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The Composix Kugel Mesh patch, manufactured by Davol, Inc., a subsidiary of CR Bard, is a medical device that is used to repair ventral hernias caused by thinning or stretching of scar tissue that usually occurs after hernia surgery. These tissue that is already delicate and sensitive, and after serious medical procedures is the even more. They threw the update is inserted into the body behind the hernia area, where the spring loaded plastic memory recoil keep it in place.
Unfortunately, there is a significant problem with memory recoil ring. In some cases, the memory ring can break all the way which may lead to an intestine perforation or chronic enteric fistulae, or abnormal relations between the two tissues that are not normally connected. Further complicating the potential problems of Composix Kugel Mesh update is that even mild pressure exerted in different surgical techniques may lead to it to break and result in potentially serious consequences.
The Food and Drug Administration and Bard came together to recall a number of defective many Composix Kugel Mesh Updates because of their propensity to commit. There were three different memories that took place in December 2005, January 2006 and March 2006 as follows:
• 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 on 24 March 2006 will recall that the doctors and healthcare professionals: "immediately end the use of the specific product codes and lot numbers are listed below. Optional you can immediately distribute copies of this important Patient Management Information to clinicians that can be implanted or who can deal with patients already implanted with one of these products under the voluntary recall.
Moreover, the FDA recall notice stated: "Patients who have been implanted with a Composix Kugel Mesh update during hernia surgery should seek medical attention immediately if they experience symptoms that may be associated with ring breakage. These symptoms include: unexplained or persistent abdominal pain, fever, soreness at the surgery site or other unusual symptoms. "
The danger of a defective medical equipment that Composix Kugel Mesh update will likely continue to influence society for a while. When the public loses confidence in medical devices, it is difficult if not impossible to regain.
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