Following the November 2018 “storm” that occurred before and immediately after several journalists released The Implant Files Investigation, which contained data they collected about problems with orthopaedic implants, various reactions to this information were published. Among them was a statement from the EFORT leadership. Certainly, orthopaedic surgeons care that the best and safest implants are used in patients. No patient should ever question that. However, we, as surgeons, also must ensure we do some self-examination whenever we begin to use a new product or when the outcome of an implanted product does not meet our expectations.
EFORT welcomes European Union initiatives to further strengthen the documentation of new orthopaedic implants that are introduced to the market. They will have an impact on overall better outcomes at the end of the process. However, we must keep in mind that the outcome of surgery performed with implants is not only related to the product or device that was used but may be more related to the quality of surgery performed. This link must never be forgotten.
The link between outcomes and quality of surgery can, in fact, become stronger when there is a stronger bond between national health authorities and the organizations that deliver medical education. Furthermore, at the hospital level, we have to have systems in place that early and openly detect when a clinical outcome is not as expected. National guidelines and leadership are the keys here, as well as mandatory national registries.
A lot has yet to be done across Europe in this regard and EFORT can be a central player in that endeavor. We will never have 100% perfect orthopaedic and trauma implants that do not fail, loosen or get infected; but we must track all of our procedures — and all our implants — so that we can determine at an early stage if anything unexpected is happening. And, because we should not make that decision ourselves, an external authority is needed. However, not all sorts of implants in orthopaedics and traumatology can be looked at in the same regard. For example, when a diaphyseal femoral fracture has healed nicely using an intramedullary nail, the success rate of the product is 100% even though subsequent complications can occur. In contrast, no total knee or total hip implant will have a 100% survival rate. Thus, such validation is impossible for every orthopaedic product.
Fortunately, the November 2018 “storm” quickly quieted down. This was due, in part, to the fact the “disaster” was not as extensive as many people initially thought it would be and it simply did not capture the media interest that was expected. However, this served as a wake-up call. We shall stay the course, making sure the products we use are proven and validated. In addition, we will follow this up with the use of registries and national guidelines to ensure all implants are safe for our patients. One day, we may be the patient who needs to undergo an orthopaedic procedure, and we will certainly expect our surgeon to use proven and safe products.
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- Per Kjaersgaard-Andersen, MD, is Chief Medical Editor of Orthopaedics Today Europe. He can be reached at Orthopaedics Today Europe, 6900 Grove Road, Thorofare, NJ 08086, USA; email: email@example.com.
Disclosure: Kjaersgaard-Andersen reports no relevant financial disclosures.