Breast implants are considered implantable medical devices.

All breast implants consist of an elastic silicone shell filled with either a silicone gel or physiological saline solution. In terms of the surface, the content and the shape, breast implants can differ according to the manufacturer or according to the desired result.

  1. Water-filled implants
    Physiological saline offers the advantage of very high safety, even in case of a leakage of the contents there is no health hazard. The implant is filled after it is placed, allowing the incision - and therefore the scar, to be kept small. With these implants, the volume can also be adjusted during surgery, which is sometimes useful to adjust small asymmetries during surgery.

    However, they have a shorter lifespan, in the magnitude of 12 years, as the filling valve sometimes leaks after this period. Small leaks inevitably occur and over the years lead to a decrease in volume and the formation of sometimes perceptible folds. Premature wearing may occur in these folds.

    Finally, the breast curve obtained is similar to that of a silicone implant, but the feel is less soft because water is not elastic nor compressible.
  2. Silicone-filled implants 
    The vast majority of breast implants today are filled with a silicone gel.  Older generations' implants (more than 20 years ago) were often filled with a liquid silicone gel, on the assumption that this would guarantee a supple breast for longer. However, when the breast becomes rigid, this is due to "capsular contracture" (about which more information can be found under "Are breast implants safe?"), and not related to the content.

    Quality breast implants today are all filled with a "cohesive silicone gel". This means that this content, although perfectly flexible to the touch and compressible, cannot run out of the implant should the shell leak. This prevents large amounts of silicone gel from entering the tissues. However, they require a slightly wider incision (about 4 - 5 cm). Another important advantage of cohesive gel is that it allows teardrop-shaped ("anatomical") implants to have a more stable shape (so-called "form stable implants") which is advantageous in some situations.
  1. Composition
    The shell of all breast implants is mainly made of a multilayered silicone membrane. Silicone is a strong, stretchable, waterproof and biocompatible material. It is the material used in the vast majority of medical devices, such as the coating of injection needles, catheters, pacemakers, etc. Silicone is also widely used outside the medical world, for example in lipsticks and other make-up products, and inside milk and juice cartons.

  2. Texture

    The surface of this silicone membrane can be either smooth, or finished with some degree of roughness (= "textured"). A third distinct category of implants has a polyurethane finish on the outside of the silicone membrane.

    • Smooth implants were the first implants used in plastic surgery. They have the advantage of allowing placement through a limited incision. However, they are less resistant to displacement by gravity and muscle action. They therefore "sink" more quickly downward or move sideways, which can sometimes be a disadvantage.
    • Nanotextured implants are similar to smooth implants but are less associated with developing a capsular contraction. They have the advantage of being easy to place through a small incision.  On the other hand, because of their poor adhesion to the surrounding tissue, like smooth implants they have little resistance to gravity or to the muscle action of the pectoralis major and can therefore easily move downwards or sideways.
    • Microtextured implants have a surface with microscopic imperfections. These irregularities allow better adhesion to the tissue and offer slightly higher resistance to displacement. Their main advantage would be better prevention of capsular contracture (shell), but this is still under debate.
    • Macro-textured implants have a rougher surface. The aim is to increase the adhesion of the implant to the site where it has been placed in order to minimise the risk of displacement and rotation. Protection against capsular contracture is a secondary objective. For both these purposes, these implants have shown some effect, although not absolute. Macro-textured implants have been withdrawn from the market due to loss of CE marking and are currently banned due to a greater described association with the phenomenon of breast implant-associated anaplastic lymphoma (BIA-ALCL) which will be discussed below.
    • Finally, implants with a polyurethane coating on the shell are a separate category. The contact surface consists of a three-dimensional layer of about 1 mm that functions like Velcro. These implants show minimal displacement or rotation after placement. They are associated with a low risk of capsular contracture. However, they require a slightly larger incision (about 5 cm) and are technically more difficult to position.




Almost all breast implant manufacturers offer round and anatomical (teardrop) breast implants in their range. Filling can be done with either silicone gel or saline for each of these shapes, although saline does not support anatomical implants well.

The choice of implant shape will depend on the indication for surgery (reconstruction or aesthetic), the patient's preference, and the surgeon's preference. A round implant will more often be chosen when more upper pole bulging and marked cleavage is desired, whereas an anatomical implant will allow a more "natural" cleavage and transition into the upper chest , with a rounding of the lower part of the breast. In breast reconstruction, anatomical implants are used more often.

The choice of shape is important: be sure to discuss it and let your surgeon know your preference.

In short: yes. However, complications can occur in breast implants, as with all medical implants (orthopedic implants, stents, heart valves, etc.).

Breast implants do not increase the risk of breast cancer, nor do they hinder screening.

The two most frequent complications that can occur in the medium or long term are the occurrence of an implant leak and the formation of a capsule (capsular contracture phenomenon).

  1. Leakage
    According to the manufacturers, a good quality breast implant has an average lifespan of 10 to 15 years. In the absence of clinical signs (change in the appearance of the breast, pain, etc.), it is recommended to check the integrity of your breast implants after 15 years. This is done by performing a "high definition" ultrasound scan, and if necessary, by a magnetic resonance examination (MRI). If a rupture is detected, it is recommended that the implant be replaced or, if you wish, permanently removed. Rupture is usually not a surgical emergency, as a cohesive gel will not spread into the tissue. However, it is recommended to remove or replace the implant within 3 - 4 months after the diagnosis of rupture. 
  2. Capsular formation
    Just like a pacemaker, a breast implant is a foreign body. The body can react in two ways: reject it or encapsulate it. A wooden splinter, for example, will be repelled by the body's inflammatory response. So-called inert materials such as titanium and silicone cause a different reaction. The body forms a thin film around the implant, so they are considered to belong to the body. This is also called a capsule. The formation of this capsule is therefore a natural and perfectly normal reaction. Capsular contracture may occur in some patients because the membrane formed by the body around the implant tends to become rigid or shrink. Over time (months or years) this stiffness may become more pronounced, leading to breast deformity and discomfort or pain. Capsular contracture in itself is not dangerous but will almost always result in a re-operation in which the capsule is opened, removed or not, and the implant is replaced or not. 

In recent years, three rarer complications have emerged and are described separately below. These are BIA-ALC (Breast Implant Associated-Anaplastic Large Cell Lymphoma), BII syndrome or Breast Implant Illness and BIA-SCC (Breast Implant-Associated Squamous Cell Carcinoma). See the respective tabs for more information on their subject.

BIA-ALCL is the abbreviation used for "Breast Implant-Associated Anaplastic Large Cell Lymphoma". This very rare phenomenon has been described since 2011 in a number of women with breast implants. So far this diagnosis has been made in about 900 women worldwide. It should be noted that approximately 35 million women worldwide currently have breast implants.

A lymphoma is a malignant degeneration of lymph cells, which are part of the white blood cells. It is not the same as breast cancer. The first symptom of BIA-ALCL is usually the sudden appearance of fluid around the implant, causing the breast to swell. A breast lump may also be suspicious, but this is much less common. If such an effusion, called a seroma, occurs, it happens on the average about 8 years after the implants were placed. One notices that one breast becomes significantly larger than the other. A seroma is almost always benign and is treated by a puncture (or several punctures) under ultrasound control. The punctured fluid should always be analysed for malignant cells. If the diagnosis of lymphoma is confirmed by this analysis, the implant and the entire capsule must be removed (total capsulectomy). If this is done in time, it will be sufficient as a final treatment.

In the early stage of the disease, surgery is considered the definitive treatment and the patient is cured. In the rare cases of confirmed deaths related to BIA-ALCL (about 5%), the disease was already at a very advanced stage at the time of diagnosis.

As lymphoma is a rare disease, it is important to be vigilant and to be aware of the warning symptoms that should make you consult your surgeon:

  • Increase in breast volume.
  • Breast or axillary mass in the breast with the implant.
  • Pain, abnormally high fatigue.

Updated information on this subject is available on the fagg / afmps website.

Recently, there has been a lot of talk on social media about women with breast implants who over time suffer from various complaints of different nature and severity. These complaints are grouped under the name "Breast Implant Illness" (BII) and are also sometimes grouped under the much broader denominator of ASIA (Autoimmune Syndrome Induced by Adjuvants). The list of complaints is long and varied. It can be consulted on the website of the American Food & Drug Administration (FDA).

Although there is no consensus yet on whether there is a causal link between these complaints and the presence of breast implants, women with breast implants who experience physical complaints should be taken seriously. BII has been described in women with silicone-filled implants and saline-filled implants.

It is of course necessary to exclude a possible physical cause that can be treated. If no physical cause can be found, removal of the implants can be considered but there is no guarantee that the complaints will disappear. The advantages and disadvantages of such surgery should be discussed with your plastic surgeon.

BIA-SCC or "Breast Implant Associated Squamous Cell Carcinoma" is another extremely rare phenomenon that can occur on average 15-42 years after implant placement. The opinion of ESAPS (European Society of Aesthetic Plastic Surgeons) is as follows:

  • SCC associated with breast implants is a very rare condition (<20 confirmed cases worldwide). To date, risk factors are unknown and guidelines for patient management in confirmed cases are still not available.
  • SCC is not exclusively related to breast implants and has also been reported in patients with dental implants or pacemakers.
  • Up to now, there is no evidence-based rationale for advising the explantation of unaffected breast implants based on these newly reported cases of squamous cells associated with breast implant carcinomas.

Since 1 May 2021, all implants (breast and other) must be registered centrally with the Federal Agency for Medicines and Health Products. This traceability ensures that all people with an implant can be followed up and that your doctor can always access your implant data.

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