A Georgia-based company, MiMedx Group, Inc., processes and distributes placentas and amniotic tissue to be used in a variety of medical purposes such as healing wounds and eye surgeries. According to the FDA, human cell and tissue products do not have to go through the same safety testing that drugs do under the condition that the products are minimally altered.
The FDA is alleging that MiMedx Group is in violation of the regulations, saying that the company altered the products too much making them a”drug that is also a biological product.” The company dismisses the allegations stating the products went through 3rd party testing to ensure safety and efficacy.
MiMedx Group, Inc receives their placenta donations from placentadonations.com. ABC News reported that investors of the publicly traded company have filed a class action lawsuit against MiMedx Group stating they falsely inflated stock prices.