About breast implants

   Numerous delusions and misleading rumors have been spreading about the breast implants. Numerous, reliable investigations of several countries disproved their effect to propagate cancer or autoimmune diseases. Among those suffering in such diseases, the proportion of having or not having a breast implant is just the same as among the healthy ones.
The first generation of breast implants used in the ‘60-s and ‘70s of the last century caused many complications due to their ridiculously primitive structure. Their shell was weak, not durable and they provoked a strong tissue reaction. By the end of the ‘70-‘80-s the implants underwent a further development. Because of the complications of these formerly used implants, the so-called silicone scandal broke out in the USA at the beginning of the ‘90s, after which many factories manufacturing low quality implants were closed. A new, strict, tightly controlled system of standards developed and the expectations for the implants manufactured since then are quite different. No fundamental changes have been made in the production of the leading top quality American implants since the mid-‘90s, as they proved to be safe also on the long run. At the same time new implants primarily manufactured in Europe appeared on the market, with them the proper experience does not exist yet.

Nowadays always more natural and safer implants are available and the overly high technological demands on them developed further in the last 15 years.

An international committee (IQUAM – The International Committee for Quality Insurance, Medical Technologies and Devices in Plastic Surgery) supervises and authorizes also the use of different breast implants, their regularly updated statements are based upon continuous and wide analytical and research results.

The key points regarding silicone gel filled breast implants remained unchanged since their consensus statement of July 2006 (to see it directly please click here), and please find the recent ones on the IQUAM website.

We consider it important to emphasize the following key points of it for our patients:

1. The silicone gel implants (filled with either silicone gel or saline, textured by various methods or smooth surfaced, or covered by polyurethane) continue to be widely used for breast implants. No better alternative material is available.

2. Additional medical studies have not demonstrated any association between silicone-gel filled breast implants and cancer or any other disease. Silicone-gel filled breast implants do not adversely affect pregnancy, fetal development, breast-feeding or the health of breast-fed children.

3. The use of Titanium-coated, Hydrogel-filled and soybean oil-filled breast implants is not licensed; it is prohibited in several countries since they expose the patients’ health to danger.

We also consider it important to mention, that in the United States of America, where quality requirements are high and sometimes unreal, after 2 decades of prohibition, in 2006 the aesthetic use of silicone gel filled breast implants was authorized again, though only for the products of two companies. One of them is the MENTOR, the other one is the former McGhan-CUI, its successor is the NATRELLE produced by Allergan now.


The shell of the implants

Contrary to the most frequent silicone-elastomer coated implants, the rarely used polyurethane-coated (spongy) implants have not come in general use because of their numerous unfavourable operation-technical characteristics. The surrounding tissue grows into them strongly, their removal is very difficult or is impossible without tissue damage, and with time small particles of the shell might peel off. The most recent titanium-coated implants were banned in certain countries like Swiss since the experience with them is very few and only short-term. The use of silicone in the medicine is frequent e.g. replacing the crystalline lens, joints, or as pipe systems in the nervous system. Certainly there are great differences regarding the shell material, surface and thickness, the quality and price of the implants. The surface of the implants can be smooth or rugged (textured). Opinions of plastic surgeons are divided concerning what to choose, but the most of them know from experience that the risk for a capsular contracture around textured implants is smaller.


 

 Smooth and textured surface Mentor implants

The filling materials of implants

The implants filled with experimental substances (soybean oil, derivatives of sugar) had not come in general use due to their numerous unfavourable characteristics and the rare but severe complications; these are banned in several countries in Europe. Generally speaking and also of these implants, a conscientious plastic surgeon starts to use novelties only when some years (at least 3-4) already passed since they have been on the market, and there is enough experience also with the potential drawbacks – unfortunately at the cost of others. Numerous unfavourable incidents, like the frequent diminishing and leakage of the filling volume are known with the saline-filled single shell implants used primarily in North America from the early ‘90s, while the quality of the silicone-gel filled implants of the last decade already means a higher category than before. The modern silicone-gel of today’s implants is not liquid any more, but cohesive, that is a thick jelly-like form which doesn’t flow even in a case of an injury. Implants with different grades of cohesivity (thickness) exist, the ones filled with the thickest gel are the so-called tear drop shape (anatomical) implants, these have a relatively harder touch and keep their form under any circumstances, so they do not follow the movement of the patient with a natural form-change unfortunately.

 Split implant of grade III. cohesivity with the non-flowing, thick, form-keeping gel

   
The round and not too high implant also takes on the shape of a tear drop in standing position of the patient and follows her movements better if there is no capsular contracture around (left). The so-called tear drop (anatomical) implant keeps its form despite the gravity even if the patient moves or is in handstand (middle). With the motion of the female body the shape of the natural breast changes, not like of the statue or of someone who has a high cohesivity anatomical implant (right).

Only a serious car accident hitting the chest, or a gun fire or stabbing can damage the modern good quality implants of today. Mostly it depends on the patient, if she visits her plastic surgeon with the complaints after such an incident.

 

 
 
 

   
Microscopic pictures of breast implants damaged in the course of a head-on collision, many years after the accident (left).
Magnetic Resonance Imaging (MRI) of the damaged implant of the left side (right).

Regarding the best quality implants of our days there is no regulation any more, which would prescribe their exchange in certain years because of the shell aging process, but it is advisable to exchange the implants of lower quality in 8-10 years.

 

 

Picture of a 25 year old, heavily damaged 2nd generation implant of low quality (left)
Fluid from the surrounding tissues visible inside of the gel of a removed French implant, proving also the leakage of the implant shell (right)

We consider it important, that a patient carefully gathers information before a breast enlargement about the quality and brand of available implants, besides the only one she would know or have been offered to her. The principle of our practice is, that at the selection of an implant for a lifetime the worst aspect is the cheapness, the cheapest implants will be the most expensive ones on long term, since the risk and the number of repeated operations with them is higher. The hazard of getting a cheap implant threatens the patient mostly there, where they get a “package price” offer for the operation, meaning that the patient doesn’t really know how much the price of the implant is of that.

 

 

Different implant brands

The most commonly used silicone gel filled breast implants are the Mentor, the former McGhan-CUI which is called Natrelle now, (only these two are licensed by the FDA, that is the government office for licensing in the USA), the Nagor, Polytech and the Brazilian Silimed demerged years ago of Polytech (these tow produce only polyurethane-coated implants), and other French products like the Eurosilicone, Arion, Sebbin and until its banning in 2010 the PIP.
It makes the overview more difficult, that some manufacturers fuse for ownership interests or acquire each others companies and thereby their markets. By the summer of 2009 the production of the McGhan-CUI stopped, the Allergan company took over the product, the production of certain models discontinued, the manufacturing itself was placed to Costa Rica (but under the supervision of the FDA, government office of the USA), the guarantee and exchange conditions of the previous implants became constricted and are valid only for the implants placed after the 31st of March 2004. Their new Natrelle implants already have a lifetime exchange guarantee valid for implant shell rupture, and compensate the operation and narcosis costs until a 1000 Euro limit. The exchange guarantee of the Nagor implants (NagorEnhance Patient warranty) is valid not only for implant rupture, but also for cases with severe capsular contracture.
The exchange guarantee programs are different, regarding the coverage of the contralateral implant, if they compensate some operation costs and to what limit, if patients have to register or not, and conditions are different in many countries where the implants were placed. All implant manufacturers provide the implant exchange only in that country, where the patient was operated before.
Each company has its smooth and textured, round and anatomical implants with various profiles (height), with different cohesivity, which make the orientation for non-professionals very difficult. Certain manufacturers (Natrelle and Nagor) specify the implant size in grams, others per volume (ml, cc.) which makes their comparison more complicated.
It is worth mentioning, that the average specific weight of modern silicone-gel filled implants is approximately 1.0, that used to be 1.18 years ago. That means, that an older implant was by 20% heavier, than the same volume of the glandular tissue of the breast. Nowadays, the modern implants have the same weight, as the same size of breast tissue.

Certainly that patient is safe on a long run, who doesn’t look for the cheapest implant, who examines her own breast regularly even years after the breast augmentation and goes for a check-up to her plastic surgeon yearly even after a decade; and safeguarded the documentation of her implants.

Once again we would like to point out, that the patient who gets a so-called “package price” for a breast augmentation, where she doesn’t know the price of the implant, can’t compare it to other implants in terms of price and the corresponding quality. Easily can happen, that the implant in the package is the cheapest one, probably of inferior quality! There is no such thing as a free implant, even although it is advertised this way in certain places; it is not more than low-quality, namely dangerous to the patient!