The dental implant had been touted as a particularly simple System: It should also be of inexperienced dentists easily and directly with dentures. Yet in 2006 – as the implant was already two years on the market – it made headlines: Two Swedish professors went to the Public, because the one of the market leaders manufactured the System failed more often than the average. In 20 to 25 percent of the cases, it has led to a significant bone loss.
The case back is years. The special is, but Really nothing happened after that. That is a scarce commodity, became public. Normally, faulty systems disappear from the market again without the be Concerned will be informed that your implant is worse than promised. Even today, even in Germany.
“Still questionable dental implant systems with a lot of advertising and without adequate scientific documentation in the market down,” criticized the oral surgeon Martin Bonsmann, education officer of the German society for mouth-, jaw – and facial surgery.
Health damages are to be reported
There is a gap between the application, monitoring and control: According to the German medical product regulation, the manufacturer, or (Dental are committed to)Physicians, to report a product defect, if this is a serious health damage has occurred or could arise. In practice, this provision is being implemented, but, apparently, careless.
“According to industry estimates, are set in Germany, around 1.3 million dental implants per year,” says Frank Schwarz from the Executive Board of the German society for Implantololgie (DGI). “If only 0.1 per cent of the cases, problems would occur, should the competent Federal Institute annually 1000 messages.”
In fact, the Federal Institute for drugs and medical devices (BfArM) from January 2016 to December 2018 received implants, a total of 878 messages to the tooth. The vast majority of them not in systematic product turned out to be “errors as the cause for a Problem,” says BfArM spokesman Maik Pommer.
Between 2005 and 2016 1448 messages to dental implants were received, of which, according to the BfArM, only 73 cases could be attributed to a production error or design defect. This Definition is not the image but the Problem with some innovations, criticized Thomas Dietrich, head of the Department of oral surgery at the University of Birmingham: “The CE process for medical devices does not require evidence of Effectiveness in controlled clinical trials. Implantology has evolved significantly ,Trial-and-Error’ to the patient.”
Manufacturer guarantees free replacement
And not only Frank Black is certain: “It will be much reported.” Martin Bonsmann says: “Many dentists are aware of this reporting obligation, nothing. And other do simply, because a Re-Implantation is already expensive enough, and a message brings no advantage.” Dentists sent instead of the defective implants directly from the manufacturer and get a replacement free of charge. “This is a black box,” says Black. The former DGI President, but also emphasizes: “the crux of The problem with dental implants: We don’t know how many of the problems or losses are the result of the medical product.”
Error when implant about breaks, cracks or Defects in the bolt. A total of six recalls of the manufacturer are published on the BfArM website, in the case of some implants, for example, the interior is missing the thread.
But if a System is not standard, or after years of inflammation occurs, the most other reasons and not the case under the reporting obligation. “Can failure of an implant is also a good System,” says Black, “for example, due to craftsmanship error of the dentist.” This incorrect positioning could count, and problems in bone formation. Also the oral hygiene of the patient plays a crucial role, as well as other factors such as Smoking, poorly controlled Diabetes, or periodontitis.
At their annual Congress in November, the DGI recommended that in view of the debate to a poorly controlled medical products the use of dental implants, “the documented scientifically and their long-term success in clinical studies, it has been demonstrated”.
No registry for bad implants
There are more than 200 different implant systems on the market, advised to the society patients to ask their dentist, whether for a recommended System of long-term success is scientific evidence. The CE-marking”, per se, unfortunately, there is no evidence for a clinical documentation”. In front of problematic systems, the DGI legal uncertainties, not, could, however, warn says Black.
However, even if problems are reported, know patients often nothing. The reason is that There is no Central Register for dental implants exists. Who has which get used, knows only the treating practice. The Patient can be read sometimes in the implant to Pass, in the System, and OP-time noted.
X-ray picture of a mandible: An implant (left) powered with a single crown, behind two broken ceramic implants
But such a Pass is not compulsory. The result is that Neither the Patient nor the new dentist to know what was installed in the mouth. Again and again, dentists, therefore, are x-ray images with problematic, unfamiliar dental implants on the tray sides to the discussion and ask for peer assistance with the question to which it could act.
The idea of a single register for dental implants has been discussed by the European Association for Osseointegration (European Association for Osseointegration, EAO) the previous autumn. But implementation is still far off. How many dental implants in Germany is really made of, and how many when why will be lost, you do not know simply. Even a implant Register, as it plans, the Federal government is now across medicine products, would not help, since dental implants are not covered as a private performance.
In Sweden, the case was resolved 13 years ago, very coordinated: The regulatory authority for medical products (MPA) has confirmed that shortly after the publication of the shortcomings that the implant led some patients to unexpectedly severe bone loss, and recommended that the marketing to Change in the sales documents. The implant type should be used with restraint, until reliable long-term results were available. The System was already over 60,000 changes.