12729.F 3/21/06 7:25 AM Page F - Incontinence

1 For the Treatment of StressUrinary Incontinence in WomenInformation For PatientsRefer to Coaptite Injectable Implant Instructions for Useprovided with product for complete instructions for :Coaptite Injectable Implant is indicated for softtissue augmentation in the treatment of stress urinaryincontinence (SUI) due to intrinsic sphincter deficiency (ISD) inadult females. CONTRAINDICATIONS:The Coaptite Injectable Implant iscontraindicated for use in a patient: who has significant history ofurinary tract infections without resolution; who has current oracute conditions of cystitis or urethritis; who has fragile urethralmucosal lining.

2 POTENTIAL ADVERSE EFFECTS that may occurinclude: genitourinary adverse events ( , urinary retention,hematuria, dysuria, UTI, urinary urgency and frequency), erosion,erythema, embolic phenomena, and vascular :Note: Failure to follow any instructions or to heedany Warnings or Precautions could result in serious patient : Following injection of Coaptite Implant, dissection ofthe device through tissue may lead to 1) tissue erosion and mayrequire corrective surgery or 2) elevation of the bladder wallcausing ureteral obstruction. This may be caused by improperinjection technique using Coaptite Implant. (See adverse eventsection in IFU for further information.

3 WARNING:Women withperipheral vascular disease and prior pelvic surgery may be atincreased risk for tissue erosion following injection of CoaptiteImplant. (See adverse event section in IFU for further information.)Please refer to complete instructions for use for a complete listingof all warnings and potential adverse effects. CAUTION: FederalLaw (USA) restricts this device to sale by or on the order of aphysician trained in diagnostic and therapeutic depicted in this brochure are models and included forillustrative purposes only; models depicted are not users and donot endorse the Coaptite Injectable exclusively by:Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760-1537 Toll Free: 1-888-272-1001 2006 Boston Scientific Corporation or its affiliates.

4 All rights 20M 06/06 Manufactured by:BioForm Medical, Courtney Road Suite 10 Franksville, WI 53126 Questionsfor my DoctorCoaptite INJECTABLE 3/21/06 7:25 AM Page FGlossary of Terms1 Introduction3 Contraindication5 Warnings5 What are the risks of Coaptite Implant injections?6 Are there other options?6 What are the benefits of Coaptite Implant injections?7 What can I expect during my procedure with the Coaptite Injectable Implant?7 Can I go back to normal activity? 3/15/06 8:30 AM Page iGlossary of Terms Bladder:Sack-like organ in the lower abdomen where urine isstored for elimination from the body.

5 Calcium Hydroxylapatite: A natural occurring material that is found in bones andteeth. Coaptite Injectable Implant: A material used to bulk or fill out the tissues surroundingthe urethra to provide additional support during physicalactivity. The Coaptite Injectable Implant is made of roundparticles made of calcium hydroxylapatite. Contraindications: A statement in the product information that, if the product is used for a certain condition, you may be harmed. Forexample, the Coaptite Injectable Implant is contraindicatedfor patients who have urinary tract infection at the time of treatment. Cystoscope: An optical instrument placed in the urethra to enable thephysician to examine directly inside the urethra and bladder.

6 Erosion: The breakdown of the tissue that covers the CoaptiteImplant material. Exposed bulking material:When the Coaptite Implant leaks out of your tissue. Frequent urination:Condition where you need to go to the bathroom to urinate many times during the day and night, more than 8-12 times a day. Hysterectomy:Removal of your uterus. Peripheral Vascular Disease:Damage to your blood vessels that are not in your heartand brain from diabetes, high blood pressure, high cholesterol, and smoking. Urinary Retention:Condition where you are unable to urinate because your urethra is INJECTABLE 6/16/06 3:53 PM Page 1 Risk: Complication that may result from the procedure.

7 Stress Urinary Incontinence (SUI): The accidental leakage of urine during exercise or physicalactivities such as coughing, sneezing, laughing, or otherbody movements that put pressure on the bladder. SUI isthe most common type of urinary problem in younger and middle age women. In some cases, it is related to child-birth. It may also begin around the time of menopause. Urethra: The tube that carries urine from the bladder to outside thebody for elimination. Urethral Bulking: The injection of material (bulking agent) into the tissues surrounding the urethra to help the urethra close to avoidaccidental leakage.

8 Urethral bulking does not close the urethra totally; the urethra can still open normally to allow for urination. Urethral Sphincter: A circular muscle around the urethra that opens it whenyou want to urinate but keeps it closed at other times. Urethral Stricture: An abnormal narrowing or "kink" in the urethra that may prevent normal urination. The Coaptite Injectable Implantshould not be used if a urethral stricture is not corrected. Urgency: A strong desire to urinate but does not result in accidentalleakage or an episode of Incontinence . Urinary Tract Infection: Condition where the presence of bacteria in urine cause frequent urination and pain during urination.

9 Warnings: A statement in the product information that alerts you to apotentially harmful condition in which you should contactyour physician. 2 For the Treatment of Stress Urinary Incontinence in 6/16/06 3:53 PM Page 2 IntroductionThe Coaptite Injectable Implant is a material that isused to bulk or fill out the tissues surrounding the urethrato provide additional support during physicalactivity. The Coaptite Implant is made of round particlesmade of calcium hydroxylapatite, which is a naturalcomponent of your teeth and bones, in a Urinary Incontinenceis the involuntary loss ofurine during physical activity such as coughing, laughingor sneezing.

10 The round muscle (sphincter) used to keepurine in the bladder can become weak and urine leaksout during these activities (See Figure 1). This type ofincontinence is treated both surgically and with the Coaptite Injectable Implant increasesthe resistance of the urethra to urine brochure is to help you make a decision as towhether or not to have a urethral bulkingprocedurewith the Coaptite Injectable Implant. Over 13 millionadults have Stress Urinary Incontinencein the UnitedStates, 85% of these adults being women. CoaptiteImplant treatment is only one way to treat Stress UrinaryIncontinence. Your physician will provide you with recommended options for treating your incontinenceand help you make the right treatment INJECTABLE 3/15/06 8:30 AM Page 3 Figure 1 Source: Marcia Williams, MwMI4 For the Treatment of Stress Urinary Incontinence in 3/15/06 8:30 AM Page 4 Coaptite INJECTABLE IMPLANT5 Contraindication You should not have the procedure at this time if you have inflammation of the bladder(cystitis) or the urethra(urethritis) or other infections.