PMCF Study of LiquiBand FIX8® OHMF Device

PMCF Study to Evaluate the Safety and Performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device

Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.

Inclusion Criteria:

• Subject is able to understand and give informed consent to take part in the study
• Subject has a primary inguinal hernia.
• Subject is scheduled to undergo open inguinal hernia repair using the LiquiBand FIX8® OHMF device.
• Subject is willing and able to comply with the protocol assessments at time of surgery and during the post-surgical follow-up period.

Exclusion Criteria:

• Subject is undergoing open repair surgery for recurrent hernia, where the primary surgery was also open. Subjects with recurrent hernia whose primary surgery was laparoscopic are not excluded.
• Subject has an anatomical defect or had prior surgical procedures that in the opinion of the investigator makes them unsuitable for open hernia repair with the LiquiBand FIX8® OHMF device.
• Subject is known to be non-compliant with medical treatment.
• Subject is pregnant or actively breastfeeding.
• Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study.
• Subject has a known sensitivity to cyanoacrylate or formaldehyde, D&C Violet No.2 dye or any other component of LiquiBand FIX8® OHMF device.
• The hernia mesh to be used in the repair is constructed from Polytetrafluoroethylene (PTFE) or absorbable materials.
• The hernia mesh to be used in the repair is a self-gripping mesh (e.g. ProGrip).
• Subject has active or potential infection at the surgical site.
• Subject has a history of keloid formation.
• Subject has a known vitamin C or zinc deficiency.
• Subject has a connective tissue disorder.