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Anaplastic Large Cell Lymphoma (ALCL)

In recent years, there has been much debate about breast implants and the development of diseases. It is understandable that women with breast implants are worried about these types of messages. This page contains information on breast implants and ALCL, a form of lymphoma. You will also read about the Inspectorate’s actions and what you can do yourself.

New research

On 4 January 2018, the results from a Dutch study on the relationship between ALCL and breast implants were published. This study indicates that although women with breast implants have a 400 times increased risk of getting ALCL, their chances of getting ALCL is still very small since the disease is so rare. There is a risk of approximately 1 in 7,000 that a woman with a breast implant will get this disease by the time she is 75 years old.

The Inspectorate takes the results of this study seriously. We consult with experts and other European regulatory bodies on joint follow-up research and other possible steps.

Complaints

Despite the increased risk for women with breast implants, ALCL is a very rare disease. If you have implants, swelling of the breast and lumps are reasons to see your doctor. Even if you have breast implants, the chances of developing ALCL are very small. This is why preventive removal of breast implants is not necessary
You can find more information on this page and please also check the frequently asked questions and answers about ALCL (in Dutch). Plastic surgeons also provide information on their website (in Dutch).
 

Information for doctors

We encourage doctors who see patients with breast implants, including general practitioners, (plastic) surgeons, pathologists, radiologists and oncologists to inform themselves about ALCL. ALCL is often seen in women who undergo repair surgery due to persistent, late seroma. This is a fluid accumulation in the breast. However, ALCL can also be present as a palpable mass. Women with breast implants who have symptoms that could point to ALCL must be referred to the right specialist as soon as possible. In case of removal of breast implants, it is important to register this and the indication in the DBIR breast implant register. More information and guidelines can be found on the NVPC site. We request doctors treating women with breast implants and (a suspicion of) ALCL to report to the IGJ. The data based on this document (in Dutch) should also be reported.

International research on ALCL

Experts and governments from other countries are also carrying out research on ALCL. Several recent studies are briefly described below:

  • European Commission - SCHEER, the scientific committee of the European Commission, issued a new advisory report on ALCL in October 2017. The commission conducted extensive literature research and spoke with experts.
  • France - The French regulatory body ANSM (Agence Nationale de Sécurité du Méedicament et des produits de santé) has asked all manufacturers of breast implants to carry out additional research on the biocompatibility of breast implants. This is the extent to which and manner in which the human body responds to the implants. This study is mainly focused on ALCL. ANSM expects the results in the course of 2018.

    This study is a follow-up study on previous research results that were published in May 2015 and July 2016. The French National Cancer Institute (INCa) assembled a group of experts. They carried out research on the link between breast implants and this rare form of cancer. In France, 46 cases of breast implant-related ALCL have been found in women with (textured) breast implants up to the first of Januari 2018. See also this update from ANSM published in July 2018 and this press release from INCa (in French).

    In November 2018, ANSM published an advice to no longer opt for textured implants. The Netherlands does not (yet) adopt that advice, just like several other European member states. They have drawn up a joint statement in which they explain their point of view.
  • Australia - In May 2017, Australian researchers published a study on BIA-ALCL in Australian and New Zealand women with breast implants. In September 2017, 56 cases were known to the Australian regulatory body TGA. Four women have died. All patients had textured implants.
  • United States - American researchers also published a study in May 2017 on BIA-ALCL. Between 1996 and 2015, they found 100 registered cases of BIA-ALCL in the US. In this study, ALCL also appeared to occur mainly with textured breast implants. The researchers found that women with a (textured) breast implant have an increased risk of developing ALCL in the breast compared to all women in the American population. They also mention that the risk of ALCL for carriers of breast implants is nevertheless low.