The Kugel Mesh Hernia Patch manufactured by Davol/Bard has issued an expanded recall on Jan 10, 2007 a complete market withdrawal of the Kugel Large Oval and the Kugel Large Circle hernia patches which link reports of the recoil ring breakage. There are over 750,000 hernia repair surgeries performed each year. Dr. Kugel developed the hernia patch in hopes of reducing the recovery time and amount of recurrent hernias. Instead, the Kugel patch has been recalled due to serious complications.
Such as, bowel perforation, abdominal pain, migration of the recoil ring,
breakage of the recoil ring, chronic enteric fistulas, unnatural connections of the tissue growth between bowels.
On Dec. 22, 2005, the first “Class 1″ recall notice was issued by the FDA regarding the Bard Composix Kugel Mesh Patch then again on March 31,2006 the FDA updated the “Class 1″ recall of the Bard Composix Kugel
Mesh Patch. A Class 1 is the highest possible alert the FDA will use meaning that the exposure to the product may cause serious injury or death.
The “memory recoil ring” which is an integral part of the Bard Composix Kugel Mesh Patch can break causing life threatening injuries such as, bowel perforation and intestinal fistulae and damage to the gastrointestinal organs. Symptoms may include abdominal pain, fever, pain at the implant site or unusual symptoms.
The FDA has received over 80 reported injuries including many fatalities. The FDA has accused Davol, Inc the manufacturer of the hernia mesh patch product of not accurately reporting the severity of the defects of the Kugel hernia mesh product. Davol claimed that in 2005 over 10 complaints of the ring breakage and one fatality were the result of doctors improperly folding the patch while implanting. The FDA ran an inspection at the Davol headquarters and found that company officials had not reported the severity of the hernia mesh defects. On Feb, 1 2007 the FDA classified the recall of the Bard Composix Kugel Mesh Large Patch as a Class 1 recall recommending that doctors stop using the product that the Kugel mesh large patch may cause serious injury and or death.
If you or someone you know has undergone a hernia patch surgery we can not stress enough the importance of knowing which patch was used during surgery and if you are experiencing fever, abdominal pain, pain at he site, or unusual pain seek your doctor immediately and contact us to get the best legal advice from the top Hernia patch Attorneys in the nation.