FDA has received reports of more than 80 injuries and other problems possibly related to it. An article in today’s New York Times questioned the behavior of Davol, a division C.R. Bard, after it became aware of defects in its Kugel Hernia Mesh product. The FDA has received reports of more than 80 injuries and other problems possibly related to it, including several fatalities. In late 2005, Bard recalled certain versions of the mesh because a plastic component could break and cut through a patient’s internal organs and tissue.
The article claims that Bard executives said they knew about some serious injuries potentially caused by the device.
In a recent statement statement Bard officials said the company acted responsibly and that they didn’t take the product off the market earlier because there weren’t enough complaints to warrant such actions.
However, in a copy of an inspection report obtained by The New York Times under the Freedom of Information Act shows, in early 2006 inspectors reported “discrepancies” and “inconsistencies” in how Davol tracked and analyzed device-related complaints. The FDA also said Davol did not accurately report the possible severity of complaints to the agency.
The Kugel hernia patch is made of two pieces of mesh that surround a flexible plastic ring
The Kugel hernia patch is made of two pieces of mesh that surround a flexible plastic ring. To implant it, a doctor folds a patch, places it at the site of the hernia, which is a spot where an organ pops through internal tissue that has become weak or torn.
The released ring then springs back into its original shape, flattening the patch. The meshlike material then serves as a substrate that allows internal tissue to grow and resolve the hernia.
Davol, which is based in Cranston, R.I., makes the patch in various sizes and shapes. And it was not long after it introduced the largest units in 2002, F.D.A. records show, that company officials began to receive a small but disproportionately high number of complaints about broken rings in those “extra large” versions of the device.
Bard officials said that the initial numbers were small given the number of patches sold, and the problems cited were too random to form a troubling pattern.
But in mid-2005, Bard said, Davol received 10 complaints about ring breaks over a three-month period starting that June. Six of those reports, including one involving a possible fatality, came from Germany, half of them from the same doctor there.
Bard said that Davol officials initially had concluded, based on their review, that the ring breaks were occurring because doctors were improperly folding the patch while implanting it.
Davol halted production in August 2005 of the extra-large patches
As a result, Davol halted production in August 2005 of the extra-large patches, began to hold training sessions for doctors in Germany and started work on revising its instructions to doctors elsewhere about how to implant the device, Bard said. But the company kept distributing the patch and doctors kept implanting it. That allowed the problem to continue because Davol’s assessment proved wrong.
In early December 2005, tests run by the company on a failed patch “suggested for the first time that the source of the ring break was caused by a failure at the ring weld,” according to Bard.Davol soon recalled the extra-large versions of the patch and, several weeks later, expanded that recall to include large versions of the device. It was after that initial patch recall that F.D.A. officials went to Davol’s headquarters in early 2006 to do an inspection.
What they found there, their report indicates, was a range of problems, including flaws in the system used by Davol to track complaints. For example, while Davol had purchased a new tracking system in 2004, that program was incompatible with the earlier one it had been using, resulting in significant “discrepancies” in how problems were recorded and reviewed, agency inspectors reported.
Davol officials disagreed, that same report shows, saying they cross-checked complaints by hand
Davol officials disagreed, that same report shows, saying they cross-checked complaints by hand. But inspectors also reported that company officials had also understated in several reports to the agency the potential severity of device-related injuries, including three reports involving injuries and one report involving a possible device-related death.In a statement, Bard said that it had not submitted those reports to mislead the agency but said that the company had incorrectly categorized the complaints based on the information it had at the time.
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