Endometrial Ablation for Heavy bleeding “A new treatment for an old problem”

Abnormal Uterine Bleeding: Scope and Impact

Widespread Impact In the United States, AUB affects more than 40 of every 100 women between the ages of 35 and 55

A Common Condition 1 woman in 5 says “Yes” When asked: Does heavy menstrual bleeding disrupt your life? Abnormal Uterine Bleeding Affects 7.5 Million American Women 20% 80% Warner P. British Med J. 2001;323:24

Heavy Bleeding Disrupts Lives “How often does your period cause you to miss the following activities?” National Women's Health Resource Center. National survey of 653 women, with reported heavy periods and intact uterus; conducted Sept 29-Oct 12, 2005.

“Do you have the following problems often, sometimes, rarely, never?” Other Symptoms Accompany Bleeding Nausea Low blood count or anemia Headaches Really bad cramps Depression or moodiness Other severe symptoms Fatigue or tiredness Often (%) Often/ Sometimes (%) National Women's Health Resource Center. National survey of 653 women, with reported heavy periods and intact uterus; conducted Sept 29-Oct 12, 2005.

Many Women Suffer in Silence Silent Sufferers >5 Million Silent Sufferers  Don’t recognize heavy bleeding as a problem  Fertility concerns  Past therapy ineffective  Unaware of alternatives  Problem not diagnosed 2 Million Diagnosed, Receiving Therapy

Few Women Mention Abnormal Uterine Bleeding Have you discussed this problem with your doctor? No 71% Yes 29% Data on file. BioVid; January 2005

Assess Abnormal Uterine Bleeding With Four Questions  How are your periods?  How many days do they last?  Do you think they are heavy?  Do your periods bother you or disrupt your life? Answers to these questions provide an excellent gauge of how a woman perceives her menstrual bleeding

Diagnostic Techniques in AUB  Careful history and PE *  Laboratory work-up *  Endometrial biopsy *  Transvaginal ultrasonography (TVS) *  Hysteroscopy  Saline infusion sonography (SIS) *  Magnetic resonance imaging (MRI)

Etiologies of Abnormal Uterine Bleeding  Organic causes –Reproductive tract lesions –Systemic disease  Iatrogenic causes –Hormones –Nonhormonal drugs –Foreign bodies  Dysfunctional causes –Anovulatory –Ovulatory Mishell D in Comprehensive Gynecology 4th Edition 2003

Current Management of AUB (Among Women 35-55) 5 MM Surgical Intervention  D&C  Hysterectomy  Endometrial Ablation < 2 MM < 1MM No Treatment “Silent Sufferers” Medical Management  Hormonal  NSAIDs Cytyc Corporation, 2005, Data on file.

Perspective on Management  Medical management for women wanting to preserve their fertility  Hysterectomy for women not concerned about fertility Historically, Two Predominant Modalities:  Drug-eluting IUDs  Endometrial ablation Newer Treatment Modalities Have Expanded The Options:

Medical Management Options Include  Dual-hormone contraceptives  Progestins  Levonorgestrel-releasing IUD  NSAIDs  Antifibrinolytics <2 MM

Identifying Candidates for Endometrial Ablation

1976Laser 1983Resection 1987Desiccation 1990sVaporization Endometrial Ablation History  Skill dependent: <10% gynecologists able to perform  General anesthesia/O.R. setting  Risk of fluid overload and electrolyte disturbances  Risk of thermal or mechanical perforation of the uterus or adjacent organs  Risk of hemorrhage Global Endometrial Ablation Late 1990s

Ablation vs. Hormone Therapy  More immediate relief from problem bleeding  Fewer contraindications  No additional medications to monitor or remember  No drug interactions  If failure, other options remain for medical or surgical intervention Advantages of Ablation

Ablation vs. Hysterectomy  Fewer contraindications  Option for local anesthesia, or conscious sedation  Minimal morbidity  Outpatient or office-based procedure  Diminished potential for post-op complications  If failure, other options remain for medical or surgical intervention Advantages of Ablation

Impact of Endometrial Ablation Reduction in Hysterectomy Rates Jacobson GF et al. Obstet Gynecol. 2006;107:1278

NovaSure ® Contraindications *  Pregnant or the desire to be pregnant in the future  Known or suspected endometrial carcinoma or pre-malignancy  Any anatomic condition that could lead to weakening of the myometrium: –Classical C-section –Transmural myomectomy  Uterine cavity length < 4 cm  Uterine cavity width < 2.5 cm as determined by the Disposable Device Width Dial  Active pelvic inflammatory disease  Genital or urinary tract infection  IUD currently in place * complete descriptions of contraindications refer to the NovaSure ® Instructions for Use *For complete descriptions of contraindications refer to the NovaSure ® Instructions for Use

NovaSure ® Success Rates Fulop I. 2nd World Congress on Controversies in Obstetrics, Gynecology & Infertility. September 6-9, 2001.

NovaSure ® Avoids Additional Intervention NovaSure ® Instructions for Use Gallinat A. J Reprod Med. 2007;52:467. Fulop T et al. J Minim Invasiv Gynecol. 2007;14:85 Long-term avoidance of hysterectomy

NovaSure ® Improves Quality of Life “During your last menstrual cycle did you experience … ?” NovaSure ® Instructions for Use

Many Women May Prefer In-Office Scheduling  Increased patient acceptance of in-office procedures  Preference for office vs. hospital setting –More comfortable for some –Perceived as more “confidential” –Charges may be limited to office co-payment  Ease of access and scheduling

Given Options, Women Prefer Ablation % Ranking as Top Choice % Ranking as Bottom Choice 49% 8% 37% 23% 15% 69% Endometrial Ablation Hormone Therapy Hysterectomy Data (rounded to the nearest whole number) on file. BioVid; January 2005

NovaSure ® Procedure

Uterine Cavity, Hysteroscopic View, After 85-Second Treatment Endometrium completely removed, leaving only myometrium BeforeAfter