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 plastic surgeon and agreed upon by you.
Semi-permanent filler injections are customized for every patient, depending on his or her particular needs. These can be performed in areas involving the face and eyelid region, forehead, and lips. Fillers cannot stop the process of aging. They can however, temporarily diminish the look of wrinkles and soft tissue depressions.
Filler injections may be performed as a singular procedure, in combination with other treatments such as BOTOX ® , or as an adjunct to a surgical procedure. Filler injections require regional nerve blocks or local anesthetic injections to diminish discomfort. Soft tissue fillers produce temporary swelling, redness, and
needle marks, which resolve after a few days time.
Continuing treatments are necessary in order to maintain the effect of fillers over time. Once injected, fillers will be slowly absorbed by the body. The length of effect for injections is variable.
Alternative forms of management include not treating the skin wrinkles or soft tissue depressions by any means. Improvement of skin wrinkles and soft tissue depressions may be accomplished by other treatments: laser treatments, chemical skin-peels, dermabrasion, 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.
INHERENT RISKS OF ABDOMINOPLASTY SURGERY
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 of facial volume/filler injections.
SPECIFIC RISKS OF ABDOMINOPLASTY SURGERY
Bleeding and Bruising:
It is possible, though unusual, to have a bleeding episode from a filler injection or local anesthesia used during the procedure. 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 seven days before or after filler injections.
Swelling (edema) 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.
Visible needle marks from the injections occur normally and resolve in a few days.
Acne-Like Skin Eruptions:
Acneiform skin eruptions can occur following the injection of tissue fillers. This generally resolves within a few days.
Skin rash, itching, tenderness and swelling may occur following injections. 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. If you are considering laser treatment, chemical skin peeling or any other procedure based on a skin response after filler treatment, or you have recently had
such treatments and the skin has not healed completely, there is a possible risk of an inflammatory reaction at the implant site.
Erythema (Skin Redness):
Erythema in the skin occurs after injections. It can be present for a few days after the procedure.
Although infection following injection of tissue fillers is 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 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 infectionfrom this virus. Should any type of skin infection occur, additional treatment including antibiotics may be necessary.
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 tissue 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.
The human face is normally asymmetrical in its appearance and anatomy. It may not be possible to achieve or maintain exact symmetry with tissue filer injections. There can be a variation from one side to the other in terms of the response to injection. This may require additional injections.
Damage to Deeper Structures:
Deeper structures such as nerves and blood vessels may be damaged during the course of injection. Injury to deeper structures may be temporary or permanent.
Lumpiness can occur following the injection of fillers. This tends to smooth out over time. In some situations, it may be possible to feel the injected tissue filler material for long periods of time.
Visible Tissue Filler Material:
It may be possible to see any type of tissue filler material that was injected in areas where the skin is thin.
Painful masses in the skin and deeper tissues after a filler injection are extremely rare. Should these occur, additional treatments including surgery may be necessary. Fillers should not be used in areas with active inflammation or infections (e.g., cysts, pimples, rashes or hives).
Migration of Filler:
The filler substance may migrate from its original injection site and produce visible fullness in adjacent tissue or other unintended effects.
It is very unusual to experience death of skin and deeper soft tissues after injections. Skin necrosis can produce unacceptable scarring. Should this complication occur, additional treatments, or surgery may be necessary.
Allergic Reactions and Hypersensitivity:
As with all biologic products, allergic and systemic anaphylactic reactions may occur. 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
Drug and 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.
Antibodies to Fillers:
Presence of antibodies to tissue fillers may reduce the effectiveness of this material or produce a reaction in subsequent injections. The health significance of antibodies to tissue fillers is unknown.
Accidental Intra-Arterial Injection:
It is extremely rare that during the course of injection, fillers 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 of fillers is unknown and not predictable.
Fillers should not be used in patients with known susceptibility to keloid formation or hypertrophic scarring. The safety of patients has not been studied.
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 from filler injection(s). Additional injections may be necessary. Surgical procedures or other treatments may be recommended along with additional treatments.
The long term effect of tissue fillers beyond one year is unknown. The possibility of additional risk factors or complications attributable to the use of tissue fillers may be discovered.
Combination of Procedures:
In some situations, Botox® injections or other types of tissue filler materials may be used in addition to facial volume/filler injections 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 tissue fillers is unknown.
Pregnancy and Nursing Mothers:
Animal reproduction studies have not been performed to determine if tissue fillers could produce fetal harm. It is not known if tissue fillers or its breakdown products can be excreted in human milk. It is not recommended that pregnant women or nursing mothers receive tissue filler treatments.
It is not known if tissue fillers react with other drugs within the body.
Long-Term Effects Facial volume/filler injections should not be considered as a permanent treatment for the correction of wrinkles and soft tissue depressions. Over time most filler material is slowly absorbed by the body and wrinkles or soft tissue depressions will reappear. Continuing filler treatment (injections) is necessary in order to maintain the effect of the filler. 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 these filler injections. Future surgery or other treatments may be necessary. Volume filler injections do not arrest the aging process or produce permanent tightening of the skin or improvement in wrinkles.
Additional Treatment Necessary:
There are many variable conditions in addition to risk and potential complications that may influence the long-term result of filler injections. Even though risks and complications occur infrequently, the risks cited are the ones that are particularly associated with facial volume/filler 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 good results are expected, there is no guarantee or warranty expressed or implied, on the results that may be obtained.
GENERAL RISKS OF SURGERY
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, possibility of additional surgery, prolonged recovery, color changes, shape changes, infection, not meeting patient goals and expectations, and added expense to the patient. There may also be a longer recovery due to the length of surgery and anesthesia. 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 from 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.
It is possible, though unusual, to experience a bleeding episode during or after surgery. Should post-operative bleeding occur, it may require emergency treatment to drain accumulated blood or you may require a blood transfusion, though such occurrences are rare. Increased activity too soon after surgery can lead to increased chance of bleeding and additional surgery. It is important to follow postoperative instructions and limit exercise and strenuous activity for the instructed time. Do not take any aspirin or anti-inflammatory medications for at least ten days before or after surgery, 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, usually in the first three weeks following injury to the operative area. If blood transfusions are necessary to treat blood loss, there is the risk of blood-related infections such as hepatitis and HIV (AIDS). Heparin medications that are used to prevent blood clots in veins can produce bleeding and decreased blood platelets.
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, infection in other part of the body, may lead to an infection in the operated area.
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.
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 at the ends of the incisions or “dog ears” 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 will 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.
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.
Major Wound Separation:
Wounds may separate after surgery. Should this occur, additional treatment including surgery may be necessary.
Most surgical techniques use deep sutures. You may notice these sutures after your surgery. Sutures may spontaneously poke through the skin, become visible or produce irritation that requires suture removal.
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 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.
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.
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.
Both local and general anesthesia involves risk. There is the possibility of complications, injury, and even death from all forms of surgical anesthesia or sedation.
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.
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 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 pains, or unusual heart beats, seek medical attention immediately. Should any of these complications occur, you may require hospitalization and
Venous Thrombosis and Sequelae:
Thrombosed veins, which resemble cords, occasionally develop in the area of the breast or around IV sites, and usually resolve without medical or surgical treatment. It is important to discuss with your surgeon any birth control pills you are taking. Certain high estrogen pills may increase your risk of thrombosed veins.
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.
Unexpected drug allergies, lack of proper response to medication, or illness caused by the prescribed drug are possibilities. It is important for you to inform your physician of any problems you have had with any medication or allergies to medication, prescribed or over the counter, as well as medications you now regularly take.
Symmetrical body appearance may not result after surgery. Factors such as skin tone, fatty deposits, skeletal prominence, and muscle tone may contribute to normal asymmetry in body features. Most patients have differences between the right and left side of their bodies before any surgery is performed. Additional surgery may be necessary to attempt to diminish asymmetry.
Surgical Wetting Solutions:
There is the possibility that large volumes of fluid containing dilute local anesthetic drugs and epinephrine that is injected into fatty deposits during surgery may contribute to fluid overload or systemic reaction to these medications. Additional treatment including hospitalization may be necessary.
Persistent Swelling (Lymphedema):
Persistent swelling can occur following surgery.
Although good results are expected, there is no guarantee or warranty expressed or implied, on the results that may be obtained. The body is not asymmetric and almost everyone has some degree of unevenness which may not be recognized in advance. One side of the face may be slightly larger, one side of the face droopier. The breast and trunk area exhibits the same possibilities. Many of such issues cannot be fully corrected with surgery. The more realistic your expectations as to results, the better your results will be in your eye. Some patients never achieve their desired goals or results, at no fault of the surgeon or surgery. 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.
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 and 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: