In the USA, the artificial Durom-Metasul hip the company room from Indiana got no approval. But in Germany, it was used thousands of times – although there were hints that your metal abrasion dissolves the bone. Hanspeter Hauke, the part had been five years in the body and suffers until today from the consequences.
Today, Hanspeter Hauke from Emmendingen in Breisgau regretted to have his hip replacement surgery waited for for so long. “Two years earlier, and I would be today, probably healthy,” says the former SWR-editor. In 2005, he got a hip Prosthesis, which was only started in 2003 the European market, and by many surgeons as a great improvement was seen.
Meanwhile, the “Durom-Metasul” by the US manufacturers, Zimmer Biomet, alongside other errors of medical products in the centre of the “Implant Files”, an international research work on dangerous medical products. 250 employees from 60 international media have researched on one and a half years in 36 countries, files, and documents reviewed, and patients and experts are talking about. In Germany, NDR, WDR and Süddeutsche Zeitung were involved in a massive medical scandal to uncover.
Hanspeter Hauke’s surgeon was so impressed by the novel hip Prosthesis: they had a much larger head than previous models. This should guarantee more agility and make sure that the artificial joint is jumping so easily from the acetabulum.
1000 faulty hip implants alone to a hospital in Freiburg, Germany
The then-50-year-old Hauke, who was tortured for over ten years, with increasing hip pain (“a congenital deformity of the hip, and a lot of sports as a football player”), was operated on in June 2005 in Freiburg, Loretto hospital, the “Durom-Metasul” was used in his left hip. “The model has been implanted most frequently, about 1000 Times between 2003 and 2008,” says the head of the self-help group “Durom-Metasul-LDH-hip e. V.” “As often happens in other clinics in Germany, we don’t know unfortunately. The manufacturer is not aware of any Numbers.“ private Hanspeter Hauke suffers from the consequences of a defective hip Prosthesis
After the initial relief of pain with him again soon noticeable. Longer or Going was gradually getting more painful. “I was hospitals, Doctors and University-and it was said: ‘The x-ray image looks good. You should have no pain‘. What I didn’t know at the time: The Problem was sitting under the metal head, the x-rays penetrate through.“
A handful of dead tissue at the time of Revision SURGERY
It lasted until 2010, when finally it became clear that Hauke’s symptoms indicated the use of the all on a massive inflammation in the operated hip. The thing out. It was a shock. “The surgeon took out with me a handful of dead tissue, the neck of the femur bone was eaten away. Debt-to-solid metal abrasion from the big-head made of chromium-cobalt-titanium.“
The rotten and missing bone substance has been built with artificial bone material, and the large metal head is replaced by a smaller one made of ceramic. The shaft had to remain in the thigh and could be easily freed from the toxic metal debris. The following five weeks after the OP, Hauke was not allowed to lie. It lasted five months, until the editor could work.
Of dangerous metal debris from chromium and cobalt
What he learned in this time, made him stunned: In about 130 Affected by the defective Durom hip had been replaced already. Also, the abrasion of chromium and cobalt had caused severe damage. To date, more than 230 are Re-operations.
And: The risk of this metal debris was already before the admission of the prosthesis in the year 2003, at least the manufacturer room knew by the doctoral thesis of one of his employees from this serious health hazard due to the metal head.
Perhaps the officials at the US health authorities have taken to FDA on the notes. They refused the product approval in the United States. In Europe, the company met Biomet room, the group sitting in headquarters in Warsaw, Indiana, in, no resistance.
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Manufacturer, not to the defectiveness of still
Today, the hip Prosthesis has disappeared from the market – not because the company had admitted a debt to the illness of thousands Hüftpatienten. “Officially it was called that because of the lower demand, the sales had been made,” says Hanspeter Hauke.
About 100 of the Injured party to complain against the room. Four cases are based in Freiburg, the European companies have already been negotiated, and in favour of the plaintiff is assumed. 25,000 to 30,000 euros for Pain and suffering was awarded in each case. The room has loaded, at the last Moment appeal. “Now the matter goes to the higher regional court,” says Hauke. The company wants to delay the final decision for as long as possible. Many of the older people will experience the final judgment. “But after all, the court has stated in its grounds of judgment of the defectiveness of the Hip replacement “Durom-Metasul”.”
Hanspeter Hauke is now an expert on the topic of “testing and approval of medical products”. He hopes that the revelations of the “Implant Files” to bring something in movement: For the highest risk class of devices, such as pacemakers, breast implants, knee and hip joints would have to be made prior to approval of clinical Tests. The approval should not be made solely on the Basis of documents. And there should be an independent Central prosthesis register, in which all the data are collected. “Everything must be transparent and safe for the patient.
The once athletic Hanspeter Hauke can’t walk long distances, and even shorter in him, and on some days problems. “I can’t stand any longer. I must therefore always hold to the Seating on the look-out,“ says the 64-Year-old, can’t be more professional. The dangerous metal that is used in Hauke’s body is undetectable. “As a result, the tissue in the thighs hardens gradually, he becomes hard as bone.” The condition is irreversible, so the pain he cannot get rid of.