Facial Sculpting

Ellanse Product Consent Form


SECTION 1: PATIENT HEALTH QUESTIONNAIRE AND PATIENT EXPECTATION

This consent form will be used during your consultation and treatment. This form (and the Ellansé® brochure that has been provided to you separately) contains important information about your proposed treatment and should be read in full prior to your consultation and treatment

PATIENT PERSONAL INFORMATION

Date:  

Title: First Name:  Surname(s):  

Address:  

Postcode:  

Telephone Number:   Email:  

Date of Birth: Age:  Gender:  

Next of Kin*: Relationship to you:  

Next of Kin Telephone Number:  

Name of GP*: GP Address:  

*We will only contact your GP or your next of kin in the event of an emergency.

PATIENT MEDICAL INFORMATION

Please ask the treating physician if you are unsure how to answer a particular question.

Occupation:  

Height: Weight:  

Do you take regular exercise?: Type:  

Do you follow any special diet? (Yes/No): If yes, please give details:  

Do you smoke? (Yes/No): If yes, how many a day?:  

If you have stopped smoking, when did you give up?:  

Do you drink alcohol? (Yes/No): If yes, how many units a week?*  

*One medium (175ml) glass of wine = 2 units/Single spirit measure (25ml) = 1 unit/Pint of beer = 2-3 units

Please answer the following questions. Male patients should start at Section B.

SECTION A

Are you currently pregnant or breast feeding?  

Are you trying to conceive or undergoing IVF treatment?  

Date of last menstrual period:  

SECTION B

Are you currently receiving (or have you in the last 3 months received) any medical treatment or taken any medication or treatment including steroids and any self-prescribed over the counter medication (for example pain killers, anti-inflammatory tablets, antacids etc.)?  

If yes, please specify:  

Do you have any allergies or hypersensitivities (including foreign body sensitivity)?  

If yes, please specify:  

If you have an allergy card, please present it to the physician during your consultation.

Are you taking aspirin, warfarin, or other anticoagulants to minimize blood clotting  

Do you currently have or have you in the last 3 months had any skin infection or inflammation in your facial or
neck area?  

Have you taken Roaccutane/Accutane or Isotretinoin (for acne) in the past 12 months?  
Are you planning or currently undergoing dental treatment (other than routine check-ups)?  
Have you had any immunisations during the last 3 months?  
Do you have a phobia of blood or needles?  
Are you prone to fainting?  
Are you prone to bruising?  
Have you been on a sunbed during the last 3 months?  

Do you or have you ever suffered from any of the following (tick all that apply):

*If yes, please provide details:  

SECTION C

Have you ever received local anaesthetic injections (including at a dentist)?  

If yes, were there any problems? Please specify:  

Have you previously undergone any type of cosmetic intervention in your facial or neck area of any kind (for example cosmetic surgery, facial implants, facial fillers or other injectable treatment)?  

If yes, please specify all such treatments and provide approximate treatment dates:  

Please provide details of any side effects or adverse reactions you experienced after any of those treatments:  

Were you happy with the results of your previous cosmetic interventions?  

SECTION D

Why would you like this treatment?  

What outcome are you expecting from the treatment?  

What are you most concerned about in relation to the treatment?

Please list any questions or concerns that you would like to discuss with the physician?  

SECTION 2: – RECORD OF DISCUSSION WITH TREATING PHYSICIAN

During your consultation you will be informed about the Ellansé® treatment including the potential benefits and risks as well as any alternative treatments that may be appropriate. Whilst the treating physician will give you information in relation to these factors during the consultation it is important that you read the information in this form and the Ellansé® brochure that has already been provided to you in full. If you don’t understand any of this information please ask the physician during your consultation. Similarly if you have any concerns about the Ellansé® treatment including potential side effects please raise these concerns with the physician. You are not obliged to have the Ellansé® treatment and may change your mind at any time and you should ensure that you have enough information to make an informed decision as to whether to have the treatment or not.
The physician will record any additional points that arise during the consultation session in the ‘comments’ section below.

PATIENT INFORMATION

The physician will discuss the information you provided in Section 1 and any questions or concerns raised by you will also be addressed.

 

BENEFITS OF THE ELLANSÉ® TREATMENT

The main benefits of the Ellansé® treatment will be discussed by the physician with you. Information in relation to these benefits is set out in the Ellansé® brochure and you should ensure that you have read this in full prior to the consultation. The physical and mental benefits of the treatment will be discussed by the physician with you.

 

ALTERNATIVE TREATMENTS

The improvement of skin wrinkles and soft tissue depressions may be accomplished by other treatments including but not limited to: laser treatments, chemical skin-peels, dermabrasion or other skin procedures, alternative types of tissue fillers or surgery such as a face or brow lift when indicated. The physician will talk through potential alternative treatments (and the risks associated with these) with you, including the option to not to receive any treatment.

RISKS RELATING TO THE TREATMENT

There are a number of potential risks that you should be aware of prior to being treated with Ellansé®.

Whilst cosmetic treatments such as Ellansé® are effective in most cases, there is a risk that it won’t be effective in your case or that the outcome will not be what you hoped for. Failing to achieve the outcome you hoped for or experiencing side effects may have a psychological impact as well as a physical one.

As with other similar treatments there are a number of possible side effects associated with Ellansé®. These side effects are listed in the Ellansé® brochure which you should read in full. These side effects include:

  •  injection related reactions, including swelling, redness, pain, itching, discoloration or tenderness may occur at the site of the injection. These usually resolve spontaneously within several days after the injection;
  • adverse reactions to the implant material (filler) including, but not limited to the following: hypersensitivity, allergic reactions, inflammation, infection, , excessive bruising, accumulation of fluid, inadequate healing, skin discoloration, localised circulation problems, blood clots or obstructions in blood supply or abscess formation at the implant site which may in turn result in hardening and/or scar formation;
  • the formation of nodules (lumps) or granulomas (a collection of inflamed cells) which may require removal or other treatment;
  • rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia (lack of blood supply to the brain) or cerebral haemorrhage leading to stroke, skin necrosis (death of skin tissue), and damage to underlying facial structures; and
  • other adverse reactions to those mentioned above, could occur including vision loss/permanent blindness in the event of an occlusion of the retinal artery.

POTENTIAL USE OF ANAESTHETIC

An anaesthetic may be used to cause temporary numbness and loss of feeling to the treated area. Some side effects may occur with this anaesthetic, the nature and severity of which cannot be foreseen. Such side effects include but are not limited to: flushing or redness of the skin, itchy skin, small red or purple spots on the skin and unusually warm skin. Some less common side effects include but are not limited to: bruising, bleeding, burning, swelling, pain or allergic reaction.

 

COMMENTS TO NOTE ARISING FROM THE DISCUSSION

WHAT TO DO IF YOU EXPERIENCE A SIDE EFFECT OR OTHER ADVERSE REACTION

If you experience (or suspect you are experiencing) any sort of side effect or adverse reaction following the treatment you should contact the treating physician or the clinic using the contact information set out in this form.

Hollie Neale (DR Nina’ s PA): 07340093939 or/and info@facialsculpting.co.uk

WHAT TO DO FOLLOWING TREATMENT

It is recommended to avoid hot bathing and vigorous exercise for 24 hours and to keep the treatment area clean (for example by avoiding wearing make-up) during this period. You should also avoid excessive-exposure to the sun, UV light exposure and extreme cold weather for 1 week after treatment or, if longer, until any swelling and redness has gone.

SECTION 3: CONSENT

The use of the Ellansé® treatment I will be treated with has been explained to me by the physician and I have been given sufficient opportunity to raise any questions and/or concerns, which I confirm have been satisfactorily addressed. I also confirm that I understand the general nature of the proposed treatment, the prospects of success and the possible risks and benefits of such a treatment as well as the alternatives and have read and understood this form and the Ellansé® brochure. I hereby declare that I have answered all questions about my health and any medical conditions affecting me accurately. I can confirm that I am in a healthy physical and mental state to proceed with the treatment and that I am a suitable candidate to undergo the procedure. I fully accept that my request for this treatment is voluntary, that I can change my mind at any point and will inform the physician immediately should I want the treatment to stop at any point. I understand that the purpose of the treatment is to improve appearance and, there is a possibility that results will not meet my expectations.
It has been explained that the results of the treatment are not permanent and I also understand that the treatment may affect me differently and that the results could last for a longer or shorter period than the norm.

I understand that I should not have any Ellansé® treatment if I have: any known allergy or foreign-body sensitivities to plastic biomaterial or permanent fillers, acute or chronic skin diseases, autoimmune diseases, sepsis or infection, or if I am unwilling to follow the post treatment guidance that has been provided.

I understand that I should not have any Ellansé® treatment if I am pregnant, breastfeeding and/or under the age of 18 and confirm that I am not pregnant, breastfeeding nor under the age of 18.

I understand that Ellansé® should not be used in or close to sites where previous skin augmentation procedures have been applied, especially with permanent implants and that I have informed the physician of any previous treatments.

Patient: By signing this consent form, I confirm that I have read and understood the information contained in this form and the consultation with the physician, agree with all of the statements set out above in this Section 3 and consent to the Ellansé® treatment (and if applicable) the use of anaesthetic cream or injected anaesthetic products during the treatment. I accept that any treatment I have is at my own risk and I understand that if I fail to disclose information requested by this form that this may result in an adverse side effect for which I accept full liability and responsibility.

Patient Name:  

Date:  

Physician: I hereby certify that I have undertaken a detailed consultation with the patient and explained the benefits and risks associated with the treatment as well as alternative treatments. I have answered any questions the patient has raised regarding the treatment and believe the patient fully understands the information he or she has been given. I have also reviewed the patient’s expectations and advised the patient on the expected result of the treatment. To the best of my knowledge, based on the information provided by the patient and the detailed consultation I have undertaken there are no reasons why this patient should not be treated with Ellansé®.

Physician Name:  

Physician Title:  

Date:  

Contact Number:  

Physician email:  

Alternative Contact Number/ email:  

 

Leave this empty:

Signed by Nina Bal
Signed On: 8th January 2020

Signature Certificate
Document name: Ellanse Product Consent Form
Unique Document ID: c6dd6968001e053ba48f35bf368c2a04041a5d87
Timestamp Audit
7th November 2019 12:50 pm BSTEllanse Product Consent Form Uploaded by Nina Bal - info@facialsculpting.co.uk IP 51.179.98.227