Patient Satisfaction and Societal Benefits

Patient Quality of Life after Hernia Repair

Ventral hernia repairs have significant economic ramifications for employers, insurers, and patients because of the volume of procedures, complications rate, the significant rate of recurrences, and escalating costs. Ventral hernia repairs in the United States are estimated to cost at least $3.2 billion annually1, based on 2006 data. Notably, the report also found that every reduction in recurrence results in substantial cost savings – each 1% reduction would save about $32 million annually.2

The Complex Open Bioabsorbable Reconstruction of the Abdominal Wall (COBRA) study, using GORE® BIO-A® Tissue Reinforcement, is the first prospective, multi-center study of bioabsorbable mesh used in complex ventral hernia (CVH) repair that actually evaluated Patient Quality of Life (QOL). This is a key consideration in value analysis that extends beyond the cost of the products or complications.

Figure 5. EQ-5D index score, mean baseline score of 0.73, indicates significant improvement in general health status since CVH surgery; the VAS score, mean baseline score of 64, trended higher.3

 

Figure 6. SF-12 physical score, mean baseline score of 38, indicates significant improvement in physical health status since CVH surgery; the mental health score, mean baseline score of 42, did not change significantly.3

* indicates statistically significant change in score from baseline (p<0.01)

The challenging population of patients who underwent complex ventral hernia (CVH) repair using the biosynthetic material had an interim hernia recurrence rate of 15.5% at 24 months and a postoperative surgical site infection rate of 18% with no removals of infected bioabsorbable material required.  Patients had significant, sustained improvements in QOL after CVH repair.4

Societal Benefits of Biosynthetic Materials

This product is synthetically made in a controlled environment.  The product does not utilize human or animal derived tissue, so there is no risk of cell, disease, or virus transmission.

The use of this product alleviates concern or need for patient discussion to consider religious beliefs or cultural practices regarding the use of certain animals, or their body parts.5

References

  1. Poulose BK, Sherlton J, Phillips S, et al. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012; 169(2): 179-183
  2. Frangou C. Ventral hernia repairs a financial bust for hospitals? General Surgery News 2012;39(8):1,6.
  3. Rosen M, Bauer J, Carbonell A, et al; Complex Open Bioabsorbable Reconstruction of the Abdominal Wall (COBRA) Study Group. Quality of Life Improves after Complex Ventral Hernia Repair using a Bioabsorbable Material: Preliminary Results of a Prospective, Multicenter Study. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2013. [Poster]. AS1852-EN2.
  4. Rosen M, Carbonell A, Cobb W, et al. Multicenter prospective longitudinal trial evaluating recurrence, surgical site infection and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh. Presented at the 1st World Conference on Abdominal Wall Hernia Surgery; April 25-29, 2015; Milan, Italy. Hernia 2015;19(2)Supplement 2:S106. CO16:03.
  5. Jenkins ED, Yip M, Melman L, Frisella MM, Matthews BD. Informed consent: cultural and religious issues associated with the use of allogeneic and xenogeneic mesh products. Journal of the American College of Surgeons 2010;210(4):402-410.