Kugel Mesh Hernia Patches
The Rhode Island-based medical device manufacturer Davol, Inc is being sued for their Composix Kugel Mesh Hernia Patches. This material was used in hernia repair surgeries throughout the United States. In 2005 Davol recalled several of the patches under order of the FDA for a FDA Class I recall. A “Class I” recall means that the product can cause life threatening injuries. In 2006 the recall was expanded to include additional lots of the patches manufactured by Davol.
Some recipients of the patches have had to undergo additional surgeries to have the hernia patches removed. The device was recalled because the “memory recoil ring” is subject to failure once inserted into the abdomen. The failure of the “memory recoil ring” can cause bowel perforations and/or chronic intestinal fistulae (an abnormal connection between organs). Additionally, in some patients the mesh patches had adhered to vital organs such as their intestines or bowels requiring extensive surgery and pain.
Thousands of people have undergone hernia repair with Composix Kugel Mesh Patches. It is unknown how many people will be adversely affected by these patches. C. R. Bard, Inc. the parent company of Davol, Inc. reports they have already received notice of 24 incidents of failure of the memory coil ring.
If you had hernia repair surgery involving a Composix Kugel Mesh Hernia Patch, call us toll free today at 1-800-531-9191 for a free consultation or contact us via email.