|A new debate has flared up around a possible connection between breast implants and the emergence of an anaplastic, large-celled lymphoma (ALCL) in Europe. Background is the current decision of France to forbid several models.
Concernedly ANSM (french authority) are the products of six manufacturers. They are not allowed to offer these implants. The ban refers on implants of the manufacturer Allergan (Biocell), Arion, Eurosilicone, Nagor, Polytech and Sebbin.
|With the ban the health authorities have drawn the conclusion from an “important increase” of the cases of ALCL in connection with breast implants since 2011. The authority explained 56 cases of this rare but aggressive cancer form have been registered for 500.000 bearers of breast implants in France. All women concerned would had implants with a rough surface. Three of the persons affected died meanwhile.
The BfArM (german authority) pointed out that the special lymphoma which can arise in the implanted chest as a T cell lymphoma is largely unexplored till now. About 800 cases worldwide have been documented at about 35 million implants. Twelve cases of BIA-ALCL are reported to the BfArM in Germany. In opinion of the BfArM patients have very much low, but nevertheless risk for the development of a BIA-ALCL. This information was given in 2011 already.
The BfArM pointed out on a meeting with the FDA. The decision of the ANSM differs from the statement of the EU task-force. The minister said that Germany will not follow the example of France “at the present time” and not impose any ban.
Particularly a detailed patient information should be made by the doctor over risks connected to the application of breast implants. This should include the low but nevertheless existing risk for the BIA-ALCL, but also longer known risks, such as capsule contractions or inflammations. These risks concern both smooth and textured breast implants.
Moreover, doctors should inform that breast implants show a limited durability and one has be prepared to have secondary surgery. With a more detailed information the patient shall be enabled better with their doctor to take the individually best decision.
Normally the first manifestations of the BIA-ALCL are recognizable well for patients as well as for doctors. At a diagnosis in the early stage the forecast is very good.
|editorial staff||aerzteblatt.de, Apr 04 2019 (german)|
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