Informed Consent. Informed Consent for Acne Treatment with the Sciton BBL Pulsed Light Module. Patient Acct# Introduction.

Transcription

1 Informed Consent Informed Consent for Acne Treatment with the Sciton BBL Pulsed Light Module Patient Acct# Please initial all of the following sections confirming that you have read and understand each statement. Introduction The Sciton BBL is intended for selective photothermolysis to remove acne from the face and body. The BBL light pulse is often described as a warm or rubber band snap sensation as the light is absorbed by the targeted areas. You may experience some redness that should resolve within a few hours. Most people notice a significant result the day of treatment and will continue to notice a reduction in acne lesions over the following 1-2 weeks. Multiple treatments may be needed over a time span of 1-2 week intervals to reduce acne lesions in most areas. The treatments may not completely improve or prevent future acne outbreaks and a maintenance program is recommended for most patients. Off Label Use When a drug or device is approved for medical use by the Food and Drug Administration (FDA), the manufacturer is required to produce a label to explain its use. Providers, using their best medical judgment, may not follow FDA protocols exactly and/or may use a drug or device for things not on the label. This is called off-label. We cannot guarantee to document every off-label use in every patient.

2 Possible Complications Adverse effects include but are not limited to: Scarring - Although normal healing after the procedure is expected, abnormal scars may occur both in the skin and deeper tissues. In rare cases, keloid scars may result. Scars may be unattractive and of different color than the surrounding skin. Though rare, scarring can occur following any photothermal procedure and can be permanent. Additional treatments may be needed to treat scarring. Burns - BBL energy can produce burns. Adjacent structures including the eyes may be injured or permanently damaged by the BBL. Burns are rare yet represent the effect of heat produced within the tissues by BBL energy. Additional treatment may be necessary to treat BBL burns. Blistering - During treatment, blistering may be an indication of sun exposure. This can occur during the first three days following the procedure. Contact your provider immediately if blistering occurs. Blistered areas should be treated with care, keeping the area moist with an ointment until the area has healed. Your provider will prescribe the appropriate treatment if you experience blistering. Hives - Some patients develop raised bumps similar to hives. This irritation usually subsides in a few hours. Color change - BBL treatments may potentially change the natural color of your skin. There is the possibility of irregular color variations within the skin including areas that are red, lighter and/or darker. A line of demarcation between normal skin and skin treated with lasers can occur. Though rare, color change can occur following any photothermal procedure and can be permanent. Eye exposure - There is a risk of harmful eye exposure to the BBL energy. Safeguards have been provided including the use of safety eyewear during treatment. It is important for you to keep these protective glasses on at all times during treatment to protect your eyes from accidental BBL exposure. Allergic reactions - In rare cases, local allergies to tape, preservatives used in cosmetics or topical preparations have been reported. Systemic reactions, which are more serious, may result from drugs used during medical procedures and prescription medicines. Allergic reactions may require additional treatment by your provider. Infection - Although infection following laser skin treatment is unusual, bacterial, fungal, and viral infections can occur. Herpes simplex virus infections around the mouth or other areas of the face can occur following a laser 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. Your provider may prescribe specific medications to be taken both prior to and following the laser 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. Retin-A, Retinol, AHA and Accutane (Isoretinoln) - These prescription medications are used to treat certain skin diseases. These drugs may impair the skins ability to heal following treatments or surgery. Individuals must avoid Retin-A, Retinol and AHA for 1 week before and 1 week after treatment. Those using Accutane must allow their skin to recover for at least 9 months (or longer if advised by their provider) before undergoing laser skin treatment procedures.

3 Possible Complications Continued Sun exposure - You must avoid sun exposure, tanning beds and tanning creams for 3-4 weeks prior to treatment and throughout the course of treatment. Sunless tanning lotions must also be avoided for 3-4 weeks before and after treatment. Recent sun exposure may result in cancellation of the treatment. Damaged skin - Skin that has been previously treated with chemical peels or dermabrasion, or damaged by burns, electrolysis (hair removal treatments), or radiation therapy may heal abnormally or slowly following treatment by lasers or other surgical techniques. The occurrence of this is not predictable. Additional treatment may be necessary. Unsatisfactory results - There is the possibility of an unsatisfactory result from these procedures. Laser procedures may result in unacceptable visible deformities, skin slough, loss of function, and permanent color changes in the skin. You may be disappointed with the final result from laser treatments. Patient Responsibility for Costs I understand that I am responsible for payment in full for treatment with the Sciton BBL for acne treatment. The fee structure has been fully explained to me and I understand that, should complications develop, any further costs for medical treatment would be my responsibility. Patient Eligibility Profile BBL therapy is contraindicated for patients who: Have photosensitivity. Take medication that is known to increase sensitivity to sunlight such as accutane, ciprofloxicillin, silver and gold treatment therapy. Inform your provider of all medications you are currently taking. Have seizure disorders triggered by light. Have suspicious pigmented lesions. Have a history of keloid formation. Take immunosuppressant drugs. Have a history of poor wound healing and/or have had sun exposure or tanning within the last 3-4 weeks. You must avoid sun exposure, tanning beds and tanning creams for 3-4 weeks prior to treatment and throughout the course of treatment. Sunless tanning lotions must also be avoided for 3-4 weeks prior to treatment. Have tattoos and moles in treatment area. These areas cannot be treated. The ink may absorb energy resulting in a color change or a risk of skin damage. Moles may also absorb energy resulting in a color change creating an increased risk of skin damage and inability to monitor the lesion for changes.

4 Marketing We use a variety of ways to inform our patients about various procedures. Examples include radio, TV and print advertising, the internet, patient seminars, consultations with staff members, phone calls, mailings, brochures, videos and literature. Some of these materials are generated by the product manufacturers and/ or advertising companies. Medicine is constantly changing and therefore the information in these materials may have changed. Reading this informed consent, consulting with your provider about the procedure, its alternatives and risks and asking questions is the best way to understand potential complications and decide if this procedure is right for you. Disclaimer Informed consent documents are used to communicate information about the proposed treatment of a disease or condition along with disclosure of risks and alternative forms of treatment. 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 the facts in your particular case and the 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. It is important that you read the entire consent carefully and have all of your questions answered before signing. Joint Decision Making I understand I must work together with my provider to agree on treatment plan. My provider relies on the information I gave. I have fully disclosed my medical history, including allergies, prior surgeries, medications I am taking, and current health conditions. I understand that following the pre-procedure and post-procedure instructions will affect the success of my procedure. I will follow those instructions carefully, asking questions when they arise. Communication We encourage you to be direct about any concerns you are having, particularly during your post-procedure period. Often patients are not sure whether their recovery is typical and we want to address that. We encourage you to bring a list of any questions or concerns you have. State them clearly so your provider can respond to them:: I have some concerns today, and they are... I have one concern today, and it is... I have no concerns today. Medical Records I understand and agree that this consent document will become a part of my medical record.

5 Marketing We use a variety of ways to inform our patients about various procedures. Examples include radio, TV and print advertising, the internet, patient seminars, consultations with staff members, phone calls, mailings, brochures, videos and literature. Some of these materials are generated by the product manufacturers and/ or advertising companies. Medicine is constantly changing and therefore the information in these materials may have changed. Reading this informed consent, consulting with your provider about the procedure, its alternatives and risks and asking questions is the best way to understand potential complications and decide if this procedure is right for you.

6 PATIENT S STATEMENT OF ACCEPTANCE AND UNDERSTANDING I certify that I can speak, read and write English. Initials The details of this procedure have been presented to me in full in a way that I understand. All of my questions have been answered and, as needed, I have been provided further explanation to my satisfaction. I have read this informed consent (or it has been read to me) and I fully understand the procedure, the possible risks, complications, alternatives and benefits. I understand that there are other options for treatment available and each of these other options has been fully explained to me to my satisfaction. I acknowledge that no guarantee has been given by anyone as to the results that may be obtained. 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. I recognize that during the course of the procedure and medical treatment or anesthesia, unforeseen conditions may necessitate different procedures than originally planned. I therefore authorize the physician and assistants, or designees to perform such other procedures that are in the exercise of his or her professional judgment necessary and desirable. The authority granted under this paragraph shall include all conditions that require treatment and are not known to my physician at the time the procedure is begun. I understand that there is a possibility of rare side effects and I further understand the importance of carefully following the post-care instructions and that failure to comply may increase the probability of complications. For purposes of advancing medical education, I consent to the admittance of observers to the treatment room. I q DO q DO NOT (check one) give permission for photographs and other audio/visual or graphic materials to be used by Medical Eye Center or Sciton, Inc. for marketing or educational purposes. Although photographs or accompanying material will not contain my name or other identifying information unless I give subsequent written permission, I am aware that I may still be identified by the photographs. I consent to treatment with the Sciton Profile BBL for treatment of acne. PATIENT SIGNATURE DATE WITNESS SIGNATURE DATE

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