1. What this procedure is
Platelet-rich plasma (PRP) and autologous plasma gel bio-filler are prepared from a sample of your own blood. The blood is drawn, spun in a centrifuge, and separated into components. The platelet-rich portion (PRP) may be injected into fine lines and the skin surface to stimulate collagen. The platelet-poor portion may be heated to form a soft gel (“plasma gel” / bio-filler) that is injected to add volume and contour. Both are made from your own tissue and contain no synthetic filler material.
2. Regulatory status — please read carefully
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Off-label / not FDA-approved as a filler. There is no FDA-approved or FDA-cleared “plasma gel filler.” Devices used to prepare PRP are cleared by the FDA only to prepare PRP — not for any specific cosmetic or anti-aging treatment. Using PRP or plasma gel to treat wrinkles, volume loss, or skin quality is an “off-label” use. I understand this and consent to it.Initial: ______ Not reversible. Unlike hyaluronic-acid (HA) fillers, plasma gel CANNOT be dissolved or reversed with hyaluronidase. Once injected, it must resorb on its own over time or be managed by other means. I understand this product cannot be “undone.”Initial: ______ |
3. Alternatives
Reasonable alternatives have been explained to me, including: doing nothing; FDA-approved hyaluronic-acid or other synthetic dermal fillers; autologous fat transfer; botulinum toxin; energy-based skin treatments (radiofrequency, laser); topical skincare; and combinations of these. I have had the opportunity to ask about the risks, benefits, cost, and expected duration of each.
4. Risks and complications
Common and usually temporary: pain, bruising, swelling, redness, tenderness, itching, firmness or small lumps, and temporary asymmetry at injection or draw sites.
Less common: infection, bleeding, prolonged swelling, persistent nodules or granuloma, contour irregularity, under- or over-correction, pigment change, injury to underlying structures, and reaction to topical anesthetic. Blood-draw risks include bruising, lightheadedness/fainting, and rarely nerve irritation or infection.
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Vascular occlusion (serious). If material enters a blood vessel it can block blood flow. This can cause skin color change, pain, tissue breakdown (necrosis) and scarring, and — though rare — vision changes or permanent blindness, and stroke. Because plasma gel is not reversible with hyaluronidase, a vascular event is managed by emergency measures rather than dissolving the product. I understand these serious risks.Initial: ______ |
5. Results, duration, and no guarantee
6. My health disclosures
To the best of my knowledge, I confirm that I have informed the clinic if I: am pregnant or breastfeeding; have a bleeding or clotting disorder or take blood thinners; have a platelet, blood, or autoimmune disorder; have an active infection, or a skin infection/inflammation at the treatment area; have a history of keloids or poor healing; have had prior filler or facial surgery in the area; or take medications or supplements that affect bleeding. I understand these may affect my safety or results.
7. Photography and financial acknowledgment
8. Acknowledgment and consent
I have read (or had read to me) this form. My questions have been answered to my satisfaction by Dr. Joshua Le, DO. I understand the procedure is off-label, autologous, not reversible, and carries the risks described, including the rare risk of vascular occlusion, tissue loss, and vision loss. I voluntarily consent to the PRP and/or plasma gel bio-filler procedure and to the taking of a blood sample for its preparation.
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Patient signature DatePrinted name
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Provider signature — Joshua Le, DO DateWitness (if used) / Date
