What is silicone?

In medical science, silicone is used as a component of numerous products, e.g. probes, catheters, coatings of puncture needles and pace makers, gloves and wound dressings. In soft-tissue surgery, silicone implants are used for body contour correction. The first production process for silicone polymers was patented in 1958. Silicone or, as chemists call it, dimethylpolysiloxane, is produced as silicone elastomer, silicone gel and silicone oil. We encounter silicone every day: as anti-foaming agents for cooking, as water-repellent for clothing, as electrical insulation, as anti-acids for the stomach, as carrier spray in anti-perspirants, as the shine in cosmetics, etc. Silicone does not contain any additives, especially softeners. Intensive studies have not provided evidence of allergic reactions to silicone.

Are there different types of implants?

Yes, there exists a great variety of implants. Our goal at POLYTECH Health & Aesthetics is to do justice to the individual appearance of women. This is why we manufacture a wide range of silicone implants which offer a large scope for contour correction. There are four different basic models:

  • Même® – a round-based implant with central projection
  • Replicon® – a round-based implant with anatomical projection
  • Opticon® – an short-based implant with anatomical projection
  • Optimam® – a oblong-based implant with maximum projection in the lower half (anatomical projection)

The projection in turn can be defined in four different profiles: low, moderate, high and extra high. Every of these combinations is available in 18 different sizes. The resilient and highly resistant shell of our implants consists of several layers of silicone and is additionally equipped with a diffusion barrier preventing gel to permeate through the shell into the surrounding tissue.

Which filling materials are available?

For many years, silicone gel and saline solution have been proven to be the filling materials of choice for implants. Implants filled with highly cross-linked silicone gel present the state of the art for soft tissue replacement. The silicone gel used by us at POLYTECH Health & Aesthetics is form-stable and returns to its original shape after moderate compression. When cut in two, the gel in our implants shows its soft but cohesive consistency. In terms of tactility and movement it corresponds to the natural breast.

What is the reason for the existence of different implant surfaces?

Due to a natural reaction of the host organism, a capsule is formed around all foreign bodies inserted into the tissue, implants included. This capsule can close tightly around the implant and contract. This contraction deforms the implant shape and thus the shape of the breast. Additionally, the capsule can become very hard and cause pain. This complication is referred to as "capsular contracture" and the rate of its occurrence is related to the implant surface. The first implants were manufactured in the 1960s and had a smooth surface. Since the middle of the 1970s, micropolyurethane-coated implants have been in use. Textured implants were introduced at the end of the 1980s. At present, implants with these three different surfaces are available. Independently of improved operating techniques for implantations, micropolyurethane-coated implants result in impressively low capsular contracture rates of 0–3% compared to 30% with smooth implants. Textured implants also produce a clearly lower risk (15%) of capsular contracture compared to smooth implants (30%).These are the reasons for POLYTECH Health & Aesthetics to specialise in implants with micropolyurethane and textured surfaces.

Are tests performed to ensure the safety of the implants?

Yes, constantly. All over Europe, the Medical Device Directive and other international standards stipulate precise requirements for breast implants. Materials, product development, production, quality control, sterilisation and packaging are subject to strict regulations. Following two examples for the tests we perform regularly:

  • Fatigue test. In this test we check the dynamic forces working on the breast implants in the chest of a jogging woman. According to the Standard, 2 million cycles are required. This corresponds to a weekly mileage of 10km over a period of 10 years. The shell may not show any defect after this test. We do up to 36 million cycles with our implants remaining intact. This corresponds to a weekly mileage of 180km over a period of 10 years or a weekly mileage of 10km over a period of 180 years.
  • Elongation test. In this test we check the ability of the shell to resist deformation without wearing out. The maximum elongation stipulated is 450%, our shells achieve up to 950%, more than twice the required value.

Can an implant change my physical appearance?

Yes, and most of the time, this is exactly the objective of plastic surgery. A breast implant can give a very natural look and feel to the reconstructed breast. Obviously, the oncological aspects play a role in this context.19-21,48,49 Contour correction and augmentation can improve your looks according to your specific wishes.

Are there different surgical procedures?

Yes, a good many of them. We suggest you consult your physician if you want to know more about the surgical techniques practised in breast reconstruction and augmentation. Your physician is the specialist and she/he will explain to you individually the different methods and possible risks of the procedures.

Which incisions are used for an augmentation?

The access which is chosen by your surgeon depends on the results of his examination of your body. Incisions can be located in the armpit (axillary incision) or in the mamillary area (periareolary, transareolary incision). The most common access for implant insertion is an incision in the mammary fold beneath the breast (inframammary incision).

Where is the implant positioned?

For augmentation, the implant can either be positioned directly behind the glandular tissue (sub-glandular) or under the pectoral muscle (sub-pectoral / sub-muscular). In reconstruction, the positioning depends very much on the oncological aspects. Your physician will advise you which positioning of the implant is best for you. POLYTECH Health & Aesthetics implants with their filling of naturally soft, highly cross-linked silicone gel fit naturally to the body, whether positioned sub-glandularly or sub-muscularly.

Does cancer screening work after an implantation?

Mammography makes it possible to locate tumors. Using a special technique, the Eklund Technique, mammography can be conducted with women having breast implants. Modern imaging techniques like sonography, MRI or CT help to find tumors early.

What influence do breast implants have on cancer occurrence?

In extensive studies, it was evaluated that women with breast implants are not subject to a higher risk of breast cancer than women without such implants. A breast implant has no influence on the occurrence of breast cancer. Breast cancer due to smooth, textured or micropolyurethane-coated implants has not been observed in human beings nor in studies on animals. Independently of this situation, scientists discuss theoretical risks.

Do micropolyurethane-coated implants induce a greater infection risk than other implants?

No, not at all. Several studies show that there exists no increased risk for infection with micropolyurethane-coated implants.

Is there a link between autoimmune diseases and breast implants?

No. No plausible link between silicone gel-filled implants and autoimmune diseases has been observed.

Can silicone gel permeate through the implant shell?

In contrast to previous generations of implants, only negligible traces of gel can be found in the connective tissue capsule of state-of-the-art implants. This is due to the significantly improved quality of the implant shells now equipped with a diffusion barrier preventing gel permeation. Also, the highly cross-linked, cohesive filler gel and the reduction to an absolute minimum of low-molecular-weight silicone gel contribute to the high quality level of POLYTECH Health & Aesthetic implants.

How long does an implant last?

Each host organism shows an individual reaction to a foreign body. In the past, studies referring to saline and thin-shell implants have shown an average life span of ten years for breast implants in general. Modern implant technology combined with improved quality results in a distinct, individual expansion of this period. POLYTECH Health & Aesthetic offers patients the possibility to register with the programme Implants of Excellence. It includes an extended lifetime exchange warranty in case of shell rupture and continuous information on our mammary implants. Deciding for POLYTECH Health & Aesthetics implants and the programme Implants of Excellence means you choose the highest product quality combined with highest personal safety. Breast implants from POLYTECH Health & Aesthetics are CE-marked as medical devices. Regular testing demonstrates that the quality of our implants always meets the norms and exceeds the requirements of many of the standards. With the extended warranty for POLYTECH Health & Aesthetics implants you will enjoy liftetime benefits and additional personal safety.

What are the intervals for follow-up examinations after implantation?

The implants should be controlled semi-annually or annually by your physician.

What do I have to take into consideration after having had an implantation?

After insertion of the implants, you will receive an implant passport from your physician. Please carry this document with you always, so the information concerning the type and size of your implants is available when needed. Also, you should inform the person performing your mammography about your implants as well as any physician you see for treatment.

How do I prepare for the consultation with my surgeon?

The reconstruction or augmentation of the breast is a voluntary surgical intervention based on your personal decision. It may be helpful to prepare in advance a list of questions for your surgeon, i.e.

  • What implant size and form would you as my surgeon suggest? Why?
  • Where will the incision be located? And where the implant? Why?
  • How long will it take until the healing is complete?
  • How many days should I take off? When can I get back to work?
  • Is there anything I need to be aware of after the operation? (e.g. physical cutbacks in sports), etc.

Your surgeon will give you a thorough examination and extensive advice. Do not hesitate to discuss your questions with her/him. You should be very clear about your decision in favour of or against the surgery. This decision is very personal and will always be your own!

Where does POLYTECH Health & Aesthetics obtain the silicone used in its implants?

All silicones used for manufacturing implants at POLYTECH Health & Aesthetics are certified for long-term implantation. They are of the highest medical quality. Worldwide, there are only two companies that produce these silicones: Applied Silicone Corporation and NuSil Silicone Technology. Both are located in California. They have had their silicones tested and registered for this purpose by the FDA. The respective documentation is available to the European Notified Bodies.

What can cause a higher frequency of implant shell rupture and silicone bleeding?

To answer this we have to go to the molecular level. The physically correct term for "bleeding" is "diffusion". In the following section you will find a short explanation of what happens during diffusion. Within the context of breast implants, diffusion means that certain lowmolecular-weight silicones of the gel migrate into the shell and then diffuse through the shell. To prevent these very short silicone molecules from passing through the shell and invading the tissue, there are two strategies:

  1. One strategy is to chemically design the shell in such a manner that the low-molecular silicone particles cannot pass through. This is achieved by applying a barrier layer. This layer consists of a special silicone that does not allow the particles to migrate through the shell. Theoretically, the barrier layer could be applied directly to the inside or outside of the shell. At POLYTECH Health & Aesthetics we embed the barrier layer between two other layers of "normal silicone“, this is called the sandwich method. These layers increase the shell stability. In the chemical and/or physical processes described here there is no definite yes or no (i.e. not 0% or 100%). If we say that the silicone particles cannot pass through the barrier layer, it means that the migration rate is greatly reduced compared to that rate in "normal silicones“ – but it is not absolutely zero.
  2. Another strategy is to remove the low-molecular silicone particles from the raw silicone by applying special purifying procedures. These procedures are extremely complex and costly. The raw silicone for the gel filling that is produced in this manner is extremely pure. This is why these silicones are more expensive than simple industrial silicones. All reputable manufacturers of breast implants combine both strategies in order to avoid bleeding as much as possible. If a manufacturer used industrial silicone for the gel filling instead of the implantable silicone, it might be possible that the second strategy to avoid bleeding would no longer work and more bleeding could be the result. Industrial silicone that is not sufficiently pure may also be an explanation for a higher rupture potential of an implant shell. This would be due to the fact that the small silicone particles that migrate into the shell would lead to a "swelling" of the shell. The more particles migrate into the shell, the stronger the swelling. The swelling stunts the mechanical properties of the shell and would be a possible explanation for a higher shell rupture rate.

How do you ensure that the implants are biologically compatible?

The biological compatibility of breast implants is ensured on two levels:

  1. All raw silicones that can be used for long-term implantation must go through a series of biological tests.
  2. Additionally, finished implants are tested for biocompatibility. The international standard ISO 10993 dictates which tests must be executed and how they are to be performed. Additional tests according to the U.S. Pharmacopeia (American rules and regulations for pharmaceutical products and medical devices) are likely to be performed as the manufacturers of the silicone gel are American companies.

How does POLYTECH Health & Aesthetics ensure that the implants resist the mechanical forces during the implantation surgery and in the body for the years after?

Before and after the filling of the implants various shell tests are performed:

Directly after shell manufacturing, when the shells have been removed from the moulds, every shell is tested for thickness and weight. The maximum and minimum shell thickness are ascertained via approximately 10 measurements in three areas: the front (anterior), at the edge (equatorial), and the back (posterior). The results are checked for compliance with the specifications for implant shells. The weight is also an indicator of the thickness and regularity of the shell. Only shells that comply with the specifications proceed to the next step in the production process.

After the testing of the thickness and weight, the shell is checked visually for defects and irregularities.

Simultaneously, representative shells are selected daily from the production cycle and undergo destructive testing. Some of these tests are required by the Breast Implant Standard. Specimens are punched out of the selected shell and are subjected to tensile testing. One of these tests measures what forces are necessary to make a specimen rupture after it has been damaged by a standard cut. A non-damaged specimen from the test shell is tested for its elongation until rupture, and a third is checked for its ability to return to its original shape after a standard elongation without wearing out. Just to give an example: the maximum elongation according to the standard has to be 450%, our shells achieve an average elongation of 950%, which is twice the required value. With these tests we simulate the forces the implants are subjected to during implantation surgery. Just as with the tests described above, the lot from which the test shell had been selected only proceeds to the next step in the production process if all specimens have successfully passed the tests. This is a 100% control as one test shell is selected from every lot.

An integral part of the shell is the patch which closes the opening at the back of the shell created during the production process: the mould of the shell is mounted on a mandril and that is fixed to the workbench. The spot where the mandril is linked to the mould creates the opening. The patch is punched out from silicone sheets that are produced in the same way and have the same structure as the shells. These sheets undergo the same testing as the shells. The resilience of the connection between the patch and the shell is examined with tensile tests on representative specimens picked out daily from the production. Per patch lot one patch is picked for testing, thus 100% of all patch lots are tested. Of the patch tests performed by POLYTECH Health & Aesthetics only some are required by the Breast Implant Standard; we perform additional tests on the patches and the shells.

Before the patch is attached to the shell and prior to the filling of the implants with silicone gel the products undergo several small production stages. Every employee who takes over a semi-finished product in order to perform another step in the process will check the product forwarded to him. He will only process it if it complies with the specifications. This checking consists of visual controls for defects and irregularities. Once the employee has finished his task he will again check the product. He will only forward it to the next production step if it complies with the requirements. The next in line in the production cycle will apply the same checking procedure. As every product passes through 5 to 10 production steps it will be checked 10 to 20 times in addition to the destructive tests described above.

After the attachment of the patch, the shell is filled with silicone gel and vulcanized. The vulcanization will make the gel cross-link, producing the semisolid, cohesive consistency that is state of the art. Before being packed for sterilization, every implant is then checked in a final control. The criteria for the check are weight, irregularities, defects and damages, attachments/contamination, the stability of the connection between shell and patch. Then the implants are boxed in transparent blister packages and sterilized.

After sterilization and before the products are packed into the final cartons they are checked visually once more – one of the reasons why we use transparent sterilization packages. In this check we examine the packaging according to criteria ensuring that the sterility of the products is guaranteed for a minimum of 5 years. We also check the surface of the implants for contamination and verify that no bubbles developed during the sterilization procedure.

The quality of the sterilization is tested in special microbiological procedures. These tests are performed externally, by an independent test institute (Institut SGS Fresenius, Taunusstein, Germany). Additional tests that we regularly perform on finished implants are described in the following.

Fatigue test In this test we check the dynamic forces working on the breast implants in the chest of a jogging woman. According to the Standard, 2 million cycles are required. This corresponds to a weekly mileage of 10km over a period of 10 years. The shell may not show any defect after this test. We do up to 36 million cycles with our implants remaining intact. This corresponds to a weekly mileage of 180km over a period of 10 years (more than 4 marathons per week) or a weekly mileage of 10km over a period of 180 years.

Impact test A weight of 4.4kg drops free fall on an implant from a standard height. The forces working on the implant correspond to the impact created by the safety belt on an implant when a woman hits a wall in a car riding at 45km/h without using the brakes. Our implant shells resist these forces unharmed.

Static rupture test The implant is put in between two compression plates and slowly subjected to an increase in pressure until it ruptures. Typical values achieved are 500kg and more – much more than a human body would stand without damage.

What is the thickness of an implant shell?

The thickness of the shell depends on the type of implant. Implants with a textured surface have a thickness of 0.7 +/– 0.2mm.

Who grants POLYTECH Health & Aesthetics their CE Mark? and What certification procedure is followed by POLYTECH Health & Aesthetics?

A company‘s right to use the CE Mark for their products is the result of their having passed a Conformity Assessment Procedure (certification procedure). This procedure is audited by a Notified Body. The Notified Body responsible for POLYTECH Health & Aesthetics is MDC – Medical Device Certification GmbH. The certification procedure that we apply to our breast implants (and our other implants) is conform to Annex II of the Medical Device Directive 93/42/EEC including Section 4.

Are the POLYTECH Health & Aesthetics products recommendable without hesitation for implantation?

Definitely. We have more than 25 years of experience in the breast implant business and can provide comprehensive literature to document the safety of our products. We exclusively utilize materials certified for long-term implantation. Our products are checked scrupulously before and after each step in the production process. In this way, we ensure consistently high quality and safety for the surgeons and patients. We proved our dedication to safety when we launched the warranty program Implants of Excellence for our breast implants in 2007. This program enables us to follow-up on the patients‘ well-being after they receive our implants.

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