An updated recall was issued by the FDA and the manufacturer, Davol, Inc., a subsidiary of C.R. Bard, Inc., on January 10, 2007 for the Kugel mesh hernia patch. The action came following reports linking it to several fatalities, and over 80 injuries and other related problems. The hernia patch recall expanded two previous product recalls which had been issued for the Kugel mesh patch product.
The “hernia patch” consists of two pieces of synthetic mesh surrounded by a flexible ring, and is implanted at the site of a hernia. The plastic ring that surrounds the patch then springs into place, allowing damaged tissue to regrow around the flattened patch. In 2002, Davol began receiving reports of broken plastic rings in the largest models of the Kugel mesh hernia patch. These broken rings were reported to cause side effects such as internal tears, leading to bowel perforation, bowel obstruction or chronic enteric fistula, an abnormal connection between two organs or parts of the body that aren’t supposed to connect.
Company tests showed that these failures consistently occurred at the spot where the ring was welded together, forcing Davol to issue a hernia patch recall for the extra large model of the Kugel mesh hernia patch. This recall was later expanded to include the oval, large oval and large circle models of the patch.
Over 2,000 hernia mesh lawsuits have been filed as a result of problems with the Kugel Patch mesh. The federal hernia mesh litigation has been consolidated as “multi district litigation” in the United States District Court of the District of Rhode Island. Swartz & Swartz, P.C. currently represents clients in the pending Rhode Island lawsuit.
If you or a family member have suffered significant personal injuries – including bowel perforation, bowel obstruction, chronic enteric fistulas or other injuries — as the result of a defective Kugel mesh patch, contact the law office of Swartz & Swartz, P.C., one of the most successful product liability firms in the country. Call (617) 742-1900 in the Boston area, or for clients in greater Massachusetts, New England, or other states across the U.S., call toll-free at 1-800-545-3732.