James A. Rieger MD -Board Certified Plastic Surgeon -Wichita,Hutchinson,Salina,Newton,Garden City,Dodge City Kansas
316-652-9333


Radiesse Informed Consent                                                                    

This is an informed-consent document which has been prepared to help us inform you concerning Radiesse (Calcium Hydroxylapatite) 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.

INTRODUCTION

Radiesse is filler used to smooth moderate to severe facial wrinkles and folds around the nose and mouth or shape facial contours. Radiesse is popular especially for filling the nasolabial folds - the creases that extent from the corner to your nose to the corner of your mouth. Radiesse has been FDA approved for the cosmetic treatment of moderate to severe facial wrinkles and soft tissue depressions.

Calcium hydroxylapatite is a biocompatible (compatible with living systems), biodegradable (dissolves in the body ) material. Calcium hydroxylapatite is identical in composition to the mineral portion of teeth and bone.  Radiesse is synthetically produced contains micro spheres made of a natural material called calcium hydroxylapatite in a water based gel carrier. 

Radiesse injections are customized for every patient, depending on his or her particular needs.  These can be performed in areas involving the face.  Radiesse cannot stop the process of aging.  It can however, temporarily diminish the look of wrinkles and soft tissue depressions.  Radiesse injections may be performed as a singular procedure, in combination with other treatments such as BOTOX®, or as an adjunct to a surgical procedure.  Radiesse 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 may be necessary in order to maintain the effect of Radiesse over time.  Radiesse once injected will be slowly absorbed by the body.  The length of effect for Radiesse injections is variable, in a clinical study it was reported to last 6 months.

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 RADIESSE 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 Radiesse injections.  Additional information concerning Radiesse may be obtained from the package-insert sheets supplied by Allergan.

Problems associated with the use of tissue fillers can relate to normal occurrences following tissue filler injections, or potential complications following tissue filler injections.   

NORMAL OCCURRENCES DURING TISSUE FILLER INJECTIONS, INCLUDING RADIESSE

Bleeding and Bruising - It is possible, though unusual, to have a bleeding episode from a Radiesse 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, and 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 and after Radiesse injections.

Pain- Discomfort associated with Radiesse injections is normal and usually of short duration.

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 Radiesse.  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 Radiesse injection.  This may require additional injections.

Skin Sensitivity- Skin rash, itching, tenderness and swelling may occur following Radiesse 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 Radiesse 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.

Radio-opacity- Since Radiesse is radio-opaque it is visible on CT scan and xrays.

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 filller 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.  Radiesse 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- Scarring of the skin may occurs. Tissue fillers 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 filler injection are extremely rare.  Should these occur, additional treatments including surgery may be necessary. 

Skin Disorders-   Fillers 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 Radiesse- 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 Radiesse is unknown and not predictable.

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. 

Migration of Filler - Fillers 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- 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 in additional to filler treatments.

Unknown Risks- 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 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 fillers 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 is unknown. 

Pregnancy and Nursing Mothers- Animal reproduction studies have not been performed to determine if fillers could produce fetal harm.  It is not known if fillers or its breakdown products can be excreted in human milk.  It is not recommended that pregnant women or nursing mothers receive treatments. 

Drug Interactions- It is not known if fillers reacts with other drugs within the body.

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

HEALTH INSURANCE

Most health insurance companies exclude coverage for cosmetic surgical procedures and treatments or any complications that might occur from the same.  Please carefully review your health insurance subscriber information pamphlet.

ADDITIONAL TREATMENT NECESSARY

There are many variable conditions in addition to risk and potential complications that may influence the long-term result of injections.  Even though risks and complications occur infrequently, the risks cited are the ones that are particularly associated with 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.

FINANCIAL RESPONSIBILITIES

The cost of injection may involve several charges.  Additional costs of medical treatment would be your responsibility should complications develop from injections.

DISCLAIMER

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).  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.  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.

I have read and understand the following Informed Consent Material for my specific procedure:

RADIESSE 

The risks, benefits, and alternatives of the procedure(s) were explained to me. I understand the specific risks in the consent material for my surgery and understand the significant risks of bleeding, infection, blindness, injury to neighboring structures, capsule contracture(if implants involved), lumpiness, asymmetry, pulmonary emboli, deformity, skin loss or necrosis, healing problems, poor scars, loss of sensation(feeling), appearance/psychological  changes, unsatisfactory result, need for future revision surgery and anesthesia. I understand the anticipated results and limitations of the surgery procedure(s). I have realistic expectations and realize that there are no guarantees in plastic surgery. The following instructions were explained to me: Pre and Post procedure instructions, DVT prevention instructions, and medications to avoid instructions. I agree to follow all instructions, to follow up as directed, and to notify the office if any problems or questions arise.

 

 

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