Implant Files

Priv.-Doz. Dr. med. habil. Johannes Schauwecker
Munich, December 3, 2018 – Under the heading “Implant Files”, leading media all over the world are currently reporting on defective implants, including hip endoprostheses. An important topic also finds Priv.-Doz. Dr. med. habil. Johannes Schauwecker of the Orthopedic Center Munich East (OZMO). The orthopedic specialist is an experienced specialist in minimally invasive joint replacement at the hip and knee joints and has been a certified main surgeon for joint replacement operations for five years.

Dr. Schauwecker, the Süddeutsche Zeitung and other leading international media have been discussing defective implants under the collective term “Implant Files”. Rightly so?

Dr. Schauwecker: “Medical devices can perform almost biblical miracles,’ writes the Süddeutsche Zeitung, for example, and is absolutely right. However, and here I also agree: ‘This medical high-tech also has a dangerous side if it is sloppily developed and carelessly controlled’. I therefore very much welcome the fact that the issue of medical device safety is now being widely discussed. It has been known for years that the use of implants is not automatically safe.
their suitability and safety can be assumed. In this case, the patient must trust his treating physician to the extent that he has sufficiently checked such properties of an implant himself. And because implant costs are usually part of the flat rate per case and are not billed separately, there is unfortunately also an incentive to increase the overall revenue of an operation by using cheaper implants. However, the topic of implant safety has long been given importance in the field of orthopedics and trauma surgery. For example, in response to the prosthesis scandal, among other things
with metal-on-metal bearing couples founded the German Endoprosthesis Register in 2010 on the initiative of the German Society for Orthopedics and Orthopedic Surgery.”

As a patient, how can I protect myself from receiving a defective implant?

Dr. Schauwecker: “The insertion of an implant is usually an intervention that can be planned. The patient therefore has time to obtain information and ask, for example, who the manufacturer is and which implant it is. Subsequently, the patient should obtain a second specialist opinion before agreeing to a scheduled surgery. This can clarify whether the surgery makes sense at all and whether the implant is suitable and meets the necessary standard. Of course, a second medical opinion is only worthwhile if the second doctor has extensive experience in the relevant specialty. But then it can avoid an unnecessary operation or unsuitable implant or, by confirming the indication, clear up doubts in the patient and make him feel more secure.”

Are there really implants that are of dubious quality?

Dr. Schauwecker: “I only use implants that I myself have previously checked for a sufficient study situation, that have already been used over a longer period of time and that also have the strict American FDA approval and are continuously monitored. Due to my many years of experience with joint replacement operations and my work as a TÜV expert, I am aware that there are inadequately tested implants on the market, such as cheap replicas from low-wage countries. Who as a patient this
risk, should ask his attending physician for the exact designation, i.e., manufacturer and type, of the intended implant before undergoing surgery.”

Experts estimate that one in three orthopedic surgeries in Germany is actually unnecessary. Artificial joints are inserted too often and too quickly, especially at the knee and hip. How come?

Dr. Schauwecker: “Often, a decision is made only on the basis of the X-ray image and surgery is advised. Although the doctor can recognize the signs of wear in the joint on the images, the decisive criterion for a surgery that can be planned is always the patient’s level of suffering. If the level of suffering is not that high or if non-surgical treatment options have not yet been exhausted, then surgery may be too hasty and thus unnecessary. Therefore, it is important to take the time for an in-depth conversation and
To perform a comprehensive examination of the patient and recommend surgery for each patient individually.”

As a patient, how can I tell if the doctor has the appropriate expertise?

Dr. Schauwecker: “In general, every patient has a free choice of which doctor to choose. A patient should therefore ask exactly what experience the surgeon has and how often per year he performs the surgery in question. It is advantageous if the physician is an Endocert-certified main surgeon, i.e. can demonstrate the corresponding routine and competence as well as the required infrastructure. This also assures the patient that both the surgeon and the clinic adhere to strict guidelines and standards.”

As a patient, should I expect extra charges if I get a second opinion?

Dr. Schauwecker: “Patients who seek a specialist second opinion do not usually have to undergo all examinations again, but bring their initial examination results with them. Since the Healthcare Strengthening Act passed by the Bundestag in 2015, every patient has a right to have all documents and results of the initial findings handed over. There are no costs for the patient, as these are covered by the health insurers – which is also in their interest, as this may prevent an operation.”