Hernia Patch By the Numbers
1.5%—Advertised recurrence rate of problems with Composix Kugel mesh hernia patch. Tissue-to-tissue operations have a recurrence rate of up to 10%.
3—Kugel mesh hernia patch recalls issued: December 2005, March 2006 and January 2007.
6—Versions of the Kugel mesh hernia patch that have been recalled: extra large oval (7.7″ × 9.7″), extra large oval (8.7″ × 10.7″), extra large oval (10.8″ × 13.7″), oval (6.3″ × 12.3″), large oval (5.4″ × 7″) and large circle (4.5″).
10—Complaints about Kugel mesh hernia patch side effects over a three-month period in mid-2005.
80—Injuries, plus several deaths, prompted the Food and Drug Administration and Davol Inc. to issue an updated product recall for the Kugel mesh hernia patch in January 2007.
32,000—Units of Kugel mesh hernia patch sold and put to use by the time of Davol’s first recall.
750,000—Hernia surgeries done in the United States each year.
$11 million—Sales of Kugel mesh hernia patches since 2005.