1994—A patent is granted to Dr. Robert D. Kugel for a mesh patch to repair hernias.

November 1996—The Kugel mesh hernia patch wins Food and Drug Administration approval, and Davol Inc. puts it on the market.

2002—Davol introduces a new, larger Kugel mesh hernia patch. Soon thereafter, the company starts to get disturbing reports about the larger hernia patches—that the plastic memory-recoil ring tends to break, resulting in injury to internal organs and tissue. These cases of hernia patch side effects include chronic intestinal fistulas and bowel perforations.

Mid-2005—10 complaints about ring breaks are made to Davol over a three-month period.

August 2005—Davol stops making the Kugel extra-large mesh hernia patches and suggests that the memory-recoil ring does not adequately withstand the stress of surgical placement.

December 22, 2005—Davol’s parent company, Bard Inc., informs doctors and patients that it has voluntarily issued a Class 1 hernia partch recall for the Composix Kugel extra-large mesh hernia patch. By this time, some 32,000 Kugel mesh hernia patches have been sold and put into use.

March 24, 2006—Surgeons and hospital administrators learn that the Kugel mesh hernia patch recall has been expanded by Bard to include the large oval and large circle versions.

December 18, 2006—In Rhode Island, a Kugel mesh hernia patch lawsuit is filed against Davol. The Kugel mesh patch lawyers allege that their client suffered severe pain and had to undergo bowel dissection surgery, resulting in chronically inflamed bowels—due to failure of the Kugel mesh hernia patch.

January 10, 2007—Davol, which has gotten more reports of busted memory-recoil rings, expands the Kugel mesh hernia patch recall to include large Kugel mesh patches, both the oval and circle versions.

February 2007—The modified Kugel patch, featuring a stronger weld of the memory-recoil ring, is released by Davol.

March 16, 2007—An FDA report is secured by the New York Times under the Freedom of Information Act. It indicates that the number and severity of complaints about the Kugel mesh hernia patch have been understated by Davol.

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