The FDA approved anatomical implant, Silimed cohesive gel 

As I talk to my patients, I feel that they are open to inaccurate and dangerous information from the medical related news, internet portals, and other sources of information.

FDA Good Manufacturing Practice (GMP)

This is the reason why I put information on my blog.

Silimed anatomical implant / round type cohesive gel implants were approved by FDA early last yeat and it was approved to be imported to our country late last year. This implant can be used in our country today.

Then what changes has this Silimed implant brought to our patients (customers)?

I would like to talk about this today.



Q1. Since Silimed is the only one that got the FDA approval, is it the best one?

There was a social issue in 1988 as Dow Corning, the largest silicone manufacturer, was faced with a lawsuit from 170,000 women around the world. After that, the FDA regulated the usage of silicone gel implants in 1992.

If such decision is made in a country like US, it becomes really difficult to overturn the decision and it takes a very long time to do so. After 14 years, in 2006, this decision was overturned and the FDA approved cohesive gel implants from companies such as Mentor and McGann(Allergan) to be sold in the country.
But, at this time, only the round type implant was approved.
The anatomical type cohesive gel implant was not approved until last year when Brazil’s Silimed got all their products, whether it was round type or not, approved.
If you compare this to that of our country, our country did not approve the sales of Samsung or LG phones but has approved the sales of Apple or Sony products. (Mentor and Allergan are US companies)

This decision was questionable by many, but nobody knows why this decision was made. I don’t think that anybody would know in the future as well. This type of decision is very political and is not made based only on research data.

Here is the answer to the question above. Silimed did not get FDA approval, because it has the best anatomical product.



Products such as Mentor’s anatomical implant CPG that is still not imported to our country,
Allergan’s anatomical implant, Stype 410,
Polytech’s replicon optimam opticon implant that was imported quickly to our country,
Sebbin’s Naturgel that is disliked because it is made in France,
Are all good products. There is no evidence that Silimed’s product is superior to these other implants.


Q2. What is the difference? Do the prices differ among the products?

You need to have a date with long time of observation in order to know the differences of all these implants. You need at least 10 years of data.
This is why it is difficult to say which company product is better than the other.
There is no one who can answer this question confidently.
We can only say some obvious facts such as  if the implant is thick or not when we touch it, or if there is any difference in spec according to the volume, height or width, or how the surface feels.




Oo product from 00 company has highest incidence rate of capsular contracture!
00 product has lowest collapse rate!
00 product has highest revision rate!

These are the important data....
But, we do not have any. Not as yet. It is difficult to compare such data.......
But those anatomical implants that are used in our country have been used and approved for a long time in the markets abroad, therefore, we can see them as best choices to use.

Although the price of these implants are different, the cost of the surgery does not depend on the price of the implants.




Q3. I have heard that Silimed is from Brazil, is it reliable?

Yes, it is reliable and you can trust the product. Silimed is a Top 3 company globally.
Doctors from Europe, South American, Japan and other countries have used many of these products.
The HQ is located in Brazil but it also has subsidiary, Sientra in California, US.
Anyway, it was funny and big news that US companies such as Mentor and Allergan did not get FDA approval but a foreign company, Silimed, did.


Q4. Then, which product is the best, and which one do you recommend?
There are few conditions of artificial substances in order to use them in the body.

No side effect, and fuses well with the body
Chemically stabled
Shape can be changed as you want
Strong durability
Easily removable
No illness caused



There are many people who are trying to make such a perfect product.
But, there is not one product that gets the score of 100 / 100. This applies to all the companies.

Mentor, Allergan, Similed, Polytech, and Cervin are all trying their best to makes better products than what is available today. I make careful decisions when selecting these implant and consider the spec (height, width, thickness, etc) a lot.
I try to find which of the 100’s of products that these 5 makers make are most fitting or appropriate to the patient.
Of course, this is nothing simple.

But not all problems are solved because you have chosen the best implant.
It is obvious, but it depends on how the surgeon performed the surgery.


Q5. I have used cohesive gel in the past, do I need to change the old one when a new one comes out?

Nobody should ask this. There are those who used saline bag type 20 years ago, but did not suffer any capsular contracture, implant collapse or other problems so far maintaining the beautiful look.
No matter how old the implant is in your body, if your current breasts do not have any problems, you do not need to touch them.
Reconstruction or revision can damage the body tissue and lead to other sider effect. You cannot disregard such risks.

Revision should be considered only if there is a definite reason. It is different from changing your smartphone because a new model comes out every year.

But, such news that the only FDA approved product is imported to our country is welcoming news for a breast correction specialist like me.
Also, it is good for the customer as she would have more choice of products.

This is all for today. Thank you very much.

Breast augmentation - About illegal breast implants

I have found few Chinese made cohesive gel implants when I conducted revision surgeries abroad.

I thought that China is a great country, because, it can make such fake products. There was a logo ‘Shanghai’ at the back of this fake Chinese implant.




It is not wrong to say that all the medical devices and the products that we used are all from the western countries. All the breast implants are from either Europe or US.
But, Chinese people do not consider western products good enough. They have such pride that their technical ability is not bad compared to those of the western countries. They are the followers compared to US or Russia in satellites or rocket physics but they still have good technical skills.




However, one can question Chinese techniques except for a few areas in the medical industry. The biggest problem is that the land is too large with great population so the political powers can only reach so much. It is difficult to know who is making what in that large country. This is why the Chinese people also do not rely on their Made in China products although they have much pride in them.

For the same reasons, I as a doctor, do not trust Chinese medical related product. There is no national restriction or certification on these medical products. This is a big problem.







Anyway, I was curious about this Chinese implant so I kept on touching it and compared it with other implants from US / Europe. There is not much difference in the products if you look at it vaguely, however, there are many problems that you can recognize.

First, the appearance of the exterior texture is not stable.
If you look at Mentor’s product, the texture is smooth and slippery. Allergan’s texture is a little bumpier but is smooth also.

However, this Shanghai implant is not uniform in appearance (similar to hair that you have not combed).

Also, it seems that there is shortage of gel in the implant. There needs to be enough gel within the product in order to maintain the shape. There are some doctors who think that there should be excess amount of gel. The Chinese product looks alright from the outside, but there is not enough gel on the inside.



As I conducted the revision and took out the implant, I have observed that there was much sticky liquid in the implant pocket. I think that the cohesive gel might have leaked out from the implant and this is why there weren’t enough gel in the product.

I do not want to judge this Shanghai product badly without any evidence. Also one cannot think that China is far behind Europe.
But, if the doctors in China are still using their local products today, they need to report their evaluation on the implants. There is not one report on this Shanghai implant. Nothing about collapse rate, capsular contracture rate, revision rate, etc….

Such implants without any data cannot be used in the actual cosmetic surgery.
Currently there are 4 products; Polytech from Germany, Mentor and Allergan from US, and Sebbin from France; imported to our country. All have been evaluated and used by many doctors.

KIES-U Mongolia Surgery room

Today, I posted on how I felt about the Chinese implant.
I don’t think that there is any doctor who uses this uncertified product in Korea but there are many news on it so I do not know what to say about it.


This is all for today.
Thank you very much.

Correction of Breast Asymmetry

There are many of those who are worried about “what shall I do with my breasts?” when they have uneven (asymmetry) breasts. (There are those who want anatomical implant for the uneven breasts as well)

It is obvious that a person has two different sides. But there are different opinions on how the two breasts can be different.

The two lower lines are never at the same level (height). 1000 patients out of a thousand would have different heights.
The lower lines are different after the breast correction as well, but this has absolutely no cosmetic influence.





The positions of the two nipples are different as well. This is the same after the breast correction also. If you know this, then you are right.

We do not need to have a cosmetic surgery in order to make the lower lines or the nipples come up to be at the same level. It is alright to be at a different level, and the first correction does not try to correct the two locations. The purpose of the cosmetic correction is not to change something that is common to everyone.

The problem exists when there is difference in volume of the two breasts.
If the difference in the volume is easily visible, then you need to use implant to make up the lost in volume.



 

If you use the saline bag type, we can control the volume up to 1cc by controlling the amount of the liquid. But if you use silicone gel bag implant that has already been filled up, it is difficult to fill up the minor difference with the cohesive gel.

But there is one important fact that you need to know. The two breasts under the same condition do not have difference in shape or the size. (Most patients do not know this)
Your spinal might be leaned on to one side of the body, the two ribs might be asymmetry, or the sternal rib might not be positioned correctly in the middle.




This problem applies to the face as well. There are some celebrities who only take pictures of the left side of the face because the left side looks better than the right side. Just as the two sides of the face are asymmetric, it is common that the same applies for the body.

Let’s say that you are constructing a 2 storied building on the ground that has different levelling. Which side do you think would look taller? The side with higher leveled ground would look taller.

The side with lower ribs needs more volume implant. If you had an accident or got injured ribs, the injured part might stick out more than the other. In this case, you would need a less volume implant.
If you have a nipple with no volume on the lower part and the other that has no volume on the upper, you might need anatomical implant for the lower part and the round type for the upper part.




We conduct correction for only one side of the breast if you have a Poland syndrome.
If the shape is asymmetric but only the volumes are different between the two breasts, we just consider the volume of the round type or the anatomical type and go on with the procedure.

The process of selecting the implant size for uneven breasts is

1) Measure the diameter of the breast and then decide on the volume size of the implant
2) Use the Sizer in order to measure the volume and the shape of the breast with the saline bag liquid after the desquamation
3) Then input the cohesive gel. Final decision is made with the visual guide and experience of the doctor

Normally the measurement is important for me. But is the asymmetric is severe, the experience and the judgment of the doctor becomes really important.





Anatomical implant is different from round type in that we need to put in the implant by tilting it.
There are many of those who think that the 6 o’clock side of the anatomical implant needs to be positioned at 6 o’clock side of the breast, but this does not apply to the uneven breasts.
The implant can be positioned at 5 o’clock or 7 o’clock position in order to make the two breasts look similar in shape and in volume.




Then does the implant remain at that tilted position? This may be the question that you have. Textured implants rarely change its position or rotate once put into the breast. It is difficult to rotate it by hand purposely.

Anatomical, in such sense, might be better for those with asymmetric breasts. It has directional nature so it can be used to match the asymmetric breasts.

This is one topic that many do not understand during the interviews. Has this blog been helpful to you?


Thank you very much.

What is industrial silicone? Fake breast implants

KBS News

I became curious about how an industrial silicone looks like as I watched news on the people who tried to make and sell industrial silicone to many hospitals. I still have not seen one. I wanted to know the difference between the industrial silicone and cosmetic surgery silicone, so I searched for it on the web.

What is a commercial silicone? Let’s refer to the online information.



Polysiloxane is usually called silicon and has shapes of oil, rubber, and others. R is a form of methyl that is the most representative of the silicones. The properties are rather unique in that it has no reaction or toxicity. It does not burn well, and therefore used as lubricant and brake oil. The silicone rubber is made by mixing the linear silicone polymer. Silicone is not only used as oil but used as silly putty (play dough) and is used to make toys such as Superball that is very elastic. It is widely used for weatherproof materials, glue, cosmetics, rubber, medical tools, contact lens, etc. Silicone implant used in cosmetic surgery is also included.

Reference: Naver


Silicone is a molecular structure of polysiloxane that is chemically stable therefore does not react within the body or any type of environment. Silicone is widely used in the medical field because it has this chemical stability. The biggest advantage is that it does not react to any type of environment and stays as it is, unchanged.

A silicon is just a silicon, there is no distinction of industrial silicon and medical silicon. The problem is if there are an impurities added during the manufacturing stage and how pure the substance is.

The core problem is what type of impurities are mixed and what type of vinyl is mixed with the polyiloxane but these were not covered in the news.


Analyzing the news

So I tried to analyze the news.
The news said that a company with a plant in Kyungki Sihung has sold silicone withough Korean Food and Drug Administration (KFDA) certification to various hospitals.

There was an interview with contents that said "The skin decayed due to the industrial silicone…”

This news is shocking but is not medical or scientific. There was no news on what types of impurities were added, if these impurities cause cancer or what kind of effect the impurities have on the body. (I feel this a lot with the medical or scientific related news. There aren’t much details or analysis. The news only provides simple selective headlines)
When I do reconstruction nose surgeries on patients who are aged in the 50’s or 60’s, I see that those silicones are different from the ones that we use today. No matter how many times I see these silicones, I feel that these are not pure silicones. It feels very strong as well. I observed this many times. We cannot check on the substances because the silicones are too old.

But as the news said, “Does such silicone cause ulcer and infection, skin necrosis and decaying of skin?”

The answer is no in reality.
If you are one who is considering cosmetic surgery and want to check on the silicone that would be used, you can get the lot number, serial number of the implant and check it with the KFDA or Customs office.

But how worried would one be if she has used silicone for her body 20~30 years ago.
I think that people would feel sick if they hear that "industrial silicone leads to skin decay.”

What is the news said this?
"The purity is not up to standard, the those implants with impurities are not determined to be safe as it might cause cancer, capsular contracture, and tissue reaction, therefore, one needs to check with the hospital.”


Fake breast implants

As many of you know, there are many fake products in China. They sell fake eggs that are made of plastic.

I was invited to a Chinese hospital for breast reconstruction and found a breast implant that I have never seen before. It was not made by a company that I had heard of. There was no brand name either.

From what I know, I don’t think there is such a product in Korea. So this news was very chocking to me.

Breast implant was certified in 2007 July, and this cohesive gel product is registered in the KFDA so that there are records of the products. The hospitals also need to keep records of the implant and the patients.

Reference : KFDA Homepage

But those silicone used for the nose is not under the tracking scheme.
But those of you who want nose correction can ask for the package, manufacturing company name, production date and other information before having the surgery. I always use products from Bistool and show the complete product to the patient if he/she wishes to see it. I use products from Polytech Germany and Natrelle US for breast augmentation implants. They both have CE and KFDA certifications and are imported through official routes.

I wrote this for those patients who are worried due to the news (those patients who received cosmetic surgery). But you do not need to worry about this.
If you used low purity implant, the implant would have already caused chemical problems.

As for the silicone gel breast implant in China, I hope that the police find out about this and check on the substance in scientific investigating labs. If they find out what kinds of substances are in the product, it would be helpful to the patients as well as future customers. There should be no simple news that say “industrial implants lead to skin decay.”

Let’s summarize



We, at our clinic, provide the product certification sticker along with a patient diary that I have made for the breast augmentation surgeries.

Before you get a nose correction, ask for the implant serial number that will be used on your nose. Check the product package of the implant used, after the nose correction and match the product number.
I think that there will be some patients who do not check the above contents although I have mentioned it.

The most important thing is the conscience of the medical agencies. Find a hospital or a clinic with appropriate price. Do not go to a clinic because there are many patients. Go to a clinic that the doctor takes big responsibility under his/her own name. This is important.

Thank you for reading. Have a nice day.

Reason why your skin condition is important when choosing your breast implant size 

Many are interested in why size implant to use for the breast augmentation.

The name of the cosmetic surgery is breast augmentation, i.e. breast enlargement. It is obvious that many want their breasts to be larger.

KIES-U Breast augmentation Korea

However, for some, there aren’t any problems when using large sized implants but there are also others who might have difficulty in putting in the large sized implants and have future problems.

First, we measure the width of the breast and then select the appropriate implant. This actually determines the size of the implant.

The width of the breast simply means that if you have a large body, you can use a large sized implant, vice versa.

However, this is not as simple as we think it is. Measuring the width of the breast is mandatory but this is not a 100% solution in selecting the implant. Another consideration point is how elastic the outer skin covering the breast is.

This is very important. It is like when choosing a house. The size of the house might be fitting for 4 persons but if you utilize the interior structure properly, you might have enough space for 6 people.

If the skin is elastic, you might be able to use a large sized implant although you have a small body. If your skin is tight, then you might have to use a small sized implant although you have a large sized body.

KIES-U Breast augmentation Korea

The outer skin that covers your breast is formed by many things. There are flesh, subcutaneous fat, muscle (pectoral muscle), fascia, and others.

We are talking about the fat that covers the implant which lies on top of the ribs.

As you get older, your skin loses elasticity and sags much also. This leads to sagging breasts.

As you give more births, your breast skin sags much also.
When you gain fat, and then loose about 10 ~ 20 kg in a very short time, your breast skin loses elasticity as well.

If you put implant in such loose skin, it is easy to put in even a large size implant. This is very easy. The shape looks natural in a short time as well.

If you have not given a birth, or if you are very young, you would have strong elastic skin. The skin would not extend easily. Also, it would be very troubling to put something in it. Although, somehow you put in a large sized implant, your breast would not look natural.

Breast augmentation Korea KIES-U

Those aged patients who have given birth to many children and have sagging breasts can use maximum sized implants. The scar / wound disappears quickly also. The scar/wound is formed when the pulling strength of the skin is strong.

If the weight of this large implant is heavy, the weight would pull down the breasts making them sag more. Therefore, one needs to consider the size and weight together appropriately.

Young, single women with no experience in giving birth have many restrictions in the implant volume size. The skin pulls strongly. One needs to have a big desquamation spot in order to put in the implant. Also, the breast would look unnatural after the breast augmentation. As time flies, your breast would look more natural. But, there is one thing that you need to remember. The more elastic your skin is, the more difficult it is to put in the large sized implants.
Let’s summarize. First, we need to consider the width of the breast when choosing the implant size. Second, we need to consider how elastic the skin is.
If you have large body and elastic skin, you can use a large sized implant.
If you have small body and inelastic skin, you need to use a small sized implant.

If you are small but have elastic skin, you can use a large size implant.
But, if you are big but have inelastic skin, you need to use a small sized implant.

Before and after breast augmentation

Today, we looked at considering points focused on skin elasticity when choosing the implant size. I hope that this content has helped you.

Thank you and have a nice day.