Amsterdam, 17 December 2025
Breast implants from American manufacturer not defective 
The Amsterdam court rules that the breast implants from Allergan marketed until 2018 are not defective. There is insufficient scientific evidence that the implants cause the autoimmune complaints some women suffer from. However, after years of research it has become clear that there is an increased risk for women with these breast implants to develop the rare form of lymphoma (BIA-ALCL). This risk is very small in absolute terms, while the chance of recovery is very high. The court rules that - even if this increased risk is caused by the implants - this does not make the implants defective products after weighing all circumstances. Allergan, as the manufacturer, is therefore not liable for the damage to the women.

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Bureau Clara Wichmann (BCW) started a collective action in December 2022 on behalf of 60,000 women against breast implant manufacturer Allergan. These women had textured breast implants (i.e., implants with a rough outer surface). According to BCW, the implants are defective products because they cause various immune system-related complaints (also called ‘ASIA complaints’ in relation to breast implants), such as muscle pain, rheumatic complaints, dry eyes, hair loss, fatigue, and forgetfulness. They also pose a risk of a very rare form of lymphoma (BIA-ALCL). BCW claims that Allergan provided insufficient information about these risks, although it was aware of them. According to BCW, the women are therefore entitled to compensation from manufacturer Allergan.

The court must decide, based on applicable (European) regulations and scientific evidence, whether Allergan’s implants cause the health complaints and/or a very rare form of lymphoma. And if so, whether Allergan, as the manufacturer of the implants, is liable.

Development of autoimmune complaints (ASIA)

In this case, it is not disputed that women with the implants can have (had) autoimmune complaints. However, the court rules that there is insufficient scientific evidence that the implants cause these complaints. Recent research, conducted at the Antoni van Leeuwenhoek (AVL), indicates that there is no causal relationship. Allergan is therefore not liable for damages suffered by women with these complaints. 

Development of lymphoma (BIA-ALCL)

Concerns have long existed about a link between BIA-ALCL, a rare type of lymphoma, and breast implants. How this cancer precisely develops and the role of the implants is still a subject of scientific debate. After years of research, it has become clear that there is an increased risk for women with textured breast implants to develop this form of cancer, but this risk is very small in absolute terms and the cure rate is very high. The court rules that if this increased risk is caused by the implants, this does not immediately mean the product is legally defective. This concerns a serious but very rare complication with a medical device. As with any implantable device, breast implants carry risks. This does not mean such a device must be immediately withdrawn from the market. Otherwise, no one would benefit from it, for example, in breast reconstruction after breast cancer treatment. Textured breast implants were very suitable for this and the alternatives also carried risks. 

Such a risk means that a manufacturer must inform the doctors to whom the product is supplied. Allergan has done this sufficiently since 2015, when more became known about the possible risk of BIA-ALCL. When the risk became concrete in 2018, supported by scientific evidence, Allergan withdrew the implants from the market.

The court concludes that Allergan’s breast implants are not defective and that Allergan is therefore not liable for the claimed damages. This means that the compensation demanded by BCW is rejected.

More information

For more information, you can send an email to the Communication team of the Amsterdam court. 

Judgment

    ECLI:NL:RBAMS:2025:9951