The Department of Veterans Affairs has advised its facilities to avoid some injectable amniotic tissue products used in wound care because of questions about purity and effectiveness.
The Wall Street Journal, which reported the nationwide advisory, broke the story about MiMedx’s micronized products not meeting federal regulatory standards. The Food and Drug Administration has previously questioned the maker about the sterility of its products, often used to treat plantar fasciitis, tendinitis and osteoarthritis. The VA’s warning to its providers said that evidence does not support those uses.
MiMedx products use powderized amniotic membranes in topical and injectable formulations. Though the VA has urged its facilities to stop use, the products are still on the market, and it was unclear whether other long-term care facilities will follow suit in stopping the use of the products.
“The company respects the VA’s position on the micronized, injectable product category and will continue to work with them as they assess this class of products,” a MiMedx spokeswoman told the newspaper in a statement.
