The Dutch Reporting Centre for Adverse Effects of Medical Implants (MEBI), which is part of RIVM, has received a report about Rebound HRD® (Hernia Repair Device), an inguinal hernia mesh. A patient suffered a bowel perforation after the metal ring in the implant broke. Because these implants stay in the body for a long time, MEBI estimates there is a significant risk of other Rebound HRD® implants breaking in the longer term. Sales of the Rebound HRD® were halted in 2018. In the Netherlands, use of the implant was limited.

MEBI is asking for all healthcare professionals and patients concerned to stay alert to (serious) health complaints related to this type of inguinal hernia mesh. People who have been implanted with this implant and experience health complaints can consult their physician. Both physicians and patients are requested to report any health complaints they relate to the Rebound HRD® (or other implants) to MEBI via the following website:

Risk of metal ring breaking

An inguinal hernia mesh normally remains in place for the rest of a patient’s life. The Rebound HRD® mesh is different to other inguinal hernia meshes because of the thin metal ring present along the edge of the mesh. Due to the frequent movement in the groin area, repeated bending can cause this ring to develop metal fatigue. Because the implant remains in the body for such a long time, MEBI estimates there is a significant risk of the metal wire breaking during the lifespan of the implant.

More insight needed into side effects and tissue damage

The extent of the risk of (serious) side effects or tissue damage when the metal ring breaks is still unknown. Another unknown factor is when these implants break. Also, not all broken rings will necessarily cause health complaints immediately or in the longer term. It is important to gain insight into the incidence of the metal ring breaking causing side effects. To that end, healthcare professionals and patients who suspect that health problems have been caused by the mesh can report such problems to MEBI.

Sales halted in 2018

In the Netherlands 3,266 Rebound HRD® implants were sold between 2014 and 2018. Every year 27,000 to 30,000 inguinal hernia meshes are implanted in the Netherlands. This means that when the Rebound HRD® device was being used, it represented only a small proportion (approximately 1 in 50) of the total number of inguinal hernia meshes implanted. After complaints about the metal ring in the mesh breaking, the product was withdrawn from the market in October 2018.