Warnings about specific breast implants
In the recent past, the Inspectorate has issued several warnings about breast implants. In these cases, there were problems in the production process, administrative deficiencies or fraud.
- PIP and M-Implants
In 2010, implants from the brands PIP and M-Implants were withdrawn from the market. The French manufacturer Poly Implant Prothèse (PIP) used industrial silicones. These silicones were not approved for medical use. In addition, PIP falsified documents and misled various regulators.
The PIP implants were also sold in the Netherlands under the name M-Implants by the company Rofil. In January 2012, the Netherlands Society for Plastic Surgery (NVPC) advised removing PIP implants and M-Implants. The Inspectorate adopted this recommendation. The implants have an increased risk of premature rupture.
In February 2014, the Inspectorate was informed that there were administrative problems with Cereform implants from the French manufacturer Cereplas. Therefore Cereplas' CE certificate was suspended. As a result, the implants could no longer be sold. The CE certificate would become valid again when the problems were resolved. Cereplas is now bankrupt, however.
The CE certificate from the Brazilian manufacturer Silimed was suspended on 17 September 2015. Subsequently, the certificate was withdrawn by the notified body that issued the CE certificate on 30 September 2016. During an inspection visit, the notified body found particles on the surface of breast implants. They turned out to be glass fibre particles, among other things. In cooperation with other member states, the Inspectorate commissioned RIVM to investigate the Silimed breast implants. The results of this investigation showed that there is no reason to replace the implants.
Furthermore, the notified body suspended the certificate for the assessment of the technical documentation of the breast implants of Silimed (the ‘Design Examination Certificate’) on 1 June 2016. This certificate was withdrawn by the end of September 2016. Now that both certificates have been withdrawn, Silimed is not allowed to place new products on the European and Dutch market.