Purpose of the Consent: To provide written information regarding the risks, benefits, and alternatives of Hyaluronic Acid Filler such as Restylane®, Juvederm, Versa, & Belotero (Non-Animal Stabilized Hyaluronic Acid). This consent is written. It is important that the patient should fully understand the treatment prior to. Before signing the consent, the patient should ask any questions regarding the treatment, Hyaluronic Acid Filler, and procedures to their doctor or healthcare professional.

The Treatment Information: All mammals have hyaluronic acid naturally and it contains several soft tissues. This acid can also be produced synthetically. Dermal Fillers use hyaluronic acid which is a non-animal product, so the risk of animal-based disease or allergy is low. To lessen the discomfort, the injections contain a local anesthetic. For lasting effects, the treatment should continue. After injection, the body absorbs dermal fillers slowly and the length of the effect depends on the person.

Risks and Side Effects: The possible side effects are listed below. However, the patients should be aware that there may be unique effects to certain people that are not known currentlt. Some possible occurrences  during Tissue Filler Injections: Bleeding and Swelling,  Blindness, Erythema (Skin Redness), Needle Marks, Acne-Like Skin Eruptions, Skin Lumpiness, Visible Tissue Filler Material, Asymmetry, Pain. Risks of Dermal Filler Injections: Damage to Deeper Structures, Infection, Skin Necrosis, Allergic Reactions and Hypersensitivity, Scarring, Granulomas, Antibodies to Fillers, Accidental Intra-Arterial Injection, Under /Over Correction, Migration of Dermal-Fillers, Drug, and Local Anesthetic Reactions.

Limitations and Alternatives: From time to time, there are cases when the treatment may not be successful or wears off quickly. Alternatives may include: laser treatments, chemical skin peels, other skin procedures, or alternative types of tissue fillers. 

This is an informed consent document which has been prepared to help your team inform you concerning neurotoxin injections and its risks. It is important that you read this information carefully and completely. Please initial each page, indicating that you have read the page, and sign the consent for this procedure as proposed by your injector and agreed upon by you.

 In the case my filler must be dissolved, I consent to the following: 

HYLENEX® recombinant is a purified preparation of the enzyme recombinant human hyaluronidase produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). It is used to increase the absorption and dispersion of injected drugs or to disrupt the structure of certain organs.   It is used off label to help decrease excess hyaluronic acid fillers or the Tyndall effect (blue-ish tint) which can occur if hyaluronic acid fillers are injected too superficially. I understand that this medication can be unpredictable and spread, and may dissolve all the filler that was injected. 

RISKS OF INJECTION: Every procedure involves a certain amount of risk, and it is important that you understand these risks and the possible complications associated with them. In addition, every procedure has limitations. An individual’s choice to undergo this procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience the following, you should discuss each of them with your physician to make sure you understand the risks, potential complications, limitations, and consequences.  Additional information concerning Hylenex® may be obtained from the package-insert supplied by Halozyme Therapeutics, Inc.   

Bleeding and Bruising: It is possible, though unusual, to have a bleeding episode from an injection.  Bruising in soft tissues may occur. Should you develop post-injection bleeding, it may require emergency treatment or surgery. Aspirin, anti-inflammatory medications, platelet inhibitors, anticoagulants, Vitamin E, ginkgo biloba and other “herbs / homeopathic remedies” may contribute to a greater risk of a bleeding problem. Do not take any of these for 7 days before or after injections.

Itching/Swelling/Pain/Redness: Itching and swelling is a normal occurrence following the injections. It decreases after a few days. If swelling is slow to resolve, medical treatment may be necessary. Discomfort associated with injections is normal and usually of short duration. Redness in the skin occurs after injections. It can be present for a few days after the procedure.

Infection: Although infection is unusual, bacterial, fungal, and viral infections can occur. Herpes simplex virus infections around the mouth can occur following treatment. This applies to both individuals with a past history of Herpes simplex virus infections 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.  Hylenex®  should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection.

Pregnancy and Nursing Mothers: It is unknown if Hylenex® can cause harm to the fetus. If you become pregnant while taking Hylenex®, discuss with your doctor the benefits and risks of using Hylenex® during pregnancy. Hylenex® does not cause problems during labor, but it is unknown if it can cause harm to the fetus during labor. It is unknown if Hylenex® is excreted in breast milk.

Drug Interactions: Some medicines may interact with Hylenex®. Tell your health care provider if you are taking any other medicines, especially any of the following: Local anesthetics (eg, lidocaine) because risk of side effects of Hylenex®  may be increased;  Antihistamines (eg, diphenhydramine), certain hormones (eg, corticotropin, estrogens), cortisone, or salicylates (eg, aspirin) because the effectiveness of Hylenex® may be decreased.  Tell your doctor if you are taking benzodiazepines (eg, alprazolam), furosemide, or phenytoin because effectiveness may be decreased by Hylenex®.

Allergic Reactions:  In rare cases, adverse reactions to hyaluronidase have been known. The allergic reactions are quite rare, but persons with known allergies to hyaluronidase of bovine or ovine origins should not be treated with hyaluronidase. Allergic reactions may include hives, difficulty breathing, and swelling of the face, lips, tongue, or throat. 

Unknown Risks: The long term effect of Hylenex® is unknown.  The possibility of additional risk factors or complications attributable to the use of Hylenex® may be discovered.

 I understand that it is not uncommon for the treated area to look “over-dissolved or pruned.” This is due to the reaction of native hyaluronic acid in the skin, which is quickly repleted and hydrated.

GENERAL INFORMATION

Clostridia botulinum bacteria produce a class of chemical compounds known as “toxins”. The Neurotoxins are processed and purified to produce a sterile product suitable for specific therapeutic uses. Once the diluted toxin is injected, it produces a temporary paralysis (chemodenervation) of muscle by preventing transmission of nerve impulses to muscle. The duration of muscle paralysis generally lasts for approximately three to four months. Continuing treatments are necessary in order to maintain the effect of neurotoxins over time.

Neurotoxins have been approved to treat certain conditions involving crossed eyes (strabismus), eyelid spasm (blepharospasm), cervical dystonia (spastic muscle disorder with the neck) and motor disorders of the facial nerve(VII cranial nerve). As of April 2002, it has been FDA approved for the cosmetic treatment of forehead wrinkles caused by specific muscle groups. Other areas of the face and body such as crows feet wrinkles and neck bands may be treated in an “off-label” fashion. Neurotoxins have also been used “off-label” to treat migraine headaches, colorectal disorders, excessive perspiration disorders of the armpit and hands, and musculoskeletal pain disorders.

Neurotoxin injections are customized for every patient, depending on his or her particular needs. These can be performed in areas involving the eyelid region, forehead, and neck. Neurotoxins cannot stop the process of aging. It can, however, temporarily diminish the look of wrinkles caused by muscle groups. Neurotoxin injections may be performed as a single procedure or as an adjunct to a surgical procedure.

ALTERNATIVE TREATMENTS

Alternative forms of management include not treating the skin wrinkles by any means. Improvement of skin wrinkles may be accomplished by other treatments or alternative types of surgery such as a blepharoplasty, face or brow lift when indicated. Other forms of eyelid surgery may be needed should you have intrinsic disorders affecting the function of the eyelid such as drooping eyelids from muscle problems (eyelid ptosis) or looseness between the eyelid and eyeball (ectropion). Minor skin wrinkling may be improved through chemical skin peels, lasers, injection of filling material, or other skin treatments. Risks and potential complications are associated with alternative forms of medical or surgical treatment.

RISKS OF NEUROTOXINS

Every procedure involves a certain amount of risk and it is important that you understand these risks and the possible complications associated with them. In addition, every procedure has limitations. An individual’s choice to undergo a surgical 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 plastic surgeon to make sure you understand risks, potential complications, limitations, and consequences of neurotoxin injections.

Risks include but are not limited to: Incomplete Block, Bleeding and Bruising, Damage to Deeper Structures, Corneal Exposure Problems, Dry Eye Problems, Migration of Neurotoxins, Drooping Eyelid (Ptosis), Double Vision, Eyelid Ectropion, Other Eye Disorders, Blindness, Asymmetry, Pain, Allergic Reaction, Antibodies to Neurotoxins, Infection, Skin Disorders, Neuromuscular Disorders, Migraine Headache Disorders, Unsatisfactory Result, Long Term Effects, Pregnancy and/ or nursing complications, Drug Interaction, and any other Unknown Risks.

DISCLAIMER

Informed consent documents are used to communicate information about the proposed surgical treatment of a disease or condition along 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. Your provider may provide you with additional or different information which is based on all of the facts pertaining to your particular case and the current state of medical knowledge.

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.

OFF-LABEL FDA USE

There are many devices, medications, injectable fillers, and botulinum toxins that are approved for specific use by the FDA, but this proposed use is “Off-Label”, which is not specifically approved by the FDA. It is important that you understand this proposed use is not experimental and your physician believes it to be safe and effective.

Examples of commonly accepted “Off-Label” use of drugs or devices include the use of aspirin for prevention of heart disease, retinoids for skin care, and injection of botulinum toxin for wrinkles around the eyes. Botox® is approved for Glabellar frown lines, Blepharospasm, and would be Off-Label for all other uses. I acknowledge that I have been informed about the Off-Label FDA status of Botox®, and I understand it is not experimental and accept its use.

General Information

I confirm that I consent to receiving treatment using the cosmetic 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, and rehydration of the skin.

I have been given sufficient information to enable me to understand the use of these products for the approved indications.

I have also received information regarding contraindications to the administration of products and potential side effects.

Cosmetic products give an aesthetic result for an average of 6-18 months. 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 touch-up treatments help to optimize 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 practitioner.

General Information About Dermal Filler Injections:

Some redness, swelling, hematoma, and bruising may occur following treatment. Resolution is typically spontaneous within a few days.

As with all injectable treatments, there is a minimal risk of infection, 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.

General Information About Botulinum A Toxin Injection:s

Botulinum A Toxin injections in the area of the glabella muscles are made to relax these muscles temporarily or in the forehead or crows feet around the lateral area of the eyes, or other areas consulted with and approved by your practitioner.

Botulinum A Toxin injection has been FDA approved for use in the cosmetic treatment for glabella frown lines only and crows feet (Botox)– the wrinkles between the eyebrows.

Injection of Botulinum A Toxin into the small muscles between the brows causes those specific muscles to halt their function (be paralyzed), thereby improving the appearance of the wrinkles. I understand the goal is to decrease the wrinkles in the treated area. This paralysis is temporary, and re-injection is necessary within three to four months. It has been explained to me that other temporary and more permanent treatments are available.

The possible side effects of Botulinum A Toxin include but are not limited to:

1. 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.

2. Infection: Infections can occur which in most cases are easily treatable but in rare cases a permanent scarring in the area can occur.

3. Most people have lightly swollen pinkish bumps where the injections went in, for a couple of hours or even several days.

4. Although many people with chronic headaches or migraines often get relief from Botulinum A Toxin, a small percent of patients get headaches following treatment with Botulinum A Toxin, for the first day. In a very small percentage of patients these headaches can persist for several days or weeks.

5. Local numbness, rash, pain at the injection site, flu like symptoms with mild fever, back pain.

6. Respiratory problems such as bronchitis or sinusitis, nausea, dizziness, and tightness or irritation of the skin.

7. 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.

8. While local weakness of the injected muscles is representative of the expected pharmacological action of Botulinum A Toxin, weakness of adjacent muscles may occur as a result of the spread of the toxin.

9. Treatments: I understand more than one injection may be needed to achieve a satisfactory result.

10. Another risk when injecting Botulinum A Toxin 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.

I will follow all aftercare instructions as it is crucial I do so for healing.

As Botulinum A Toxin injection is not an exact science, there might be an uneven appearance of the face with some muscles more affected by the Botulinum A Toxin than others. In most cases this uneven appearance can be corrected by injecting Botulinum A Toxin 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 A Toxin, as there are both known and unknown side effects associated with any medication or procedure.

Botulinum A Toxin should not be administered to a pregnant or nursing woman.

Additionally, the number of units injected is an estimate of the amount of Botulinum A Toxin required to paralyze the muscles. I understand there is no guarantee of results of any treatment. I understand the regular charge applies to all subsequent treatments.

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.

By accepting, I acknowledge that I have read the foregoing informed consent 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 doctor, the person injecting the Botulinum A toxin and/or the dermal filler, and the facility from liability associated with this procedure.

ADDITIONAL TREATMENT NECESSARY

There are many variable conditions in addition to risk and potential complications that may influence the long term result of BOTOX injections. Even though risks and complications occur infrequently, the risks cited are the ones that are particularly associated with BOTOX injections. Other complications and risks can occur but are even more uncommon. Should complications occur, additional surgery or other treatments may be necessary. The practice of medicine and surgery is not an exact science. Although satisfactory results are expected, there is no guarantee or warranty expressed or implied, on the results that may be obtained.

It is important that you read the above information carefully and have all of your questions answered before signing the consent on the next page.

INFORMED CONSENT FOR NEUROTOXIN INJECTIONS

1. I hereby authorize Lady Lagniappe Aesthetics, PLLC, to perform the following procedure or treatment: BOTOX/XEOMIN INJECTION, DERMAL FILLERS

2. I recognize that during the course of the procedure and medical treatment or anesthesia, unforeseen conditions may necessitate different procedures than those above. I therefore authorize the above practitioner or designees to perform such other procedures that are in the exercise of their professional judgment necessary and desirable. The authority granted under this paragraph shall include all conditions that require treatment and are not known to my practitioner at the time the procedure is begun.

3. I acknowledge that no guarantee has been given by anyone as to the results that may be obtained.

4. I consent to be photographed or televised before, during, and after the operation(s) or procedure(s) to be performed, including appropriate portions of my body, for medical, scientific or educational purposes, provided my identity is not revealed by the pictures.

5. For purposes of advancing medical education, I consent to the admittance of observers to the treatment room.

6. IT HAS BEEN EXPLAINED TO ME IN A WAY THAT I UNDERSTAND:

 a. THE ABOVE TREATMENT OR PROCEDURE TO BE UNDERTAKEN

b. THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF TREATMENT

c. THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED

CONSENT TO THE TREATMENT OR PROCEDURE AND THE ABOVE LISTED ITEMS. I AM SATISFIED WITH THE EXPLANATION.

As the patient, I give full consent to allow my provider to take photos of treatment areas for my chart. I also give full consent to allow photos to be taken at follow-up appointments for my chart to render the most ideal future plan of care. 

As the patient, I understand I will be charged $20 per year for medical clearance, but this will be credited toward cost of treatment. 

I GIVE FULL CONSENT TO THE TREATMENT OR PROCEDURE AND THE ABOVE LISTED ITEMS. I understand that if I am more than 15 minutes late for my appointment, or I cancel my apportionment less than 24 hours in advance, I will be charged $50, and it will not be refunded.

I understand that Lady Lagniappe Aesthetics, PLLC's touch-up policy is the following: 

1-2 units complimentary for asymmetry after 21 days post-treatment

0.1ml - 0.2ml filler for asymmetry after 21 days post-treatment

I understand that under NO CIRCUMSTANCES will any refunds be given. 

*I understand that coupons and specials cannot be retroactively redeemed after treatment has been completed.

I understand that if I, as the patient, refuse payment after services are rendered, Lady Lagniappe Aesthetics, PLLC, reserves the right to charge the card on file for the full amount of services applied.