IGJ position on textured and smooth breast implants and BIA-ALCL
At the beginning of this year, scientific research was published that shows that there is a link between a certain type of cancer and breast implants. This type of cancer, a lymphoma, is called BIA-ALCL and is very rare. The risks are therefore small. Read more about this on our website. Nevertheless, there is sufficient reason to carry out further research.
The Health and Youth Care Inspectorate (IGJ) participates in the European and international working groups on BIA-ALCL. With the help of these working groups, member states can more easily gather and exchange information and thus gain a better understanding of this rare disease.
The research into BIA-ALCL is ongoing. Researchers found that women who developed BIA-ALCL usually have (had) textured implants. Smooth implants are used far less frequently in the Netherlands. Research into this area is yet to provide a definitive answer as to how BIA-ALCL develops although there are several competing theories available.
On Monday, 19 November 2018, there was an international conference on BIA-ALCL. This conference was organised by RIVM, supported by the Ministry of Health, Welfare and Sport and the Inspectorate. Experts from other authorities from Europe as well as from the United States and Canada, scientific experts, representatives of breast implant registries and manufacturers participated. During that conference, participants discussed future directions for research on BIA-ALCL.
Although a predominance of the BIA-ALCL cases have been reported in patients with textured implants, there is still insufficient scientific evidence to comment on the link between BIA-ALCL and smooth breast implants. This requires controlled clinical trials that compare the results between groups of women with the two different implants. Scientific proof of causal relationship has not been established and the cause and the mechanism for the development of BIA-ALCL is yet to be determined. More research is needed. The scientific committee SCHEER, part of the European Commission, arrived at the same conclusion in its advice from October 2017.
In November 2018, the French competent authority (ANSM) advised opting for smooth implants from now on. However, IGJ is not prepared to follow that advice because it is not yet clear whether women are not equally at risk or even more at risk of developing BIA-ALCL with this type of breast implant. . We believe it is still too early to draw this conclusion from the research available thus far. Other EU member states are also not yet prepared to adopt the French advice. That is why they have taken a joint position, as described in this message.
Awareness and the number of internationally confirmed cases of BIA-ALCL increase. That means that more research is possible. In the future, hopefully even more data on the risks of breast implants will be available. The Inspectorate would like to emphasise that every implant and every operation involve risks. Women who are considering breast implants should talk to their physician to discuss the risks and benefits of breast implants in order to make a well-informed decision. Physicians must address the possible risk of BIA-ALCL during patient education. They should also discuss this risk with women who already have breast implants and return for review. The Dutch Society for Plastic Surgery has provided for extensive information about this topic. We advise patients who have any health concerns relating to breast implants, to consult their healthcare professional.