Breast Implants and BIA-ALCL Cancer?

What are breast implants and what are the different types?

A woman’s breast is one of the traditional symbols of femininity. For that reason, there is a long history of methods and devices aiming to achieve a fuller décolleté. In the early 1960’s the first silicone implants were used in a surgical procedure. Since then, millions of women worldwide have opted for augmentation with breast implants. For many patients, breast augmentation provides a boost in self-confidence or stands for a new beginning, if their breast has been removed due to cancer.

Since their introduction in the 1960’s, breast implants and also the surgical techniques have been constantly developed, to offer you a high level of safety and comfort. Nowadays you have a wide variety of breast implant shapes, sizes, fillings and also surfaces to choose from. For the vast majority of patients, the goal is to achieve a natural look and feel. Your specific physical characteristics therefore play a decisive role in selecting the right implant.

Breast Implant Shapes:

The first distinguish is between round and anatomical (tear-drop) shaped implants. While round implants provide a fuller look especially in the upper pole (area) of the breast, the tear-drop or anatomical-shape provides a more natural-looking bust. When choosing a POLYTECH implant, you can choose between four different basic shapes:

• The traditional round breast implant with circular support surface or base and a uniformly convex profile.
• The classic among the anatomical shapes, they have a round base and a tear-drop profile with more volume in the lower half.
• These implants are a variant of the anatomical shape. They have a shorter base surface and are particularly suitable for women with a lot of subcutaneous fat tissue in the neckline.
• These implants are again based on the anatomical shape: they have an extended base, so that for patients with little subcutaneous fat tissue, an aesthetic, gradual transition from the chest can be achieved.

As already mentioned, your specific preferences and body characteristics will determine which shape is the most suitable for you. The size of the implant usually depends on the same physical characteristics.

Breast Implant Filling:

The most popular implant filling is a cohesive silicone gel, which has several positive properties in achieving a natural and even shape, and a very pleasant feel and natural touch. Even in the rare cases of damage to your implant (due to excessive forces such as car accidents), the silicone gel generally retains its shape due to its characteristics as cohesive silicone.

Breast Implant Surfaces:

There are different breast implant surfaces. The first implants introduced in the 1960’s had a round shape and a smooth surface – the same surface is still in use today. The first anatomical implants coated with polyurethane were introduced in the 1970s, followed by round implants with polyurethane coating in 1984. In the late 1980’s, textured implants were introduced, aiming to copy the beneficial properties of polyurethane coated implants, especially to reduce the common problems with smooth surface – mainly capsular contracture or fibrosis. At POLYTECH, alongside smooth implants you will find two types of textured implants, one finely textured (Mesmo®) and the other slightly rougher (POLYtxt®). According to the current ISO standard, both surfaces are defined as micro-textured surfaces. POLYTECH also offers a micropolyurethane foam coated shell surface for breast implants, an extra-fine medical grade polyurethane foam, which is approved for long-term implantation and which has clinically proven advantages in reducing the risk of capsular contracture.(1)

What are the quality characteristics of implants?

Breast implants are regulated under the strictest medical devise category of CE – Class III, and are subjected to stringent safety standards and strict regulatory controls. Attributes to the high-quality implant are for example, the shell and the filling. The shell technology includes, among other things, a barrier layer to prevent permeation of molecular components of the silicone gel through the shell, and a unique sealing „patch“ on the back of the implant. The capacity of the shell is tested, among other things, in an elongation test and a material fatigue test.

In the fatigue test, for example, the dynamic forces working on the breast of a woman jogging are simulated. 6 million cycles corresponding to 30 km of jogging per week over a period of 10 years is the standard required. POLYTECH does 36 million cycles corresponding to 180 km/week for ten years. The implants have to be without any defect at the end of the test.

Implant filling

Cohesive silicone is used for the filling. This means that the silicone is strongly cross-linked, giving the implant a high degree of dimensional stability so that it cannot leak into the body in the unlikely event of damage to the implant shell. In terms of consistency, it is usually compared to the feel of gummy bear candy. However, the most important safety criteria is ensuring your breast implant has updated CE certification.

What is the significance of CE certification and what products are required to have it?

CE certification markings are known to virtually everyone in Europe, but few people understand what stands behind these two letters. „CE“ stands for „Communautés Européenes“ and can be translated as „European Communities“. This Certification is the “European Passport” for medical devices. With the help of this marking it should be immediately apparent that the product distributed meets the safety standards of the respective notified body in the EU and may therefore be distributed in all European countries without contradicting national regulations.

What is the CE certification process for breast implants?

Breast implants are classified under the CE as Class III medical devices, which is the most strictly reviewed medical devices class. The allocation of a product to the medical device classes is regulated by the European Directive for Medical Devices. Originally, breast implants were class IIb medical devices. In contrast to the rules of the Directive, the European Commission classified breast implants in Class III in 2003. Products with this classification are subjected to particularly strict rules during the manufacture period. These rules, which must be followed, are anchored in the European Medical Devices Directive. This Directive will be replaced in March 2020 by an even more stringent European Medical Device Regulation. Products can only be certified and approved if the manufacturer can demonstrate the performance and safety of its products.

The higher the class, the stricter the certification procedure, also known as the conformity assessment procedure. The conformity assessment procedure includes both of the examination of the quality assurance system from the entire company as well as the examination of the product design and is carried out by a state-appointed institution. Where available, compliance with so-called harmonized standards is checked, among other things. The harmonized standard EN ISO 14607 applies to breast implants.

There are announced (annual) and unannounced inspections in which the manufacturer must not only disclose all his processes, but also make the entire premises accessible. Compliance with the applicable standards and the notified manufacturing process (including sterilization, packaging and labelling of the products) is checked. Breast implants are recertified every five years.

Only if the fulfilment of the requirements is proven, a product receives the CE-certification and may be sold in the EU countries. Already in 1995, POLYTECH was the first implant manufacturer to immediately receive the CE mark and thus the approval to distribute the products throughout the EU.

Why are patients with breast implants currently concerned?

In December 2018, the French Notified Body G-MED refused to recertify an internationally leading implant manufacturer for textured breast implants. This manufacturer then recalled textured products throughout Europe. With this, the French health authority once again started a discussion on the safety of textured implants. Finally, on the 2nd of April, the French health authority decided only in France, to exclude from distribution in France implants classified as „macrotextured“ according to the specific definition of the French health authority. No other European country has yet adopted this approach.

The French health authority assumes that implants with a slightly more textured surface may contribute more to the development of an already extremely rare breast implant associated anaplastic large cell lymphoma. The first case of this disease, which was recorded in a possible association with a silicone implant, was described in 1997.

In Germany the number of patients with BIA-ALCL is currently 15 (as of 19.08.2019), in France the number of cases from 2011 to March 2019 is 59. The American Food and Drug Administration (FDA) published 573 cases worldwide (as of 06.07.2019). There is no clear data on the cases of BIA-AL documented worldwide. Nor is there any scientifically substantiated evidence of a casual connection between the implants, which have a textured surface, and the increased development of BIA-ALCL. However, it is more than understandable that the situation leads to great uncertainty for you.

What is breast implant associated anaplastic large cell lymphoma? (BIA-ALCL)

BIA-ALCL is a very rare type of lymphoma. Although this disease is associated with breast implants and occurs in the breast area, it is not breast cancer. Symptoms often include pain, heavy fluid retention, swelling and constant irritation. In many cases, however, the symptoms only appear after at least one year post implantation, often even after seven or eight years or even much later. It is important to emphasize that ALCL may not only occur with breast implants, but also with other implants. The risk of being affected by BIA-ALCL is geographically very different and is described as 1:3,000 to 1:30,000.

The exact cause of this lymphoma has not yet been identified. There are many theories. One assumption is that the coarser surface structure of some implants offers more space for bacteria, so that more bacteria can settle. These bacteria cause a permanent activation of the immune system. This permanent activation could possibly lead to BIA_ALCL. However, this is only an assumption.

„The ALCL issue is a serious one. ALCL is not a breast tumor in itself. It is an uncontrolled T-cell growth, which has been proven to occur with other implants in orthopaedics, oral surgery, etc.. The first publications were published in 1997 and 2008. In between, there is a very long period in which no ALCL cases have been reported. Only in recent years, several cases have been described, but mainly in Australia.
If you take a closer look at these publications, you will find that there is a lack of evidence. The few deaths were either not treated properly or started much too late. The risk of developing ALCL associated with a breast implant is in the per mille range. The advantages of high-quality silicone implants far outweigh this minimal risk. Nevertheless, this disease must be pointed out in the educational discussion. However, if there are serious concerns, the possibility of breast augmentation with the patients’ own fat can still be offered”.
Dr. med. Thomas Rappl

As already mentioned, this lymphoma occurs only very rarely. To find out if you have BIA-ALCL, the physician must remove fluid from the implant environment and send it to BIA-ALCL’s specialized diagnostic laboratories. If the test is positive, appropriate treatment will follow. Depending on the stage, it is sufficient for the surgeon to completely remove your implants and the capsule around the implants. If the disease has progressed further, you will usually need chemotherapy. Thanks to modern medicine, the chances of recovery are very good!

What role does the surface of the implant play?

Implants are divided into smooth, micro- and macro-textured surfaces, and polyurethane-coated implants. The classification of implants according to these surface structures is not uniform. For example, the French authorities have developed their own classification which does not concur with the globally acceptable standards, such as the ISO standard. The implants banned for use by the French health authorities are implants they defined as macro-textured. Implants with a smooth surface, micro or nano-texturing are excluded from the ban. The ISO classification is measured in µm. Nano-texturing, as promoted by one manufacturer, does not exist. However, there is still no scientifically substantiated connection, especially as the American Food and Drug Administration (FDA) has also identified cases of BIA-ALCL, in which implants with a completely smooth surface were used.

„The discussion, which is primarily conducted in plastic surgery circles and not in breast surgery or senology circles, is to my regret, not only undermined by personal journalistic and political interests, but also by clearly company-driven motivations. This leads to unjustified uncertainty among patients and a high degree of confusion among practitioners. BIA-ALCL is definitely multifactorial and it has not yet been conclusively clarified whether it is a purely proliferative disease in early stages. The numbers are uncertain. For example, the number of cases detected so far must be put in relation to the total estimated number of 35 million implanted implants. This leads to completely different statistical data on the figures, e.g. from Australia. Thus, if it would be a truly progressive disease, fatal cases would have been found in carcinoma statistics since the mid-2000s. This is not the case. The interplay of genetic principles, implant-immune system interactions and infections currently seems to be a possible aetiology. The quintessence of all the knowledge we have so far is that every practitioner must be highly attentive to patients with seroma formation after 5-8 years around an implant and with lump formation around an implant. Premature implant removals or even implant changes are not indicated.“

Expert – Prof. Dr. med. Ernst Magnus Noah

What is the MESMO® surface?

MESMO® is a special implant surface from POLYTECH that has been classified as microtextured by both of the French health authorities and other national authorities. The implants do have a textured surface, but a very fine texturing. The advantage of the MESMO® surface is that it is also well suited for anatomical implants, while smooth implants are not (require additional fixation).

Should I only insist on smooth implants for breast augmentation?

No. According to the vast majority of plastic surgery associations, textured implants, including anatomical implants, are considered to be preferred in breast augmentation. This is even more true if you are very slim, and in breast reconstruction and congenital anomalies. Anatomical implants can achieve natural looking results. According to the information gathered to date, the occurrence of BIA-ALCL cannot be excluded for any implant surface.

Do I have to remove or replace my implant?

The short answer is no. All of the global associations and health authorities currently recognize that according to the information available at present, there is no need to have the implants removed or replaced as a precaution. An operation always involves certain risks and stress on your body. Another reason for not acting prematurely is that replacing textured implants with smooth implants may increase the risk of capsule contracture, which will also require reoperation.

„[…] It is extremely important for the patient to have breast augmentation and breast reconstruction performed by appropriately trained specialists in plastic, aesthetic and reconstructive surgery, who are also available for the patient during the important aftercare phase to deal with questions and problems and can act accordingly. The American FDA (Food and Drug Administration,MOOCI) and the health ministries of many EU countries have recently allowed the continued use of macrotextured implants. Breast implants with all surface qualities can therefore continue to be used for both aesthetic and reconstructive purposes“

Expert – Priv. Doz. Dr. med. Lorenz Larcher, MRM

I have implants, can I still screen-test for breast cancer?

Yes. You can undergo cancer screening with breast implants. Using a special technique, the Eklund technique, mammography is also possible with breast implants. However, as a general rule, more images may be required. Make sure to inform the radiologist about having breast implants prior to the mammography.

Where can I get independent information?

It is very common to have concerns and uncertainties before and also after breast augmentation. If you have any questions, your surgeon should be your first choice for additional information. Our MOOCI specialists are always on hand to help and advise you. They can answer questions about the safety of implants and help you to obtain important information on related topics.