Botulinum Toxin Type-A Wrinkle and Contracture Reduction Consent Form
Medical Condition Of The Skin:
Skin wrinkles are symptoms of age-related skin fragility and photoaging from chronic exposure to ultraviolet radiation. This exposure leads to atrophy or degeneration of dermal or subcutaneous connective tissue, resulting in symptomatic rhytides (wrinkles/lines) when muscles under the skin are contracted (dynamic wrinkles/lines). Over time, tissue atrophy and continued muscle contracture can lead to further wrinkle atrophy into the skin tissue, resulting in skin wrinkles, even when muscles are relaxed (static wrinkles/lines).
Medical Treatment
At Lumiere Medispa, our Medical Aesthetic Nurse Practitioners prescribe Botulinum Neurotoxin Type-A to manage facial dynamic rhytide symptoms, reduce muscle contracture, and protect the skin's health from further infringement of wrinkle atrophy caused by the following medical conditions, as defined by the World Health Organisation ICD-11: EE40.31, EJ20, EE40, EJ20.0, FB32.4.
Botulinum Toxin Type-A inhibits acetylcholine receptor attachment to the muscle in which it is injected. This neuromuscular blocking action relaxes skin-to-muscle attachment, reduces symptomatic dynamic rhytides, and protects the skin from further deepening of atrophic wrinkling that will become permanent (static) if unmanaged.
BOTOX® is licensed to temporarily improve the appearance of moderate to severe vertical lines between the eyebrows, horizontal forehead lines, and lateral canthal lines (crow's feet lines) seen at maximum contraction. This licence is applicable when the severity of these lines has a meaningful psychological impact on adult patients.
The use of Botox® outside of these license terms is considered "off license" and is administered based upon general medical practitioner consensus for using Botulinum Neurotoxin Type-A. "Off license" indications may include dynamic lip lines, chin dimpling, chin crease, mouth corner pulling, jaw clenching, jawline muscle asymmetry, and slimming the contours of the lower face. Treating "off Licence" may carry additional unknown risks or side effects.
Treatment Process:
The treatment involves a series of injections into the specific muscles that are causing skin creasing or contraction in the targeted areas. If requested, a topical anaesthetic cream may be applied 30 minutes before treatment, particularly for those with needle phobia or discomfort during the procedure.
Treatment Effects:
The onset of the treatment effect can take 2-14 days, remaining effective for 12-16 weeks. During the initial onset, you will notice the contraction of your muscles becoming weaker, reducing the creasing of your skin. Initial treatments may only be effective for 8 weeks, requiring multiple cycles to build up the duration of effectiveness to 12-16 weeks. Rarely, there may be little or no effect, possibly linked to the formation of antibodies.
Alternative Treatments:
While your practitioner will recommend the safest and most effective treatment based on your medical history and skin appearance, you are encouraged to consider the option of no treatment. Alternative wrinkle treatments are available, including hyaluronic acid–based dermal fillers, facial creams, chemical peels, and skin microneedling. Please discuss these options with your practitioner if you wish to explore alternative possibilities.
Contraindications
You cannot have treatment with Botulinum Neurotoxin Type-A if:
You have a known hypersensitivity to Botulinum Neurotoxin Type-A, sucrose, human albumin, alcohol, or sodium chloride.
You have an active infection or inflammation near the intended treatment area.
You have generalised muscle activity/weakness disorders, such as myasthenia gravis and Lambert-Eaton syndrome.
You suffer from any disorder that disturbs the interaction between nerves and muscles.
You think you could be pregnant, are pregnant, or are lactating or breastfeeding. There are no adequate and well-controlled studies of Botulinum Neurotoxin Type-A in pregnant or nursing women; therefore, safety cannot be guaranteed.
Cautions:
You need to tell your aesthetic practitioner if:
You are taking aminoglycoside antibiotics, such as gentamicin or spectinomycin.
You are taking tubocurarine-type muscle relaxants.
You are taking anti-malarial medications.
Material Risk (the level of significance you personally apply to the risks, side effects or complications of this treatment within your own circumstances):
As with any medical procedure, this treatment carries the risk of side effects or complications. Discuss these risks with your practitioner to fully comprehend their implications. Consider the risks in relation to your personal circumstances, including your health, lifestyle and career and decide if they are acceptable. If not, discuss alternatives or take more time to decide.
Associated Risks:
Injection site bruising. This is usually mild and lasts less than a week but can last longer. Patients using medications that prolong bleeding, such as aspirin, warfarin, steroids, and ibuprofen (and other NSAIDs), may experience increased bruising or bleeding at the injection site. Certain vitamins and supplements can also have this effect.
Pain, swelling, rash, local numbness, or itching. The simple action of the needle passing into muscle tissue can cause this effect for some and is usually mild and short-lived.
Headaches are possible and usually last one day but may persist longer in a very small percentage of patients.
Asymmetry of expression. Perfect symmetry may not be achievable; that caused by the treatment can often be corrected at your review appointment.
Mouth weakness. Where treatment of the lower face is performed, asymmetry or weakness of the mouth may occur temporarily for days, weeks, or even months. You must contact your practitioner as soon as possible if this occurs.
Uncommon side effects include:
Little to no effect. Very rarely, botulinum toxin may not reduce muscle contraction and/or may not reduce the intended facial lines. This should be discussed with your practitioner at your earliest convenience. Whilst we will endeavour to increase the effect for you, there is no guarantee it will be effective, and no refunds will be given in this case.
Nausea
Anxiety
Dry mouth
Altered skin sensation, muscle twitching or spasm in the treated area
Swelling/ puffiness around the eyes
Fever
Lack of strength
Flu-like symptoms
Itching or dry skin
Muscles weakness
Rash
Facial pain
Eyelid or eyebrow ptosis. Local weakness of the injected muscles is the expected outcome; however, the weakness of adjacent muscles may also occur, which can result in a temporary eyelid or eyebrow ptosis (eyebrow or lid heaviness/droop) for days, weeks or even months. This rarely occurs, but should you experience eyebrow or eyelid heaviness/droop, please inform your practitioner, who will guide you further.
Eye Injury. Treatments with Botulinum Neurotoxin Type-A around the eye area may reduce blinking or the effectiveness of blinking. You should contact your practitioner and seek immediate medical attention if eye pain, dryness, or irritation occurs following treatment. An inability to blink the eyelids normally may result in corneal exposure and has been associated with damage to the eye, such as impaired vision or double vision, which is usually temporary. The reduced ability to blink has been associated with corneal ulcerations. These side effects can last for several weeks or longer.
Infection. As with any procedure that involves a break to the skin’s surface, there is a risk that an injection of any material could introduce an infection that may require treatment. Contact your practitioner if you experience skin redness, irritation, or pain in the treatment area.
Allergy and/or anaphylactic shock. As with any medical procedure, there is a risk that you could develop an allergic or anaphylactic shock response to the treatment delivered. This is a very rare occurrence with Botulinum Toxin Type-A. Whilst your practitioner is trained to deliver initial emergency treatment, you may be required to attend a local emergency department for further treatment and monitoring. If you experience shortness of breath, swelling of the skin and mucosa, or airway swelling after you have left the clinic, please call 999 for an ambulance. This is an emergency that requires immediate medical attention. When it is convenient, please also inform the clinic of the reaction. You should also know that an allergic or anaphylactic shock response could result in disability or death.
Swallowing and Breathing Difficulties. Treatment with Botulinum Neurotoxin Type-A products can very rarely result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. These reactions can occur hours to weeks after injection with Botulinum Neurotoxin Type-A.
Seek immediate emergency medical care if swallowing, speech, or breathing difficulties arise.
If you experience loss of strength, muscle weakness, blurred vision, or drooping eyelids following Botulinum Toxin Type-A treatment, avoid driving a car, operating heavy machinery, or engaging in other potentially hazardous activities.
Photographs:
We need to take photos of the treatment area to document the original condition before treatment begins and to monitor results and potential changes throughout the treatment process. These photos will become part of your medical aesthetic treatment record at Lumiere Medispa.
You have the right to refuse consent for these photographs. However, please be aware that without this consent, we will not be able to treat you for medico-legal reasons.
If we wish to use your photos for any other purpose, we will always seek separate written consent from you. You have the right to refuse this additional use of your photos, and it is not mandatory to consent to any other photo usage to receive treatment.
Informed Consent:
This consent form is not meant to include all possible risks associated with Botulinum Toxin Type-A treatment, as there are both known and unknown side effects and complications associated with any medical treatment. We have written this consent form to ensure you are fully informed of the procedure, the reasons why you may not be able to receive treatment, and the known risks of Botulinum Toxin Type-A treatment.
By signing this consent form, you acknowledge and confirm the following:
Risks and complications
You have discussed the potential risks and benefits of Botulinum Toxin Type-A treatment with your practitioner, and your questions have been answered satisfactorily.
You understand that medical attention may be required to resolve any complications associated with your treatment. In most cases, except those in an emergency, you should immediately contact the clinic for advice/treatment.
Medical History
To the best of your knowledge, you have provided the details of your medical history and will inform your practitioner if this changes before any future treatments.
You understand that withholding aspects of your medical history could lead to serious physical and mental harm.
Contraindications & Cautions
You are not pregnant or possibly pregnant, lactating or nursing, and you will inform your practitioner if this changes before any future treatments.
Fees & Charges
You understand and agree that all services rendered will be charged directly to you, and you are personally responsible for payment.
You further agree, in the event of non-payment, to bear the cost of collection, court costs and reasonable legal fees, should they be required.
Refunds
Fees charged for treatment are for the delivery of a treatment and the accompanying service, which is inclusive of the following;
-Consultation and assessment
-The provision of information and advice
-The provision of the treatment itself, as described above
-Follow-up appointments and aftercare advice and support as appropriate
Whilst we undertake to provide excellent service, factual, honest, and ethical advice, safe, expert treatment in experienced hands, and only the best products, we cannot guarantee your results and cannot offer refunds if the results achieved fail to meet your expectations. The successful outcome varies by degree, and how long these effects last varies from one individual to another and cannot be guaranteed.
You understand that whilst you have been advised of a probable result, this should not be interpreted as a guarantee.
You will contact your practitioner if you are unsatisfied with your treatment outcomes.
Aftercare
You have verbally discussed the aftercare required following Botulinum Toxin Type-A injections, and you have been informed that you will also receive this via email. You understand the importance of following the post-treatment advice and agree to follow it.
You understand that failure to follow this advice could lead to serious physical and mental harm.
Photograph Use Consent:
You understand that receiving treatment at Lumiere Medispa requires photographs to be taken of the treatment area. These photographs may be taken before, during, and after each treatment and will form part of your legal medical record at Lumiere Medispa. By signing below, you freely give your consent for your photos to be used solely for this medico-legal purpose. If we wish to use your photos for any other purpose, we will always seek separate written consent from you, and you have the right to refuse.
Valid Consent
By signing below, you acknowledge that you have read and understood this consent form and have had the opportunity to discuss any questions you have with your practitioner to your satisfaction. You consent to receive Botulinum Toxin Type-A treatment under the terms of this consent form and understand that you have the right not to consent to this treatment and that your consent is voluntary.
