Press release of the company INCOM trading ltd - 12. 1. 2012

Press release of the company
INCOM Trading spol. s r.o. regarding the import of breast implants
POLY IMPLANT PROTHESE

Prague, 12th January 2012

The company INCOM Trading spol.s.o. was an exclusive importer of breast implants of the French company POLY IMPLANT PROTHESE (PIP) in the Czech Republic between July 2006 – March 2010. 2926 pieces of implants were imported into the Czech Republic within this period. 2427 pieces in total were sold for reconstructive and cosmetic plastic surgery. The PIP implants had been on the markets of all the countries of the European Union, as well as many other countries in the world, since 1991.

The PIP breast implants held all necessary certificates of quality and safety of medical material which allowed their sale in the countries of the European Union. The certificates were issued by a supervisory body which has the authority to issue such certificates – TÜV Rheinland Group, headquartered in Cologne, Germany. Every implant manufacturer must undergo a similar procedure of quality and safety inspection of implants. The certificates were submitted to state institutions in accordance with the valid regulations of the Czech Republic. The company INCOM Trading spol. s.r.o., like any other importer, had neither the legal right nor the practical means to approve the certificates and thus inspect the quality of the medical material. Therefore, the manufacturer and the supervisory body which issued the certificate bear full responsibility for the quality of the medical material. When the company INCOM Trading spol. s r.o. started importing the PIP implants into the Czech Republic, the implants had been on the market in developed countries for over 10 years without any signs of defect.

In March 2010 the Department of Incidents and Clinical Evaluation of Medical Devices of the State Institute for Drug Control got a safety report within the Rapid Alert Vigilance system of the European Commission regarding the PIP manufacturer, in which a defect on the side of the manufacturer was detected. The implants were withdrawn from the world markets and the company INCOM Trading spol. s r.o. immediately halted the sale of imported implants without delay.  All implants were duly recalled from doctors´ storerooms.  In April 2010 the number of imported implants and the number of recalled implants were duly reported in accordance with regulations of the State Institute for Drug Control.

After the 20-year-long presence of PIP on the market, there is no evidence supporting the connection between the implants and cancer.

The way in which, for some inexplicable reason, after nearly two years, the case has been reopened and dramatically presented by the media is inappropriate. The patients concerned have been informed about the possible problems with the PIP implants since April 2010; they have been communicating with their doctors and upon recommendation they have been advised to undergo regular ultrasound check-ups once every six months. Any other intervention of the media is inappropriate and unethical.

The company INCOM Trading spol. s r.o. disclaims any liability or any legal, expert or moral fault in the PIP affair. The company INCOM Trading spol. s r.o., just like the patients and doctors who implanted the implants, is only one link in the chain of the deceived, which has significant financial consequences.

Tomáš Hradil

Executive Director

Statement by the importer of PIP implants

In Prague, 21st of December

Dear ladies,

behalf of INCOM Trading Co.Ltd, we repeatedly apologies for any problems and concerns of mammary implants POLY IMPLANT PROTHESE (PIP).

Since 2006 till March 2010 our company INCOM Trading Co. Ltd was an importer and a distributor of mentioned mammary implants PIP.

We cooperate systematically with State institute for Dug control in Czech republic (SÚKL) and also with Medicines and Healthcare products Regulatory Agency (MHRA).

 

INCOM Trading CO Ltd. is  fully aware of the recent report in France of the death of a woman implanted with Poly Implant Prosthese (PIP) Breast Implants associated with an anaplastic large cell lymphoma (ALCL).  Woman died in November 2010, but no evidence of association with PIP implants.

 

MHRA agency publicated the announcement below..

 

-   We informed UK healthcare professionals about the FDA’s communication via a Medical    Device Alert (MDA/2011/017) which was issued in February 2011.

 

-   We have continued to monitor the safety of these breast implants. In 2010 we commissioned testing on the silicone gel filler.  Results from this testing demonstrated that there was no evidence of genotoxicity (potential for cancer) or chemical toxicity.

 

-   We have also continued to review available evidence for association of cancers of women with breast implants in consultation with the relevant UK Professional Bodies for breast surgery and surgical oncology and has concluded that there is no evidence to indicate an association with cancer.  Additionally the MHRA worked with the Cancer Registry and could find no evidence for an association.  The MHRA has not received any reports of women with breast implants of any type in the UK with a diagnosis of ALCL.

 

-   We continue to monitor any associations of all types of breast implants, including PIP, with cancers and any other health implications.  We continue to liaise with AFSAPPS and will study the French evidence, discussing these findings with our experts as a matter of priority.

 

-          There is currently no evidence to support routine removal of PIP breast implants.

We repeatedly apologize for any inconvenience that we did not cause. Have a nice day.

 

Best regards

Tomas HRADIL

Chairman of the board