Suspended sales of Silimed implants 

Silimed implants are produced in Brazil and are exported around the globe. Artificial products for breasts, thighs, and buttocks are some of the representative products.





It is estimated that more than 20,000 people around the world have gotten a surgery with Silimed implants.

In Europe, there is a certification organization named CE and you need to get its certification to sell implants that are used in the bodies. Silimed has this certification in Europe and also has an approval from Ministry of Food and Drug Safety in Korea.
In US, Silimed has FDA approval to sell breast and buttocks implants.




In September this year, an information tip-off has led to UK MHRA to investigate on Silimed’s production facilities and found out that there are some type of fiber on the surface of the implants.

Such finding of fiber can lead to high possibility of contamination therefore the implants are currently under a test. Also there is a temporary hold on the sales of these implants in Europe.

There is no problem with the implant in US, and people use it as usually.
In Korea, MFDS sent a warning notice on the Silimed implants. Since then, the importing companies voluntarily decided not to sell the products until the test results come out in Europe.



Safety and contamination of the implants are directly related to the health and illness of the user therefore, the safety related departments in each countries have reacted quickly to this sensitive issue.

UK’s MHRA is yet to announce its results on the Silimed implants and there is no information is the patients who used this implant have any health problems or not.
A representative from MHRA, John Wilkenson stated “This could be a result of the manufacturing process. We are looking into whether this indeed is a contamination or not.”

“As of now, we did not provide any information on what health issues the users can face and we are testing to find out what kind of problems might arise.”



We still do not know if the fiber found was only on that particular implant or on all the implants sold. The result of this testing could take about 3 months or more.




There are no problems with the Korean patients who have used Silimed products since 2012 when the products were first imported.

However, we need to stay alert for the result of this testing.
Thank you for reading. Have a great day.

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.

The types and differences of breast augmentation implants Part.I [Breast augmentation Korea KIES-U]

In Korea at present, there are 4 water drop type brands, and 5 round type of breast augmentation implants ones imported. There are many patients who ask about the differences in these products whenever I talk to them. Surprisingly there are many doctors who are unaware of these differences. Today, I would like to share about the imported implants that are used in our country as of 2013.

Breast augmentation Korea KIES-U

I think that there were a lot of implants used at our country before the official registration in Food and Drug department in 1990’s. Those who had breast augmentation at this time do not know the origin of the implants that they used.
In 1993, FDA in US restricted the usage of silicone gel implants and only allowed the saline bag type. Korea followed this act and allowed only the importing of saline bag type while restricting the silicone gel. (Korea tends to follow US restrictions)
So as the breast augmentation became popular (in early 2000’s), we could only use the saline bag type therefore, most of the patients had them.




Then in 2007, FDA neutralized this restriction leading to a trade of cohesive gel, i.e. silicone gel implants, causing a great demand and interest of breast augmentation due to the “good feel on the breast”.
At this time, Mentor and McCann (Known as “Allergen” today) were the two companies that were approved in Korea. Both manufactured only the round types.

As time passed, the interest grew and in 2012, Germany’s Polytech silicone gel type ( = water drop type) was approved leading to greater variety of the product in Korea.

Breast augmentation Korea KIES-U plastic surgery clinic

Reason why we still use the silicone type today

A good implant:
First, it does not harm the body or cause side effects.
Second, it should look similar to the body so that it looks natural
Third, the price must be reasonable
Fourth, it should have the durability which the shape does not change over long time period
Fifth, it should be easy to replace for reconstruction
Sixth, it should be adaptable to the body so that it matches well

These are the characteristics that an implant should have. But there is no such one right now. This would only be possible in Sci-Fi movies and it is difficult to make something that is perfectly fitting for the body.

So we still use the silicone type today. The silicone type is soft and feels very much like our body. It is separated well from the body and is well fitting with the body causing no harm, and it can be removed easily.
But there are some disadvantages as well. Separation from the body means that it caused metabolic effect of the body by creating a barrier that leads to capsule. This capsule can become stiff at any time lading to capsular contracture.

Therefore, silicone gel separating itself from the body can be both advantage and a disadvantage.






Entrance of Texturing technology

In order to overcome the limitation of the silicone type, texturing technology on the surface of the implant was applied. The idea behind was that the tissue would grow into the different textures leaving no space therefore avoiding the capsular contracture.

But in conclusion, this was not a successful effort. Textured implants did not have better incidence rate of capsular contracture compared to the non-textured types (especially for the sub-pectoral).

But the textured form prevented the changing of the location or the move abouts of the implant in the body. The main objective behind the usage of the textured type today is to securely fix the location of the implant.

Mentor has a textured implant named Siltex. It has small pores with smooth surface. So there is a lot criticism that it cannot stick to the body properly.
There is a water drop type form Mentor as well called CPG, but this cannot be imported to our country. (I do not know why)



The textured type from Allergen is called Biocell. This is different from Siltex in that it has big pores and rough surface. So Biocell sticks well to the body and has strong texturing. But as always, advantage and disadvantage is like the two sides of the coin. Some say that the rough surface on Boicell causes trauma on the surrounding cells that may cause capsular contracture.

Polyurethane

Since long time ago, many people thought that is there was a coating on the surface of the silicone implant so that the coating extends to the body having one natural feel of the breast and the implant itself that this might lead to the avoidance of capsular contracture.

There were many substances used for the coating material, but the only certified one was polyurethane.

The Polytech’s implant from Germany is known for the polyurethane coating implant. There isn’t much findings or results from the lab experiments for this product at our country so we cannot import it. But I have seen it used in Germany and Hong Kong. The capsular contracture incidence of this polyurethane coated implant in near 0%. The capsular contracture is almost not caused on the body. But we still need to know what long term effect polyurethane has on the body, and the durability of the implant in order to know that it is secure and use it.

We will share more in Part 2.