FDA Cracks Down on Placenta Products


Though the company lists three patient studies on its website, a review of those studies revealed that only 53 patients actually received the treatment in a trial setting. Twenty-three patients received a MiMedx product to treat diabetic foot ulcers. Thirty patients received it for plantar fasciitis, a condition that involves inflammation of the foot.

Though MiMedx'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.

Petit told ABCNews.com that only 10 percent of the company's business comes from the products the FDA says need to be approved, and that it will contest whether that approval is necessary in the coming weeks.

"There are a lot of things going on here that don't meet the eye," he said, adding that the FDA letter, which stopped short of ordering MiMedx to stop selling its product, came as a surprise.

MiMedx solicits placenta donations via a website called PlacentaDonation.Com, which bears the slogan "Give the gift of healing." In the frequently asked questions portion of the site, the donation is referred to as "an act of charity," though MiMedx's federal financial filings indicate that its business is dependent upon donations.

"Any disruption in the supply of donated human tissue could restrict our growth and could have a material adverse impact on our business and financial condition," the filing reads.

Injections of the dehydrated, crushed placental product cost $400 or $500 each, but patients may need more than one dose depending on their condition and their physician's orders, a MiMedx spokeswoman told ABCNews.com.

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