YTF Cosmetic Surgery Patient Network

Radiesse Injections

• Radiesse For Facial Augmentation
• What Is Radiesse?
• Indications For Radiesse
• Am I A Candidate For Radiesse?
• Your Consultation Appointment
• How Radiesse Is Injected
• Recovery
• Risks & Complications of Radiesse
• Contraindications
• How Much Does Radiesse Cost?
• The Least You Need To Know
• Product and Procedure Comparison Based Upon My Own Experience
• References

Additional Information

• Radiesse Cheek Augmentation Video

• Radiesse Discussion Forum

• Consultation Help 

Consumer Tools

• How To Choose A Surgeon
• How To Prepare For Injections
• Radiesse Costs
• Helpful Print-outs: Consultation Questions, Recovery Shopping Lists & more!

Unfortunately, my first Radiesse® experience wasn't this successful.  I first had Radiesse® injected in 2004, although back then it was known as Radiance FN® and it was into my lips.  I had heard so much about the product and felt at the time that it would be a good option.  I was told that it should last about 2 years and that in the long run, I would save money that I would normally spend on temporary fillers every 4 months.  The distributor had even comped the product (it was for a documentary on Discovery) so I was excited all over the board.  Well, unfortunately I had blanching and palpable lumping (both visual and with manual manipulation) which necessitated removal so needless to say I wasn't too sold on the product at first.  These were the early days so some of us had to take the fall for the learning curve.  Radiesse is no longer recommended for lips. To read more on this, see: Radiesse Removal. 

But I think Radiesse is a great product for dermal facial augmentation and volume restoration!

What Is Radiesse?
Made by Bioform Medical, Inc. (manufactured in Franksville, WI) in partnership with Merz Pharmaceuticals (Frankfurt, Germany), now Merz Aesthetics, Radiesse is an injectable filler comprised of synthetic calcium hydroxylapatite (CaHA)  (55.7%) microspheres 25 to 45 microns in size, suspended in a polysaccharide gel made from 1.3% sodium caboxymethylcellulose USP (United States Pharmacopeia), 6.4% glycerin USP and 36.6% water USP.   The gel which suspends the CaHA microspheres gives you immediate augmentation which slowly dissipates over time.  During this time your body's fibroblasts (essentially, collagen) integrate around the CaHA and give you augmentation which grows over time.  No allergy test is required and the effects of Radiesse last up to 2 years.

Indications For Radiesse
"Radiesse is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds such as nasolabial folds." - FDA

Since it is approved by the FDA, off-label use is possible for other forms of facial augmentation including cheek augmentation and chin augmentation.  Radiesse should not be injected in areas with thin skin, such as the lips, under the eyes and under superficial wrinkles.  Some reports of palpable nodules have been reported when too much product is injected in one area, including the mid-face and buccal area.  It has been reported that Radiesse works well within the backs of the hands, although thinner skinned patients may experience prolonged palpable nodule formation and blanching.

Am I A Candidate For Radiesse?
Patients must be in good health, not have an auto-immune or wound healing disorders, and also have realistic expectations.  Although Radiesse is an injectable, and considered less invasive, anesthetics are used and there are inherent risks of any procedure including allergic reactions to the anesthetics.  Please read the risks section.  

Your Consultation Appointment
After having chosen a doctor to possibly inject your Radiesse, you will schedule a consultation appointment.  This meeting is designed for you and your surgeon to discuss the procedure, its risks, and see before and after photos.  Experience with injecting Radiesse is very important so please determine the amount of patients and injections the doctor has performed before choosing to undergo the procedure.  Inexperience has resulted in excessive nodules, superficial injection, product misplacement and other complications which are very difficult to reverse.

The doctor will examine your skin and ask you which areas of your face you feel need correction as well as offer where he or she feels you would benefit from Radiesse injections.  After discussing your medical history, your doctor will then determine if you are a good candidate for the treatment.

If you have decided that the doctor is the one for your treatment, you may or may not have your procedure that very same day.  If so, you will be asked to sign more paperwork, which may include an informed consent sheet explaining the risks of the procedure.

Lidocaine is drawn up into a 3mL syringe (0.5-1mL).  This syringe is then connected to the 1.5mL Radiesse® syringe and the product is mixed back and forth between each syringe about 10 times to disperse the Lidocaine into the Radiesseze="2">®.  See the Radiesse Cheek Augmentation Video and photo above.  A 28 gauge needle is then attached to the Radiesse syringe and the product is ready for injection.

If you chose to have an topical anesthetic as well, your doctor will wait until you are sufficiently anesthetized.  Your surgeon will pinch the skin between his or her fingers and inject Radiesse either in small thin lines while removing the needle or in small amounts under the fold or in the cheeks or other area.  The surgeon will release pressure on the plunger as he removes the needle so that no product is accidentally injected near the skin's surface.  Your doctor will feel the area and product and then massage and tap gently if necessary. 

The consultation	Radiesse Injection
Defining the area and ascertaining there is no excessive product accumulation	Swelling after Radiesse to cheeks and Restylane to under the eyes

Radiesse Directions For Use

General (Page 6)

6. Use a 1:1 correction factor. No overcorrection is needed.

7. If significant resistance is encountered when pushing the plunger, the injection needle may be moved slightly to allow easier placement of the material or it may be necessary to change the injection needle. Needle jams are possible with needles smaller than 27g or if the needle is not properly tightened onto the syringe.

8. Advance the needle into the subdermis to the starting location. Carefully push the plunger of the Radiesse syringe to start the injection and slowly inject the Radiesse material in linear threads while withdrawing the needle. Continue placing additional lines of material until the desired level of correction is achieved.

9. The needle should slide under the dermis to the point you wish to begin the injection. This should be easily palpable with the non-dominant hand.

10. Apply slow continuous even pressure to the syringe plunger to inject the implant as you withdraw the needle. The implant material should be completely surrounded by soft tissue without leaving globular deposits. The injected area may be massaged as needed
to achieve even distribution of the implant material.

(FDA Website: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_10.pdf )

Recovery
I felt that the recovery was rather mild after Radiesse injections.  The swelling will last for about a week, but should be minimal.  You will normally only be able to tell via before and after photos, but not so much to the casual observer after day 3 or 4.  Swelling will be most apparent in the first day.  However, report any considerable swelling to your doctor.  A small number of patients have reported excessive and prolonged  inflammation in the face and the backs of the hands.

There will be small pinpricks from the injections and bruising is possible which may last for 2 weeks, depending upon how you bruise as an individual.  I did not have bruising from the Radiesse, but I had bruising under my left eye from the Restylane and on one area for Botox® (my right outer brow).  I had two glasses of wine the day before my treatment, so be sure not to do this.  See?  Proof positive that you are more likely to bruise if you consume alcohol a day or two before your treatment (and no aspirin or vitamin E  either!).  I know I preach not to have alcohol for at least 24 to 48 hours before an injection, so do as I say, not as I do, haha!  Or you more than likely may end up bruised like I did. 

I apologize for not having any proper before photos directly prior to this procedure so I removed some stills from the video that best show the angle.  As you can see, I do have natural cheeks but I wanted a bit more.  I think the change is subtle.

DISCLOSURE: I had just removed EMLA from my face in the treatment photos and that always irritates my skin and makes everything look even more red.  So I must disclose that I touched up the few spots on my chin (that you can clearly see in the video) on the photos from the treatment day because it is bad enough that it is blaringly obvious in motion.  I normally do not do this as a rule, but  I don't feel it is necessary to have my pimples forever emblazoned on this page in stills. :) But that is ALL that I touched up, just the few blemishes on the chin, nothing else.  The 3 day post photos are not touched up at all as I had some mineral powder on my chin.

Before Radiesse, Restylane & Botox	Before Radiesse, Restylane & Botox
3 Days post-injection	3 Days post-injection

The bruise under the left eye is from the Restylane, at the right outer brow, Botox.

Risks & Complications of Radiesse
The risks and complications of Radiesse include an allergic reaction to the anesthetic (rare), infection (rare) and hematoma (rare).  More common complications may be nodules from either improper injection technique, lack of proper product distribution, or from your own collagen forming around the product.  Usually the product is only felt and not seen when this happens, unless injected superficially or in thin-skinned areas.  Hyperpigmentations are also an uncommon risk associated with bruising.

Although you may read negative reviews about this product, I can tell you from experience that when injected in the appropriate place  and when injected properly, this product is a wonderful and immediate alternative to other injectable fillers or fat grafting.  Most complaints are when the product was injected into the area under the eyes (tear trough), along the bridge of the nose and within the lips.  I have also heard from patients who had Radiesse improperly injected along the jaw line and in the marionette folds which caused the skin to droop more.  Proper distribution of the product in the appropriate areas of the face is imperative.  This is why choosing a doctor with experience with the product is a must!

Radiesse is not recommended for under the eyes or in the lips.

Contraindications
Taken from the Radiesse Instructions Page:

CONTRAINDICATIONS

• Radiesse is not to be used in patients with known hypersensitivity to any of the components.
• Radiesse must not be injected into blood vessels. Introduction of Radiesse into the vasculature may occlude the vessels and could cause infarction or embolization.

WARNINGS

• Use of Radiesse in any person with active skin inflammation or infection in or near the treatment area should be deferred until the inflammatory or infectious process has been controlled.
• Injection procedure reactions to Radiesse have been observed consisting mainly of shortterm bruising, redness and swelling. Refer to adverse events section for details.
• The safety and efficacy of Radiesse for use in the lips has not been established.
   

PRECAUTIONS

• The calcium hydroxylapatite (CaHA) particles of Radiesse have been shown to be radiopaque. Studies have shown that the CaHA particles are clearly visible on CT Scans and may be visible in standard, plain radiography. The study did not provide any evidence of significant risk of the injected Radiesse potentially masking abnormal tissues or being interpreted as tumors in CT Scans. Patients need to be informed of the radiopaque nature of Radiesse, so that they can inform their primary care health professionals as well as radiologists.
• Radiesse is packaged for single patient use. Do not resterilize. Do not use if package is opened or damaged. Do not use if the syringe end cap or syringe plunger is not in place.
• Long-term safety and effectiveness of Radiesse beyond one year have not been investigated in clinical trials.
• The safety of Radiesse in patients with increased susceptibility to keloid formation and hypertrophic scarring has not been studied. Radiesse should not be used in patients with known susceptibility to keloid formation or hypertrophic scarring.
• As with all transcutaneous procedures, Radiesse injection carries a risk of infection. Standard precautions associated with injectable materials should be followed. No infections have been reported in the clinical study. Refer to adverse events section for details.
• Safety of Radiesse for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established
• Patients who are using medications that can prolong bleeding, such as aspirin or warfarin, may, as with any injection, experience increased bruising or bleeding at the injection site.
• After use, treatment syringes and needles may be potential biohazards. Handle accordingly and dispose of in accordance with accepted medical practice and applicable local, state and federal requirements.

(Source: RADIESSE™ - INJECTABLE IMPLANT, INSTRUCTIONS FOR USE, Page 1 - FDA Website: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_10.pdf)

How Much Does Radiesse Cost?
The cost of Radiesse varies with the doctor and region of the country where you live.  The average price runs anywhere from $750 to $1,200 per 1.5 cc.

The Least You Need To Know

• What: Radiesse is an injectable filler comprised of synthetic calcium hydroxylapatite (CaHA)  (55.7%) microspheres 25 to 45 microns in size, suspended in a polysaccharide gel made from 1.3% sodium caboxymethylcellulose USP (United States Pharmacopeia), 6.4% glycerin USP and 36.6% water USP.
• Made by: Bioform Medical, Inc. (headquartered in San Mateo, CA; manufactured in Franksville, WI) in partnership with Merz Pharmaceuticals (Frankfurt, Germany), now Merz Aesthetics
• FDA Approved? Yes
• Indications: "Radiesse is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds such as nasolabial folds." - FDA and Bioform Product Sheet
• Good for: Nasolabials, Cheek Augmentation, Chin Augmentation, Buccal area augmentation.
• Not recommended for: Lip Augmentation or filling the hollows under the eyes
• Does it hurt?  Yes, however Lidocaine is mixed in with the product and further relief can be sought by using a topical anesthetic or regional anesthetic injection (nerve block).
• Risks: Infection, Hyperpigmentations from bruising, hematoma, prolonged inflammation, palpable nodules, blanching when injected superficially or in thin-skinned areas.
• Recovery time: Swelling can last a week, however most visible swelling subsides within 3 days.  Bruising can be apparent for a few weeks, depending upon how you tend to bruise as an individual.
• Cost: $550 to $1,200 per 1.5 cc, although some wonderful doctors charge $1,300 for 2 syringes.  I feel that $1,200 for one syringe is a bit excessive.