Breast implants that threaten to tear; Hip prostheses, in which the metal is rubbing to each other, and toxins free: the Only two examples of problems with medical devices, which are firmly anchored in the body of the Affected.
In Germany alone, in 2017, more than 14,000 deaths, injuries, and other complications associated with medical devices were reported. So many, as never before, reports the Süddeutsche Zeitung, WDR and NDR. Accordingly, the number of suspicious transaction reports in the last ten years has tripled.
That alone does not mean that implants and prostheses are more dangerous today than it was even ten years ago. The Numbers can be explained, inter alia, that Doctors and clinics to report today, common problems with medical products to the authorities. Today more products are being used.
It is beyond dispute that even for risky medical devices such as pacemakers or hip replacements still tab approval conditions and Doctors have little Chance to inform themselves about the risks and Benefits of new products. What does this mean for the patient? The most important questions and answers in an Overview.
Which products are affected by the problems?
In principle, all medical devices, from surgical tape on the OP-hook up to insulin pumps. Particularly critical, however, it is in the group of medical products with a high risk for the patient. Including, among other things, breast implants, hip prostheses, cardiac catheters, artificial heart valves and Stents.
What are the problems in the approval of these products?
In comparison to drugs, the hurdles for the approval of medical products are extremely low – even when it comes to critical products such as pacemakers or hip replacements. After the scandal around faulty breast implants, the System was revised in the year 2017, while Europe-wide. The experts, however, criticize up several problems:
- The wrong financial incentives used during the test: unlike in the case of medicines decides in the case of a pacemaker, and co. have no authority over the approval. The task is instead in the hands of so-called “Notified Bodies” – in Germany, various TÜV-branches. You test the products and give the market free.
A Problem of this system is funding. The “Notified Bodies” are of the orders of the company. In addition, the manufacturer of medical products in Europe may choose one of the approval bodies. This increases the competitive pressure and creates incentives to make the process for businesses as simple as possible. - Hardly any study data is necessary: In the case of new drugs with elaborate studies demonstrate that the Use of the funds, the risks exceeds. In the case of medical products, the main criteria are to demonstrate the safety of the product and to show that it works technically and medically. In the past, many products is on the market, without being systematically tested on patients.
This has changed in 2017, at least in the case of the medical devices with the highest risk. Since then, the manufacturer must demonstrate that an acceptable Use of cash-to-risk ratio exists. Unlike drugs, no studies are however still required, in which different therapies in randomly selected patients groups against each other will be tested. They are considered to be the best way to the effectiveness of a treatment. - Lack of transparency: so Far, it is for Doctors and patients is hardly possible, different medical products to compare and select the best. This is partly due to the fact that the data on the basis of which a product has been approved, often remain secret. On the other, a directory in which all the available medicine, are listed on the products is missing.
That’s about to change, according to a decision of the European Commission in the future. Therefore, the Public should be informed in a database about the existence of all available products and a summary of the clinical evaluation. It remains to be seen, however, whether the information published actually write sufficiently detailed, neutral, and fully will be, a critic.
In summary, one can say that there are significant criticisms of the marketing authorisation for medical products. The endangering the Welfare of a patient, because many of the products are tested in the market approval and Use of Doctors of information and risks is missing.
There are plans to improve the System further?
In the year 2020, a new European regulation in force, to exacerbate the clinical evaluation of the products. Federal health Minister Jens Spahn promised now in the “Rheinische Post” is an industry-independent body in which all of the implants used must be reported, in order to obtain a better Overview.
The consequences of the lugs schemes from the past, however, resonate for a long time. Often years pass until defects at implants make a noticeable
How do I find out if my implant everything is in order?
A product of a recall, a warning or other problems is affected, Doctors must inform their patients about it. Who gets no message and still have concerns, you can also ask his doctor for an evaluation. In specialised centres, doctors have a range of experience with different implants.
It is more difficult to obtain information on the risks of an implant. The Federal Institute for drugs and medical devices BfArM, there is a database in which measures such as call-back are recorded.
Patients are advised to use an implant, they should at least ask a second doctor for an evaluation. Often, it is also advisable to not let the all the latest, little-used products. You should also ensure that after the procedure, an implant passport. This contains information on which product was used.
What do I do if there are problems with my implant?
It is best, at that time attending surgeon. This know of the findings, at best, cited the “Süddeutsche Zeitung” an expert. He can verify, therefore, whether the implant should be replaced. In case of doubt, it is, however, also in these cases it is advisable, a second opinion.
Even if a product is affected by a recall, that doesn’t mean automatically that it has to be removed. In addition, the supervision may be by the doctor adjusted. These include, for example, regular blood samples, if in the case of an implant of metal rubbing on each other and hazardous substances can be released.
Am I entitled to compensation?
Who needs to leave due to complaints of an implant of renew, you should document the process well and in the hospital after the SURGERY documentation issues. In addition, the hospital should give the patient the removed implant – he has a right to it. It can be used in court proceedings as evidence.
A company has recalled a implant, can contact the patient with the surgical pads in a first step, directly to the manufacturer. The company’s offer in these cases is directly for Pain and suffering. Then it is up to the discretion of the patient, to decide whether the sum is reasonable. If not, patients can consider a lawsuit, and a specialist lawyer for medical law consult. This possibility also exists if the company makes an offer.
Help patients receive the procedure from their health insurance companies. A further possibility is to ask a self-help group to support, there are, for example, for defective hip replacements.
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