Helpful Answers A bout the cause and treatment of excessive uterine bleeding due to benign causes

1. Helpful AnswersAbout the cause and treatment of excessive uterine bleedingdue to benign causes These materials are DRAFTS prepared by Boston Scientific Corporate and are intended to be customized and finalized by the physician. Boston Scientific is not responsible for physician customization. MVU3068 3M Jan/04-Jan/06

3. WELCOME [insert physician name] [insert name/address of practice, hospital affiliations, etc.]

4. CONDITION What is excessive uterine bleeding? • A heavy, prolonged period lasting 7 days or more • The use of a total of 15 or more sanitary pads or tampons • Daily activities often interrupted; quality of life diminished • Medical name: menorrhagia

5. CONDITION What causes menorrhagia? • Hormonal imbalance • Uterine fibroids, polyps • Other abnormalities • Anticoagulants

6. CONDITION How can it be treated? • Pharmacotherapy/medically • Hysterectomy • Endometrial Ablation

7. TREATMENT What are medical treatment options? A variety of prescription medications are available • provides temporary relief of symptoms • easily administered • no invasive procedure required • does not provide long-term solution

8. TREATMENT What is a hysterectomy?A surgical procedure in which a woman’s uterus is removed • eliminates menorrhagia completely • requires hospitalization / general anesthesia • major surgery with long recovery time • patient may require subsequent hormone replacement therapy, if ovaries are also removed

9. TREATMENT What is endometrial ablation?A minimally invasive procedure that permanently eliminates all or most of the tissue lining of the uterus (the endometrium) that is responsible for menstrual bleeding

10. TREATMENT How do you decide which method to use? • Safety • Reliability • Effectiveness • Patient comfort

11. HTA®SYSTEM A medical device that allows a physician to treat excessive uterine bleeding by performing endometrial ablation on an outpatient basis, using heated fluid within the uterine cavity under direct visual control The HTA® System is a hysteroscopic thermal ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete

12. HTA®SYSTEM Procedure Steps • Patient’s cervix is gently dilated • Sheath, including miniature telescope, is inserted • Telescope provides physician with clear view of the uterine cavity to ensure proper placement • System gently fills, cleans and flushes the uterine cavity with physiologic saline

13. HTA®SYSTEM Procedure Steps System gradually raises the temperature of the physiologic saline circulating in the uterine cavity • After reaching the proper temperature, heated saline is circulated for 10 minutes to treat the endometrium • Uterus is cooled by circulation of room-temperature saline • All saline is removed, sheath is removed

14. HTA®SYSTEM Expected Outcomes • Three years following the Phase III Multi-Center: • over half of the 135 patients reported no menstrual bleeding* • 94% achieved and maintained a normal or better menstrual cycle* *per protocol data, “Evaluation of Hydrothermablator…after 3 Years…”, Miton Goldrath, MD, Journal of the AAGL,Vol. 10, No.4, November 2003.

15. HTA®SYSTEM AnesthesiaThe Hydro ThermAblator® System is designed so that treatment can be administered without the necessity for either general or regional anesthesia

16. HTA®SYSTEM How do you know if the HTA® System is an appropriate treatment for a patient? • Physician evaluates the patient to determine the cause of excessive uterine bleeding before any treatment option is initiated – usually an endometrial biopsy • Other tests may include: Pap smear, ultrasound, hysteroscopy

17. COMMON QUESTIONS Does the patient feel anything during treatment? • Pain medication is provided to minimize cramping during and after procedure • Physician and patient decide which form of anesthesia is best • Patient may feel some discomfort, but it should not be severe

18. COMMON QUESTIONS What can be expected after the treatment? • Return home shortly after procedure • Any cramping should dissipate within 24 hours • Vaginal discharge typically experienced during the first few days following the procedure may last as long as a few weeks

19. COMMON QUESTIONS Is pregnancy possible after treatment? • Women should not have an endometrial ablation if they desire pregnancy in the future • Endometrial ablation does not necessarily prevent pregnancy • Contraception should be used or a sterilization procedure should be performed • Serious potential complications may result to both mother and fetus if a woman becomes pregnant after endometrial ablation

20. COMMON QUESTIONS Are there any risks involved with the HTA® System? Potential adverse effects include, but may not be limited to: • thermal effects to adjacent tissue, including cervix, vagina, vulva and/or perineum • heated saline escaping into the vascular spaces • hemorrhage • perforation of the uterus • complications with pregnancy (note: pregnancy following endometrial ablation is dangerous to both mother and fetus) • risks associated with hysteroscopy

21. THANK YOU I hope that you feel more knowledgeable about menorrhagia Women and physicians should consider the options I am available to answer any additional questions