MiMedx boldly claims on its website that it has “distributed more than 1 million allografts to date with zero reported adverse reactions attributed to our products”. Yet, according to a lawsuit filed earlier this month, an Epifix patient suffered an adverse reaction so severe that she was left permanently maimed. Read More

This report specifically exposes severe undisclosed manufacturing problems and contamination risks. Even though FDA investigators identified issues that “pose a significant risk to the recipient”, the company is marketing unapproved products produced by these facilities for risky experimental indications such as spinal injections. Unsuspecting patients are being defrauded through false advertisements used by dubious clinics to entice them into receiving the injections. Because these activities appear to put patients in danger, we believe the FDA has no choice but to immediately intervene. Read More