Injectable Tissue Filler Consent

Transcription

1 Injectable Tissue Filler Consent Fillers are injectable gel is a colorless hyaluronic acid gel that is injected into facial tissue to smooth wrinkles and folds, especially around the nose and mouth. Hyaluronic acid is a naturally occurring sugar found in the human body. The role of hyaluronic acid in the skin is to deliver nutrients, hydrate the skin by holding in water, and to act as a cushioning agent. It cannot, however, stop the process of aging. It can temporarily diminish the look of wrinkles and soft tissue depressions. These injections may be performed as a singular procedure, in combination with other treatments such as Botox, laser treatments, or as an adjunct to surgical procedure. Hyaluronic acid is a natural substance found in your body. High concentrations are found in soft connective tissues and in the fluid surrounding your eyes. It's also in some cartilage and joint fluids, as well as skin tissue. It is extracted and reformulated and now has become one of the most popular kinds of injectable fillers. If the term sounds familiar, it's because the same substance is often injected into the aching joints of people with arthritis to ease pain and provide extra cushioning. Brand names of tissue fillers include Belotero, Captique, Esthélis, Elevess, Hylaform, Juvéderm, Perlane, Prevelle, Puragen and Restylane. Hyaluronic acid is not derived from animal sources. Tissue fillers produce temporary swelling, redness and needle marks, which resolve after a few days. Tissue fillers injectable gel temporarily adds volume to facial tissue and restores a smoother appearance to the face. Tissue fillers injectable gel is injected into areas of facial tissue where moderate to severe facial wrinkles and folds occur. Tissue fillers injectable gel temporarily adds volume to the skin and may give the appearance of a smoother surface. Tissue fillers injectable gel will help to smooth moderate to severe facial wrinkles and folds. Most patients need one treatment to achieve optimal wrinkle smoothing, and the results last about 6 months to 1 year. Although a very thin needle is used, common injection-related reactions could occur. These could include: some initial swelling, pain, itching, discoloration, bruising or tenderness at the injection site. You could experience increased bruising or bleeding at the injection site if you are using substances that reduce blood clotting such as aspirin or other non-steroidal anti-inflammatory drugs such as Advil. Most side effects are mild or moderate in nature, and their duration is short lasting (7 days or less). The most common side effects include, but are not limited to, temporary injection-site reactions such as: redness, pain/tenderness, firmness, swelling, lumps/bumps, bruising, itching, and discoloration. As with all skin-injection procedures, there is a risk of infection. Normal Occurrences during Tissue Filler Injections - Juvéderm and Restylane/Perlane - Bleeding & Bruising possible though unusual. Bruising in soft tissues may occur. - Swelling Edema is a normal occurrence. It can be present for several days post procedure. - Needle Marks Occur normally and resolve in a few days. - Acne-Like Skin Eruptions can occur, generally resolves within a few days. - Skin Lumpiness can occur, tends to smooth out over time. In some situations may be possible to feel injected tissue filler material for long period of time. - Visible Tissue Filler Material may be possible to see any type of tissue filler injected in areas where skin is thin. - Asymmetry The human face is normally asymmetrical in appearance and anatomy. It may not be possible to achieve or maintain exact symmetry with fillers. There can be a variation from one side to the other in terms of response. This may require additional injections. - Pain - discomfort is normal and usually of short duration. - Skin Sensitivity Skin rash, itching, tenderness and swelling may occur. After treatment you should minimize exposure of treated area to excessive sun or UV lamp exposure and extreme cold weather until any initial swelling or redness has gone away. If you are considering laser treatment, chemical

2 skin peeling or any other procedure based on a skin response or if you have had such treatments and the skin has not healed completely, there is a possible risk of an inflammatory reaction in the implant site. Risks of Juvéderm and Restylane/Perlane Injections - Damage to Deeper Structures-such as nerves and blood vessels may be damaged. Injury to deeper structures may be temporary or permanent. - Infection Although unusual, bacterial, fungal, and viral infections can occur. Herpes simplex virus infections around the mouth can occur following a tissue filler treatment. This applies to both individuals with a past history of Herpes simplex and individuals with no known history of Herpes simplex virus infections in the mouth area. Specific medications must be prescribed and taken both prior to and following the treatment procedure in order to suppress an infection from this virus. Should any type of skin infection occur, additional treatment including antibiotics may be necessary. - Skin Necrosis very unusual to experience death of skin and deeper soft tissues after dermal filler injections. Skin necrosis can produce unacceptable scarring. Should this complication occur, additional treatments or surgery may be necessary. - Allergic Reactions & Hypersensitivity as with all biologic products, allergic and systemic anaphylactic reactions may occur. Juvéderm and Restylane/Perlane SHOULD NOT BE USED IN PATIENTS WITH A HISTORY OF MULTIPLE SEVERE ALLERGIES, SEVERE ALLERGIES MANIFESTED BY A HISTORY OF ANAPHYLAXIS, OR ALLERGIES TO GRAM-POSITIVE BACTERIAL PROTEINS. Allergic reactions may require additional treatment. - Scarring Should not be used in patients with susceptibility to keloid formation or hypertrophic scarring. The safety of patients has not been studied. - Granulomas Painful masses in the skin and deeper tissues after an injection are extremely rare. Should these occur, additional treatments including surgery may be necessary. - Skin Disorders Should not be used in areas with active inflammation or infections (e.g., cysts, pimples, rashes or hives - Antibodies to hyaluronic acid tissue fillers my reduce the effectiveness or produce a reaction in subsequent injections. The health significance of antibodies to HA tissue fillers is unknown. - Accidental Intra-Arterial Injection extremely rare that during the course of injection could be accidentally injected into arterial structures and produce a blockage of blood flow. This may produce skin necrosis in facial structures or damage blood flow to the eye, resulting in loss of vision. The risk and consequences of accidental intravascular injection is unknown and not predictable.- Under/Over Correction the injection of soft tissue fillers to correct wrinkles and soft tissue contour deficiencies may not achieve the desired outcome. The amount of correction may be inadequate or excessive. It may not be possible to control the process of injection of fillers due to factors attributable to each patient s situation. If under correction occurs, you may be advised to consider additional injections of tissue filler materials. - Migration may migrate from its original injection site and produce visible fullness in adjacent tissue or other unintended effects. - Drug & Local Anesthetic Reactions there is the possibility that a systemic reaction could occur from either the local anesthetic or epinephrine used for sensory nerve block anesthesia when tissue filler injections are performed. This would include the possibility of light headedness, rapid heartbeat (tachycardia) and fainting. Medical treatment of these conditions may be necessary. Additional Advisories Unsatisfactory Results dermal filler injections alone may not produce an outcome that meets your expectations for improvement in wrinkles or soft tissue depressions. There is the possibility of a poor or inadequate response. Additional injections may be necessary. Surgical procedures or other treatments may be recommended in additional to additional dermal filler treatments. Unknown Risks long term effect of dermal fillers beyond one year is unknown. The possibility of additional risk factors or complications attributable to the use of dermal fillers as a soft tissue filler may be discovered.

3 Combination of Procedures In some situations, Botox injections or other types of tissue filler materials may be used in addition in order to specifically treat areas of the face or to enhance the outcome from tissue filler therapy. The effect of other forms of external skin treatments (laser and other light therapies, microdermabrasion, dermabrasion, or chemical peels) on skin that has been treated with dermal fillers is unknown. Pregnancy & Nursing Mothers Animal reproduction studies have not been performed to determine if dermal fillers could produce fetal harm. It is not known if their breakdown products can be excreted in human milk. It is not recommended that pregnant women or nursing women receive dermal fillers. Drug Interactions It is not known if dermal fillers react with other drugs within the body. Long-Term Effects dermal fillers should not be considered as a permanent treatment for the correction of wrinkles and soft tissue depressions. Over time, the filler material is slowly absorbed by the body and wrinkles or soft tissue depressions will reappear. Continuing treatments (injections) are necessary in order to maintain the effect. Subsequent alterations in face and eyelid appearance may occur as the result of aging, weight loss or gain, sun exposure, or other circumstances not related to dermal filler injections. Future surgery or other treatments may be necessary. Injections do not arrest the aging process or produce permanent tightening of the skin or improvement in wrinkles. Patients who are using substances that can prolong bleeding, such as aspirin or ibuprofen, as with any injection, may experience increased bruising or bleeding at the injection site. You should inform your physician before treatment if you are using these types of substances If laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after treatment with Tissue fillers injectable gel, there is a possible risk of an inflammatory reaction at the treatment site Tissue fillers injectable gel should be used with caution in patients on immunosuppressive therapy, or therapy used to decrease the body s immune response, as there may be an increased risk of infection. Advisories for patients considering non-permanent tissue filler injections: Off-label usage of hyaluronic acid tissue filler - HA, depending on its manufacturer is labeled for specific use. The use of for other conditions and disorders would be considered off-label usage by your practitioner. FDA defines off label use as, Use for indication, dosage form, dose regimen, population or other use parameter not mentioned in the approved labeling. The FDA recognizes that off label use of drugs by prescribers is often appropriate and may receive endorsement from published literature. Hyaluronic Acid may be used according to a physician s practice to treat other conditions. The safety of Tissue fillers injectable gel for use during pregnancy, in breastfeeding females, or in patients under 18 years has not been established. Pregnancy and Nursing Mothers - Animal reproduction studies have not been performed to determine if HA tissue filler could produce fetal harm. It is not known if tissue filler or its breakdown products can be excreted in human milk. It is not recommended that pregnant women or nursing mothers receive tissue filler treatments. The safety of Tissue fillers injectable gel in patients with a history of excessive scarring (eg, hypertrophic scarring and keloid formations) and pigmentation disorders has not been studied Possible Side Effects can include but are not limited to: Allergic reaction or infection, bleeding, tenderness or pain, redness, bruising, scarring, lumps, bumps or swelling at injection site. People with a history of cold sores may experience a recurrence after the treatment, although this can be minimized by the use of antiviral medicines. I agree to consult with my physician if I have a history of cold sore or fever blisters prior to this treatment. I have advised my physician or nurse if I have severe allergies, particularly allergies to bacterial proteins. If I have an allergy to bacterial proteins I understand I am not a candidate for this treatment. I have also advised my physician or nurse if I have asthma, hay fever, eczema or a history of multiple allergies as any of these issues may increase my risk of allergic reaction. Initial t (Note: Sign, remove, and file in patient record.) I have read the information above about Tissue fillers in its entirety and have discussed the risks and benefits of dermal filler treatment with my physician and his/her representative. I understand the information provided. I agree to my being treated with tissue fillers. Initial

4 Within the first 24 hours after injection, you should avoid strenuous exercise, extensive sun or heat exposure, and consumption of alcoholic beverages. Exposure to any of the above may cause temporary redness, swelling, and/or itching at the injection sites. If there is swelling, you may need to place an ice pack over the swollen area. You should ask your physician when makeup maybe applied after your treatment. These temporary side effects generally resolve themselves within one week. An ice pack can be applied to the site if you experience swelling. You may apply make-up as usual. After treatment, you should minimize exposure of the treated area to excessive sun or UV lamp exposure and extreme cold weather until any initial swelling or redness has gone away. Initial I am giving my permission to undergo a filler treatment. I understand that I will be injected with Tissue filler sin the facial area. These injections are implanted intradermally through a fine gauge needle into the treated area. Tissue fillers is composed of Hyaluronic acid gel. Initial I have read and understand the Pre and Post-Treatment Instructions. I agree to follow these instructions carefully. I understand that compliance with recommended pre- and post- procedure guidelines are crucial for healing, prevention of side effects and complications as listed above. I have advised my physician or nurse if I am pregnant, trying to get pregnant or if I am nursing. Initial I understand that the purpose of this treatment is to reduce the appearance of my wrinkles or volumize specific areas of my face (such as my lips, cheeks or other regions). I understand that the filler reduces wrinkles and regions of volume loss by revolumizing the area. I understand that injectable fillers are considered a medical device/implant and that they are given by injection. Initial I understand that there are always possible side effects when having a medical treatment. I understand that with fillers, possible side effects include: allergic response, bruising, skin infection, lumpiness, and volume asymmetry. Clinical results will vary per patient. Aspirin, anti-inflammatory medications, platelet inhibitors, anticoagulants, Vitamin E, Ginko biloba and other herbs/homeopathic remedies may contribute to a greater risk of a bleeding problem. Do not take any of these for seven days before injections. Bleeding and bruising can produce permanent tissue color changes. Additional Treatment Necessary There are many variable conditions in addition to risk and potential complications that may influence the long-term result of HA tissue filler injections. Even though risks and complications occur infrequently, the risks cited are the ones that are particularly associated with tissue filler injections. Other complications and risks can occur but are even more uncommon. Should complications occur, additional surgery or other treatments may be necessary. You are advised to seek medical care should complications or adverse events occur after tissue filler treatments. Although good results are expected, there is no guarantee or warranty expressed or implied, on the results that may be obtained with the use of tissue filler injections. The practice of medicine and surgery is not an exact science. Financial Responsibilities This treatment provides a defined amount of HA tissue filler for the treatment of wrinkles and other conditions. If additional interim injections of HA tissue filler are needed in order to maintain or improve results, you will be responsible for these costs in addition to the cost of this treatment session. It is unlikely that tissue filler injections to treat cosmetic problems would be covered by your health insurance. Additional costs of medical treatment would be your responsibility should complications develop from HA tissue filler injections. You would also be responsible for additional forms of treatments or surgery recommended to improve the appearance of facial wrinkles and soft tissue depressions. In signing the consent for this surgery/procedure, you acknowledge that your have been informed about its risk and consequences and accept responsibility for the clinical decisions that were made along with the financial costs of all future treatments. Bleeding & Bruising - possible though unusual. Bruising in soft tissues may occur. Swelling Edema is a normal occurrence. It can be present for several days post procedure. Some patients may experience additional swelling or tenderness at the injection site and in rare occasions,

5 pustules might form. These reactions might last for as long as approximately 2 weeks, and in appropriate cases may need to be treated with oral corticosteroids or other therapy. Needle Marks Occur normally and resolve in a few days. Acne-Like Skin Eruptions can occur, generally resolves within a few days. Skin Lumpiness can occur, tends to smooth out over time. In some situations may be possible to feel injected tissue filler material for long period of time. Visible Tissue Filler Material may be possible to see any type of tissue filler injected in areas where skin is thin. Asymmetry The human face is normally asymmetrical in appearance and anatomy. It may not be possible to achieve or maintain exact symmetry with fillers. There can be a variation from one side to the other in terms of response. This may require additional injections. Pain - discomfort is normal and usually of short duration. Skin Sensitivity Skin rash, itching, tenderness and swelling may occur. After treatment you should minimize exposure of treated area to excessive sun or UV lamp exposure and extreme cold weather until any initial swelling or redness has gone away. If you are considering laser treatment, chemical skin peeling or any other procedure based on a skin response or if you have had such treatments and the skin has not healed completely, there is a possible risk of an inflammatory reaction in the implant site. Initial Damage to Deeper Structures-such as nerves and blood vessels may be damaged. Injury to deeper structures may be temporary or permanent. Infection Although unusual, bacterial, fungal, and viral infections can occur. Herpes simplex virus infections around the mouth can occur following a tissue filler treatment. This applies to both individuals with a past history of Herpes simplex and individuals with no known history of Herpes simplex virus infections in the mouth area. Specific medications must be prescribed and taken both prior to and following the treatment procedure in order to suppress an infection from this virus. Should any type of skin infection occur, additional treatment including antibiotics may be necessary. Skin Necrosis very unusual to experience death of skin and deeper soft tissues after dermal filler injections. Skin necrosis can produce unacceptable scarring. Should this complication occur, additional treatments or surgery may be necessary. Allergic Reactions & Hypersensitivity as with all biologic products, allergic and systemic anaphylactic reactions may occur. Tissue fillers SHOULD NOT BE USED IN PATIENTS WITH A HISTORY OF MULTIPLE SEVERE ALLERGIES, SEVERE ALLERGIES MANIFESTED BY A HISTORY OF ANAPHYLAXIS, OR ALLERGIES TO GRAM-POSITIVE BACTERIAL PROTEINS. Allergic reactions may require additional treatment. Initial Scarring Should not be used in patients with susceptibility to keloid formation or hypertrophic scarring. The safety of patients has not been studied. Granulomas Painful masses in the skin and deeper tissues after an injection are extremely rare. Should these occur, additional treatments including surgery may be necessary. Skin Disorders Should not be used in areas with active inflammation or infections (e.g., cysts, pimples, rashes or hives). In rare instances, granuloma or abscess formation, localized necrosis and urticaria have been reported. Antibodies to hyaluronic acid tissue fillers my reduce the effectiveness or produce a reaction in subsequent injections. The health significance of antibodies to HA tissue fillers is unknown. Accidental Intra-Arterial Injection extremely rare that during the course of injection could be accidentally injected into arterial structures and produce a blockage of blood flow. This may produce skin necrosis in facial structures or damage blood flow to the eye, resulting in loss of vision. The risk and consequences of accidental intravascular injection is unknown and not predictable. Under/Over Correction the injection of soft tissue fillers to correct wrinkles and soft tissue contour deficiencies may not achieve the desired outcome. The amount of correction may be inadequate or excessive. It may not be possible to control the process of injection of fillers due to factors attributable to each patient s situation. If under correction occurs, you may be advised to consider additional injections of tissue filler materials.

6 Migration may migrate from its original injection site and produce visible fullness in adjacent tissue or other unintended effects. Drug & Local Anesthetic Reactions there is the possibility that a systemic reaction could occur from either the local anesthetic or epinephrine used for sensory nerve block anesthesia when tissue filler injections are performed. This would include the possibility of light headedness, rapid heart beat (tachycardia) and fainting. Medical treatment of these conditions may be necessary. Initial Improvement of skin wrinkles and soft tissue depressions may be accomplished by other treatments: laser treatments, chemical skin-peels, microdermabrasion, or other skin procedures, alternative types of tissue fillers or surgery such as a blepharoplasty, face or brow lift when indicated. Risks and potential complications are associated with alternative forms of medical or surgical treatment. This is strictly a voluntary cosmetic procedure. No treatment is necessary or required. Other alternative treatments which vary in sensitivity, effect and duration include: animal-derived collagen filler products, dermal fillers derived from the patient s own fat tissues, synthetic plastic permanent implants, or bacterial toxins that can paralyze muscles that cause some wrinkles. Initial Unsatisfactory Results dermal filler injections alone may not produce an outcome that meets your expectations for improvement in wrinkles or soft tissue depressions. There is the possibility of a poor or inadequate response. Additional injections may be necessary. Surgical procedures or other treatments may be recommended in additional to additional dermal filler treatments. Unknown Risks long term effect of dermal fillers beyond one year is unknown. The possibility of additional risk factors or complications attributable to the use of dermal fillers as a soft tissue filler may be discovered. Long-Term Effects dermal fillers should not be considered as a permanent treatment for the correction of wrinkles and soft tissue depressions. Over time, the filler material is slowly absorbed by the body and wrinkles or soft tissue depressions will reappear. Continuing treatments (injections) is necessary in order to maintain the effect. Subsequent alterations in face and eyelid appearance may occur as the result of aging, eight loss or gain, sun exposure, or other circumstances not related to dermal filler injections. Future surgery or other treatments may be necessary. Injections do not arrest the aging process or produce permanent tightening of the skin or improvement in wrinkles. Term Effects - HA tissue filler injections should not be considered as a permanent treatment for the correction of wrinkles and soft tissue depressions. Over time, the tissue filler material is slowly absorbed by the body and wrinkles or soft tissue depressions will reappear. Continuing HA tissue filler treatment (injections) are necessary in order to maintain the effect. Subsequent alterations in face and eyelid appearance may occur as the result of aging, weight loss of gain, sun exposure, or other circumstances not related to tissue filler injections. Future surgery or other treatments may be necessary. Tissue filler injections do not arrest the aging process or produce permanent tightening of the skin or improvement in wrinkles. I agree to adhere to all safety precautions and regulations during the treatment. Initial I understand that it is not possible to give guarantees when using medications or having a medical treatment. In keeping, I acknowledge that I have not been given a guarantee and I am aware that no refunds will be given. The cost of treatment will be the patient s responsibility. Insurance does not cover cosmetic procedures. Initial I understand that the clinic would want to hear from me if I had any concerns and I agree to call. I know that my questions are always welcome, and all my current questions have been answered. I hereby give my permission to undergo a filler treatment. Initial I consent to the administration of such anesthetics considered necessary or advisable. I understand that all forms of anesthesia involve risk and the possibility of complications, injury, and sometimes death. You have been given a copy of this consent form. Your consent and authorization for this procedure is strictly voluntary. By signing this informed consent you herby grant authority to perform Facial Augmentation and Filler Therapy/Injections using Tissue fillers to administer any related treatments as may be deemed necessary or advisable in the diagnosis and treatment of your condition. Initial

7 Informed consent documents are used to communicate information about the proposed surgical treatment of a disease or conditions long with disclosure of risks and alternative forms of treatment(s). The informed consent process attempts to define principles of risk disclosure that should generally meet the needs of most patients in most circumstances. However, informed consent documents should not be considered all inclusive in defining other methods of care and risks encountered. Informed consent documents are not intended to define or serve as the standard of medical care. Standards of medical care are determined on the basis of all of the facts involved in an individual case and are subject to change as scientific knowledge and technology advance and as practice patterns evolve. It is important that you read the above information carefully and have all of your questions answered before signing the consent below. Informed Consent Belotero, Radiesse, Restylane, Perlane, Juvederm Ultra, Juvederm Ultra Plus, Juvederm Voluma 1. I recognize that during the course of the procedure and medical treatment or anesthesia, unforeseen conditions may necessitate different procedures than those above. 2. I consent to the administration of such anesthetics considered necessary or advisable. I understand that all forms of anesthesia involve risk and the possibility of complications, injury, and sometimes death. 3. I acknowledge that no guarantee or representation has been given by anyone as to the results that may be obtained. 4. I consent to be photographed before, during and after the procedure(s) to be performed, for the purpose of being included as a part of my record. 5. I realize that not having this procedure is an option. 6. IT HAS BEEN EXPLAINED TO ME IN A WAY THAT I UNDERSTAND: A. The above procedure to be undertaken B. There may be alternative procedures or methods of treatment C. There are risks to the procedure or treatment proposed 7. I understand that I should avoid strenuous exercise, consumption of alcoholic beverages, and prolonged sun exposure for 24 hours after treatment. The nature and purpose of this procedure, with possible alternative methods of treatment as well as complications, have been fully explained to your satisfaction. I have read this informed consent and certify that I understand its contents in full. I have had enough time to consider the information from my physician and feel that I am sufficiently advised to consent to this procedure. I hereby give my voluntary consent to this procedure. Patient s Signature Date I have discussed the risks and benefits of dermal filler treatment with this patient, have answered his/her questions, and find him/her an appropriate candidate for treatment. Signature of Physician or Physician s Representative Date