THE WOMAN-FRIENDLY STERILIZATION METHOD

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1 THE WOMAN-FRIENDLY STERILIZATION METHOD Urogyn BV Transistorweg 5a 6534 AT Nijmegen The Netherlands t +31(0) info@urogynbv.com

2 THE MOST WOMAN-FRIENDLY STERILIZATION METHOD VERY WOMAN-FRIENDLY Ovalastic is the most woman-friendly sterilization method available. As it does not damage the reproductive system, it prevents tissue ingrowth. The method relies on occlusion of the fallopian tubes and, if necessary, implants may be removed in a simple procedure without the risk of (partial) salpingectomy. RELIABLE AND SAFE The Ovalastic method has been used for many years, and there is extensive experience using the product. And while no contraceptive is 100% safe, chances of becoming pregnant after Ovalastic treatment are lower than the prevailing standard of 0.8% for other types of contraception. Over the past few decades, the Ovalastic method has been proven safe and without discomfort to patients. The method enables gynecologists to perform the procedure fast, with reproducibility and low failure rates. 15 MINUTE TREATMENT The treatment takes around 15 minutes. An ultrasound is performed post treatment, to ensure the correct positioning of the plugs. As the treatment is an outpatient procedure, patients will be able to leave the hospital immediately afterwards and resume their daily activities. Ovalastic is a trademark of Urogyn bv. rev.0 2

3 BENEFITS OF USING OVALASTIC FAST PROCEDURE WITHOUT THE NEED OF AN OPERATING THEATER LESS STRESS FOR PATIENTS, NO ANESTHETIC, NO INCISIONS PATIENTS GO HOME THE SAME DAY TO RESUME THEIR USUAL ACTIVITIES NO NICKEL ALLERGY NO WOUNDS OR SCARS 3

4 NECESSARY EQUIPMENT THE OVALASTIC KIT THE OVALASTIC KIT CONTAINS: 1. A dispenser gun for squeezing the dual Ovalastic syringe 2. One dual syringe with 2.5 ml of each component 3. Two static mixers needed for mixing of the two components 4. Two catheters 5. An Instruction For Use (IFU) 6. Three patient labels (6) HYSTEROSCOPIC EQUIPMENT Collins speculum Hegars up to 8 mm CF hysteroscope with 7 French working channel Ovalastic is a trademark of Urogyn bv. rev.0 4

5 THE PROCEDURE EXAMINING THE WOMB Before the procedure, the womb is examined using a hysteroscope. INSERTING THE CATHETER The catheter is pushed through the hysteroscope. The obturator tip should be gently placed into the ostium of the fallopian tube. 5

6 Catheter Ovalastic PLACING THE DEPOSITS The Ovalastic material is carefully expressed until visible at the tip of the catheter. Within 2 minutes the gynecologist needs to start injecting, before increasing viscosity renders it too difficult. Selecting a dosage of 0.1 ml per stroke will facilitate injection of sufficient material (0.3 ml) in three strokes. After injection is complete, the doctor must unlock the spiral tip within 2 minutes by pushing the separator. The catheter can then be retracted carefully. When the material is cured (approximately 5 min), the catheter and the mixer are unlocked. Hysteroscope The procedure is repeated to occlude the other fallopian tube, using the unused catheter and static mixer. Ovalastic is a trademark of Urogyn bv. rev.0 6

7 END OF PROCEDURE An ultrasonic examination of the occluded fallopian tubes must be performed immediately after the procedure to confirm that the plugs are intact and in place. 7

8 POST INSTALLATION INSTRUCTIONS FOR PATIENTS The patient is to remain on her current form of birth control for the next three months. (If the patient was using an IUD immediately prior to the Ovalastic procedure, the physician must prescribe an appropriate interim method of contraception.) The physician will contact the patient after 72 hours to record any occurrences of pain, bleeding or elevated temperature. An appointment for the patient s 3-month visit is also scheduled. In case the patient has a fever over 100 F or 38 C, cervix cultures must be taken (for checks including Chlamydia). Additionally, the patient should be instructed to contact the physician for follow-up treatment, should any post-procedural complaint persist. At the 3-month appointment, the physician must confirm the proper positioning of the implants using imaging techniques. If bilateral normal plugs are confirmed the patient is advised to discontinue contraception and rely on the Ovalastic tube occlusion plugs for sterilization. Ovalastic is a trademark of Urogyn bv. rev.0 8

9 PRESCRIBING INFORMATION WHO SHOULD USE OVALASTIC? INDICATIONS Ovalastic is a method for permanent birth control. It must not be considered reversible. Ovalastic is indicated for women who desire permanent contraception, who are of legal age and who have given consent to perform the procedure. The woman must be in good general health, as determined by medical history and gynecological examination, and must have two patent fallopian tubes (oviducts). Women missing one tube, but with a patent other tube, can also be included. Ovalastic may be considered: - where an anesthetic poses a risk - for obese women - for women with a history of multiple abdominal operations WHO SHOULD USE OVALASTIC? CONTRAINDICATIONS Ovalastic is contraindicated in the following conditions: pregnancy, or suspicion of pregnancy in the past three months. Any abnormalities noted upon examination like adhesions, fibroids, infections, genital bleeding, cysts or other pathological conditions that may interfere with the procedure. A significantly distorted or retroflected uterus. Abnormal menstrual cycles after a recent partus. Women who have not returned to their normal menstrual cycle after a recent partus. An unevaluated abnormal PAP smear. 9

10 ARE YOU INTERESTED IN BECOMING A CERTIFIED UROGYN PRACTITIONER? Urogyn offers training, free of charge, to doctors interested in conducting procedures, provided by experienced colleagues. Interested doctors will receive a training certificate after three successfully performed procedures. Doctors may train at their own hospital or at the hospital of a colleague, where they can bring their own patients, with the latter s consent. If you would like more information about training, or if you would like to attend a procedure performed by a trained colleague, please send us an at info@urogynbv.com. Ovalastic is a trademark of Urogyn bv. rev.0 10

11 WHAT DO WE OFFER? A very cost effective procedure Free training provided by experienced colleagues Training either at your hospital or at a hospital nearby Training manual VISIT OUR WEBSITE: CONTACT US: info@urogynbv.com For more information about clinical data, please go to: 11

12 Ovalastic is a trademark of Urogyn bv. rev.0 PROGRESS THROUGH INNOVATION!