Kugel Recall Timeline
1994—Dr. Robert D. Kugel is granted a patent for a mesh patch to repair hernias.
November 1996—Davol Inc.’s Kugel mesh hernia patch gets approval from the Food and Drug Administration, and goes on the market.
2002—Davol introduces the Kugel large mesh hernia patch. Not long thereafter, the company begins to receive reports that the plastic memory-recoil ring in the larger hernia patches was breaking, thus causing injury to internal organs and tissue, such as bowel perforations and chronic intestinal fistulas.
Mid-2005—Davol receives 10 complaints about ring breaks over a three-month period.
August 2005—Davol halts production of Kugel extra large mesh hernia patches but speculates that the memory-recoil ring cannot withstand the stresses of surgical placement.
December 22, 2005—Bard Inc. (parent company of Davol) notifies customers of its voluntary Class I hernia patch recall of the Composix Kugel extra large mesh hernia patch. About 32,000 units of the Kugel mesh hernia patch have been sold and put into use at this time.
March 24, 2006—Bard advises surgeons and hospital administrators that the Kugel mesh hernia patch recall has been expanded to include the large oval and large circle, as well the small oval device.
December 18, 2006—Kugel mesh hernia patch lawsuit is filed against Davol in Rhode Island. Lawyers in the case allege that failure of the Kugel mesh hernia patch caused their client to suffer severe pain and to require bowel dissection surgery, which resulted in chronically inflamed bowels.
January 10, 2007—Davol expands the recall to include large Composix Kugel mesh patches (oval and circle) after getting more reports of broken memory-recoil rings.
Circa February 2007—Davol releases the modified Kugel patch, with a stronger weld of the memory-recoil ring.
March 16, 2007—The New York Times obtains an FDA report under the Freedom of Information Act. It shows that Davol has concealed the number and severity of complaints about the Kugel mesh hernia patch side effects.