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. 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 injectable treatments. 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. 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 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
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 your physician to make sure you understand the risks, potential
complications, limitations, and consequences of Restylane injections. 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.
INFORMED CONSENT – RESTYLANE® INJECTION
Normal Occurrences During Tissue Filler Injections
Bleeding and Bruising: It is possible 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.
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.
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.
INFORMED CONSENT – RESTYLANE® INJECTION
Allergic Reactions and Hypersensitivity: As with all biologic products, allergic and systemic anaphylactic reactions may occur. Restylane 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 treatment.
Scarring: Restylane should not be used in patients with known 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
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.
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.
Pregnancy and Nursing Mothers: Animal reproduction studies have not been performed to determine if Restylane could produce fetal harm. It is not known if Restylane or its breakdown products can be excreted in human milk. It is
not recommended that pregnant women or nursing mothers receive Restylane treatments.
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
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
Off-Label FDA Issues: There are many devices, medications and injectable fillers 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 believes 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.