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