The MAN removes the dental implant market
Published the 30.06.2017 at 18h32
implants dentairesdentistedispositif medical
Implants to say the least, suspicious. The MSNA (National Security Agency of the Drug) has suspended the placing on the market and the manufacturing of medical devices designed by the company Ethical Medical Implant (EMI), based in Mérignac (Gironde). The materials involved are implants, comblements, construction implant, and diaphragms, all for the dental implant.
In its decision of sanitary police (DSP), the agency indicated that it had conducted an inspection in November 2016 in the premises near Bordeaux. The inspectors then discovered that the raw material from which the implants were made should never have been used for medical purposes.
“Not for human implantation”
“The packaging of the raw material reference VESTAKEEP 4000P found in stock on the website of the company EMI was wearing a labelling yellow with a statement reflecting the prohibition of the use in the state this raw material in implantology, human (” this material is not for human implantation “), ” notes the MAN.
The implants are designed from poly-ether-ether-ketone (PPEK), a material used for medical purposes after having been used for this purpose. Except that in the state, the reference VESTAKEEP 4000P ” figure on the list of raw materials for industrial use “, and non-medical – and even less in implantology.
Biocompatibility and toxicity
In the state, there is no guarantee the biocompatibility of the medical device that is not a, nor its toxicity. And this, then that such devices must be manufactured according to strict procedures “for mutual compatibility between the materials used and the tissues, cells and body fluids, “and to” minimize the risk posed by contaminants and residues “. The clinical data and preclinical provided by the company did not “demonstrate the performance of safety and health” of the equipment.
Moreover, the MSNA note of the failures in the sterilization process and storage devices. The agency shall request the manufacturer to proceed with the withdrawal on the market of the affected products and to contact professionals and companies that may hold these products.
According to the site societe.com the company Ethical Medical Implants is a very small structure, of three to five employees, including the sales in 2015 amounted to 7000 euros. Not what irrigate to the French market, therefore. Contacted to evaluate the risk to patients and the potential number of people involved, the MAN could not respond to our requests in the allotted time.
Patients who have a dental implant may refer to the card (or passport) implant, which contains the information relating to references of their implants.