Breast implants from the former company GfE Medizintechnik GmbH
11 January 2012, Cologne/Nuremberg
The former company and legal predecessor of the current pfm medical titanium GmbH, GfE Medizintechnik GmbH, also obtained silicone implants from the company PIP on the basis of a contractual cooperation. The product’s silicone shell was finished by GfE Medizintechnik GmbH with the application of a covalent bonded titanium coating on the inside and outside. After it was correctly approved, it was put on the market under the name TiBREEZE with a CE label between September 2003 and August 2004. Worlwide around 400 patients received the implants out of which ca. 280 were used in Germany.
At this point, no secure evidence exists as to whether the implants which were obtained from PIP by GfE Medizintechnik GmbH were also filled with the silicone that was not approved for this use. However, scientific clues exist that the covalent bonded titanised coating of the TiBREEZE implants, reduces “bleeding” of the silicone filling by 40%, which would result in reduced patient risk.
In view of this unclear initial situation, in its capacity as the legal successor of GfE Medizintechnik GmbH, pfm medical titanium GmbH, is closely cooperating with the responsible authorities. The treating physicians have already been informed and on the basis of their medical assessment, they have to make the decisions as to which extent they follow the German Federal Institute for Drugs and Medical Devices´ recommendations and decide on the necessity of medical actions.
The pfm medical Group has committed itself to ensuring the highest standard of product reliability and the patient safety. Mrs Herwald-Schulz, our head of Corporate Communications would be pleased to answer any queries you might have.
The English NHS Medical Directorate has published an Interims Report, that provides an extensive analysis of the situation.
https://www.wp.dh.gov.uk/mediacentre/files/2012/01/PIP-Breast-Implants_interim-report.pdf
Press contact:
pfm medical ag
Iris Herwald-Schulz
Head of Corporate Communications
T +49 (0)2236 9641-370
F +49 (0)2236 9641-99-370
M +49 (0)173 7016382
