Tell the FDA that PRP Treatments Should Be Exempt from Regulation!

Platelet-rich-plasma (PRP) injections are used by orthopedic doctors to treat bone and joint pain. Blood is drawn from a patient, platelets are separated from other components of the blood using a centrifuge, then the platelet-rich blood is injected into arthritic joints. PRP is safer, less costly, has a more rapid recovery time, and shows promising results.

According to FDA rules, if you remove blood cells from an individual and implant them back into the same individual during the same surgical procedure, you are exempted from the FDA’s regulations—but spinning blood in a centrifuge for PRP treatment is not mentioned explicitly. It’s unclear whether this is a conscious move by the FDA to make it more difficult and costly to perform PRP treatments, or an error of omission.

Please urge the FDA to clearly indicate that PRP treatments using in-office centrifuges are exempt from their regulations.

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PRP Treatments Should Be Exempt from FDA Regulation!

Dear [Decision Maker],

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I was excited to learn recently that platelet-rich-plasma (PRP) injections are used by orthopedic doctors to treat bone and joint pain. Blood is drawn from a patient, platelets are separated from other components of the blood using a centrifuge, then the platelet-rich blood is injected into arthritic joints. PRP is safer, less costly, has a more rapid recovery time, and shows promising results.

According to FDA rules, if you remove human cells, tissues and cellular or tissue-based products (HCT/Ps) from an individual and implant them back into the same individual during the same surgical procedure, the procedure is exempted from regulation. But spinning blood in a centrifuge for PRP treatment is not mentioned explicitly.

I have no idea whether this is a conscious move by the FDA for some unfathomable reason, or an error of omission. But not including PRP treatments in the exemption would force doctors to go to approved centers for the type of cells they could far more easily extract from a patient's blood in their own in-office centrifuges. This will almost certainly result in increased costs, fewer physicians willing to go through the hassle, and worst of all, patients not being able to use their own blood and therefore incurring a much greater risk of infection. But even if the omission was unintentional, the uncertainty created by the FDA concerning PRP will likely cause many doctors not to offer the treatment to their patients to avoid having the book thrown at them.

PRP treatments are effective. One study of patients with chronic elbow tendinitis ("tennis elbow") found significant improvement in patients treated with PRP in comparison to a control group. Another controlled study compared patients treated with PRP versus patients treated with hyaluronic acid, a lubricant that is often used to treat joint pain; those who received PRP experienced statistically better results. Two other studies also concluded that PRP decreased pain and improved function better than placebo and hyaluronic acid.

In other words, PRP treatment is a safer, cheaper, and more natural alternative to surgery and pharmaceutical drugs for a whole spectrum of bone, muscle, tendon, and ligament injuries.

I urge the FDA to clearly indicate that PRP treatments by doctors using their own in-office centrifuges are exempt from their regulations.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]