Consent Form hyaluronic acid dermal fillers and hyaluronidase
What are dermal fillers
Dermal fillers are used in cosmetic procedures to smooth wrinkles, plump up the skin, and enhance facial contours. Dr Lynch will generally use hyaluronic acid-based fillers as these have been in use for many years so we know that they are generally safe and we understand the risks well.
Hyaluronic acid is a naturally occurring substance in the skin that helps retain moisture. When used as a dermal filler it is a gel-like substance that, when injected, can add volume to the facial tissue. The effects of hyaluronic acid fillers are temporary, as the body gradually absorbs the substance over time, typically lasting from six months to a few years depending upon the type of filler used.
Treatment is generally not medically necessary and is performed for cosmetic purposes and therefore it is very important that you are aware of the potential risks of treatment when deciding whether this treatment is right for you.
Alternatives to treatment include doing nothing, topical treatments, chemical peels, laser treatments, forehead/brow lift, facelift and botulinum toxin injections.
What is hyaluronidase
Hyaluronic-acid based fillers can be dissolved with injection of a substance called hyaluronidase. This is an enzyme the digests the filler material allowing the body to absorb it. In the very unlikely event that you have blockage of a blood vessel (vascular occlusion) due to a filler injection hyaluronidase injections are performed to help dissolve this and reduce the risks of serious adverse consequences. You are asked to give consent to these injections as well in order that they can be performed promptly if needed.
Contraindications
It is essential that you inform Dr Lynch if you any of the following are relevant as the treatment may not be safe or suitable for you:
- Allergy to Filler Components: Known allergies to any components of the filler, such as hyaluronic acid or lidocaine (local anaesthetic).
- Severe Allergies or Anaphylaxis: Patients with a history of severe allergies or anaphylaxis, especially to bacterial proteins, as some fillers are produced using bacterial fermentation.
- Bee or Wasp Skin Allergy: This increases the risk of severe reactions to hyaluronidase.
- Immunosupression: Immunosupressive medications or conditions that suppress the immune system can increase the risk of infection or other adverse consequences.
- Autoimmune Diseases or chronic healthy problems: Certain autoimmune conditions, like lupus or rheumatoid arthritis, may increase the risk of adverse reactions or complications.
- Bleeding disorders or blood thinning medication: These increase the risk of bruising and bleeding. Aspirin, rivaroxaban, exoxaban, clopidogrel, warfarin, vitamin E, ibuprofen and naproxen can all thin the blood.
- Pregnancy and Breastfeeding: Dermal fillers and hyaluronidase are not recommended for pregnant or breastfeeding women due to the lack of research on the effects on the fetus or infant.
- Previous Bad Reactions to Fillers: Patients who have had previous negative reactions to dermal fillers should avoid further treatments.
- Skin Infections: Any active skin infections, such as cold sores or bacterial infection. Please inform Dr Lynch if you suffer from frequent cold sores as it may be advisable to take a tablet medication to reduce this risk after injection.
- Skin Conditions at Injection Sites: Conditions like eczema, acne or psoriasis.
- Recent Dermal Fillers: A minimum of 2 weeks should be allowed before repeating dermal filler injections to the same site.
- Hypertrophic or keloid scars: If you have experienced lumpy or unsightly scars or have a family history of this there is an increased risk of developing unsightly scarring due to injections. .
Limitations of treatment
- Hyaluronic acid fillers may not have the desired effect initially or later.
- The final outcome may take a number of weeks to become fully apparent due to movement of the filler and absorption of water by the filler.
- Treatments are temporary as filler will dissolve over time.
- The product may last for a longer or shorter time than usually expected.
- Treatments are often “off label”, as licensed use does not cover all of the areas that are commonly treated.
- There will often be swelling immediately after the procedure and the area will appear lumpy. This usually resolves within 2 weeks.
- As the immediate swelling resolves you may notice that fullness that was present immediately after the treatment has not persisted. This is normal and you may require multiple treatments to achieve the desired results.
Risks of dermal fillers
Dermal filler injections are generally safe and millions of treatments have been performed with the vast majority of patients having satisfactory outcomes. As a Dermatological Surgeon, Dr Lynch is very familiar with facial anatomy and will take a number of steps to reduce these risks including, where appropriate, the use of a blunt tipped cannula that is less likely to enter blood vessels. Nevertheless it is important that you are aware of the potential risks of treatment:-
- Pain: There will be some degree of pain and discomfort during the injections. This is usually manageable. Pain can be reduced by the application of a topical anaesthetic cream such as EMLA. Rarely pain can persist or very rarely fail to resolve.
- Injection site reaction: Any injection can cause inflammation, itching, scarring, keloid scar formation, pins and needles, burning, pain, decreased sensation / numbness, tenderness, swelling, redness, muscle twitching, increased pigmentation, decreased pigmentation, redness. Rarely these can be permanent.
- Damage to important structures: Rarely, passage of a needle or cannula under the surface of the skin can result in damage to underlying structures including veins, arteries, nerves, salivary glands, lymph nodes, bone, muscle and other structures. In rare cases this could cause problems with movement, appearance, sensation or function and may require medical intervention to treat or may be permanent
- Bleeding, bruising, haematoma: Bruising is normal and usually will peak 1-2 days after the procedure. Rarely there can be more significant bruising or a blood collection under the surface (haematoma) and very rarely this may require surgical drainage.
- Infection:: Injections may trigger bacterial infection or herpetic infection (e.g. cold sores or shingles). Very rarely cosmetic injections can lead to rare or unusual infections that may persist for a long period of time and prove resistant to treatment.
- Swelling, lumpiness, nodules: Nodules may form immediately or later, and may rarely be permanent. There can also be persistent swelling and lumpiness.
- Vascular occlusion (very rare): In rare instances, blood supply to areas of the face may be affected resulting in tissue death, ulceration and potentially loss of tissue and severe scarring which is permanent.
- Blindness (extremely rare): This is an extremely rare complication and occurs when filler enters blood vessels that can communicate with those that supply the eye.
- Tyndall effect: In thin areas of skin or when filler is injected superficially it may cause a blue or brown discoloration of the skin surface.
- Facial assymetry: Although good results are expected, it is possible that after treatment the face may appear uneven as some areas may be greater affected by the product than others.
- Failure to achieve the desired outcome: There is no guarantee as to the results that can be obtained through treatment. As with any treatment, you may not be satisfied with the results.
- Local anaesthetic reaction: Local anaesthetic contained in some fillers may cause allergy, cardiac arrhythmias, anaphylaxis or, extremely rarely, death. Topical lidocaine can also cause allergy or irritation.
- Allergic reaction: There is a very small risk of allergic (anaphylactic) reaction which can be serious or life threatening.
- Additional risks: Hyaluronic acid-based fillers have been used for many years, however it is possible that additional risks or complications become apparent in the future that are not currently recognised.
Risks of hyaluronidase
Hyaluronidase injections are used to remove injected filler in the very rare event that you have a vascular occlusion (blockage of a blood vessel). Risks are as follows:-
- Pain:There may be pain during the injection or afterwards as the enzyme takes effect.
- Injection site reaction / damage to important structures: As above.
- Bleeding, bruising, swelling, redness: This is common and usually resolves over a few days, however very rarely could be permanent.
- Loss of tissue volume, skin laxity, assymetry: In addition to the filler material, hyaluronidase can break down natural hyaluronic acid that you do not want removed. This may lead to loss of volume and an uneven appearance as some areas may be greater affected by the enzyme than others.
- Failure to resolve vascular occlusion: Whilst they will often be of benefit, there is not guarantee that hyaluronidase injections can resolve a vascular occlusion.
- Dissolving of other filler material: Hyaluronidase spreads widely in the tissue and will dissolve any other hyaluronic acid-based filler that is present from previous treatments.
- Allergic reaction: Allergic reaction including anaphylactic shock are possible, they occur at a rate of between 1/2000 and 1/100 depending on the data source. Anaphylactic shock has a mortality rate 0.3 to 5% depending on the study. When hyaluronidase injections are planned in advance, an allergy (patch test) is advised to assess for allergy prior to full exposure, however this is not possible where hyaluronidase is given as an emergency treatment for vascular occlusion.
Aftercare
It is essential to follow aftercare instructions carefully to ensure the best results, minimize the risk of side effects and detect any complications early. This can be found at the following location:
www.drmagnuslynch.com/dermal-filler-aftercare or by following the QR code. Please save the link on your phone so that you have it available.
See the aftercare information for full details, some key points include:-
- Avoid touching the treated area or applying products for 24 hours following treatment.
- Do not expose the area to intense heat, for example sauna, hot showers, sunbeds, sunbathing etc until the swelling has resolved. Also avoid intense cold.
- Do not participate in strenuous exercise for 48 hours after your procedure as it can cause migration of filler due to increased blood flow and excess bruising/ swelling.
- Avoid alcohol and the use of aspirin, ibuprofen or naproxen for 24 hours following treatment as they increase the risk of bruising or bleeding.
- You may eat and drink as normal, however avoid hot drinks if you have numbness of the lips following the injections.
- Monitor for signs of vascular occlusion including: severe pain, skin discoloration, mottling of the skin, coldness, swelling, blistering, the developement of dark or bluish areas on the skin, vision change or loss, painfull redness or heat. Vascular occlusion is a medical emergency and untreated can lead to severe tissue loss, scarring and permanent vision loss.
Other important information
- Dermal filler is charged per vial used. There will be additional charges if you request that additional filler is injected.
- The cost of treatment does not include the cost of additional medical care should complications arise.
- You should contact Dr Lynch immediately if you have any concerns following the treatment, however the clinic is not open 24 hours and it will not be possible to review you in person out of hours.