About the suspended sales of Silimed implants - Korea Breast augmentation

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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.

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