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Statement on media reports concerning dangerous breast implants

ALCL

At present, about 600 cases of this disease are described and verified worldwide. This means in absolute numbers and the number of patients with implanted breast prostheses (in the millions) all over the world, a very low number of this diseases.

What is lymphoma?

ALCL (anaplastic large cell lymphoma) is a rare form of T-cell lymphoma (cancer of the white blood cells), which probably occurs in connection with foreign bodies in the patient's body, and occurs about 6-8 years after a possible implantation.

However, this type of lymphoma has happened not only for textured implants, but also for smooth implants, expanders, (tissue expanders to build up the skin before breast augmentation and reconstruction), alveolar implants (in dentistry), but also described for osteosynthetic material in the treatment of fractures.

Texture is not the sole cause of the disease

Each type of implant consists of a texture (except smooth implants), and each implant manufacturer has its "own" patented texture of the silicone breast prostheses.

Today, texture is often discussed as one of the possible supporting factors for ALCL.

However, the cause of ALCL is multifactorial (there are a number of causes) and texture is not the main cause of this type of lymphoma.

The causes of disease with ALCL are unclear

At present, even experts and specialists do not have a clear view on this disease and there are considerable differences of opinion on the subject.

Some of the articles published do not have clear conclusions or recommendations, and there is further research.

Usually the incidence (frequency) is about 1: 30000 However, this may depend to a large extent on the region, or even the continent. The genetic make-up of the population of different countries/continents can also play a role (association with the HLA system - the antigen system in humans under immunity).

Clinical phenomena

Clinically, the disease leads to chronic accumulation of fluid in the breast, and its unilateral swelling. This should be taken as an opportunity to consult a doctor. The doctor will puncture the seroma and send it for analysis. We have already performed several dozen examinations in our clinic, and none of our patients has been diagnosed with this disease.

Currently, one case with this rare disease is being described in the Czech Republic. If treated in time, this disease is very well curable.

Every drug or implant used in the Czech Republic are approved by the State Institute for Drug Control. The quality is very closely monitored.

In case of doubt, it is ordered to stop using the drug or implants.

What we work with

At present we use Mentor and B-Lite implants, which, according to the ISO 14607: 2018 classification, belong to the category of implants with microtexture, i.e. with a texture of 10 to 50 micrometers (no macrotexture). The use of these implants are approved by the State Institute for Drug Control of the Czech Republic and the FDA (Food & Drug Administration) of the United States of America.

It is not appropriate to replace the implants, or uncertainty regarding this disease, even if the patient already has Natrelle Biocell implants in the macrotextured implants category.

The FDA does not recommend removing these implants in women who have not experienced symptoms associated with BIA-ALCL. However, it is recommended to monitor the breast area around the implant and have it checked by ultrasound.