Mesh surveillance after hernia repair

In 2016, Johnson and Johnson recalled their high-volume mesh product Physiomesh because of high failure rates (1). Since then, patients have filed major lawsuits against the company, and the use of mesh in general for hernias has been heavily debated in media (2). Hernias are among the most frequently treated diseases in surgery, and repair with synthetic mesh materials for reinforcement have for many years been considered the gold standard to prevent hernia recurrence (3). There are more than 200 different meshes for hernia repair on the market. Unfortunately, many of these are replaced with upgraded versions before sufficient long-term outcome data have been collected on the previous editions (4). Based on high quality data, there is no doubt that meshes in general reduces the risk for recurrence significantly (5-7). Nevertheless, a mesh is not just a mesh, and properties varies widely between different meshes (8).

Regrettably, and in contrast to drugs, the safety and effectiveness for most medical devices including surgical implants have not been subject to strict experimental or clinical documentation as well as final approval from governmental institutions (9,10). In recent years it has been shown that long-term follow-up after hernia repairs are mandatory in order to evaluate outcome, and that the reduced risk for hernia recurrence, may be on the expense of increased complications over time (6). In particular studies showing significantly poorer outcome from one specific mesh compared with other synthetic meshes, have contributed to the debate about mesh surveillance (11,12). In the wake of this, companies faced million-dollar lawsuits and several mesh products have been with-drawn from the market (13). New regulations demanding more pre-marketing data and continuous post-marketing surveillance in Europe has now been initiated to be fully implemented in 2022 (14). Until now, the FDA requires no post-marketing surveillance (15).

For the mesh industry and the healthcare systems the new regulations raise a number of questions: for instance, what does it take to get a mesh approved? How long follow-up is needed? Will companies stop producing meshes because it becomes un-profitable? What is required for a sufficient surveillance? What do we tell the patients? But most importantly, how should a cost-effective surveillance be performed.

From a research perspective, randomized controlled trials (RCTs) and meta-analyses of RCTs are considered the highest level of evidence (16). Such studies have high internal validity and are easy to reproduce if studies are performed under the same conditions. Unfortunately, hernia patients are very heterogenic and hernia recurrences and mesh-related complications continue to appear after many years (6). As a result, sufficient surveillance after hernia repair in a randomized setting are considered impossible to perform from a research as well as an economical point of view (16). In contrast, studies from clinical databases such as the Danish Hernia Registry and the German HerniaMed have proven to be valuable tools to identify underperforming meshes (17,18).

Interpretation of outcome after mesh repair is complex and requires significant insight since numerous factors are involved e.g., surgeons’ skills, type of mesh, type and size of hernia, surgical technique and patient co-morbidity. Until know the most common, and easiest to measure, outcome parameter has been recurrence. Outcomes such as acute and chronic pain, and chronic infection, are probably affected by even more variables. Thus, in order to evaluate mesh safety massive data are needed to adjust for a large number of variables. Large registers have high volume potential, but because of the statistical complexity and large numbers of variables results on mesh safety can only be indicative regardless of the register size. Therefore, surgeon’s choice of mesh should be supported not only by high volume studies but also on recommendations from surgical societies.

Another issue to be dealt with before evaluating short- and long-term mesh outcome is the lack of consensus on which variables should be assessed and how they should be analysed. In addition, many countries have healthcare systems that rules out long-term patient follow-up. In the Nordic countries, all citizens are given an unique social security number at birth, making it possible to track all contacts to the healthcare system from birth to death (19). Given the opportunity to combine systematic perioperative data from a well-established clinical database with long-term data from nationwide health-related registries, it seems that such registries are the most cost-effective tools for mesh surveillance (17). Since this platform already exists and has proven its worth, the problem to be solved is to define when a mesh can be considered inadequate (11).

Acknowledgments

Funding: None.

Footnote

Provenance and Peer Review: This article was commissioned by the Guest Editor (Jacob Rosenberg) for the series “Hernia Surgery” published in Laparoscopic Surgery. The article has undergone external peer review.

Peer Review File: Available at http://dx.doi.org/10.21037/ls-20-110

Conflicts of Interest: Both authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/ls-20-110). The series “Hernia Surgery” was commissioned by the editorial office without any funding or sponsorship. The authors have no other conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

References

1. Drug Watch. Physiomesh flexible composite hernia mesh. 2016. Available online: https://www.drugwatch.com/hernia-mesh/physiomesh/ (Accessed July 1 2020).
2. BBC News. Mesh implants. 2020. Available online: https://www.bbc.com/news/topics/c7z4n8xjz27t/mesh-implants (Accessed July 1 2020).
3. Burger JW, Luijendijk RW, Hop WC, et al. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg 2004;240:578-83; discussion 583-5. [Crossref] [PubMed]
4. Le D, Deveney CW, Reaven NL, et al. Mesh choice in ventral hernia repair: so many choices, so little time. Am J Surg 2013;205:602-7; discussion 607. [Crossref] [PubMed]
5. Bay-Nielsen M, Kehlet H, Strand L, et al. Quality assessment of 26,304 herniorrhaphies in Denmark: a prospective nationwide study. Lancet 2001;358:1124-8. [Crossref] [PubMed]
6. Kokotovic D, Bisgaard T, Helgstrand F. Long-term recurrence and complications associated with elective incisional hernia repair. JAMA 2016;316:1575-82. [Crossref] [PubMed]
7. Kaufmann R, Halm JA, Eker HH, et al. Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial. Lancet 2018;391:860-9. [Crossref] [PubMed]
8. Klinge U, Park JK, Klosterhalfen B. 'The ideal mesh?'. Pathobiology 2013;80:169-75. [Crossref] [PubMed]
9. Fargen KM, Frei D, Fiorella D, et al. The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation? J Neurointerv Surg 2013;5:269-75. [Crossref] [PubMed]
10. Ciociola AA, Cohen LB, Kulkarni P, et al. How drugs are developed and approved by the FDA: current process and future directions. Am J Gastroenterol 2014;109:620-3. [Crossref] [PubMed]
11. Helgstrand F, Thygesen LC, Bisgaard T, et al. Differential recurrence after laparoscopic incisional hernia repair: importance of a nationwide registry-based mesh surveillance. Br J Surg 2020;107:1130-6. [Crossref] [PubMed]
12. Köckerling F, Simon T, Hukauf M, et al. The importance of registries in the postmarketing surveillance of surgical meshes. Ann Surg 2018;268:1097-104. [Crossref] [PubMed]
13. Dyer O. Johnson and Johnson faces lawsuit over vaginal mesh devices. BMJ 2016;353:i3045. [Crossref] [PubMed]
14. European Commission. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Available online: https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_en (Accessed April 5 2020).
15. U.S. Food and Drug Administration. Medical Device Overview. 2018. Available online: https://www.fda.gov/ForIndustry/ImportProgram/ImportBasics/RegulatedProducts/ucm510630.htm (Accessed May 5 2020).
16. Slack MK, Draugalis JR. Establishing the internal and external validity of experimental studies. Am J Health Syst Pharm 2001;58:2173-81; quiz 2182-3. [Crossref] [PubMed]
17. Helgstrand F, Jorgensen LN. The Danish Ventral Hernia Database - a valuable tool for quality assessment and research. Clin Epidemiol 2016;8:719-23. [Crossref] [PubMed]
18. Stechemesser B, Jacob DA, Schug-Paß C, et al. Herniamed: an internet-based registry for outcome research in hernia surgery. Hernia 2012;16:269-76. [Crossref] [PubMed]
19. Lynge E, Sandegaard JL, Rebolj M. The Danish National Patient Register. Scand J Public Health 2011;39:30-3. [Crossref] [PubMed]