Laser Skin Resurfacing
This informed-consent document has been prepared to help inform you about laser resurfacing procedures of skin, its risks, as well as alternative treatment(s).
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 surgery as proposed by your plastic surgeon and agreed upon by you.
Lasers have been used by plastic surgeons as a surgical instrument for many years. Laser energy can be used to cut, vaporize, or selectively remove skin and deeper tissues. There are many different methods for the surgical use of lasers. Conditions such as wrinkles, sun damaged skin, scars and some types of skin lesions/disorders may be treated with the CO2 and Erbium laser. Certain surgical procedures may use the CO2 laser as a cutting instrument. In some situations, laser treatments may be performed at the time of other surgical procedures.
Skin treatment programs may be used both before and after laser skin treatments in order to enhance the results.
Alternative forms of treatment include not undergoing the proposed laser skin resurfacing procedure. Other forms of skin treatment (chemical peel) or surgical procedures (dermabrasion or excisional surgery) may be substituted. In certain situations, the laser may offer a specific therapeutic advantage over other forms of treatment. Alternatively, laser resurfacing procedures in some situations may not represent a better alternative to other forms of surgery or skin treatment when indicated. Risks and potential complications are associated with alternative forms of treatment that involve skin resurfacing(s) or surgical procedures.
RISKS OF LASER RESURFACING PROCEDURES OF SKIN
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. Risks involve both items that specifically relate to the use of laser energy as a form of surgical therapy and to the specific procedure performed. An individual’s choice to undergo a 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 all possible consequences of laser skin resurfacing.
Specific Risks of Laser Resurfacing Procedures
Infection: Although infection following laser skin resurfacing is unusual, bacterial, fungal, and viral infections can occur. Herpes simplex virus infections around the mouth can occur following a laser treatment. This applies to both individuals with a 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 laser treatment procedure in order to suppress an infection from this virus. Should an infection occur, additional treatment including antibiotics, hospitalization, or additional surgery may be necessary.
Burns: Laser energy can produce burns. Adjacent structures including the eyes may be injured or permanently damaged by the laser beam. Burns are rare, yet represent the effect of heat produced within the tissues by laser energy. Additional treatment may be necessary to treat laser burns.
Color Change: Laser resurfacing may potentially change the natural color of your skin. Skin redness usually lasts 1-3 months and occasionally 6 months following laser skin resurfacing. There is the possibility of irregular color variations within the skin including areas that are both lighter and darker. A line of demarcation between normal skin and skin treated with lasers can occur.
Accutane (Isotretinoin): Accutane is a prescription medication used to treat certain skin diseases. If you have ever taken Accutane, you should discuss this with your surgeon. This drug may impair the ability of skin to heal following treatments or surgery for a variable amount of time even after the patient has ceased taking it. Individuals who have taken this drug are advised to allow their skin adequate time to recover from Accutane before undergoing skin treatment procedures.
Fire: Inflammable agents, surgical drapes and tubing, hair, and clothing may be ignited by laser energy. Laser energy used in the presence of supplemental oxygen increases the potential hazard of fire. Some anesthetic gases may support combustion.
Laser Smoke (Plume): Laser smoke is noxious to those who come in contact with it. This smoke may represent a possible biohazard.
Skin Tissue Pathology: Laser energy directed at skin lesions may potentially vaporize the lesion. Laboratory examination of the tissue specimen may not be possible.
Visible Skin Patterns: Laser resurfacing procedures may produce visible patterns within the skin. The occurrence of this is not predictable.
Distortion of Anatomic Features: Laser skin resurfacing can produce distortion of the appearance of the eyelids, mouth, and other visible anatomic landmarks. The occurrence of this is not predictable. Should this occur, additional treatment including surgery may be necessary.
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. If you have ever had such treatments, you should inform your surgeon.
General Risks of Laser Procedures
Healing Issues: Certain medical conditions, dietary supplements and medications may delay and interfere with healing. Patients with massive weight loss may have a healing delay that could result in the incisions coming apart, infection, and tissue changes resulting in the need for additional medical care, surgery, and prolonged hospitalizations. Patients with diabetes or those taking medications such as steroids on an extended basis may have prolonged healing issues. Smoking will cause a delay in the healing process, often resulting in the need for additional surgery. There are general risks associated with healing such as swelling, bleeding, and the length of surgery and anesthesia that include a longer recovery and the possibility of additional surgery, prolonged recovery, color changes, shape changes, infection, not meeting goals and expectations, and added expense to the patient. Patients with significant skin laxity (patients seeking facelifts, breast lifts, abdominoplasty, and body lifts) will continue to have the same lax skin after surgery. The quality or elasticity of skin will not change and recurrence of skin looseness will occur at some time in the future, quicker for some than others. There are nerve endings that may become involved with healing scars during surgery such as suction-assisted lipectomy, abdominoplasty, facelifts, body lifts, and extremity surgery. While there may not be a major nerve injury, the small nerve endings during the healing period may become too active producing a painful or oversensitive area due to the small sensory nerve involved with scar tissue. Often massage and early non-surgical intervention resolves this. It is important to discuss post-surgical pain with your surgeon.
Bleeding: Bleeding is rare following laser skin resurfacing procedures. Do not take any aspirin or anti-inflammatory medications for ten days before or after your procedure, as this may increase the risk of bleeding. Non-prescription “herbs” and dietary supplements can increase the risk of surgical bleeding. Hematoma can occur at any time following injury. Should bleeding occur, additional treatment may be necessary.
Infection: Infection is unusual after surgery. Should an infection occur, additional treatment including antibiotics, hospitalization, or additional surgery may be necessary. It is important to tell your surgeon of any other infections, such as ingrown toenail, insect bite, or urinary tract infection. Remote infections, infections in other parts of the body, may lead to an infection in the operated area.
Scarring: All surgery leaves scars, some more visible than others. Although good wound healing after a surgical procedure is expected, abnormal scars may occur within the skin and deeper tissues. Scars may be unattractive and of different color than the surrounding skin tone. Scar appearance may also vary within the same scar. Scars may be asymmetrical (appear different on the right and left side of the body). There is the possibility of visible marks in the skin from sutures. In some cases scars may require surgical revision or treatment.
Firmness: Excessive firmness can occur after surgery due to internal scarring. The occurrence of this is not predictable. Additional treatment including surgery may be necessary.
Change in Skin Sensation: It is common to experience diminished (or loss) of skin sensation in areas that have had surgery. Diminished (or complete loss of skin sensation) may not totally resolve.
Skin Contour Irregularities: Contour and shape irregularities may occur. Visible and palpable wrinkling of skin may occur. Residual skin irregularities are always a possibility when there is excessive redundant skin. This may improve with time, or it can be surgically corrected.
Skin Discoloration / Swelling: Some bruising and swelling normally occur. The skin in or near the surgical site can appear either lighter or darker than surrounding skin. Although uncommon, swelling and skin discoloration may persist for long periods of time and, in rare situations, may be permanent.
Skin Sensitivity: Itching, tenderness, or exaggerated responses to hot or cold temperatures may occur after surgery. Usually this resolves during healing, but in rare situations it may be chronic.
Delayed Healing: Wound disruption or delayed wound healing is possible. Some areas of the skin may not heal normally and may take a long time to heal. Areas of skin may die. This may require frequent dressing changes or further surgery to remove the non-healed tissue. Individuals who have decreased blood supply to tissue from past surgery or radiation therapy may be at increased risk for delayed wound healing and poor surgical outcome. Smokers have a greater risk of skin loss and wound healing complications.
Damage to Deeper Structures: There is the potential for injury to deeper structures including nerves, blood vessels, muscles, and lungs (pneumothorax) during any surgical procedure. The potential for this to occur varies according to the type of procedure being performed. Injury to deeper structures may be temporary or permanent.
Fat Necrosis: Fatty tissue found deep in the skin might die. This may produce areas of firmness within the skin. Additional surgery to remove areas of fat necrosis may be necessary. There is the possibility of contour irregularities in the skin that may result from fat necrosis.
Seroma: Infrequently, fluid may accumulate between the skin and the underlying tissues following surgery, trauma or vigorous exercise. Should this problem occur, it may require additional procedures for drainage of fluid.
Surgical Anesthesia: Both local and general anesthesia involve risk. There is the possibility of complications, injury, and even death from all forms of surgical anesthesia or sedation.
Shock: In rare circumstances, your surgical procedure can cause severe trauma, particularly when multiple or extensive procedures are performed. Although serious complications are infrequent, infections or excessive fluid loss can lead to severe illness and even death. If surgical shock occurs, hospitalization and additional treatment would be necessary.
Pain: You will experience pain after your surgery. Pain of varying intensity and duration may occur and persist after surgery. Chronic pain may occur very infrequently from nerves becoming trapped in scar tissue or due to tissue stretching.
Cardiac and Pulmonary Complications: Pulmonary complications may occur secondarily to both blood clots (pulmonary emboli), fat deposits (fat emboli) or partial collapse of the lungs after general anesthesia. Pulmonary emboli can be life-threatening or fatal in some circumstances. Inactivity and other conditions may increase the incidence of blood clots traveling to the lungs causing a major blood clot that may result in death. It is important to discuss with your physician any past history of swelling in your legs or blood clots that may contribute to this condition. Cardiac complications are a risk with any surgery and anesthesia, even in patients without symptoms. If you experience shortness of breath, chest pain, or unusual heart beats, seek medical attention immediately. Should any of these complications occur, you may require hospitalization and additional treatment.
Allergic Reactions: In rare cases, local allergies to tape, suture material and glues, blood products, topical preparations or injected agents have been reported. Serious systemic reactions including shock (anaphylaxis) may occur in response to drugs used during surgery and prescription medicines. Allergic reactions may require additional treatment.
Unsatisfactory Result: Although good results are expected, there is no guarantee or warranty expressed or implied, on the results that may be obtained. You may be disappointed with the results of surgery. Asymmetry, unanticipated shape and size, loss of function, wound disruption, poor healing, and loss of sensation may occur after surgery. Size may be incorrect. Unsatisfactory surgical scar location or appearance may occur. It may be necessary to perform additional surgery to improve your results.
Unknown Risks: There is the possibility that additional risk factors of laser skin resurfacing may be discovered. The risks of performing skin tightening surgery and laser resurfacing is unknown in terms of the combination effect of the two procedures and potential complications, depending on the area treated. Skin slough, delayed healing and poor surgical outcome may occur.
Smoking, Second-Hand Smoke Exposure, Nicotine Products (Patch, Gum, Nasal Spray):
Patients who are currently smoking or use tobacco or nicotine products (patch, gum, or nasal spray) are at a greater risk for significant surgical complications of skin dying, delayed healing and additional scarring. Individuals exposed to second-hand smoke are also at potential risk for similar complications attributable to nicotine exposure. Additionally, smoking may have a significant negative effect on anesthesia and recovery from anesthesia, with coughing and possibly increased bleeding. Individuals who are not exposed to tobacco smoke or nicotine-containing products have a significantly lower risk of this type of complication. Please indicate your current status regarding these items below:
___ I am a non-smoker and do not use nicotine products. I understand the potential risk of second-hand smoke exposure causing surgical complications.
___ I am a smoker or use tobacco / nicotine products. I understand the risk of surgical complications due to smoking or use of nicotine products.
___ I have smoked and stopped approximately _________ ago. I understand I may still have the effects and therefore risks from smoking in my system, if not enough time has lapsed.
It is important to refrain from smoking at least 6 weeks before surgery and until your physician states it is safe to return, if desired. I acknowledge that I will inform my physician if I continue to smoke within this time frame, and understand that for my safety, the surgery, if possible, may be delayed.
Off-Label FDA Issues: 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 this proposed use is not experimental and your physician believe 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.
____ I acknowledge that I have been informed about the Off-Label FDA status of _________________________, and I understand it is not experimental and accept its use.
Medications and Herbal Dietary Supplements: There are potential adverse reactions that occur as the result of taking over-the-counter, herbal, and/or prescription medications. Aspirin and medications that contain aspirin interfere with clotting and can cause more bleeding. These include non-steroidal anti-inflammatories such as Motrin, Advil, and Alleve. It is very important not to stop drugs that interfere with platelets, such as Plavix, which is used after a stent. It is important if you have had a stent and are taking Plavix that you inform the plastic surgeon. Stopping Plavix may result in a heart attack, stroke and even death. Be sure to check with your physician about any drug interactions that may exist with medications which you are already taking. If you have an adverse reaction, stop the drugs immediately and call your plastic surgeon for further instructions. If the reaction is severe, go immediately to the nearest emergency room. When taking the prescribed pain medications after surgery, realize that they can affect your thought process and coordination. Do not drive, do not operate complex equipment, do not make any important decisions and do not drink any alcohol while taking these medications. Be sure to take your prescribed medication only as directed.
Sun Exposure – Direct or Tanning Salon: The effects of the sun are damaging to the skin. Exposing the treated areas to sun may result in increased scarring, color changes, and poor healing. Patients who tan, either outdoors or in a salon, should inform their surgeon and either delay treatment, or avoid tanning until the surgeon says it is safe to resume. The damaging effect of sun exposure occurs even with the use sun block or clothing coverage.
Travel Plans: Any surgery holds the risk of complications that may delay healing and delay your return to normal life. Please let the surgeon know of any travel plans, important commitments already scheduled or planned, or time demands that are important to you, so that appropriate timing of surgery can occur. There are no guarantees that you will be able to resume all activities in the desired time frame.
Long-Term Results: Subsequent alterations in the appearance of your body may occur as the result of aging, sun exposure, weight loss, weight gain, pregnancy, menopause or other circumstances not related to your surgery.
Body-Piercing Procedures: Individuals who currently wear body-piercing jewelry in the surgical region are advised that an infection could develop from this activity.
Female Patient Information: It is important to inform your plastic surgeon if you use birth control pills, estrogen replacement, or if you suspect you may be pregnant. Many medications including antibiotics may neutralize the preventive effect of birth control pills, allowing for conception and pregnancy.
Intimate Relations After Surgery: Surgery involves coagulating of blood vessels and increased activity of any kind may open these vessels leading to a bleed, or hematoma. Activity that increases your pulse or heart rate may cause additional bruising, swelling, and the need for return to surgery and control bleeding. It is wise to refrain from intimate physical activities until your physician states it is safe.
Mental Health Disorders and Elective Surgery: It is important that all patients seeking to undergo elective surgery have realistic expectations that focus on improvement rather than perfection. Complications or less than satisfactory results are sometimes unavoidable, may require additional surgery and often are stressful. Please openly discuss with your surgeon, prior to surgery, any history that you may have of significant emotional depression or mental health disorders. Although many individuals may benefit psychologically from the results of elective surgery, effects on mental health cannot be accurately predicted.
Skin Cancer / Skin Disorders– Laser skin resurfacing procedures may not offer protection against developing skin cancer or skin disorders in the future.
ADDITIONAL TREATMENT OR SURGERY NECESSARY
There are many variable conditions that may influence the long-term result of surgery. It is unknown how your tissue may respond or how wound healing will occur after surgery. Secondary surgery may be necessary to perform additional tightening or repositioning of body structures. Should complications occur, additional surgery or other treatments may be necessary. Even though risks and complications occur infrequently, the risks cited are particularly associated with this surgery. Other complications and risks can occur but are even more uncommon. The practice of medicine and surgery is not an exact science. Although good results are expected, there is no guarantee or warranty expressed or implied, on the results that may be obtained. In some situations, it may not be possible to achieve optimal results with a single surgical procedure.
Follow all physician instructions carefully; this is essential for the success of your outcome. Postoperative instructions concerning appropriate restriction of activity, use of dressings, and use of sun protection must be followed in order to avoid potential complications, increased pain, and unsatisfactory result. Your physician may recommend that you utilize a long-term skin care program to enhance healing following a laser skin resurfacing. Successful post-operative function depends on both surgery and subsequent care. Physical activity that increases your pulse or heart rate may cause bruising, swelling, fluid accumulation and the need for return to surgery. It is wise to refrain from intimate physical activities after surgery until your physician states it is safe. It is important that you participate in follow-up care, return for aftercare, and promote your recovery after surgery.
Most health insurance companies exclude coverage for cosmetic surgical operations such as laser skin resurfacing or any complications that might occur from surgery. Please carefully review your health insurance subscriber-information pamphlet or contact your insurance company for a detailed explanation of their policies. Most insurance plans exclude coverage for secondary or revisionary surgery.
The cost of surgery involves several charges for the services provided. The total includes fees charged by your surgeon, the cost of surgical supplies, anesthesia, laboratory tests, and possible outpatient hospital charges, depending on where the surgery is performed. Depending on whether the cost of surgery is covered by an insurance plan, you will be responsible for necessary co-payments, deductibles, and charges not covered. The fees charged for this procedure do not include any potential future costs for additional procedures that you elect to have or require in order to revise, optimize, or complete your outcome. Additional costs may occur should complications develop from the surgery. Secondary surgery or hospital day-surgery charges involved with revision surgery will also be your responsibility. In signing the consent for this surgery/procedure, you acknowledge that you have been informed about its risks and consequences and accept responsibility for the clinical decisions that were made along with the financial costs of all future treatments.
___ I understand and unconditionally and irrevocably accept this.
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), including no surgery. 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 plastic surgeon may provide you with additional or different information which is based on all the facts in 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.
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.
CONSENT FOR SURGERY / PROCEDURE or TREATMENT
- I hereby authorize Dr. _________________________ and such assistants as may be selected to perform the following procedure or treatment: LASER SKIN RESURFACING SURGERY
I have received the following information sheet:
INFORMED CONSENT – LASER SKIN RESURFACING PROCEDURES OF THE SKIN
- I recognize that during the course of the operation and medical treatment or anesthesia, unforeseen conditions may necessitate different procedures than those above. I therefore authorize the above 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 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 understand what my surgeon can and cannot do, and I understand there are no warranties or guarantees, implied or specific about my outcome. I have had the opportunity to explain my goals and understand which desired outcomes are realistic and which are not. All of my questions have been answered, and I understand the inherent (specific) risks of the procedures I seek, as well as those additional risks and complications, benefits, and alternatives. Understanding all of this, I elect to proceed.
- 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.
- For purposes of advancing medical education, I consent to the admittance of observers to the operating room.
- I consent to the disposal of any tissue, medical devices or body parts which may be removed.
- I consent to the utilization of blood products should they be deemed necessary by my surgeon and/or his/her appointees, and I am aware that there are potential significant risks to my health with their utilization.
- I authorize the release of my Social Security number to appropriate agencies for legal reporting and medical-device registration, if applicable.
- I understand that the surgeon’s fees are separate from the anesthesia and hospital charges, and the fees are agreeable to me. If a secondary procedure is necessary, further expenditure will be required.
- I realize that not having the operation is an option.
- IT HAS BEEN EXPLAINED TO ME IN A WAY THAT I UNDERSTAND:
- THE ABOVE TREATMENT OR PROCEDURE TO BE UNDERTAKEN
- THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF TREATMENT
- THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED