Informed Consent for Platelet-Rich Plasma (PRP) Therapy

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Informed Consent for Platelet-Rich Plasma (PRP) Therapy

Patient and Provider Information

What PRP Therapy Involves

Platelet-rich plasma (PRP) therapy uses the patient's own blood to create a concentrated solution of growth factors and platelets. The process has three steps: (1) A small amount of the patient's blood (usually 20 to 60 mL) is drawn from a vein in the arm, the same way a routine blood test is taken. (2) The blood sample is placed in a centrifuge machine that spins at high speed to separate the blood into its components. The platelet-rich layer is isolated and drawn into a syringe. (3) The PRP solution is injected into the target area (such as the scalp for hair loss, or the face for skin rejuvenation) using a fine needle. Because PRP is made from the patient's own blood, the risk of allergic reaction is very low. The procedure usually takes 45 to 90 minutes in total. Most patients need a series of 3 monthly sessions followed by maintenance injections every 4 to 6 months.

Blood Draw Authorization

I authorize the treating provider to draw the volume of blood stated above from my arm for the purpose of preparing PRP. I understand that the blood draw is performed by trained staff using sterile single-use equipment. I understand that this is an autologous procedure, meaning the blood drawn and the PRP prepared from it are used only for me and are not transferred to any other person.

Pre-Treatment Health Screening

[ ] I am NOT pregnant or breastfeeding.
[ ] I do NOT have a platelet dysfunction syndrome or a blood clotting disorder (such as hemophilia, von Willebrand disease, or thrombocytopenia).
[ ] I do NOT have an active systemic infection, fever, or sepsis.
[ ] I am NOT currently undergoing anticoagulant therapy (warfarin, heparin, direct oral anticoagulants). I have disclosed any blood-thinning medications to my provider.
[ ] I do NOT have a diagnosis of cancer, lymphoma, or another hematological malignancy that could affect the composition of my platelets.
[ ] I do NOT have an active skin infection or open wound at the planned injection site.
[ ] I have disclosed any history of steroid injections in the past month at the site to be treated, as steroids can impair the PRP response.
[ ] I have eaten a light meal and am well-hydrated today to reduce the risk of dizziness during the blood draw.

Regulatory Status Notice

I understand that PRP therapy for aesthetic purposes (such as facial skin rejuvenation and hair restoration) is not FDA-approved as a stand-alone treatment. The FDA has cleared PRP systems and devices for processing blood, but has not approved PRP as a drug or medical device for cosmetic indications. PRP injections for aesthetic use are performed based on physician judgment and a growing body of clinical research evidence. This does not mean the treatment is unsafe; it means the level of regulatory review that applies to approved pharmaceutical drugs does not yet apply to autologous PRP. I have been informed of this status and consent to proceed.

Risks and Possible Side Effects

Pain and discomfort: the blood draw and the injections into the treatment area cause some discomfort. Topical numbing cream or local anesthetic injections are used to reduce this. Pain typically resolves within 24 to 48 hours.
Bruising and swelling at injection sites: common and expected. Bruising usually fades within 5 to 10 days. Applying ice and avoiding blood thinners before the session reduces bruising risk.
Redness and tenderness: the treated area may remain red and sensitive for several days after injection, especially on the scalp.
Infection: rare because PRP is derived from the patient's own blood and sterile technique is used throughout. Patients should avoid touching treated areas with unwashed hands and should report any unusual warmth, pain, or discharge.
Vasovagal reaction: some patients feel lightheaded, dizzy, or faint during the blood draw. Patients are asked to remain seated or lying down during and immediately after the draw. Staff are trained to manage this response.
No response or limited results: PRP effectiveness varies significantly between individuals. Some patients see excellent results; others see minimal improvement. Multiple sessions are usually required before results can be evaluated. No specific outcome is guaranteed.
Nerve irritation: injections near nerve endings may cause temporary tingling, numbness, or altered sensation.
Calcification (rare): calcium deposits can occasionally form at injection sites, particularly with repeated injections over the same area.

Alternatives to PRP Therapy

Minoxidil and finasteride (for hair loss): FDA-approved medical treatments for androgenetic alopecia. Finasteride is for males only. These require daily use and are discontinued if side effects occur.
Low-level laser therapy (LLLT): cleared devices that use light energy to stimulate hair follicles. Non-invasive and suitable for home use.
Hair transplant surgery: a surgical procedure that moves follicles from a donor area to the thinning area. Provides permanent results but requires surgery and recovery.
Topical skincare and microneedling (for skin rejuvenation): non-invasive alternatives to PRP for facial rejuvenation.
No treatment: declining this procedure does not affect access to other care at this clinic.

What to Expect from Results

For hair restoration, most patients begin to notice less shedding after 2 to 3 months and new hair growth after 4 to 6 months. For skin rejuvenation, improvement in texture and tone usually becomes visible 4 to 6 weeks after treatment and continues to improve over the following months. Results vary significantly between individuals. Maintenance sessions every 4 to 6 months help sustain results. PRP does not stop the underlying cause of hair loss; it supports the hair follicles but must be combined with an appropriate medical treatment plan if a diagnosed condition is causing the hair loss.

Post-Treatment Care Instructions

For the 24 to 48 hours after treatment: (1) Avoid washing the scalp or face for at least 6 hours after scalp or facial PRP injections. (2) Do not apply styling products, hair dye, or chemical treatments to the scalp for at least 48 hours. (3) Avoid strenuous exercise, saunas, and hot baths for 24 hours. (4) Do not apply ice directly to a scalp injection site, as cooling may affect growth factor activity. (5) Avoid anti-inflammatory medications such as ibuprofen for 48 hours after treatment, as inflammation is part of the intended healing response. (6) Contact the clinic if you notice unusual swelling, persistent pain, or any sign of infection.

Right to Refuse Treatment

The patient has the right to decline this procedure or to stop after the blood draw but before the injection is performed. If the patient stops after the blood draw, the PRP prepared from their blood will be discarded. The patient is responsible for the cost of the session up to the point of stopping, as the blood draw and centrifuge processing have been performed.

Patient Understanding

I confirm that I have read this consent form or had it explained to me. I have asked questions about the blood draw, the preparation process, the injection sites, and the expected results. All my questions have been answered. I understand that PRP is not FDA-approved for aesthetic use, that results vary between individuals, and that multiple sessions are usually needed.

Language Access

If English is not your main language, please ask for an interpreter before signing. This form must be fully understood before you agree to treatment.

Copy of Consent

I acknowledge that I have been offered a signed copy of this consent form for my records.

Patient Authorization

I voluntarily agree to receive PRP therapy as described in this form. I authorize the blood draw and the preparation and injection of my own PRP. I confirm that I have disclosed all relevant medical history, medications, and conditions. I understand and accept the risks, limitations, and regulatory status of PRP therapy for aesthetic use.

Signatures and Verification

Patient Signature
Treating Provider Signature
Witness Signature
Date and Time of Consent
Document ID: CC-PENDING
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