If you have had complications due to the Bard Composix Kugel Patch you may be entitled to compensation.

The Bard Composix Kugel Mesh Patch is used during surgery to repair hernias – a type of surgery performed nearly 800,000 times a year in the U.S. However, in January 2007, the U.S. Food and Drug Administration issued a “Class 1 Recall” of the patch, the highest health alert possible, and patch maker Davol Inc. expanded an earlier recall and market withdrawal of its Kugel Large Oval and Kugel Large Circle patches.

Both patches, which have been used in a number of hernia repair surgeries, have been known to cause serious complications in patients. The patch, developed by Dr. Robert D. Kugel, was designed to repair ventral (incisional) hernias that occur when post-surgery scar tissue is stretched. After the hernia operation, the patch is held open by a “memory recoil ring” that allows the patch to be folded so it can be inserted through a small incision behind the affected area. Once in place, that memory ring allows the patch to spring open and lay flat.

The reason the patches were recalled is because certain lot numbers with the memory recoil ring would break under the stress of placement, causing tears in the bowel or problems with the intestines and other organs. Symptoms may include severe pain, nausea, vomiting, or a large bulge at the site of the previous surgery.

 Problems reported by Davol include:

• Broken ring migrated into or through abdominal wall with associated infection
• Ring migration into vagina
• Bowel perforation
• Bowel obstruction
• Death from septic shock
• Consumptive coagulopathy and acute myocardial infarction

The January 2007 recall expands on two previous recalls of similar defective medical devices: In December 2005 and January 2006, the Extra Large Patches were recalled, and in March 2006 the Large Patches were recalled. The current recall requires the immediate discontinuation of use of the Large Oval and Large Circle, because they have the same component design as the previously recalled patches. The FDA notice lists the following product codes that were to be immediately withdrawn from the market: 

• Product Code: 0010202, Bard Composix Kugel Large Oval, 5.4” x 7.0”
• Product Code: 0010204, Bard Composix Kugel Large Circle, 4.5”

Anyone who has had hernia surgery since 2005 may be at risk of serious physical injury or death.

If you or someone you care about had a hernia surgery where a Bard Composix Mesh Patch was used and suffered from abdominal pain, fever, tenderness at the incision site, or painful lumps or bulges where surgery occurred, contact your doctor immediately. You may be entitled to compensation, even if you have an implanted device on the recall list but have not experienced any symptoms. 

Contact Brown & Crouppen today for a free and confidential case evaluation. We’ll find answers, hold negligent companies responsible and get you the compensation you deserve.

Brown & Crouppen can help you make informed decisions about your legal rights, so please call Brown & Crouppen at Toll Free: 1-888-891-2022for your free legal consultation or save time with our online Contact Form.

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My name is Ron Brown, along with my partner Terry Crouppen we founded Brown and Crouppen almost 20 years ago. Today, we are proud to say that we are one of mid-America’s largest personal injury law firms. For some time now we have concentrated a lot of our time and resources in the area of dangerous drug litigation. We have partnered with some of the country’s best drug litigation specialists to create a legal team we feel is second to none.   CONTINUE

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 It’s really terrible to read about a prescription drug being recalled because of dangerous side effects, when you’re one of the people taking it. That’s what happened to me a few years ago. I suffer from a chronic disease and my doctor prescribed a drug to help me manage it better. After being on the drug for a while I began to feel weak and reported it to my doctor. I can’t say enough good things about him, he saved my life. He realized that my problems were being caused not by my disease but by the prescription drug that was supposed to be helping me.   CONTINUE

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