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The Danish Medicines Agency repeats its warning against silicone breast implants manufactured by Poly Implant Prothèse, France

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A group of experts in France are investigating the possible connection between PIP breast implants and eight women with breast implants who have developed tumours. In April and September 2010, the Danish Medicines Agency warned against these breast implants, and now we are repeating the warning.

In 2010, the Danish Medicines Agency warned against the silicone gel filled breast implants marked IMGHC-TX, IMGHC-MX and IMGHC-LS manufactured by the French company Poly Implant Prothèse. At the same time, the European Commission prohibited the use of these implants in the entire EU.

In this connection, we contacted the Danish clinics that known to us had used the concerned PIP breast implants.

We asked the clinics to contact the women concerned in order for them to have their implants examined. We also recommended women who knew that they had implants from PIP to contact the doctor/clinic responsible for their surgery. We would like to repeat this recommendation.

The Danish Medicines Agency still estimates that less than 100 PIP breast implants have been performed in Denmark.

The French authorities suspended all use of the concerned breast implants in 2010 and investigated the matter further. It has been determined that there is a higher risk that the implants may rupture, and the gel has an increased tendency to cause tissue irritation. The so-called genotoxicity tests that can show if the implants cause an increased risk of cancer do not suggest any such increased risk.

The case is relevant again, as different types of tumours have been discovered in eight patients with PIP breast implants. In France, 30,000 women have these implants from the company in question.

The Danish Medicines Agency keeps in close contact with the French authorities.

Created 03 January 2012