The Bard ® Composix ® Kugel ® Mesh Patch is designed to be implanted in a patient’s abdomen to repair incisional hernias. The patch is made with an ultra thin, flexible plastic ring between two pieces of plastic mesh fabric that is placed behind the weakened area of the abdominal wall. To implant it, the surgeon folds the patch and inserts it through a small incision in the abdomen. When released, the plastic “memory recoil ring” unfolds the patch and the surgeon guides it into place where it keeps internal organs from protruding through the abdominal wall and promotes new tissue growth to repair the hernia.
Patent Application Drawing, U.S.P.T.O
Dr. Robert D. Kugel, a general surgeon and hernia specialist in Olympia, Washington, invented the Kugel patch. The ten patents on the patch design and method of use are now owned by Bard ASDI, Inc., a subsidiary of medical device manufacturer C.R. Bard, Inc. The patch is marketed by another subsidiary, Davol, Inc.
History
The original Kugel patch was introduced to the market by Surgical Sense, Inc, a Texas-based medical device manufacturer who acquired the patents from Dr. Kugel in the late 1990s. Bard purchased Surgical Sense in 2000 and assigned the patch’s production, sales, and marketing to its Davol subsidiary.
Dr. Kugel originally designed the patch for repairing inguinal hernias occurring in the groin area – the most common type of hernia. To expand the market, Davol introduced several large-size versions of the patch for use in repairing typically larger incisional hernias. These larger patches went on sale in 2002. Shortly after the large-size patches went on the market, Davol began receiving sporadic reports of plastic ring breakage after the patch had been implanted.
Davol Finds the Flaw
As the number of reports grew to more than a dozen over several years, Davol began investigating the patch itself and soon discovered a flaw. The ring is made of a length of flexible plastic rod that is bent into a circle with its ends welded together. The larger patches were made with a slightly larger-diameter plastic ring and Davol discovered that stressing the ring could cause the weld to give way, leaving the two ends of the broken ring free to cause internal injury. Soon after this discovery, Davol announced it was recalling all of its extra-large patches.
Why it Took Three Years
The initial complaints regarding ring breakage beginning in 2002 were so few and so rare, Davol did not perceive there to be a problem with the patch itself. But between June and August 2005, Davol received ten reports, three coming from the same doctor. Believing the breakage to be caused by doctors mishandling the patch during placement, they temporarily stopped production in August 2005 and quickly focused on educating physicians in the proper folding technique.
By the time Davol discovered the problem with the ring weld in December 2005, it had received 24 reports of broken rings out of 32,000 units sold since 2002. A later FDA investigation suggested that new complaint tracking software implemented in 2004 was incompatible with the previous system resulting in Davol’s inability to properly correlate complaint data. Davol countered that it had performed comparisons between the two systems manually.
The FDA also complained that Davol had filed misleading reports concerning the severity of patient injuries due to ring failures. The parent company, C.R. Bard, issued a statement in response that there was no intent to mislead, but that the complaints had been miscategorized due to incomplete information available at the time the reports were submitted.
Corrective Action
Davol’s investigation of the ring welds on its large-size patches concluded that a stronger weld was needed to preclude any possibility of failure. The specific changes Davol made in the design and manufacture of the product were:
- Changing from a 0.042” diameter recoil ring stock to a less rigid 0.030” diameter recoil ring stock (already used on other sizes of Kugel patch)
- Increasing the recoil ring weld strength by a factor of four times
- Increasing the recoil ring weld overlap at the weld joint from 0.180” to 0.480”
- Including updated “Instructions for Use” with the product providing guidance to preclude inappropriate manipulation during surgical insertion.
Current Status
Although Davol so far has not received any reports of ring failure in the newly designed patches, an FDA investigation into manufacturing practices at parent company C.R. Bard’s facilities resulted in a list of violations and a stern warning letter in July 2008. Many of the problems involved inadequate quality control procedures that resulted in mislabeled and incorrectly packaged products, including Kugel patches. At the time of this update, the FDA had no further information available on what corrective action Bard had taken in response to the warning letter.
You must log in to post a comment.