Introduction: Today the use of textile meshes has become a standard for the treatment of abdominal wall hernias and for the reinforcement of any tissue repair as the strength of the implant decreases the recurrence rates. With increasing use, side effects of the textile implants became apparent, as well.
Areas covered: Based on publications in Medline over the past decade, general and specific benefits, as well as risks, are discussed with the challenge to define individual risk-benefit ratios. For meshes, certain high-risk or low-risk conditions can be defined. In an attempt to eliminate mesh-related risks, quality control for medical devices has meanwhile been revised. In both the USA and the EU post-market surveillance studies are required to keep medical devices approved.
Expert commentary: The impact of material on the complication rate will vary depending on the patient's co-morbidity or the risks of the procedure. Even the best material can end up with disappointing results in case of poor healing or poor surgery. On the other hand, when using high-risk devices, most of the complications after excellent surgery with excellent indication can be supposed to be mesh-related. Thus, the use of low-risk devices is recommended even though its advantage may not be demonstrable in clinical studies.
Keywords: Complications; FDA; hernia; medical device; medical device regulation MDR; mesh; post market surveillance; risk benefit ratio.