CONSENT FOR KYBELLA INJECTABLE FAT REDUCTION

Transcription

1 CONSENT FOR KYBELLA INJECTABLE FAT REDUCTION INSTRUCTIONS This is an infrmed cnsent dcument which has been prepared t help yur Dctr infrm yu cncerning fat reductin with an injectable medicatin, its risks, and alternative treatments. It is imprtant that yu read this infrmatin carefully and cmpletely. Please initial each page, indicating that yu have read the page and sign the cnsent fr this prcedure as prpsed by yur Dctr. INTRODUCTION Kybella is a medicatin that is injected under the skin t disrupt fat cells and reduce the amunt f fat in the treated are. The current FDA apprved use is fr the area under the chin (duble chin). Use f Kybella in ther areas is cnsidered ff- label and safety and effectiveness is nt knwn. It may take 1 t 2 mnths t see the final results and typically 2 t 4 treatments are needed. In sme cases, there may be n imprvement in the treated area. The results are expected t be lng- lasting but depend n ther factrs such as aging and yur individual bdy weight and cmpsitin. ALTERNATIVE TREATMENTS Alternatives include nt perfrming the treatment at all. Other alternative treatments which vary in sensitivity, effect and duratin include nnsurgical fat reductin with heat energy r cld therapy, lipsuctin, and surgical fat remval. DISCLAIMER OF OFF- LABEL USE Currently, Kybella is apprved fr use in the fatty tissue under the chin. Hwever, nce a prduct is FDA apprved, it may be used in ther areas f the face and bdy as determined by a medical prfessinal. Therefre, Kybella may include ff- label use in an effrt t give the best result pssible. RISKS OF FAT REDUCTION INJECTIONS Every prcedure invlves a certain amunt f risk, and it is imprtant that yu understand the risks invlved. An individual s chice t underg this prcedure is based n the cmparisn f the risk t ptential benefit. Althugh the majrity f patients d nt experience the fllwing cmplicatins, yu shuld discuss each f them t make sure yu understand the risks, ptential cmplicatins, and cnsequences f fat reductin injectins. Pain Kybella is injected int the skin using a fine needle t reduce injectin discmfrt. Yu may chse t anesthetize the treatment area either tpically, with a lcal blck r bth. Pain and tenderness shuld be expected AFTER treatment and is usually temprary, reslving in 3 t 7 days Please cnsult yur physician abut pain management. Skin Disrders It is cmmn t have a temprary redness, bruising, and swelling fllwing a treatment. This will usually subside after several days t a week. Minimize expsure f treated areas t excessive

2 sunlight, UV lamp expsure, and extreme cld weather until any swelling and redness have disappeared. Avid use f alchl fr the next 24 hurs. While very rare, scarring can ccur fllwing treatment. Occasinally, treatment may prduce ndules under the skin which might be seen r felt by the patient. These typically reslve ver time but may require further treatment. Bleeding and bruising Pinpint bleeding is rare, but can ccur fllwing treatments. Bruising is cmmn fllwing treatments. Rarely, bruising can last fr weeks r mnths and might even be permanent. Patients using Aspirin, Ibuprfen, Advil, Mtrin, Nuprin, Aleve, garlic, Gingk Bilba, Vitamin E, r bld thinners have an increased risk f bleeding r bruising at the injectin site. Unsatisfactry results There is the pssibility f a pr r inadequate respnse frm Kybella injectins. There might be an uneven appearance f the treated areas. In mst cases this uneven appearance can be crrected by mre injectins in the same r nearby areas. In sme cases, thugh, this uneven appearance can persist fr several weeks r mnths. The practice f medicine and surgery is nt an exact science. Althugh, gd results are expected, there is n guarantee r warranty expressed r implied, n the results that may be btained. Allergic reactins Kybella shuld nt be used in individuals with a knwn previus histry f reactins. In rare cases, lcal allergies t tape, preservatives used in csmetics r tpical preparatins have been reprted. Systemic reactins (which are mre serius) may result frm prescriptin medicines. Infectin Althugh infectin fllwing Kybella injectins is rare, bacterial, fungal, and viral infectins can ccur. Additinal treatments r antibitics may be needed. Mst cases are easily treatable but, in rare cases, permanent scarring in the area can ccur. Swelling Sme swelling (edema) is cmmn after Kybella injectin and tends t reslve in a few days. In rare cases, swelling may last a few weeks r mnths. Lumps and tissue irregularities Sme lumps r irregularities are pssible but usually reslve with time r gentle massage. Damage t deeper structures Althugh extremely unlikely, deeper structures such as nerves, and bld vessels, may be damaged during the curse f injectin. Asymmetry The human bdy is nrmally asymmetrical with respect t structural anatmy and functin. There can be a variatin frm ne side t the ther in terms f the respnse t Kybella injectin. Pain Discmfrt assciated with Kybella injectins is cmmn and reslves after a few days. Unknwn risks The lng term effect f this treatment n tissue is unknwn. There is the pssibility f additinal risk factrs may be discvered. Difficulty Swallwing While extremely rare, yu may experience difficulty swallwing that usually reslves within a few days

3 Unsatisfactry result There is the pssibility f a pr r inadequate respnse frm Kybella injectin. Additinal injectins may be necessary. Surgical prcedures r treatments may be needed t imprve results after injectin. Lng Term Effects Subsequent alteratins in appearance may ccur as the result f aging, weight lss f gain, sun expsure, r ther circumstances nt related t this treatment. This prcedure des nt stp the aging prcess r prduce permanent tightening f the skin. Future surgery r ther treatments may be necessary. Pregnancy and nursing mthers Animal reprductin studies have nt been perfrmed t determine if Kybella injectins culd prduce fetal harm. It is nt knwn if Kybella can be excreted in human milk. Nerve Injury Althugh rare, nerves arund the treatment area may be affected by the injectin resulting muscle weakness which can cause asymmetry r difficulty swallwing. This is temprary and nt life threatening. ADDITIONAL TREATMENT NECESSARY There are many variable cnditins in additin t risk and ptential cmplicatins that may influence the lng term result f treatment. Even thugh risks and cmplicatins ccur infrequently, the risks cited are the nes that are particularly assciated with Kybella injectins. Other cmplicatins and risks can ccur but are even mre uncmmn. Shuld cmplicatins ccur, additinal surgery r ther treatments may be necessary. The practice f medicine and surgery is nt an exact science. Althugh gd results are expected, there is n guarantee r warranty expressed r implied, n the results that may be btained. FINANCIAL RESPONSIBILITIES The cst f injectin may invlve several charges. This includes the prfessinal fee fr the injectins, fllw up visits t mnitr the effectiveness f the treatment, and the cst f the material itself. Additinal csts f medical treatment wuld be yur respnsibility shuld cmplicatins develp frm this treatment. DISCLAIMER Infrmed- cnsent dcuments are used t cmmunicate infrmatin abut the prpsed surgical treatment f a disease r cnditin alng with disclsure f risks and alternative frms f treatment(s). The infrmed- cnsent prcess attempts t define principles f risk disclsure that shuld generally meet the needs f mst patients in mst circumstances.

4 Hwever, infrmed cnsent dcuments shuld nt be cnsidered all- inclusive in defining ther methds f care and risks encuntered. Yur plastic surgen may prvide yu with additinal r different infrmatin which is based n all f the facts pertaining t yur particular case and the state f medical knwledge. Infrmed- cnsent dcuments are nt intended t define r serve as the standard f medical care. Standards f medical care are determined n the basis f all f the facts invlved in an individual case and are subject t change as scientific knwledge and technlgy advance and as practice patterns evlve. It is imprtant that yu read the abve infrmatin carefully and have all f yur questins answered befre signing the cnsent n the next page.

5 CONSENT FOR KYBELLA - INJECTABLE FAT REDUCTION 1. I hereby authrize Elite Aesthetics Grup, LLC, Dr Ward, and such assistants as may be selected t perfrm the fllwing prcedure r treatment: Fat Reductin Injectin KYBELLA (DEOXYCHOLIC ACID) 2. I recgnize that during the curse f the treatment, unfreseen cnditins may necessitate different prcedures than thse abve. I therefre authrize the abve physician and assistants r designees t perfrm such ther prcedures that are in the exercise f his r her prfessinal judgment necessary and desirable. The authrity granted under this paragraph shall include all cnditins that require treatment and are nt knwn t my physician at the time the prcedure is begun. 3. I cnsent t the administratin f such anesthetics cnsidered necessary r advisable. I understand that all frms f anesthesia invlves risk and the pssibility f cmplicatins, injury, and smetimes death. 4. I acknwledge that n guarantee has been given by anyne as t the results that may be btained. 5. I cnsent t the phtgraphing r televising f the peratin(s) r prcedure(s) t be perfrmed, including apprpriate prtins f my bdy, fr medical, scientific r educatinal purpses, prvided my identity is nt revealed by the pictures. 6. Fr purpses f advancing medical educatin, I cnsent t the admittance f bservers t the treatment rm. 7. IT HAS BEEN EXPLAINED TO ME IN A WAY THAT I UNDERSTAND: a. THE ABOVE TREATMENT OR PROCEDURE TO BE UNDERTAKEN b. THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF TREATMENT c. THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED I CONSENT TO THE TREATMENT OR PROCEDURE AND THE ABOVE LISTED ITEMS (1-7). I AM SATISFIED WITH THE EXPLANATION. Patient Signature: Date: Print Name: