INSTRUCTIONS INTRODUCTION RISKS OF BOTULINUM TOXIN / DERMAL FILLER INJECTIONS
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1 INSTRUCTIONS This is an informed consent document that has been prepared to help inform you concerning botulinum toxin / dermal filler injections and the risks involved. It is important that you read this information carefully and completely. Please read each page and sign the consent at the bottom prior to your treatment. INTRODUCTION Botulinum Toxin: Botulinum toxin injections involve a series of small injections in order to weaken the chosen muscles for example on the brow or below the eyes. Weakening of the injected muscles begins to be apparent after 2-3 days with the peak effect being reached after days. Results can last 3-6 months. The procedure can be repeated after 3 months; however, injections given less than 3 month intervals may reduce the efficacy of the injections. Dermal Fillers: Dermal fillers are used to correct volume loss, shape, contour and reduce the appearance of fine and/or deep lines. They consist of hyaluronic acid which is a naturally-occurring gel produced in the body, which is injected into the treatable area. Some fillers consist of local anaesthetic gel which minimises discomfort. The results can often be seen immediately after injection and can last anything between 6-18 months. RISKS OF BOTULINUM TOXIN / DERMAL FILLER INJECTIONS Every procedure involves a certain amount of risk, and it is important that you understand the risks involved. An individual s choice to undergo a procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience these complications, you should discuss each of them with your practitioner to make sure you understand the risks, potential complications, and consequences of botulinum toxin / dermal filler injections: Bleeding Blindness Bruising/Swelling Numbness or itching Inflammation Infection Lumpiness Skin discolouration Asymmetry Unsatisfactory Outcome/Temporary loss of function of nearby muscles
2 CAUTIONS & CONTRAINDICATIONS (To be checked with patient prior to treatment) Known hypersensitivity to ingredients or any of its excipients e.g. Lidocaine Anticoagulant use (e.g. Warfarin/Aspirin) Pregnancy/Breastfeeding Infected skin area e.g. cold sores/cellulitis etc Neuromuscular disorder (e.g. MG/MND) Concurrent use of Aminoglycoside antibiotics (e.g Gentamicin, Neomycin)
3 PATIENT CONSENT DERMAL FILLER AND BOTULINUM TOXIN INJECTIONS General information - I confirm that I consent to receiving treatment using the products that my practitioner has recommended to me. - I have been informed that the treatment is carried out by injection for the improvement of lines, wrinkles and folds of the skin, for lip augmentation, rehydration of the skin, or for excessive sweating (hyperhidrosis) - I have been given sufficient information to enable me to understand the use of these products for the approved indications. - I understand that though complications are uncommon, they do sometimes occur. It is possible that side effects not described may occur and indeed that a complication not previously reported may occur for the first time. - I understand that if I suffer any adverse reactions that are not expected, or concern me, I must contact the clinic. An appointment will be made for me to be seen. The clinic cannot take responsibility for complications or results that have not been reported, assessed, documented and managed in a timely fashion. - I have also received information regarding contraindications to the administration of products and potential side effects. - Botulinum toxin and dermal filler products give an aesthetic result for a limited time period. This effect may be variable depending on many factors, including condition of the skin, mechanical action in the treatment area, amount of product injected and technique for injection. Lifestyle factors also effect the duration of the product. Regular top-up treatments help to optimise the duration of the product. - Post treatment: Following treatment, avoid sun exposure and saunas. Avoid manipulation of the treated area and make up, as instructed by your practitioner. - I understand that whilst I have been advised as to a probable result, this should not be interpreted as a guarantee. - I confirm that I have been provided with verbal and written information about this treatment which includes aftercare and follow up advice. - I agree to follow the aftercare advice and understand this reduces risk of adverse reactions, promotes healing and helps ensure optimum results. General information about fillers injections - Injections of dermal fillers are to restore and revolumise skin and facial contours, smooth line and wrinkles, or shape and enhance certain structures such as the lips. - Treatment is expected to last for a period of 6-18 months depending on the area treated. The successful outcome varies by degree and how long it lasts varies from one individual to another and cannot be guaranteed. - The possible side effects of dermal fillers include but are not limited to: Risks: I understand there is a risk of redness, swelling, haematomas, bruising, local numbness, pain at the injection site, and allergic reaction. Resolution is typically spontaneous within a few days
4 Infection: there is a minimal risk of infection which in most cases are easily treatable but in rare cases a permanent scarring in the area can occur. As with all injectable treatments, there is a minimal risk of vessel occlusion, granulomas, abscess formation and hypersensitive reaction. - Persistence of any inflammatory reaction for more than one week or the development of any other side effects must be reported to the practitioner as soon as possible. - Many dermal fillers also contain lidocaine, an anesthetic, with tha aim to make the procedure less painful. This causes temporary numbing of the injected areas, which may last a few hours. - Perfect symmetry is not always achievable. General information about Botulinum A toxin injections - Botulinum toxin A injections in the area of the glabella, forehead, crow s feet around the lateral area of the eyes, nasalis, chin, perioral lines and platysmal muscles are made to paralyse these muscles, thereby improving the appearance of wrinkles / lines / dimples. I understand the goal is to decrease the wrinkles / lines / dimples in the treated area. - Botulinum toxin A injections into the orbicularis oculi / levator labii / depressor anguli are made to paralyse the muscles, thereby creating a browlift / reduced smile / upturned corners of the mouth. - Botulinum toxin A injections into the chewing muscle (masseter) reduces the size of the muscle. - Botulinum toxin A injections into the armpits blocks nerve supply to the apocrine glands, preventing them from producing sweat. - Injection of botulinum toxin A has a temporary effect and it is usually necessary to repeat the procedure every 3-6 months to maintain the desired effect. - The possible side effects of botulinum toxin A include, but are not limited to: Risks: I understand there is a risk of swelling, rash, headache, and local numbness, pain at the injection site, bruising, respiratory problems, and allergic reaction. Eye lid ptosis (a drooping or heaviness of the eyelid) or brow ptosis (heaviness and or lowering of the brow) can occur, and may take 3 or more weeks to resolve. Infection: Infections can occur, which in most cases are easily treatable, but in rare cases a permanent scarring in the area can occur. Most people have lightly swollen pinkish bumps where the injections went in, for a couple of hours or even several days. Although many people with chronic headaches or migraines often get relief from botulinum toxin A, a small percent of patients get headaches following treatment with botulinum toxin A, for the first day. In a very small percentage of patients these headaches can persist for several days or weeks. Local numbness, rash, pain at the injection site, flu like symptoms with mild fever, back pain. Respiratory problems such as bronchitis or sinusitis, nausea, dizziness, and tightness or irritation of the skin. Bruising is possible anytime you inject a needle into the skin. This bruising can last for several hours, days, weeks, months and in rare cases the effect of bruising could be permanent. While local weakness of the injected muscles is representative of the expected pharmacological action of botulinum toxin A, weakness of adjacent muscles may occur as a result of the spread of the toxin.
5 Treatments: I understand more than one injection may be needed to achieve a satisfactory result. Another risk when injecting botulinum toxin A around the eyes included corneal exposure because people may not be able to blink the eyelids as often as they should to protect the eye. This inability to protect the eye has been associated with damage to the eye as impaired vision, or double vision, which is usually temporary. This reduced blinking has been associated with corneal ulcerations. There are medications that can help lift the eyelid, however, if the drooping is too great, the eye drops are not that effective. These side effects can last for several weeks or longer. This occurs in 2-5 percent of patients. - As botulinum toxin A injection is not an exact science, there might be an uneven appearance of the face with some muscles more affected by the botulinum toxin A than others. In most cases, this uneven appearance can be corrected by injecting botulinum toxin A in the same or nearby muscles. However in some cases this uneven appearance can persist for several weeks or months. - This list is not meant to be inclusive of all possible risks associated with botulinum toxin A as there are both known and unknown side effects associated with any medication or procedure. - Botulinum toxin A should not be administered to a pregnant or nursing woman. - Additionally, the number of units injected is an estimate of the amount of botulinum toxin A required to paralyse the muscles. I understand there is no guarantee of results of any treatment. I understand the regular charge applies to all subsequent treatments. Photography - I understand that photographs will be taken throughout my treatment plan and will form part of my confidential treatment records. Payment - I understand and agree that all services rendered to me are charged directly to me and that I am personally responsible for payment. I further agree in the event of non-payment, to bear the cost of collection, and/or court cost and reasonable legal fees, should this be required. Data Protection - I understand information about me will be treated as confidential and access to it restricted in accordance with the Data Protection Act, unless specific permissions given. - I understand that there may be circumstances in which my medical records will need to be shared with appropriate professional staff, such as in the case of an emergency or complication.
6 I acknowledge that I have read the Clinic Terms & Conditions, and the foregoing informed consent, understand it, accept these facts and agree to the treatment with its associated risks. I hereby give consent to perform this and all subsequent treatments with the above understood. I hereby release the aesthetics practitioner, the person injecting the botulinum toxin A and/or the dermal filler and the facility from liability associated with this procedure.
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