Despite knowing of problems with the Bard Composix Kugel Mesh Hernia Patch as far back as the summer of 2005, Davol Inc. allowed its defective product to remain on the market for months. Even when it issued a recall for the extra-large size Kugel Mesh Patch in December 2005, other versions were still being used in hernia surgeries. As a result, thousands of people may have been exposed to serious injury. In the end, it would take two more Food & Drug Administration (FDA)-ordered recalls to warn doctors and their patients about other defective Kugel Mesh Hernia Patches.
By the summer of 2005, Davol Inc. had plenty of evidence that the recoil ring that opened the hernia patch could break, leading to serious problems like bowel perforations. By then, the company had reports of at least 10 injuries – one of them fatal – linked to the Kugel Mesh Patch. Still, it took until December for the FDA to order a Class I recall of the Bard Composix Kugel Mesh X-Large Hernia Patch. A Class I recall means that a device runs the risk of causing serious injury in patients using it. Doctors were advised to stop using the device, and patients were told to seek medical attention if they experienced symptoms like unexplained fever, abdominal pain and tenderness at the incision site. The recall would need to be expanded twice – once in April 2006 for the mid-line size of the patch, and again this past January for the large patch. The FDA has accused Davol of understating the problems with the patch.
In April 2007, the FDA issued a warning to Davol after an inspection of its Rhode Island headquarters uncovered serious problems with the quality assurance programs used in the manufacture of the Kugel Mesh Patch. Among the problems cited during the inspection where those found in the system Davol used to track complaints. The FDA said that the system was so inadequate that Davol was unable to conduct timely complaint investigations. The FDA said that the lack of these procedures was to blame for Davol’s delays in dealing with the Kugel Mesh Patch’s problems.
Davol Inc. has been criticized for a lack of quality assurance procedures with some of its other devices. Some versions of the company’s Salute Reusable Fixation devices were also recalled by the FDA in 2006. This device is used to attach mesh during hernia repair. The FDA’s investigation into the Salute device found that Davol had no documentation of any testing done on the device to insure that it performed to specifications.
Because Davol chose to ignore concerns about the safety of the Kugel Mesh Patch, thousands of people who received the device run a very high risk of serious injury. Hundreds have had to undergo painful and traumatic medical procedures to have their devices replaced. Much of this misery could have been avoided had Davol acted on the reports it received during the summer of 2005.
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