Scores of patients had to undergo the ordeal of having their Kugel Patch replaced as a result of coil ring breakage, and at least one patient is known to have died from complications of a defective patch. Because Davol employed poor quality assurance practices, thousands of people who received the device still run a very high risk of serious injury. Companies like Davol have an obligation to employ the highest quality standards when they manufacture a medical device. Had Davol used such standards, many hernia patients would have been spared great misery.
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