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*** KUGEL MESH PATCH *** The Fox Law Firm is Reviewing Potential KUGEL MESH PATCH Claims Have you experienced severe health issues – such as Bowel Perforations and Chronic Intestinal Fistulae - following the use of the Kugel Mesh Patch? Have your loved ones suffered adversely after taking the Kugel Mesh Patch? If so, you should contact us immediately to protect your legal rights. If you or your loved ones have experienced any of these side effects you may have a claim for legal compensation. Contact The Fox Law Firm for superior legal representation. The Composix® Kugel® Mesh Patch is a product designed to repair ventral (incisional) hernias that have resulted from the stretching or thinning of scar tissue that may form following surgical procedures. The Composix® Kugel® Mesh Patch is placed behind the hernia defect via a small incision. The patch is then held open by a memory recoil ring that permits the patch to be carefully folded for insertion, and later to spring open and lay flat once it is firmly installed. The Composix® Kugel® Mesh Patch has been shown to pose serious health related issues. For example, in December 2005, the Food and Drug Administration (FDA) issued a recall notice of the product. In its notice, the FDA said that the memory recoil ring that specifically opens the Composix® Kugel® Mesh Patch after it has been inserted into the intra-abdominal space of the patient may break. The FDA further said that the resultant effects of such a breakage may include perforations of the patient’s bowel, and/or chronic intestinal fistulae: abnormal connections or passageways between the intestines and other organs. Davol, Inc. (a subsidiary of C.R. Bard) notified its U.S.-based customers of the recall via letter on December 27, 2005. Three months later, on March 24, 2006, Bard sent letters to U.S. hospitals and health-care professionals, informing them to further-recalled products. The letters in question included updated information for use, explaining the correct insertion techniques, and supplemental patient management information. Then, in January 2007, the FDA issued a further release in which it was stated that Davol, Inc. had issued letters to health care professionals and distributors advising them of another expansion of its recall of certain lots of Bard® Composix® Kugel® Large Oval and Large Circle Mesh Patches, specifically for product codes 0010202 and 0010204. Surgeons and hospitals were informed they should cease use of the recalled products in question, and return all unused units to the company. The FDA stated that those patients who had been implanted with one of the recalled devices should seek immediate medical attention if they experienced any symptoms that could conceivably be connected to ring breakages - including (a) unexplained or persistent abdominal pain, (b) fever, (c) tenderness at the site of the implant, or (d) any additional symptoms perceived as being unusual. Product codes 0010202 and 0010204 were involved in both recall expansions. The lots that had been manufactured before January 2004 were recalled during the March 2006 expansion. Since the date of the expansion in March 2006, Davol has been the recipient of 4 confirmed complaints of recoil ring breakage from product code 0010202, manufactured between January 2004 and September 2005. Additional Information:
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