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«GENERAL INFORMATION Restylane is a stabilized hyaluronic acid used to smooth moderate to severe facial wrinkles and folds around the nose and mouth ...»

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INFORMED CONSENT – RESTYLANE® INJECTION

INSTRUCTIONS

This is an informed-consent document which has been prepared to help your plastic surgeon inform you concerning

®

Restylane (Non-Animal Stabilized Hyaluronic Acid, Medicis Aesthetics) tissue filler injection therapy, its risks, and

alternative treatments.

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 Dr. Rothfield and agreed upon by you.

GENERAL INFORMATION

Restylane is a stabilized hyaluronic acid used to smooth moderate to severe facial wrinkles and folds around the nose and mouth or shape facial contours. Restylane has been FDA approved for the cosmetic treatment of moderate to severe facial wrinkles and soft tissue depressions.

Hyaluronic acid is a naturally occurring substance that is found within all mammals. It is a material that is contained in various soft tissues. Hyaluronic acid can be synthetically produced from a process of bacterial fermentation, chemically stabilized, and purified for use as an injectable soft tissue filler (non-animal, stabilized hyaluronic acid, Medicis Aesthetics). The hyaluronic acid in Restylane is biocompatible and is a totally non-animal product; there is little risk of animal-based disease transmission or allergic reaction.

Restylane 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. Restylane cannot stop the process of aging. It can however, temporarily diminish the look of wrinkles and soft tissue depressions.

Restylane injections may be performed as a singular procedure, in combination with other treatments such as ® BOTOX, or as an adjunct to a surgical procedure. Restylane injections require regional nerve blocks or local anesthetic injections to diminish discomfort. Soft tissue fillers, including Restylane, 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 Restylane over time. Restylane once injected will be slowly absorbed by the body. The length of effect for Restylane injections is variable.

ALTERNATIVE TREATMENTS

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.

RISKS OF RESTYLANE® INJECTIONS

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 Dr. Rothfield to make sure you understand the risks, potential complications, limitations, and consequences of Restylane injections. Additional information concerning Restylane may be obtained from the package-insert sheets supplied by Medicis Aesthetics.

Problems associated with the use of tissue fillers can relate to normal occurrences following tissue filler injections, or potential complications following tissue filler injections, including Restylane. Additional advisory information should be reviewed by patients considering tissue filler treatments that involve Restylane.

Normal Occurrences During Tissue Filler Injections Bleeding and Bruising: It is possible, though unusual, to have a bleeding episode from a Restylane 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 Restylane injections.

Swelling: 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.

Erythema (Skin Redness): Erythema in the skin occurs after injections. It can be present for a few days after the procedure.

Needle Marks: 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 Lumpiness: Lumpiness can occur following the injection of Restylane. 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.

Asymmetry: 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 Restylane injection. This may require additional injections.

Pain: Discomfort associated with Restylane injections is normal and usually of short duration.

Skin Sensitivity: Skin rash, itching, tenderness and swelling may occur following Restylane 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 Restylane 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.

RISKS OF RESTYLANE 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.

Infection: 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 infection from this virus. Should any type of skin infection occur, additional treatment including antibiotics may be necessary.

Skin Necrosis: It is very unusual to experience death of skin and deeper soft tissues after Restylane injections.

Skin necrosis can produce unacceptable scarring. Should this complication occur, additional treatments, or surgery may be necessary.

–  –  –

Scarring: Restylane should not be used in patients with know susceptibility to keloid formation or hypertrophic scarring. The safety of patients has not been studied.

Granulomas: Painful masses in the skin and deeper tissues after a Restylane injection are extremely rare. Should these occur, additional treatments including surgery may be necessary.

Skin Disorders: Restylane should not be used in areas with active inflammation or infections (e.g., cysts, pimples, rashes or hives). In rare instances, granuloma or abscess formation, localized necrosis and urticaria have been reported.

Antibodies to Restylane: Presence of antibodies to hyaluronic acid tissue fillers may reduce the effectiveness of this material or produce a reaction in subsequent injections. The health significance of antibodies to hyaluronic acid tissue fillers is unknown.

Accidental Intra-Arterial Injection: It is extremely rare that during the course of injection, Restylane 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 Restylane is unknown and not predictable.

Under / Over Correction: The injection of soft tissue fillers including Restylane 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.

Migration of Restylane: Restylane may migrate from its original injection site and produce visible fullness in adjacent tissue or other unintended effects.

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 heart beat (tachycardia), and fainting. Medical treatment of these conditions may be necessary.

Unsatisfactory Result: Restylane 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 Restylane injection(s). Additional Restylane injections may be necessary. Surgical procedures or other treatments may be recommended in additional to Restylane treatments.

Unknown Risks: The long term effect of Restylane beyond one year is unknown. The possibility of additional risk factors or complications attributable to the use of Restylane as a soft tissue filler may be discovered.

® Combination of Procedures: In some situations, Botox injections or other types of tissue filler materials may be used in addition to Restylane 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 Restylane is unknown.

–  –  –

Drug Interactions: It is not known if Restylane reacts with other drugs within the body.

Long-Term Effects: Restylane injections should not be considered as a permanent treatment for the correction of wrinkles and soft tissue depressions. Over time, the Restylane material is slowly absorbed by the body and wrinkles or soft tissue depressions will reappear. Continuing Restylane treatment (injections) is necessary in order to maintain the effect of Restylane. 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 Restylane injections. Future surgery or other treatments may be necessary. Restylane injection does not arrest the aging process or produce permanent tightening of the skin or improvement in wrinkles.

ADDITIONAL ADVISORIES

Female Patient Information: It is important to inform Dr. Rothfield 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.

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 Dr. Rothfield, 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.

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 Dr. Rothfield and either delay treatment, or avoid tanning until Dr. Rothfield says it is safe to resume. The damaging effect of sun exposure occurs even with the use sun block or clothing coverage.

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 Dr. Rothfield.



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