Dermal Filler Consent Information with Additional Patient Consent for Treatment During COVID-19 Pandemic
I understand that I am opting for an elective medical consultation/treatment/procedure.
I understand that the novel coronavirus, the World Health Organization has declared COVID-19, a
worldwide pandemic and that COVID-19 is extremely contagious and is believed to spread by person-to-person contact; and, as a result, social distancing is recommended.
This is not entirely possible with my proposed treatment, however, I am satisfied that safety measures are in place to minimise risk as much as possible, and patient contact will be kept to an absolute minimum in line with medical need.
I understand the Management and Clinical Staff are closely monitoring the COVID-19 situation and have put in place reasonable preventative measures aimed to reduce the spread of COVID-19.
However, given the nature of the virus, I understand there is an inherent risk of becoming infected
with COVID-19 by virtue of proceeding with treatment. I hereby acknowledge and assume the risk of becoming infected with COVID-19 through this elective consultation/medical treatment/procedure, and I give my express permission to proceed.
I understand the COVID-19 virus has a long incubation period during which carriers of the virus may not show symptoms and still be highly contagious. I understand that COVID-19 can cause additional health risks, some of which may not currently be known at this time, in addition to those risks associated with the medical consultation/ treatment/procedure itself.
I have been given the option to defer my medical consultation/treatment/procedure to a later date.
However, I understand all the potential risks, including but not limited to the potential short-term and long-term complications related to COVID-19, and I would like to proceed with my desired medical treatment/procedure I confirm that I am not presenting with any of the following symptoms of COVOID-19 listed below:
• Shortness of Breath
• Loss of Sense of Taste or Smell
• Dry Cough
• Runny Nose
• Sore Throat
I understand that air travel significantly increases my risk of contracting and transmitting the COVID19 virus. I confirm that I have not travelled in the past 15 days.
I confirm that if I develop COVID-19 symptoms following my medical
consultation/treatment/procedure or a known contact of mine develops symptoms, I will
immediately inform the practitioner to enable appropriate measures to be put in place and contact
tracing to commence I confirm I have been informed that.
I understand that further lockdown may impact on managing complications and immunological reactions.
TEOXANE INFORMATION SHEET & CONSENT FORM
Before the injection, please read this document carefully.
Don't hesitate to ask questions if you feel the information is not clear.
Your practitioner, who is trained in the injection techniques, will be available to answer your questions.
Take the time you need before making your decision.
1. TEOSYAL® PRODUCTS AND INDICATIONS
The Teosyal® range includes cross-linked and non-rcross-linked gels (cross-linking is a process which can transform a liquid gel to a viscoelastic gel), as well as gels with or without anaesthetic (lidocaine). An exhaustive product list is available on the website: www.teoxane.com.
Products in the Teosyal® range are viscoelastic gels of cross-linked hyaluronic acid (except for Teosyal® Meso and Teosyal® PureSense Redensity [ I ]), sterile, of non-animal origin, to be injected in the dermis. They are designed for filling wrinkles and lines, correcting the facial oval and/or increasing lip volume. Cross-linked products in the TEOSYAL® range have a 6 to 18 months duration. This mean duration depends on several factors: the patient's skin type, the severity of the wrinkle to be corrected, the injection zone and the volume injected. Teosyal® Meso and Teosyal® PureSense Redensity [ I ] non-cross-linked hyaluronic acid gels are designed to improve skin hydration and radiance.
Your practitioner will help you to choose the product for injection according to your aesthetic requirement.
2. PRECAUTIONS FOR USE AND CONTRAINDICATIONS
• Pregnant or breast-feeding women, children,
• Sports persons have to be alerted on the fact that this product contains an active compound which may lead to a positive reaction to doping tests (PureSense range),
• History of hypersensitivity to one of the components of the products tested (hyaluronic acid, lidocaine, vitamins), of anaphylactic shock or severe allergy,
• History of autoimmune disease or disease affecting the immune system (type I diabetes, polyarthritis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, thyroid disorder, scleroderma, inflammatory intestinal disease, lupus, multiple sclerosis, ulcerative colitis);
• Pathology (herpes, acne, rosacea) or unhealed skin alteration;
• Complications after a surgery during the past 5 years
• Previous injection of permanent products (silicone, acrylic polymers, dextran);
• Untreated infectious periodontitis, cellulitis of dental or ENT origin, dental abscess untreated or treated less than one week ago.
• In association with a peeling, a laser treatment or based on ultrasound.
3. SIDE EFFECTS
The TEOSYAL® product range has been available commercially within the European Union for many years, with several million syringes injected, and on the basis of current data, there is no reason to suspect any unknown risks. According to international literature and health authorities, hyaluronic acid based products, such as TEOSYAL® products with CE mark, may potentially have side effects. Indeed, although hyaluronic acid is a natural constituent of the dermis, an injection of hyaluronic acid is likely to cause a skin reaction as if this molecule was a foreign body. These reactions are usually temporary but influenced, on the one hand, by many external factors (type of product - technique, site, number of injections and quantity of product injected), and on the other by factors specific to the patient being injected (injection tolerance, phototype, nervousness at the time of injection, medical history).
• Dissatisfaction with the expected aesthetic result;
• Redness, bruising, ecchymosis, hematomas, oedema, itching, mild pain at the injection point which may occur after the injection and is resorbed after 24 hours to 8 days (on average within 72 hours);
• Indurations or nodules which may occur at the injection point 15 days to 3 months after the injection;
• Discoloration of the injection zone.
- No result is guaranteed
- Results may differ from treatment to treatment
- Exact symmetry is not always possible
- Product may be palpable of visible post procedure
I have also been informed that rare cases of medical device vigilance have been described in the literature: Necrosis in the glabellar region, abscess, granuloma and hypersensitivity following injects of hyaluronic acid. However, if you notice a side effect after a Teosyal injection, you must contact your practitioner and/or Teoxane Laboratories immediately: In France, Paris: (0033) (0) 1 44 40 88 90 or in Switzerland, Geneva: (0041) (0) 22 344 96 36