Problems with breast implants

29 September 2010

On 8 April 2010, the Danish Medicines Agency warned against the use of breast implants pre-filled with silicone based gel labelled IMGHC-TX, IMGHC-MX or IMGHC-LS manufactured by the French company Poly Implant Prothèse. The products have also been sold under the name Rofil. The product is no longer on the market.

The French authorities have performed a number of technical tests on the products. The results of the first tests were published today (see link in the factbox to the right). The results confirm that the products do not contain the correct silicone gel and do not comply with the applicable technical requirements for breast implants.

The risk of rupture for PIP breast implants is higher compared to other similar breast implants.

We are now contacting the clinics we know have used the PIP breast implants concerned, requesting them to contact women with PIP breast implants to arrange for an examination of the implant. We also advise women who know that they have received PIP breast implants to contact the doctor/clinic responsible for the surgery. 

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

For further information
, please contact Ellen Jespersen, Head of Department, on +45 4488 9790 or eje@dkma.dk.

Danish Medicines Agency, 28 September 2010