Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant in Men After Laparoscopic Inguinal or Umbilical Herniorrhaphy

Inguinal herniorrhaphy is a common surgery; approximately 2,800 per million people in the
United States (US) undergo the procedure annually.Common surgical methods of herniorrhaphy
include open and laparoscopic placement of synthetic mesh. Studies have shown that the use
of synthetic mesh greatly reduces the risk of hernia recurrence regardless of the method
used for its placement. Furthermore, utilizing the laparoscopic approach for umbilical
hernia repair, specifically with the use of mesh, may also reduce the risk of infection.

Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile.
Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a
thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine.
When inserted into a surgical site, the collagen breaks down and bupivacaine is released at
the site but very little is absorbed into the blood stream. The high levels of bupivacaine
at the surgical site may result in less pain for several days after surgery.

This open-label study will assess pain intensity after surgery in patients who receive the
CollaRx Bupivacaine implant as well as determine the feasibility of the use of the
laparoscope for sponge placement in laparoscopic hernia repair.