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FDA Calls Out MiMedx


Posted on Sep 22, 2013

The Food and Drug Administration is leading an investigation against MiMedx. The FDA found that the company has been selling un-approved products.

 ABC News reports, “MiMedx is a publicly traded company that takes donated human placentas and turns them into health products. These can be used as skin grafts or injections, and they’re intended to treat inflammation and scar tissue formation. But the FDA says there are currently no licensed products that contain placental tissue at all, and it sent MiMedx a letter explaining that the company violated federal law by failing to get the proper license or investigational new drug application.” It is unclear how many of these products MiMedx has on the market at this time.

Many MiMedx investors have filed lawsuits against the company for false advertising and misleading statements. The company is only registered with the FDA to accept placenta donations. The CEO of MiMedx defended the company in a statement saying, “Over the last two years this company has shipped about 18,000 vials of the crushed placental product, but it has not received a single report of a patient having a bad reaction.”  

While placental products are known to have possible healing effects doctors are concerned about the fact that MiMedx’s products have not been properly tested. One doctor told ABC, “Human placenta cells could carry greater health risks than placental cells from pigs or cows, which are sometimes used in other products, because they can spread human viruses and bacteria. And since the drugs are being treated as human tissue donation, they don’t have the same sterility standards as other drugs or medical devices.” Officials have found many inconsistencies in the information listed on MiMedx’s website. ABC reports, “Though MidMedx’s website says its placenta-based injections can be used in spinal surgeries, it lists no trials conducted in spinal surgery patients on its website.” 

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