The short answer
Yes, and it needs disclosures a generic aesthetic consent does not contain. PRP consent must state that the centrifuge or kit is FDA-cleared as a device while the aesthetic procedure itself is not FDA approved for that indication, describe venipuncture and blood-handling risks, name infection, bruising, nodules, prolonged swelling and treatment failure, and set realistic expectations about the number of sessions and the evidence base.
What makes PRP consent different?
Most aesthetic consents describe applying or injecting a manufactured product. PRP involves drawing the patient's own blood, processing it in a device, and reinjecting it — three separate risk domains in one appointment, plus a regulatory status that patients almost universally misunderstand.
The regulatory disclosure comes first because it drives expectations. The FDA clears PRP preparation systems — the centrifuges, tubes and kits — through the 510(k) substantial equivalence pathway. Clearance addresses the device's ability to separate blood components safely; several clearance summaries state plainly that the resulting PRP has not been evaluated for any specific clinical indication. So the equipment is regulated and the aesthetic use is off-label. Patients who hear "FDA cleared" in a consultation hear "FDA approved for my hair loss," and the consent is where that gap gets closed in writing.
Second, PRP is prepared from human blood, and how your state and the FDA treat what you do to it matters. Minimal manipulation and homologous use keep a preparation inside the practice-of-medicine framework; adding activators, culturing cells, or combining with other agents can move a product toward being regulated as a biologic drug. If your protocol adds anything, the consent and your regulatory position both need review.
Which risks must the form name?
| Domain | Risks to disclose |
|---|---|
| Venipuncture | Bruising, hematoma, vasovagal syncope, nerve irritation, phlebitis, rare infection |
| Processing | Sample handling error, need to repeat the draw, anticoagulant used in the tube |
| Injection — face | Pain, swelling that can last several days, bruising, nodules, infection, granuloma, rare vascular event when combined with filler or in high-risk zones |
| Injection — scalp | Scalp tenderness, headache, transient shedding, folliculitis |
| Microneedling delivery | Post-inflammatory hyperpigmentation, prolonged erythema, track marks, infection, granulomatous reaction |
| Outcome | Variable and unpredictable response, non-responders, multiple sessions typically required, maintenance needed, no guaranteed result |
| Cost | That the fee covers the procedure, not an outcome, and maintenance is an additional cost |
Contraindications belong on the intake but should be echoed in the consent: active infection at the site, platelet dysfunction or thrombocytopenia, anticoagulant therapy, hematologic malignancy, active cancer, sepsis, and pregnancy or breastfeeding for elective aesthetic use. Recent NSAID or corticosteroid use can affect platelet function and is worth asking about.
Who may perform it, and does that change the consent?
Venipuncture and injection are medical or delegated medical acts in essentially every state. Depending on state rules, a physician, NP, PA or RN performs the draw and injection under supervision and protocol, following a good-faith exam. Estheticians generally cannot draw blood or inject anywhere, though in some states they may perform the microneedling pass under supervision where PRP is applied topically. Because scope varies, the consent should name the treating clinician and their license type so the record is unambiguous later.
What this means for your paperwork
Keep a PRP-specific consent signed on the day of treatment, separate from any microneedling or filler consent used in the same visit. In the chart, record the kit or system used with its lot number, the volume of blood drawn, the tube and anticoagulant, spin parameters, the final PRP volume, whether an activator was used, injection sites and volumes, and needle depth for microneedling.
Round out the file with OSHA bloodborne pathogen documentation, a sharps and biohazard disposal record, staff phlebotomy competency records, the medical director's signed PRP protocol and standing order, and dated aftercare instructions covering NSAID avoidance, sun exposure and warning signs of infection. If you market PRP under a brand name, keep the marketing copy consistent with the consent — advertising a "proven" result while consenting to "variable and unpredictable" outcomes is a contradiction a plaintiff will read aloud.
Related questions
This answer is educational and is not legal or medical advice. Requirements vary by state and change over time — verify with your own legal and clinical advisors before applying anything here in practice.