Date

Event

2002

Defendants conducted interviews of physicians regarding their experiences in using the products. Failed to follow up for further detail from physicians who indicated that they were “dissatisfied” with the performance of the products.

9/04

Defendants were aware of problem with the welding process for the memory recoil ring, that the welds for all of the products marketed so far were impacted, and failed in efforts to correct the problem. No notifications were given to FDA, physicians, or patients of identification of a potential problem. Sales of the hernia mesh products with potentially defective welds continued.

2006

Establishment Inspection Report (EIR) by FDA found that post-market survey validation process conducted in 2002 was incomplete and failed to include all the data from the physicians surveyed during that time.

Spring and Summer of 2005

According to the FDA’s 2006 EIR, corporate executives for Defendants d an increase in the number of complaints associated with the Composix Kugel Hernia Mesh Patches and memory recoil rings, but failed to take any meaningful action at that time.

August 30, 2005

Defendants initiate a partial “distribution hold” on some Composix Kugel Hernia Mesh Patches. No one outside of the company was informed of this action at that time.

December 22, 2005

Issuance of first recall notice with regard to certain sizes and lots of hernis mesh patches.

1/06-2/06

FDA conducts “EIR” investigation.