RADIESSE Dermal Filler for the Correction of Moderate to Severe Facial Wrinkles and Folds, Such As Nasolabial Folds
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1 A PATIENT S GUIDE RADIESSE Dermal Filler for the Correctio of Moderate to Severe Facial Wrikles ad Folds, Such As Nasolabial Folds Read all the iformatio before you are treated with Radiesse dermal filler. Keep this iformatio. You may wat to refer to it agai. If you have ay questios, please ask your doctor.
2 A PATIENT S GUIDE to RADIESSE DERMAL FILLER Itroductio This iformatio will help you decide whether treatmet with RADIESSE dermal filler is right for you. This iformatio does ot take the place of a discussio with your doctor but will aswer some questios about RADIESSE dermal filler treatmet. Please read this iformatio ad discuss ay questios with your doctor. Oly you ad your doctor ca decide whether RADIESSE dermal filler is right for you. GLOSSARY AESThETIc: A substace that causes temporary loss of feelig that may make your dermal filler treatmet more comfortable. calcium HyDROxylAPATITE: A substace compatible with livig systems that dissolves i the body that is idetical i compositio to the mieral portio of teeth ad boe. GRAuloma: A small area of swellig (iflammatio) aroud the dermal filler material due to the body s respose to the material. ODule: A small lump of dermal filler material. SIDE effect: A udesirable evet caused by use of the dermal filler.
3 BAckGRouND iformatio WhAT is RADIESSE dermal filler? RADIESSE dermal filler is a ijectable for facial folds ad wrikles. Calcium Hydroxylapatite has a history of safe use i otology (ears), larygeal (vocal chords), ad detal ad orthopedic applicatios (see glossary). WhAT is RADIESSE dermal filler used for? RADIESSE dermal filler is used to fill moderate to severe facial wrikles ad folds, such as asolabial folds the creases that exted from the corer of your ose to the corer of your mouth. RADIESSE dermal filler will ot correct the uderlyig causes. ca RADIESSE dermal filler work for me? Talk to your doctor about your medical history whe decidig o treatmet optios. You should ot use RADIESSE dermal filler if you are allergic to ay of its igrediets. You should also ot choose RADIESSE dermal filler if you desire oly short-term results. how does RADIESSE dermal filler work? Oce ijected, RADIESSE dermal filler immediately adds fulless to your face givig you a visible result at the first treatmet sessio. RADIESSE dermal filler cotais microspheres made of a atural material called Calcium Hydroxylapatite i a water based gel carrier. how log do treatmet effects last? Although treatmet effects will differ for each perso, i a cliical study, RADIESSE dermal filler lasted up to 6 moths accordig to idepedet doctors i a blided test. The people i this study were followed after the cliical study ad the ublided treatig doctor rated some people still improved up to two years from RADIESSE dermal filler treatmet. Do ijectios of RADIESSE dermal filler hurt? As with ay ijectio, ijectios with RADIESSE dermal filler may hurt. RADIESSE dermal filler is ijected i small amouts usig a very fie eedle. Your doctor may apply a topical or local aesthetic. ARE ski TESTS EEDED before TREATmet WITh RADIESSE DERmal filler? No ski testig is required prior to use..
4 A PATIENT S GUIDE to RADIESSE DERMAL FILLER Should I TEll my healthcare PROvIDER what medicatios I am TAkig? Yes. You should tell your doctor about all the medicies you are takig, eve over the couter medicies or treatmets. If you are takig blood thiers or medicatios that may iterfere with clottig of the blood, such as aspiri, you might be more likely to have bruisig or bleedig at the ijectio site. There have bee o studies of possible iteractios betwee RADIESSE dermal filler ad drugs or other substaces or implats. WhAT ca I expect to happe at a treatmet sessio? Your doctor will aswer all of your questios ad prepare you for the treatmet. The area where the ijectios will be give will be cleaed with a atiseptic. You ad your doctor will determie if a topical or local aesthetic is eeded. RADIESSE dermal filler will be ijected i small amouts ito the ski usig a very fie eedle. A ice pack may be applied to the treatmet area before or after treatmet to help reduce swellig. WhAT are the possible side effects of treatmet with RADIESSE DERmal filler? Talk to your doctor about the possible side effects of RADIESSE dermal filler. The most commo side effects are redess, bruisig, or swellig. These side effects geerally last for a short time ad are mild i ature. As with all procedures that ivolve a ijectio through the ski, there is a risk of ifectio. However, o ifectios have bee reported i the cliical study of RADIESSE dermal filler. Report ay side effects you may experiece to your doctor. The table below shows the types of side effects reported i a cliical study of 7 patiets with RADIESSE dermal filler ad aother similar product (Tables ). Log term side effects were studied i patiets ad o log term side effects were observed through out the years of follow-up. Table. SIDE EFFECts REPortED Through PatIENt DIARIES radiesse cotrol BruISING 7 (6.) 5 (.7) SWELLING 8 (69.) 6 (5.) REDNESS 78 (66.7) 8 (7.8) GRANuloMA NoduLE (.9) (.9) PAIN (8.) 6 (.) ItchING (8.) (.5) OthER 5 (9.9) 6 (.).
5 Table. SIDE EFFECts REPortED Through OthER MethoDS radiesse cotrol BruISING (.7) SWELLING 5 (.) (.) REDNESS 6 (5.) 9 (7.7) GRANuloMA NEEDLE JAMMING (.9) NoduLE (.7) PAIN (.7) (.9) ItchING (.9) (.7) OthER (.6) (.6) Table. LENGth of time for SIDE EFFECts REPortED Through PatIENt DIARIES RADIESSE Cotrol Radiesse cotrol REPortING SYMPtoMS N REPortING SYMPtoMS N - Number of Days > - Number of Days > BruISING 9 (6.) 6 (9.7) 6 (.6) 7 (.5) (.9) 5 (.) 5 (9.9) 9 (9.) (7.9) (.6) SWELLING (5.5) 87 (5.5) (7.8) (.5) 7 (8.9) (5.) (7.8) 9 (.) (5.) (.) REDNESS 5 (5.) 8 (5.9) 9 (6.7) 6 (.) 9 (8.) (9.) 5 (9.) 5 (5.) 6 (6.9) (.7) GRANuloMA Nodule (5.) (5.) (5.) (5.) Pai (5.8) (5.) (.) (7.8) (5.5) (.) (7.) (.7) (.7) (.) Itchig (7.) 7 (5.9) 5 (9.) 5 (9.8) (5.9) (.) (.6) (9.6) (5.9) (5.9) Other 5 (56.5) (.5) 5 (6.) 7 (8.5) 8 (8.7) (.) 8 (8.7) (.9) (.) (.).
6 A PATIENT S GUIDE to RADIESSE DERMAL FILLER Table. LENGth of time for SIDE EFFECts REPortED Through OthER MethoDS RADIESSE Cotrol Radiesse cotrol REPortING SYMPtoMS N REPortING SYMPtoMS N - Number of Days > - Number of Days > BruISING (.) (5.) (5.) SWELLING 5 (.7) 7 (58.) 5 (.7) 5 (.7) (6.7) REDNESS 9 (.9) (57.) (9.) (9.5) (9.5) (.8) (9.5) (.) (9.) (.) GRANuloMA eedle jammig (.) (.) Nodule (.) (.) (66.7) Pai (75.) (5.) (5.) (5.) (5.) (5.) Itchig (.) (66.7) (.) (.) (.) Other (5.) (5.) (.5) (5.) (.5) (.5) (.5) (5.) WhAT ca I expect after treatmet? Immediately followig a treatmet sessio with RADIESSE dermal filler redess, bruisig or swellig may occur i the treatmet area. These sigs usually go away i a short period ad are geerally mild i ature. A ice pack may be applied to the treatmet area to help reduce swellig. Your health care provider will give you specific post-treatmet care istructios. For approximately hours after treatmet: Avoid sigificat movemet or massage of the treated area. Do ot apply makeup. Avoid extesive su or heat exposure. After you leave the office, you may experiece redess, bruisig or swellig for a few days. Not all patiets experiece these, but please ote that such effects ca occur ad are ot out of the ordiary for such a treatmet. You may be able to feel the area where RADIESSE dermal filler was ijected for some period after ijectio. Over time, the ijected area will feel more ad more like your ow tissue..
7 How quickly ca I get back to my daily activities? Most patiets feel comfortable goig back to their ormal activities immediately after treatmet with RADIESSE dermal filler. how may treatmets are required? Your doctor will decide with you the umber of treatmet sessios ad the amout of RADIESSE dermal filler you will eed at each treatmet sessio. Geerally, sigificat chages may be achieved i a first treatmet. A touch-up may be required to achieve optimal results. WIThout touch-up ijectios, how will my ski look? Your ski will begi to gradually look like it did before treatmet as you ear the ed of the time period RADIESSE dermal filler usually lasts. Periodic touch up ijectios will help you maitai the look you have after treatmet. WhAT other thigs do I EED to kow? The Microspheres i RADIESSE dermal filler ca be see i X-rays ad CT Scas. It is very importat that you iform your doctor ad other health care professioals that you have RADIESSE dermal filler ijected i your face. Eve though RADIESSE dermal filler ca be see i X-rays ad CT Scas, there is ot a high risk that it would cause your doctor cocer, as log as s/he kows that you have had RADIESSE dermal filler ijected i your face. QUESTIONS FOR MY DOCtoR 5.
8 Maufactured by Merz Aesthetics, Ic. Courtey Road, Suite Fraksville, WI 56 Copyright Merz Aesthetics, Ic. All rights reserved. Merz Aesthetics ad the Merz Aesthetics logo are trademarks of Merz Pharma GmbH & Co. KGaA. RADIESSE is a registered trademark of Merz Aesthetics, Ic. EM9-
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