Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH

Planned Sample Size: At minimum of 70 consecutive subjects at least 6-months post-index
procedure

Study Population: A consecutive cohort of patients who have undergone a hiatal hernia repair
with MIROMESH.

Primary Objective: Characterize the procedural and early post-operative safety profile of
MIROMESH when used as reinforcement in hiatal hernia repair.

Secondary Objectives

A retrospective chart review will identify the appropriate cohort with a prospective
follow-up survey to acquire safety and outcome information.

A retrospective chart review of appropriate subjects.

Data to be acquired will be:

Preoperative - Chart Review

- Gender

- Date of birth

- Weight

- Body Mass Index

- Specific diagnosis

- DeMeester Score

- 24 hour pH test (% acid exposure in 24 hours)

- Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Score
Peri-operative Preoperative - Chart Review

- Date of surgery

- Number of stitches used to close wound

- Paraesophageal hernia type

- Mesh shape

- Mesh size used

- Attachment technique

- Length of stay

- Complications

Post-Operative (With-in 1 month of surgery) Preoperative - Chart Review

- Complications (Mesh related)

- Complications (procedure related)

- Prolonged dysphagia (Y/N)

- Stenosis (Y/N)

- Dilations (Y/N)

- Esophagogastroduodenoscopy or Upper gastrointestinal series documented hernia recurrence

- GERD-HRQL Score

Prospective institutional review board approved Follow-Up Telephone Interview

- Have you had a revision surgery?

- GERD-HRQL Score

- How satisfied are you with the procedure?

- Have you used proton pump inhibitors in the last 3 months

- How likely are you to recommend this procedure to a loved one?

Inclusion Criteria:

- Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study

Exclusion Criteria: