Inform the public of any safety issues in a timely manner. When a medical device like the Kugel Mesh Hernia Patch is put on the market, most consumers expect that the device manufacturer will carefully monitor the use of their product, and inform the public of any safety issues in a timely manner. Unfortunately, as the sad story of the defective Kugel Mesh Hernia Patch illustrates, this is not always the case.
The Kugel Mesh Hernia Patch was supposed to offer hernia patients a good option for treating their painful condition. But by 2005, the Food & Drug Administration (FDA) was receiving more and more reports of failure with the Kugel Patch. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. The reports were so alarming that the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. 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.
According to an article in the New York Times this past March, Davol, Inc. had known of problems with the hernia patch long before the 2005 recall. In fact Davol had received its first Kugel patch complaints in 2002. All of the reports involved injuries, some of them serious, caused by the X-large size patch. According to Davol’s parent company, C. R. Bard, Inc., it was determined that the “few” number of reports did not warrant public notification.
Davol received 10 reports about ring breakage.
But in 2005, Davol received 10 reports about ring breakage over a three month period. At that time, Davol blamed doctors for implanting the device improperly. The company started work on new instructions for implanting the patch, and held training session for some physicians. But the Kugel Mesh Hernia Patch remained on the market.
By the end of 2005, Davol concluded that it had been wrong about its assessment of Kugel patch problems. In December of that year, tests run by the company showed that the source of the problem was not doctor error, but failure of the ring weld on the device itself. Finally, Davol recalled the X-Large Kugel Mesh Hernia Patch. Recalls of the other sizes would soon follow. In the end, the Kugel patch would be blamed for more than 80 injuries and at least three fatalities.
The recalls resulted in an FDA inspection of Davol’s Rhode Island headquarters. The inspection did not reflect well on the company. The FDA issued Davol a warning letter after finding 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, 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 Kugel Patch’s problems.
Since the FDA issued its warning letter, Davol has said that it has addressed the agency’s complaints. But for the many patients injured by the defective Kugel Mesh Hernia Patch, Davol’s penance comes too little, too late.
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