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Composix Kugel Mesh Patch Attorney
Personal Injury Lawyers - Representing People Nationwide
On December 22, 2005, the U.S. Food and Drug Administration (FDA) issued a class I recall of several versions of the Composix Kugel Mesh Patch manufactured by Davol Inc. of Rhode Island and its parent company CR Bard Inc. of New Jersey. Class I recalls are reserved for defective or dangerous products that could cause serious health problems or death. The original recall notice has been updated to include additional product codes and lot numbers. The latest update as of this writing was issued on January 24, 2007.
The Composix Kugel Mesh Patch is used to repair an incisional or ventral hernia, which is caused by the stretching or thinning of scar tissue that forms after surgery. The patch is folded and inserted through a small incision and placed behind the hernia. Once in place, a "memory recoil ring" then deploys and holds the patch open.
The recall was instituted because of several reports that the memory recoil ring has malfunctioned, causing various health problems for patients. It has been found that the ring can break under the stress of being placed in the intra-abdominal space. In several cases, the broken ends of the coil poked through the patch's mesh and perforated bowels or caused chronic intestinal fistulae, a condition where abnormal connections between the intestines and other organs are formed.
Physicians and health care professionals should immediately discontinue using patches with product codes and lot numbers listed in the latest FDA update. They are also urged to distribute copies of the information found at http://www.davol.com/content/productrecall.aspx to anyone who may have implanted or may be managing patients implanted with one of the devices.
Thousands of patients have had the Composix Kugel Mesh Patch implanted and it is not known how many of them will be affected by the potentially dangerous device. Those who experience symptoms associated with breakage of the patch's ring should immediately seek medical attention. Symptoms include:
- Persistent abdominal pain
- Tenderness near or at the site of the surgery or implant
- Fever
If you or a loved one has been injured by a Composix Kugel Mesh Patch, you may be entitled to financial compensation for the resulting pain and suffering. You should consider consulting with an experienced defective medical device attorney who can diligently evaluate your case. You should be aware, however, that you may need to act quickly to avoid the expiration of the statutes of limitations, or deadlines by which you must file certain kinds of lawsuits in your state.
Contact our Personal Injury Lawyers and Attorneys today to find an experienced defective medical devices lawyer.
