The Composix Kugel Mesh Patch, made by Davol, Inc, a division 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 delicate and sensitive, and after heavy 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 in effect.

Unfortunately, there’s a significant difficulty with the memory recoil ring. In a few cases the memory ring can break entirely which can lead to a bowel puncture or chronic enteric fistulae, or aberrant connections between two tissues that are not typically connected. Further complicating the potential problems of the Composix Kugel Mesh Patch is that even mild pressure exerted during other surgical methodologies can cause it to smash and result in doubtless heavy consequences.

The Food and Drug Administration and Bard joined together to recall a number of defective heaps of Composix Kugel Mesh Patches due to their wish to damage. There were 3 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 additional big Oval 10.8″ x-.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 Large Oval 5.4″ x 7″

PC0010204 Bard Composix Kugel Large Circle 4.5″

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

furthermore, the FDA recall notice stated : “Patients who have been implanted with a Composix Kugel Mesh Patch during hernia surgery should seek medical attention right away if they feel symptoms that would be related to ring breakage. These symptoms include : unexplained or persistent abdominal pain, fever, tenderness at the surgery site or other unusual symptoms.”

The dangers of a defective medical device like the Composix Kugel Mesh Patch will possibly continue to affect society for quite some time. Once the public loses trust in medical device, it is tough if not impossible to regain.

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