Korea Breast augmentation - Silimed cohesive gel

6:15 PM

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.

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