Breast implants are medical devices that are used for breast reconstruction or to enlarge the breasts. A breast implant can be placed after a breast is removed during cancer treatment, or as a preventive measure. Breast implants are often placed to enlarge the breasts for cosmetic reasons. RIVM carried out a number of studies into breast implants, namely laboratory research, a review of the manufacturers’ product files and an evaluation of the scientific literature.
Breast implants and the risk of BIA-ALCL
ALCL is a very rare form of lymphoma. Women with breast implants are more likely to develop ALCL than women without breast implants. When ALCL is found in the vicinity of breast implants is called ‘breast implant-associated ALCL’ (BIA-ALCL).
As of April 5th 2019, as a precautionary measure, France has banned certain types of breast implants. The ban concerns macro-textured and polyurethane (PU) coated breast implants. These are breast implants with a rough surface. France made this decision because they see indications that breast implants with a rough surface present an increased risk of BIA-ALCL. The Dutch Health and Youth Care Inspectorate asked RIVM to assess the scientific substantiation of the French decision.
On November 19th 2018, RIVM organised an international expert meeting on BIA-ALCL. The meeting focused on sharing knowledge internationally, formulating research questions with high priority at this moment and exploring how to bring this research forward. RIVM published a summary of the meeting.
Survey health complaints of women with a silicone breast implant
RIVM was commissioned by the Dutch Health and Youth Care Inspectorate to investigate the health complaints of women with silicone breast implants.
- Gezondheidsrisico's van siliconen borstimplantaten : Evaluatie van een selectie van recente literatuur (Dutch only)
- Health complaints in women with a silicone breast implant : A survey
- Risk analysis of particulate contamination on Silimed silicone-based breast implants
- Silicone breast implants in the Netherlands : A market surveillance study