Hernia Patch – Bard Composix Kugel Mesh Patch Injuries And Danger
The Composix Kugel Mesh Patch, manufactured by Davol, Inc., a subsidiary of C.R. Bard, is a medical device used to repair ventral hernias caused by the thinning or stretching of scar tissue that commonly occurs after hernia surgery. These tissues are already delicate and sensitive, and after serious 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 place.
Unfortunately, there is a significant problem 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 two tissues that are not normally connected. Further complicating the potential problems of the Composix Kugel Mesh Patch is that even mild pressure exerted during other surgical techniques can cause it to break and result in potentially serious consequences.
The Food and Drug Administration and Bard joined together to recall a number of defective lots of Composix Kugel Mesh Patches due to their propensity to break. There were three different recalls that occurred in December 2005, January 2006, and March 2006 that included:
• PC#0010206 Bard Composix Kugel Extra Large Oval 8.7″ x 10.7″
• PC#0010207 Bard Composix Kugel Extra Large Oval 10.8″ x 13.7″
• PC#0010208 Bard Composix Kugel Extra Large Oval 7.7″ x 9.7″
• PC#0010209 Bard Composix Kugel Oval 6.3″ x 12.3″
• PC#0010202 Bard Composix Kugel Large Oval 5.4″ x 7″
• PC#0010204 Bard Composix Kugel Large Circle 4.5″
The problem with this defective medical device is so serious that the March 24, 2006 recall stated that doctors and healthcare professionals: “Immediately discontinue use of the specific product codes and lot numbers listed below. Additionally, please immediately distribute copies of this Important Patient Management Information to clinicians who may have implanted, or who may 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 immediately if they experience symptoms that could be associated with 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 likely continue to affect society for quite some time. Once the public loses trust in medical device, it is difficult if not impossible to regain.
To learn more about the kugel hernia patch or how to hire a hernia patch lawyer please visit our website at http://www.resource4thepeople.com This article may be freely reprinted as long as this resource box is included and all links stay intact as hyperlinks.
Article Source: http://EzineArticles.com/?expert=Todd_Going
Written by admin on November 19th, 2007 with
no comments.
Read more articles on Kugel Patch Recall.
- [+] Digg: Feature this article
- [+] Del.icio.us: Bookmark this article
- [+] Furl: Bookmark this article