What is meant by PROFHILO®?
21. August 2018
PROFHILO® is one of the most highly specialized......
WHAT IS BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA?
Undergoing breast surgery can change a person’s life for the better. Well over 1,000 of our patients will attest to that. Nevertheless, every operation also involves certain risks. Breast augmentation is no exception.
One of these risks has been causing increased discussion lately: breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Various platforms and medical articles have appeared on this which we would like to summarize here:
WHAT IS BIA-ALCL?
BIA-ALCL stands for “breast implant-associated anaplastic large cell lymphoma”. This is a rare form of cancer that should not be confused with breast cancer. The World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA) talk about a possible link between BIA-ALCL and breast implants. However, this has NOT been proven. Previous studies attempting to show a link between implants and lymphoma are not scientifically robust due to the paucity of data. There are currently just over 600 cases registered with the FSA. This compares to a number of 35,000,000 implant carriers. If you compare the number of breast implant carriers to this, the frequency is less than 1:50,000. If you compare this to the fact that every 9th woman develops breast cancer, this number is much smaller.
WHAT CAUSES BIA-ALCL?
The exact cause of BIA-ALCL is unclear. It is thought that the surface texture of breast implants plays a role: according to this study, implants with textured surfaces are more commonly associated with BIA-ALCL than smooth-walled implants. One possible reason for this is that texture creates a larger surface area, which unfortunately also provides more space for bacteria. These bacteria can in turn cause infection which, in very rare cases, leads to BIA-ALCL. Unfortunately, this theory is also on shaky ground, as more than 30 cases of BIA-ALCL involved smooth implants.
It is remarkable that especially implants of the company Allergan are affected more often than all other manufacturers and also a frequent occurrence in Australia can be seen.
I – Dr. Rolf Bartsch – have used implants from the company Sebbin for many years, which has a very delicate texturing and have now been using breast implants from the company Polytech from Germany for several years. At this company we use the type: MESMOsensitive® for round implants and POLYtxt® for anatomical implants. With the first type there is not a single case of BIA-ALCL known in the world, with the second type there is one primary case known. It is important for me to point out that the “texturing” of all Polytech breast implants is created by a so-called vulcanization and the surface is not “etched” as it is the case with other manufacturers.
As a result, the textured Polytech breast implants have a completely different surface than the Allergan Biocell breast implants most affected by BIA-ALCL:
Manufacturer Surface Roughness (Sa/μm)
acc. Barr et al. 2017/ Jones et al. 2018/ University of Darmstadt
Allergan Biocell 80 / 92 / –
Polytech POLYtxt® 42 / 59 / 43
Polytech MESMOsensitive® – / – / 24
Different implant surfaces
WHAT ARE THE SYMPTOMS OF BIA-ALCL?
BIA-ALCL most commonly occurs in the tissue around the breast implant, but can spread to other regions in the body, including the lymph nodes.
Common symptoms include:
In no way does this mean that every case of capsular fibrosis should also be thought of as BIA-ALCL.
HOW IS BIA-ALCL DIAGNOSED?
Half of all reported cases of BIA-ALCL were usually reported within 7 to 8 years of breast implant placement. If a doctor suspects BIA-ALCL, several tests are performed to rule out other causes of the symptoms. For example, the physician may perform a biopsy of the tissue or ultrasound-guided secretion aspiration. Science has made enormous progress in this area in recent years and has established appropriate diagnostic standards. We can organize this special examination (examination of the secretion for CD 30 and ALK1) within a short time for our patients at the University Hospital in Vienna AKH.
HOW IS BIA-ALCL TREATED?
If BIA-ALCL is diagnosed early, it is sufficient to remove the breast implants and surrounding capsule. If BIA-ALCL is diagnosed at the second stage, in addition to the removal of the breast implants and the surrounding capsule, chemotherapy is given to stop the disease. This type of lymphoma has a very slow progressive course and can be treated very well.
SUMMARY BIA-ALCL:
BIA-ALCL is a very rare disease that is thought to be related to highly textured breast implants. Symptoms that should prompt further investigation include severe general ill feeling and sudden swelling of one or both breasts with tissue fluid formation. Prophylactic replacement of breast implants or even removal without symptoms is NOT recommended by us or by the FDA.
The recent bans of some textured implants on the French market (April 2019) lack any scientific basis and will probably involve a legal repercussion.
I will be happy to clarify more details on this in a personal meeting and will continue to report here on possible developments on this topic. Based on the current scientific situation, we are convinced that our Polytech® breast implants are among the best in the world and that, especially with these products, the risk of developing ALCL is more than low.
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