VA curbs use Of MiMedx's tissue products

The Department of Veterans Affairs (VA) in late May sent a nationwide advisory to its facilities curbing the use of injectable amniotic tissue products for the most common uses because the effectiveness of the products, including those made by MiMedx Group, is not proven.

The Department of Veterans Affairs (VA) in late May sent a nationwide advisory to its facilities curbing the use of injectable amniotic tissue products for the most common uses because the effectiveness of the products, including those made by MiMedx Group, is not proven. MiMedx's micronized products do not meet federal regulatory standards, including for purity and sterility, despite the company having advised FDA in 2017 that those standards had been met. MiMedx makes wound treatments from amniotic membranes that it processes into patches or grinds into a powder, in a process called micronizing, that can be applied topically or by injection. The products have been used at many veterans and military hospitals. VA's advisory reiterated a memo the agency sent to its PBMs in late January, urging facilities not to provide injectable human amniotic membrane or amniotic fluid tissue products "for managing plantar fasciitis, tendinitis or osteoarthritis since evidence is currently limited or is lacking." A MiMedx spokeswoman said in a statement: "The company respects VA's position on the micronized, injectable product category and will continue to work with them as they assess this class of products." The company continues to sell the products.