Information Regarding Composix Kugel Mesh Patch Implants

The Composix Kugel Mesh Patch, made by Davol, Inc, a subsidiary of C.R.  Bard, is a medical device used to fix ventral hernias caused by the thinning or stretching of scar tissue that usually occurs after hernia surgery.  These tissues are fragile and delicate, and after major medical procedures they are even more so.  The folded patch is inserted into the body behind the hernia area, where the spring-loaded plastic memory recoil holds it ready.  

Unfortunately, there’s a significant issue with the memory recoil ring.  In some cases the memory ring can break entirely which can lead to a bowel perforation or chronic enteric fistulae, or abnormal connections between 2 tissues that aren’t usually connected.  Further complicating the possible problems of the Composix Kugel Mesh Patch is that even mild pressure exerted during other surgical methodologies can cause it to damage and result in potentially serious consequences.  

The Food and Drug Administration and Bard joined together to recall a number of defective tons of Composix Kugel Mesh Patches due to their wish to damage.  There were three different recalls which happened in December 2005, January 2006, and March 2006 that included :

PC0010206 Bard Composix Kugel additional Large Oval 8.7″ x 10.7″

PC0010207 Bard Composix Kugel extra large Oval 10.8″ x 13.7″

PC0010208 Bard Composix Kugel Extra massive Oval 7.7″ x 9.7″

PC0010209 Bard Composix Kugel Oval 6.3″ x 12.3″

PC0010202 Bard Composix Kugel giant Oval 5.4″ x 7″

PC0010204 Bard Composix Kugel large Circle 4.5″

The issue with this defective medical device is so significant the March 24, 2006 recall said that doctors and healthcare executives : “Immediately drop use of the express product codes and lot numbers noted below.  Additionally, please immediately distribute copies of this Important Patient Management information to clinicians who might have implanted, or who might be managing, patients already implanted with one of these products under voluntary recall.”

furthermore, the FDA recall notice stated : “Patients who’ve been implanted with a Composix Kugel Mesh Patch during hernia surgery should seek medical attention immediately if they feel symptoms that would be associated with ring breakage.  These symptoms include : unexplained or determined intestinal agony, fever, love at the surgery site or other bizarre symptoms.”

If you liked this write up about Kugel Hernia Patch, then most definitely check into this curious website based on kugel mesh hernia patch recall.

The risks of a defective medical device like the Composix Kugel Mesh Patch will possibly continue to affect society for some time.  Once the general public loses trust in medical device, it is tough or maybe even impossible to regain.