News
Breast implant scandal opens discussion about new laws and regulations for registration process of medical devices
An EU-wide discussion has been triggered by the affair about the French company Poly Implant Prothése (PIP), who has placed defective products on the market for more than a decade. Also the Health Committee of the German Bundestag promotes that medical devices with a higher class of risk should be monitored more strictly in the future. Drugs and pharmaceutical products have to go through a complex registration procedure and it is now in question whether medical device manufacturer have to prepare for higher registration hurdles similar to the pharmaceutical industry.
Jürgen Windeler, director of the Institute for Quality and Efficiency in Health Care claims: For the benefit of the patients, the conditions for marketing products with higher risk category, such as cardiac pacemaker, knee joint, stents or hip prosthesis, should in principal not be different from the ones for pharmaceutical products.
A revision of the medical device directive is also being discussed at EU level.
The breast implant affair at PIP is not an exception. Also well-known companies from the United States got international attention due to product recalls within the past few years. However, the latest case at PIP is unusual due to the fact that the French company used industrial silicone, which is not approved for implant production, for more than 10 years. Obviously, the FDA has detected fundamental problems in their quality assurance already in the year 2000, but it seems that this has not caused any reaction on the part of the European health authorities or TÜV-Rheinland.
Furthermore, the industrial silicone for the breast implants was supplied by a German chemical trader, who evidently did not have much interest in the further usage of his product.
The question remains open, whether registration processes for medical devices with higher risk class will be changed. But certainly we will be able to follow interesting discussions this year. We will keep you informed.
Best regards,
Your MEDAGENT Team
Source:
Handelsblatt dated Jan. 09,2012
http://www.tagesschau.de/inland/brustimplantate106.html
http://www.dradio.de/dlf/sendungen/wirtschaftundgesellschaft/1648220/