PatBroc_Recon_DK_2015-09.pdf

DIE WELT Beilage Plastische Chirurgie 10.09.15.pdf

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- Juni 2015, Mybody.de: Interview mit Dr. Timo Spanholtz (LInk zu Mybody.de) - Übersetzung Englisch (PDF)

 

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  • FAQ: A list of questions and answers frequently forwarded to us in connection with implants and surgery.
  • Glossary: On the subject of implants and their use in plastic surgery many technical terms are used. For this reason, we have set up glossary where you can look up terms if need be.
  • Links: A list of interesting websites and posts connected to our core topics.
  • Press center: Check out our terms for using texts and pics from our website.

 

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A B C D E F G H I J K L M N O P R S T U V W X Y Z
A  
abdominoplasty removing excess fatty tissue from the abdomen, also referred to as “tummy tuck”
ablatio mammae surgical removal of the female breast, mostly due to carcinoma
amputation surgical ablation of a body part
anamnesis patient status and history as established by a physician
anterior the general term applied to the front part of the body or any structure
aplasia underdeveloped breasts, flat chest
areola the darkened ring surrounding the nipple of the breast
areomamillary pertaining to the nipple or the areola
aspiration removal of liquids accrued in a cavity through extraction with the help of a cannula
asymmetry irregularity of the breasts, usually referring to their differing in size
augmentation (mammoplasty) enlargement (of the breast)
autoimmune diseases diseases of the immune system where antibodies harm tissues of their home organism
autologous reconstruction (breast) reconstruction with tissue from the patient’s body
autotransplantation transplantation of tissue from one part of a patient’s body to another
axilla; axillary approach armpit; accessing the implant position via an incision in the armpit, along the chest wall
B  
Baker classification Capsular contracture may be an adverse effect occurring after the insertion of breast implants. The Baker grades I, II, III and IV are a classification system for capsular contractures; the lower the degree, the softer the contracture.
base size the diameter of a prosthesis measured at its base when placed on a flat surface
benign (med.) pertaining to tumors that do not spread and grow aggressively
bi-lateral pertaining to both sides
biopsy extraction of tissue through punction (with a needle) or excision (with the scalpel) for histological or cytological testing for tumors
bleeders vessels ruptured as a pocket is dissected, usually coagulated
blepharoplasty surgery of the eyelids
blunt dissection separation of tissue layers with blunt instruments or fingers
breast implant A medical device that is used for breast augmentation or post-cancer breast reconstruction. It consists of a dense, multilayered silicone-elastomer shell that is filled with saline solution or highly cohesive silicone gel. The current state of the art is the silicone gel-filled breast implant because the result is more permanent, highly aesthetic and more natural to the touch and in movement.
C  
capsule a natural reaction of the body to surround a foreign object with a fibrous sheath
capsular contracture / fibrosis hardening of the capsule around a foreign body, sometimes painful
caudal anat. towards the tailbone
C.D.M. Custom Design Mould. A moulage molding technique from which a custom-made implant is made.
centimetre (cm) 2.5cm = 1″ (inch)
closed capsulotomy a technique to relieve the tension of a firm capsule by applying external pressure to the breast with the heels of the hands; often called the “squeeze” technique
cohesive gel silicone gel that has a high viscosity (very slow flow rate) and tends to adhere to itself as a mass
contra-lateral on the opposite side
cooper’s ligaments suspensory ligaments of the breast
Computed Tomography / CT 3D medical imaging method created with the help of computers and a large series of 2D X-ray images
curative therapy healing treatment
cutis outer skin layer, composed of dermis and epidermis
cytological examination cell examination with the help of a microscope
cytostatica remedies to block the growth of tumors (may also damage healthy cells)
cytotoxicity noxiousness of certain substances for a cell; the term is often used to describe the adverse effects of anti-cancer drugs
cyst lump in the human organism filled with more or less liquid contents and enclosed by a capsule;
D  
dermabrasion the operative procedure used to remove acne, scars, severe sun spots or skin discoloration; may be performed using paper, wire, brushes or other abrasive materials
dermis layer of skin beneath the epidermis with numerous nerve ends, blood vessels and elastic fibers, home to the perspiratory glands
diagnosis stating a medical condition; identification of a disease
dislocation displacement (of an implant) from the original position
duckbill valve A filling valve that utilizes an elongated, flat tube that resembles a duck’s bill. Also called a leaf valve.
E  
endoscope optical device for the enlargement of cellular structures and smaller units up to 300,000 times their size
epidermis outer layer of skin situated above the dermis, contains no vessels
epithelium, epithelial formations of cells that line the cavities and surfaces of structures throughout the body
epithesis artificial body part, worn temporarily as an external replacement
estrogen female hormone occurring in various levels during the reproductive cycle
excision surgical removal of tissue
expander a device to be filled with sterile saline solution to expand and stretch the tissue covering the expander and prepare the area for an implant
F  
fiber-optic retractor an instrument for drawing back the edges of a wound with a light source provided by a fiber-optic cable
filler cannula a small tube or cannula through which fluids are added to a prosthesis
firm (or hard) capsule a condition whereby the fibrous tissue continues to contract around an object until it is firm to the touch
flap tissue used for transplantation
flash cycle to sterilize at a high temperature, usually 270 degrees or more for a short period of time
fold flaw Results when part of the shell “folds” and erosion of corners follows. Can lead to holes in shell and deflation if it occurs in an inflatable or double-lumen style.
G  
gel migration / permeation silicone molecules which are picked up and transported to other areas of the body by the lymphatic system
general anesthesia various combinations of agents used to induce a total loss of consciousness and sensitivity to pain; administered and maintained during surgery by an anesthesiologist or anesthetist
glandula, glandular (Lat.) gland; pertaining to glands
gluteus buttocks
gross examination examination of an object by the naked eye
gynecology medical science of the female reproductive system
gynecomasty uni- or bilateral enlargement of the male breast glands
H  
hematoma a collection of blood outside the blood vessels, causing tissue swelling
hemostasis arrest of bleeding or of circulation
high profile an implant that has a high or domed projection when placed on a flat surface
histology; histological science and study of the microscopic anatomy of biological tissue; histological examination of a specially prepared tissue slice permits the diagnosis of the benign or malign nature of a tumor and may indicate its origins
hormones messenger substances created by an organism
hyperplasia congenital overdevelopment of tissue; very large breasts
hypertrophy (med.) pronounced scarring
hypoplasia congenital underdevelopment of tissue; very small breasts
I  
immune system system of biological structures and processes that protects an organism against disease
implant (prosthesis) an artificial body part inserted as a permanent replacement in the body
incidence frequency of an occurrence
incision (med.) cut into the body for surgical approach
indication reason for the treatment of a disease
inferior below in relation to other parts of the body or of a structure
inframammary approach accessing the future implant position via an incision mid-point in the fold below the breast
K  
keloid bulging scar, proliferation of connective tissue, occurring several weeks or month after mutilation (through trauma or surgery)
korium = dermis; the connective-tissue skin layer situated between epidermis and subcutis
L  
lateral toward the side, opposite of median
latissimus dorsi back muscle beneath the shoulder blade used for autologous breast reconstruction
leaking the release of unattached molecules from the silicone gel that migrate through the shell (also called bleeding or weeping)
lipectomy body contouring surgery by removing fat cells
lipoaspiration / liposuction fat extraction by aspiration / suction
lipodystrophy disproportioned fat distribution
local anesthesia general sedation of a patient followed by a localized full block of the area of surgery
lot number a number assigned to each product denoting the silicone batch of origin as well as its month and year of manufacture
low profile an implant that has a low projection when placed on a flat surface
M  
macromastia congenitally overlarge breasts
malign (med.) pertaining to tumors that spread and grow aggressively
mamma; mammary the female breast; pertaining to the female breast, the female breast glands
mammary expander device for the expansion of female breast tissue to gain skin coverage for an implant
mammaplasty plastic surgery of the breast
mammography radiographic examination of the breast
mastectomy removal of the breast
mastitis inflammation of the breast glands
mastopathy benign disorder of the mammary glands (may become malign over time)
mastopexy breast-lift surgery
medial towards the middle
metastasis secondary tumor, a spread from the primary tumor; in contrast to a local recurrence a metastasis may occur in a place far from the original tumor
“milking” a technique of inserting an implant through an incision by squeezing the gel in such a manner that enough pressure is applied to force the bulk of the prosthesis into the pocket without causing it to rupture
modified radical mastectomy removal of the breast, some surrounding lymph nodes, but sparing the majority of the pectoralis muscle
MRI / Magnetic Resonance Imaging medical imaging technology used for the diagnosis of illnesses
myocutaneous flap transplantable tissue consisting of skin and muscles
N  
necrosis death of areas of tissue surrounded by healthy parts
normal saline solution a balanced 0.9% solution used for filling inflatable, bi-luminous and gel-saline implants
O  
oedema aggregation of body liquids in the intercellular gaps
oncology the science and study of cancer
open capsulotomy a surgical procedure where the breast pocket is reopened and the fibrous tissue of a firm capsule is severed or removed
overfill the filling of a prosthesis shell over and above its standard quantity
P  
palliative therapy treatment to reduce discomfort
palpate, palpation to determine by feel
patches small areas of material placed on the posterior portion of a implant to promote tissue ingrowth for stabilization. (rarely used today)
pectoralis muscle the large muscle underlying the breast
percutaneous insertion of a needle or instrument through the skin
periareolar approach accessing the implant position via an incision around a portion of the outer boundary of the areola
pigmentation accretion of biological colored substances
pocket an area to contain the breast prosthesis created by separating the fatty tissue of the breast and the underlying pectoralis muscle
Poland Syndrome congenital unilateral underdevelopment of varying characteristics; may concern the chest only but may also include anomalies of the hand
polydimethyl siloxane chemical term for silicone
posterior the general term applied to the back part of the body or any structure
postoperative after surgery
preoperative before surgery
prevention (med.) behavior to prevent the occurrence of cancer, i.e. a healthy way of living, e.g. through not smoking, no alcohol, a balanced diet, avoiding sun burns / excess weight
profile lateral shape of an implant
progesterone steroid with a central importance for the production of female sex hormones
prognosis likely course or outcome of an illness
prophylaxis medical procedure to prevent the occurrence of an illness
prosthesis artificial body part, either implant or epithesis: the implant is inserted as a permanent replacement in the body, the epithesis is worn temporarily as an external replacement
projection the outward thrust of the breast created or enhanced by the insertion of implants
ptosis sagging or hanging breast or breast tissue
punction biopsy with the help of a needle
R  
radical mastectomy removal of the breast, underlying muscle and surrounding lymph nodes
radiology medical branch using imaging technologies like x-ray, ultrasound, CT and MRI for diagnosis
reconstruction (med.) recreation of lost tissues
relapse reappearance of an illness after complete recovery
remission (med.) diminishment of a tumor
rhytidectomy surgery of the face, facelift
R.T.V. Room temperature vulcanization. A silicone compound that will “set up” at room temperature.
runny gel silicone gel that has a high flow rate and tends to separate under stress
rupture bursting or breaking, e.g. of an implant
S  
scalloping creasing or folding of the shell due to loss of volume
screening regular examinations to discover illnesses in people with no evident symptoms but a genetic disposition
self-sealing a valve that completely seals itself when the intra-cash is removed
semi-permeable membrane a membrane which will allow the passage of some molecules
sepsis blood poisoning
seroma aggregation of body liquids in cavities resulting from illnesses
serum; serous (med.) clear liquid remaining after body fluids were cleared from their cellular components; generally describes a component of the blood
silicone a synthetic polymer
sharp dissection a separation of tissue layers with a scalpel or knife
silicone polydimethyl siloxane, a synthetic polymer
silicone elastomer a synthetic polymer with reinforcing filler
silicone gel a synthetic polymer without reinforcing filler
sonography ultrasound-based medical imaging technique
steroid injection injecting steroids into inflatable or bi-lumen implants so they will be released into surrounding tissue over a period of time
subcutaneous mastectomy the removal of the majority of the breast tissue, leaving the skin and a thin layer of tissue for reconstruction purposes
subglandular positioning placing a breast implant under the mammary glands
submammary approach see: inframammary approach
subpectoral positioning placing a breast implant under the pectoralis muscle
superior above in relation to other parts of the body or of a structure
suture tab A small nylon loop usually placed on the posterior portion of a prosthesis for suturing to the chest wall or to other materials. Can also be used for orientation or positioning of implants.
symptom characteristics by which to recognize an illness
T  
tear strength the amount of pressure needed to tear a sample of silicone sheeting after a slight cut has been made in it
tensile strength the amount of pressure needed to stretch a sample of silicone sheeting until it breaks
thorax, thoracic chest
TRAM flap Transversus Rectus Abdominis Muscle flap consisting of belly skin and a section of the straight belly muscle used for autologous breast reconstruction
transareolar across the areola
tubular breast ptotic breasts with a diameter scarcely larger than the areola
tumescence; tumescence anesthesia swelling; infiltration of the liposuction area with a liquid consisting of saline solution, a local anesthetic and adrenaline
tumor benign or malign agglomeration of non-functional cells
tumor marker body substances in the blood and urine that indicate an illness
tumorectomy surgical excision of a tumor
U  
under the muscle see: sub-pectoral
underfill the filling of a prosthesis shell under its standard quantity
undermine to separate layers of tissue
unilateral pertaining to one side
V  
valve a mechanism through which additional material is added to a saline implant or expander
virus pathogenic organisms with no own metabolism that need a host cell to proliferate; will be attacked by the immune system of the invaded organism
w  
weeping another term for leaking
wrinkling term used to describe folds, ridges or creases showing on the skin after an implantation caused by a too large implant pocket
Z  
zipper effect This references a scalloping edge on a gel implant. The term “scalloping” references the same phenomena on an inflatable implant.

dellian consulting gmbh

communication + training

Karina Fritz und Margit Dellian

Hegelmaierstr. 24

74076 Heilbronn

Tel.: +49 - (0)7131-77 28 50

 

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Web: www.dellian-consulting.de

The research & development team at POLYTECH Health & Aesthetics has a long-standing tradition of cooperation with physicians. Since 1991/92, we have manufactured breast implants under our own direction. We perfected the polyurethane-coated implants, and we were able to do this because of our permanent exchange of ideas with physicians.

Our active cooperation with physicians permitted us to compile a wide portfolio of new products. To date, the cooperation based on partnership and the continuous dialog with physicians rank high for us and are pivotal for the successful adoption of our products.

This is why we listen to you. It is you who are working with our products in the operation theatre and you are in direct contact with the patients, hear how satisfied they are. Your experience and feedback are important to us. Optimizing our products is to your benefit, as your patients' satisfaction level grows.

Please do not hesitate to contact us if you have ideas for product optimization or new products: This email address is being protected from spambots. You need JavaScript enabled to view it.

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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