Macro-textured breast implants not withdrawn from the market (in the Netherlands)
The Health and Youth Care Inspectorate [Inspectie Gezondheidszorg en Jeugd] believe that that there is currently insufficient reason to withdraw macro-textured breast implants from the market. This was decided by the Inspectorate after a scientific assessment by the RIVM. This assessment was performed after the French Inspectorate (ANSM) decided last month to withdraw these implants from the market. Like other European countries and the FDA, the Inspectorate does not adopt this decision.
The Inspectorate clarifies her considerations in detail in a letter to the Minister for Medical Care and Sport, which is included below.
The reason for the French decision is to prevent a rare type of cancer among women with breast implants (BIA-ALCL). The RIVM report has shown that cases of BIA-ALCL occur primarily with Biocell implants from Allergan. These implants are currently not available on the market in Europe and therefore neither in the Netherlands. According to RIVM, it is likely that Biocell implants are associated with a higher risk of BIA-ALCL than other breast implants.
The RIVM assessment and the available scientific literature have not shown that other macro-textured breast implants present a similar risk of BIA-ALCL as Biocell implants. Consequently there is no scientific or legal basis to withdraw other macro-textured implants from the market.
The alternatives for macro-textured breast implants are associated with entirely different risks. In addition, too little is known about the development of BIA-ALCL to exclude an association with other types of breast implants.
For many women breast implants represent greater psychological well-being. That applies, for example, to women who have had breast amputation due to breast cancer, women who have had their breasts removed preventively due to an increased risk of breast cancer, transgenders and women who receive breast implants for cosmetic reasons.
The inspectorate considers it important that women, together with their doctor, list the advantages and disadvantages of breast implants and decide on the best treatment option for them based on this risk-benefit assessment.
However, we do take several actions.
The Inspectorate is asking the involved notified bodies to conduct a dossier assessment on short term and/or bring forward already planned assessments. This to check whether manufacturers have sufficiently incorporated the developments regarding BIA-ALCL and where necessary have taken appropriate measures.. The Inspectorate is doing this in consultation with other European competent authorities.
- It is important that doctors discuss the existing risks, list the advantages and disadvantages and decide together with their patient/client on the best treatment option. The Inspectorate will include this point in its supervision.
- The Inspectorate will encourage and ensure that plastic surgeons do register breast implants in the Dutch Breast Implant Registry (DBIR). The DBIR records which breast implants have been implanted, which implants have been removed and the reasons for removal, as well as cases in which BIA-ALCL has been diagnosed. Eventually this will generate valuable information about the incidence of BIA-ALCL and about the implants involved.
- Worldwide a great deal of attention is being paid to BIA-ALCL and its consequences. The Inspectorate is following developments closely through contacts with researchers, experts, other authorities in Europe and elsewhere, and through participation in meetings like the one organised by RIVM last November [LINK toevoegen].
Upon any new information from these developments, we will continuously balance the pros and cons and decide if additional action is necessary.