International research collaborations on Breast Implant-Associated Anaplastic Large Cell Lymphoma ( BIA borstimplantaat gerelateerde (borstimplantaat gerelateerde)- ALCL Anaplastisch Grootcellig Lymfoom (Anaplastisch Grootcellig Lymfoom)) initiated by a scientific meeting organised by RIVM in Amsterdam on November the 19th, 2018.

On November 19th 2018, the Dutch National Institute for Public Health and the Environment (RIVM), supported by the Dutch Ministry of Healthcare, Welfare and Sport ( VWS Ministerie van Volksgezondheid, Welzijn en Sport (Ministerie van Volksgezondheid, Welzijn en Sport)) and the Dutch Health and Youth Care Inspectorate ( IGJ Inspectie Gezondheidszorg en Jeugd (Inspectie Gezondheidszorg en Jeugd)), brought together in Amsterdam (the Netherlands) an international multidisciplinary group of regulators, public health authorities, medical specialists, epidemiologists, experts on implant registries, and breast implant manufacturers to discuss the problem of a rare form of lymphoma seen in women with breast implants. 

In the past few years, an increased risk for a rare and usually well treatable form of lymphoma in women with breast implants has become apparent. This form of lymphoma is called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL has been described in an increasing number of case reports followed by more in depth research publications, by various research groups from the United States and Australia, as well as several other countries. In a study reported in JAMA Journal of the American Medical Association (Journal of the American Medical Association) Oncology in January 2018, the Dutch BIA-ALCL Consortium found that women with breast implants are more than 400 times more likely to get this rare form of lymphoma than women without implants, although the absolute risk remains small. 

During the meeting, open questions regarding worldwide variation in incidence of BIA-ALCL, possible associations with specific implants, host susceptibility factors (i.e. age, medical history, genetics), local infections, pathogenesis and treatment were discussed. It was concluded that international collaboration is key to learn more about this rare type of lymphoma in women with breast implants. Research goals were formulated, as well as initiatives to harmonise national breast implant registries and look more closely into pathology databases for the occurrence of BIA-ALCL. The International Collaboration of Breast Registry Activities (ICOBRA™) was proposed as intermediary to align the breast implant registries worldwide.  Finally, the participants brainstormed on possible funding strategies such as a public-private partnership model maintaining full scientific independence. 

International Working Groups in specific research areas will be established to prepare research proposals that will be discussed and further elaborated in a follow-up meeting in 2019. 

This document contains a summary of the meeting.

Gerelateerde onderwerpen

  • Medische hulpmiddelen

    Medische hulpmiddelen zijn producten die vallen onder de Wet op de medische hulpmiddelen. In de praktijk komt dat neer op alle apparatuur, software en gebruiksartikelen in de zorg met de uitzondering van geneesmiddelen. Het RIVM voert laboratorium en bureauonderzoek, zoals literatuuronderzoek en beoordelingen van dossiers, uit aan medische hulpmiddelen. Dit onderzoek vindt vaak plaats na een incident met een medisch hulpmiddel of naar aanleiding van signalen uit het veld. De veiligheid van de patiënt is daarbij het uitgangspunt.

  • Medical devices

    Medical devices are products which are covered by the Medical Devices Act. In practice, this comes down to all the equipment, software and consumables which are used in healthcare, with the exception of medicines. The National Institute for Public Health and the Environment (RIVM) performs laboratory and desk research (eg. literature research and reviews of manufacturers’ product files) for medical devices, with patient safety as the primary focus.