Dear patients,
On 16 December 2018, the CE certificate for textured breast implants and tissue expanders from the manufacturer ALLERGAN was not renewed in the European Union (EU), Iceland, Liechtenstein, Norway and Switzerland. This is not due to any new scientific findings or studies on Allergan breast implants, but because the company did not provide the additional data on textured breast implants required for renewal of the CE certificate in time.
These regulations do not apply to the sale of Allergan breast implants in the United States, as they are approved by the US FDA. The CE mark for Allergan smooth breast implants has already been renewed and will continue to be offered in Europe.
As the French surveillance authority ANSM already suspected a link between the very rare breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and textured implant surfaces at the end of November this year, we would like to inform you about the symptoms of this condition and its treatment. So far, only textured implants from different manufacturers (not just ALLERGAN) have been associated with BIA-ALCL.
If you have a textured implant of any kind and you have no symptoms, there is no cause for concern, according to the current state of knowledge!
The symptoms of BIA-ALCL are:
Acute, painful swelling on one side due to a build-up of fluid around the implant that occurs years after implant surgery.
– Fluid build-up can occur for a variety of reasons, including BIA-ALCL.
– Laboratory analysis of the fluid will determine whether the rare BIA-ALCL is present.
– Breast lymphoma is not classified as breast cancer, but as a cancer of the lymphatic system in the breast, with very good treatment options.
– Surgery to remove the implant and capsule is the best treatment for BIA-ALCL.
Currently, around 615 cases of BIA-ALCL are known and have been documented worldwide since 1997. There are approximately 11 million patients implanted worldwide. Even the most unfavourable statistics show a risk of BIA-ALCL mortality that corresponds to the risk of a one-day visit to New York. However, it is important to better understand and study this rare form of breast lymphoma. Studies are already being carried out by experts around the world.
In all cases, there is no reason to panic and no reason to have the implants removed as a precaution. Patients should continue their personal breast care, including monthly breast self-examination, mammograms as recommended and an annual visit to your plastic surgeon. If you experience sudden swelling and pain years after implantation, you should immediately contact your board-certified plastic surgeon for evaluation.
As a member of the International Society of Aesthetic Plastic Surgery (ISAPS), we receive regular updates on this issue to keep you informed of any important news.
