Medical-grade silicone
Medical-grade silicone is a synthetic polymer intended for use in or on the human body, manufactured to the highest standards of purity and quality.
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Important note
This article is for information purposes only and is not a substitute for a medical diagnosis or advice. If you are unsure, or if you require a personalised treatment plan, it is essential that you consult a qualified specialist.
The term ‘cosmetic surgery’ encompasses a wide range of surgical procedures designed to alter a person’s physical appearance and bring it into line with their personal expectations. The decision to undergo such a procedure is a significant step that requires thorough information not only about the possibilities, but also about the limitations and risks involved.
This article is intended to provide you with a reliable and comprehensive overview of the field of cosmetic surgery. It explains the key terms, outlines the most common procedures and highlights the crucial factors you should bear in mind as you work towards making a safe and well-informed decision.
What is medical-grade silicone? A definition
Medical-grade silicone is a synthetic polymer developed for use in or on the human body and manufactured to the highest purity and quality standards. It is fundamentally different from industrial-grade silicone (e.g. used in the construction industry).
Owing to its unique properties, it is one of the most extensively studied and widely used biocompatible materials in the field of medicine as a whole.
Why is medical-grade silicone used for implants?
Silicone has become the gold standard for soft-tissue implants for several reasons:
- Biocompatibility: The body generally tolerates medical-grade silicone very well. Allergic or immunological reactions to medical-grade silicone are extremely rare and there is little scientific evidence to support them, but they cannot be completely ruled out.
- Dimensional stability and feel: Silicone gels can be manufactured in various degrees of firmness. Modern gels perfectly replicate the feel of natural body tissue whilst retaining their shape.
- Durability: Medical-grade silicone is extremely resistant to ageing and to the effects of the body.
The structure of modern silicone implants
- The implant shell The outer casing is made of a sturdy, multi-layered silicone elastomer that is extremely durable. There are two main types of surface texture:
- The filling: cohesive silicone gel The days of liquid silicone are long gone. Modern implants are filled with what is known as a cohesive silicone gel. This gel is ’firm to the touch‘ and has a consistency similar to that of a gummy bear. It is not a liquid that can leak out. Even in the extremely rare event of a tear in the implant shell, the cohesive gel remains in place and does not spread throughout the body.
| Surface | Description | Potential advantages / disadvantages |
|---|---|---|
| Smooth | A completely smooth, non-porous surface | ✅ Minimal friction against the tissue ❌ Higher risk of slippage as there is no grip on the tissue; a precise surgical pouch is required. |
| Textured / Micro-textured | A slightly textured, velvety surface | ✅ Promotes integration into the tissue ✅ Lower risk of rotation and capsular fibrosis ❌ In rare cases, associated with specific implant-related complications (e.g. BIA-ALCL). |
Areas of application in cosmetic surgery
Safety and risks associated with silicone implants
Silicone implants are among the most thoroughly researched medical devices in the world. They are extremely safe when CE- or FDA-certified products are used and the operation is performed by a qualified specialist. Nevertheless, there are known risks:
- Capsular fibrosis: The most common implant-related complication. The body forms a thin layer of connective tissue (a capsule) around EVERY foreign body, including every implant. This is a normal reaction. In some cases, however, this capsule hardens and thickens, contracts and can lead to pain, deformities and a hardening of the breast.
- Rupture: A tear in the implant shell is possible, and the risk increases the longer the implant remains in place. This can be caused by material fatigue, ageing or – much less frequently – significant external impact. However, thanks to the cohesive gel, the contents remain inside the implant.
- BIA-ALCL: An extremely rare form of lymphoma (anaplastic large-cell lymphoma) that can develop in the connective tissue capsule surrounding the implant. The risk is very low, but it is discussed in every proper consultation.
The importance of having the right financial protection
Complications such as capsular fibrosis requiring treatment or a rupture necessitate a further surgical procedure (implant replacement). However, the costs of follow-up operations are only covered by the statutory health insurance scheme if a medical necessity is clearly demonstrated. In many cases, however – particularly in the case of cosmetic corrections or only minor symptoms – the costs are not covered.
Insurance against follow-up costs, taken out before the initial procedure, is the only way to protect yourself against these significant financial risks.
Frequently Asked Questions (FAQ) about medical-grade silicone
After decades of intensive research, no scientific link has been established between silicone implants and autoimmune diseases or breast cancer. The only proven exception is BIA-ALCL, an extremely rare form of lymphoma. In addition, the condition known as „Breast Implant Illness“ (BII) is currently under discussion, although no clear scientific evidence for it has yet been found.
Modern implants no longer have a specified lifespan. They are designed to last a long time, but not necessarily for a lifetime. Replacement may be necessary due to complications (e.g. capsular contracture) or a desire for a different size.
Yes. Regular annual check-ups with your GP and standard breast cancer screening (self-examination, ultrasound) are recommended to monitor the condition of the implants and the surrounding tissue.
Yes. For many problems, particularly those relating to facial ageing, there is a wide range of minimally invasive treatments, such as injections of fillers or muscle relaxants, which can delay or replace the need for surgery.