Biofiller
Platelet-Rich
Plasma Procedure

Before undergoing this procedure, understanding the risks is essential as no procedure is completely risk-free. The purpose of this informed consent form is to provide written information regarding the risks and benefits of BioFiller procedure. This consent form is an addition to discussion with the treating doctor or nurse who feels that BioFiller +/- intradermal PRP injection is a reasonable treatment for you, and the potential benefits outweigh the small risks.

PRP and BioFiller procedure is safe for most individuals and there are few contraindications, however, patients with the following conditions are not suitable candidates for the procedure. Please indicate with a tick, if any of the following apply to you currently:

o Platelet disorders and blood disorders

o Cancer, Chemotherapy or Radiotherapy

o Acute and Chronic Infections or currently using antibiotics

o Anti‐coagulation therapy. (Warfarin is not a PRP contraindication, but may be for the procedure)

o Allergy to local anaesthetic or latex gloves?

o Pregnancy or breastfeeding, simply because non-medically urgent procedures can be delayed

A small volume (15 – 30ml) of the patient’s blood is collected in the same way as a standard blood test. Using a patented ARTG listed, Alocuro platelet-concentrating device and a centrifuge, the platelets are separated from the whole blood and collected in a concentrated sample known as PRP. Plasma is also collected and following platelet activation and then gelation protocols, a stable tri-dimensional plasma gel is formed, which is then mixed with high platelet-dose PRP to produce a patient’s own Biofiller – all within 30 minutes of the blood collection.

BioFiller is injected under the skin with a blunt-tip microcannula, for less traumatic injections and effective volume injection, under skin wrinkles and folds – which are lifted up and smoothed out – for a fresher but natural appearance.  Using a blunt-tip, flexible microcannula  for the Biofiller injections has many advantages to using a needle including less pain, ability to access many areas with a single skin entry point and with the type used in Biofiller, far lower risk of bruising or injury to a blood vessel or nerve as the Microcannula slides through the spaces naturally present between the tissues. 

The volume restoration results can be seen immediately, and the longer-term regeneration PRP process commences at the time of injection. The injection component of the procedure takes less than 30 minutes and is usually well tolerated by most patients and with minimal complications for the outcome achieved.

During the injections, patients usually experience a feeling of subtle stinging, tingling and tenderness, followed by increased warmth, pinkness/redness of skin over the application site. You will also likely experience mild swelling of the treated area as part of your body’s response to the regenerative power of the injected Biofiller. This will last for about 24-48 hours; ice or cold compresses can be applied to reduce swelling if required. You may also notice a tingling/activity/throbbing sensation in the injected region as part of the early phase of regeneration. If you should experience significant pain, swelling, skin redness or local infection symptoms you should contact the practitioner who performed the procedure, your GP or an A&E department if after-hours.

The following risks may occur, but there may be unforeseen risks and risks that are not included on this list. 

Major complications from the BioFiller PRP procedure are extremely rare as the material being injected below the skin is the patient’s own biology consisting of your own plasma, platelets & their growth factors and some white blood cells. Minor complications can include: local bleeding / bruising / tenderness/ subtle swelling at either the blood collection site or the application site. Occasionally patients may experience dizziness or fainting – simply from the anxiety associated with the procedure / blood collection etc.

Other potential risks – Whenever a needle penetrates the skin there is always the chance of bruising, skin infection, scarring, sensitivity, damage to underlying structures including veins, arteries, nerves, and other soft-tissue structures. Most traumatic injuries eg: a larger bruise, heal completely on their own. However, the aim is to minimise downtime while achieving best patient outcome, so strict protocols for preparation of the injected material and subsequent injection will be followed to minimise risk of adverse outcomes.

Uncommon and very rare complications -There is the possibility that the BioFiller gel product could block a blood vessel if it is injected within a larger artery. However as of September 2022 there are no reported cases of a ‘plasma gel’ like Biofiller causing a vessel occlusion. However, there is always a theoretical risk. If this occurred, the blockage could cause injury to the tissue supplied by that artery and depending on location, it may require urgent medical treatment. The injection technique and protocol recommended for BioFiller significantly reduces risk of the material being injected inside an artery but patients need to be informed of a theoretical risk.

Biofiller is not intended as a permanent filler/implanted type material, and it is expected there will be some immediate volume reduction within the first week after the procedure. The volume restoration should then stabilise for a period of 3-6 months. A second procedure may be required 4-6 weeks later to provide further volume restoration and regeneration to the injected area. I understand that with all aesthetic procedures the precise degree of improvement cannot be guaranteed, and further procedures may be required to achieve the desired outcome.