I have requested that Dr. Kotlus attempt to improve my facial expression lines with Botox® or Dysport®.  Both are a trademark for botulinum toxin type A (BTX- A). 

These injections have been used for decades in children and adults to improve muscle spasm of the facial muscles and to correct double vision due to muscle imbalance. Injection of small amounts weakens the muscles that cause selected muscle actions such as frowning and eyelid squeezing.  While the FDA has not approved injections to improve the appearance of wrinkles in other areas of the face, physicians may perform these “off-label” procedures. There are alternatives to injections, including no treatment, other injections, laser or surgery. 

Although the results are usually quite satisfactory, I have been informed that the practice of medicine is not an exact science and that no guarantees can be or have been made concerning expected results in my case.

The BTX-A solution is injected with a small needle into the muscle. You will see the benefits should be attained by about 2 weeks and are likely to last 3 to 6 months.

Side effects and complications are rare. Occasionally, slight swelling, and/or bruising may last for several days after the injections. Rarely, an adjacent muscle may be weakened for several weeks after an injection. Other risks may include but are not limited to undercorrection, facial asymmetry, droopy eyelid, headache, and development of antibodies to BTX-A.

I have been advised of the risks involved in such treatment, the expected benefits of such treatment, and alternative treatments, including no treatment at all.

I understand I should not have BTX-A treatment if I am pregnant, nursing, allergic to albumin, have an infection or muscle weakness at the site of injection, have Eaton-Lambert syndrome, Lou Gehrig’s disease, or myasthenia gravis.

The Provider has explained the contents of this form with me and I understand the nature and purpose of the BTX-A injections and I have read and understand this consent form and I agree to its terms and authorize treatment. I further understand that the Provider cannot guarantee the results and I will not hold him or the employees responsible for my individual results of the BTX-A treatment that I have requested. 

 

Fillers are administered via a syringe, or injection, into the areas sought to be filled to reduce wrinkles, hollow/deflated areas, and folds.  Results are immediate.  An anesthetic numbing medication may be used to reduce discomfort.  The treatment site is cleansed with an antiseptic solution.  The depth of the injection(s) depends on the depth of the area to be treated and its location(s). Multiple injections might be made depending on the site, depth of the wrinkle, and/or technique used. After the first treatment, additional treatments may be necessary to achieve the desired level of correction.

Periodic touch-up injections help sustain the desired level of correction.

RISKS/DISCOMFORT

Although a very thin needle or cannula is used, common injection-related reactions could typically occur.  These could include: some initial swelling, pain, itching, discoloration, bruising or tenderness at the injection site. If you are using substances that reduce blood clotting such as aspirin or other non-steroidal anti-inflammatory drugs, increased bruising or bleeding at the injection site could occur.  These reactions generally lessen or disappear within a few days but may last for a week or longer. As with all injections, this procedure carries the risk of infection.  The syringe is sterile and standard precautions associated with inject able materials have been taken.

Some lumps (seen and/or felt) may occur following the injection.   Some patients may experience additional swelling or tenderness at the injection site.  The 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.  Very rarely, injury or injection into a blood vessel could cause skin injury or visual problems necessitating further treatment.  Active inflammation or infection might prohibit the use of specific filler. There is no guarantee that you will be completely satisfied.  There is no guarantee that wrinkles and folds will disappear completely, or that you will not require additional treatments to achieve the results you seek.

ALTERNATIVES

This is strictly a voluntary cosmetic procedure.  No treatment is necessary or required. The cost of treatment will be billed to you individually.  Since most fillers are considered cosmetic, they are generally not reimbursable by government or private health care insurers.

By signing this informed consent, you hereby grant authority to your physician to perform facial augmentation and filler therapy/injections and/or to administer any related treatment as may be deemed necessary or advisable in the diagnosis and treatment of your condition.

The nature and purpose of this procedure, with possible alternative methods of treatment as well as complications, have been fully explained to your satisfaction.  No guarantee has been given by anyone as to the results that may be obtained by this treatment.

There are many devices, medications and injectable fillers and botulinum toxins that are approved for specific use by the FDA, but this proposed use is “Off-Label”, that is not specifically approved by the FDA. It is important that you understand your physician always uses FDA-cleared filler products and may sometimes use them in an "off-label" manner.  

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 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 consent to this procedure and I have been asked to sign this form after my discussion with the physician.  I agree to have my photos taken for record keeping, comparison and research purposes.