The FDA documents also say that Davol underreported the number of device-related complaints it received from doctors about injuries stemming from the Kugel mesh hernia patch.

Davol received the first reports of injuries among Kugel mesh patch users in 2002, soon after it released the largest model of the device. The reports suggested that hernia patch patients could experience severe injuries as a result of breaks in the “memory-recoil ring” that surrounds the patch.

Over a three-month period, the company received 10 reports of ring breaks, including at least one possible fatality. However, Davol did not issue the first hernia patch recall until December 2005. Two subsequent hernia patch recalls for smaller models of the Kugel mesh patch were issued in March 2006 and January 2007.

In its report on safety inspections conducted at the Davol plant in early 2006, the FDA says that problems with the company’s system for tracking complaints created “discrepancies” and “inconsistencies” in how they were monitored. In addition, the FDA says that officials from Davol understated the severity of injuries caused by the Kugel mesh hernia patch in its reports to the agency, including at least three cases of severe injury and one fatality.

The FDA has since released a Class 1 hernia patch recall for some models of the Kugel mesh patch, meaning that the device has a reasonable probability for causing severe injury or death.