Kugel Hernia Patch Recall Update

On January 10, 2007, the FDA expanded its recall of the Bard®, Composix®, Kugel® Mesh Patch. The expanded recall concerned the memory recoil ring that opens the hernia patches. The recoil ring has been prone to break under the stress of placement in the intra-abdominal space. Davol notified customers of the hernia patch in December 2005 and informed healthcare professionals of the problem in March 2006 of additional recalls.
However, Bard, Davol’s parent company, knew prior to 2005 that the ring was causing problems. The medical device company now claims that it acted responsibly in not notifying healthcare officials sooner because, according to them, the number of incidences were too few and the data was too random. Yet the truth is that the company had received 10 reports of problems with the hernia patch including one fatality. Additionally, the reports were coming out of Germany, three of them from the same doctor so Bard concluded that the problem resulted in the surgeon who was using the patch.
The real problem lies in the defective design of the recoil ring. Tests on failed patches have revealed a ring weld defect. This defect makes the device prone to breaking, sending pieces of the device into the body cavity causing bowel perforations and obstructions, serious infections, and chronic fistulae.
In response to Davol’s inaction, the FDA ordered Davol to begin an investigation into the defective device. It also accused the company of withholding important information about the defect. A subsequent FDA inspection of a Davol plant that manufactures the Kugel Mesh hernia patch revealed other problems: an ineffective complaint tracking system as well as a defective manufacturing procedures.
The FDA has laid the blame squarely on the shoulders of the company. It has accused Davol’s ineffective plant procedures for causing delays in dealing and correcting the issue.
The FDA has received more than 100 complaints about the Kugel Mesh hernia patch and is subject to further punitive measures by the governmental agency if it doesn’t start to comply with the law and FDA regulations.