Case Study

Gathering evidence for indication update for a
novel resorbable synthetic mesh

The Challenge

In hernia surgery, abdominal wall reconstruction
(AWR) often relies on biologic mesh, which, despite
its benefits, presents challenges including high costs
and infection risks. A medtech partner developed a
novel resorbable synthetic mesh and already received
approval for use in hernia surgery. Real world clinical
practice had developed around the use of this
synthetic alternative in contaminated fields, and had
seen significant anecdotal adoption, even though this
particular use was contraindicated by the FDA.

The medtech partner wanted to validate and quantify
its mesh’s value for use in complex abdominal
wall repair patients, with the aim to remove the
contraindication from its labeling.

The Objective

A Medtech partner commissioned the Caresyntax team
to conduct a Clinical Quality Improvement (CQI) data
collection project to evaluate the use of its synthetic
resorbable mesh for use in abdominal wall hernia
procedures in a contaminated field setting.

The objective of this initiative was to demonstrate the
clinical equivalence of their synthetic mesh to the current
market leader, in order to validate labeling expansion by
removal of contraindication.

”“The FDA acknowledged the signifcance of the
Caresyntax team’s efforts in providing real-world
evidence through the CQI process, emphasizing the
importance of this evidence in understanding, and
improving patient care.” [2]
from the FDA meeting minutes