The Korean Ministry of Food and Drug Safety recently suspended manufacturing by the company HansBioMed, which is the company that produces and distributes MINT PDO Threads, as well as other medical products. The suspension of production and distribution of all products by HansBioMed is related solely to the Korean Ministry of Food and Drug Safety’s determination that the manufacturing of HansBioMed breast implants did not meet their standard. While we have no knowledge of their manufacturing practices as a whole, the release by the Korean government did not include any concern relative to the safety of PDO threads.
The purpose of this letter is to clarify the ruling of the Korean Ministry of Food and Drug Safety and to explain that this ruling did not implicate MINT PDO Threads or any other threads.
During this time of transition in the marketplace, we continue to offer you the widest selection of PDO, PLLA and PCL threads currently available. Les Encres is an FDA Registered medical device company that is ISO certified and carries $1 million worth of Product Liability coverage on every pouch of threads.
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