Research on breast implants

Research on technical files of breast implants

The Inspectorate has commissioned RIVM to perform an additional study on the technical files of silicone breast implants on the Dutch market. This is a follow-up of an earlier study conducted by RIVM between 2014 and 2016.

That study showed several shortcomings in the technical files. In June 2016, the Inspectorate called upon the manufacturers to improve the technical files in consultation with their notified body. The follow-up study shows that the technical files of all manufacturers have improved. In most cases the items post market surveillance (PMS) and clinical evaluation still need further improvement.

Prior to publication, the Inspectorate has informed the manufacturers and their notified bodies about RIVM’s findings. In several cases the information necessary for assessment was available, but not sent to RIVM. Additionally, RIVM assessed some items differently than the involved notified body.

These notified bodies indicated in their reply that they agree with the view of RIVM. They will adjust their own assessment procedures accordingly. Please, refer to the frequently asked questions for more information about this follow-up study.

Openness about the results

The results of the RIVM study were published anonymously. As a result the reader could not identify which findings belonged to which manufacturer. The results of the research have raised questions from plastic surgeons, hospitals and patients. They would like to know, among other things, which results are linked to which manufacturer. Prior agreements were made about the publication of the research results and their anonymity. If the Inspectorate would violate this now, it would damage its supervisory capabilities. Investigations like this would be called into question since there is a good chance that manufacturers would no longer provide information to the Inspectorate. For manufacturers abroad, the Inspectorate also has no means to force them to supply information. Therefore, on 18 November 2016, the Inspectorate urged the manufacturers by letter (pdf file, 136 kB) to show openness about their individual results by lifting their anonymity on their own.

All manufacturers have agreed to this request. A table with the names and corresponding identification numbers of the manufacturers can be found in this attachment. Furthermore, the attachment provides additional information on resolved shortcomings for manufacturers SBI06 and SBI08. Additional information is also available on the website of RIVM.

Research on complaints from women with breast implants

RIVM has been commissioned by the Inspectorate to carry out research on complaints that women have reported to peer support group SVS (Foundation for Women with Silicone Implants). At the request of the Inspectorate, SVS supplied questionnaires in April 2016. RIVM looked at the questionnaires during the preparation of the research. It was found that the information supplied does not suffice for the purpose of responsible scientific research. The information should be more structured and a different questionnaire is needed. Therefore, the Inspectorate consulted with SVS to look at setting out a structured questionnaire among women with breast implants.

RIVM intends to use the research to acquire a clear picture of the different types of complaints that women with silicone breast implants have. RIVM is looking at whether there are trends and similarities in the complaints indicated by the women. The purpose of this RIVM inventory study is to achieve greater clarity about the variety of different complaints. The results of this RIVM research may be helpful in further scientific research on the effects of silicone.

Breast implants and diseases

Some women attribute physical complaints and diseases to their breast implants. Thus far, scientific research has not shown a relationship between certain diseases and breast implants. This involves diseases of the immune system and rheumatic complaints. However, there is evidence that women with a predisposition to allergic reactions have a risk of such symptoms if they have silicone breast implants. More research on this is needed.

Up until now, no increased risk of breast cancer has been found. However, scientific research suggests a link between silicone breast implants and ALCL – Anaplastic Large-Cell Lymphoma. This is a very rare form of cancer of the immune system. This disease particularly seems to occur in implants with a ribbed (textured) surface. It is important that women who are considering these implants are well informed about ALCL by their doctor.

In 2015, RIVM also published an investigation on the scientific literature from the past 10 years.

See also Anaplastic Large-Cell Lymphoma.