do heavy periods affect your life? - wear white again · my life would improve if i could decrease...

THEY DON’THAVE TO

TREATMENT FOR HEAVY MENSTRUAL BLEEDING

DO HEAVY PERIODS

AFFECT YOUR LIFE?

WEAR WHITE AGAIN

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HEAVY MENSTRUAL BLEEDING CHECKLISTWHAT IS MENORRHAGIA?Menorrhagia is defined as unusually heavy and/or long-lasting menstrual periods. If your bleeding lasts 7 or more days per cycle, or is so heavy that you need to change protection every one to two hours, then you may have menorrhagia.

TALKING TO YOUR DOCTOR ABOUTHEAVY MENSTRUAL BLEEDINGStudies have shown that many women who experience heavy periods do not bring the subject up with their physician or seek treatment.

Heavy periods affect 1 in 5 women.1

If getting the conversation started once you’re in front of your doctor seems hard, try one of these openers:

• “I’d like to ask you a few questions about my menstrual cycle...”

• “I’ve noticed that my periods are different than they usedto be...”

• “I’ve heard that a lot of women are getting treated for heavyperiods - is this something I should consider?”

If you experience heavy menstrual bleeding and do not wish to have any children in the future, be sure to ask your doctor if the NovaSure® endometrial ablation procedure may be right for you.

Do any of the following statements apply to you?

■ My period affects my quality of life

■ I am bothered by the amount of bleeding or the pain that I have during my period

■ My period makes me feel depressed, tired or moody

■ I am afraid of having an embarrassing accident

■ I bleed more often than once a month

■ My period lasts more than 7 days per cycle

■ My period affects my social, athletic, or sexual activities or causes me to miss work

■ My life would improve if I could decrease or eliminatemy period

■ I would like to learn about a simple procedure thatcan help me get back to my life

IF SO IT MAY BE TIME TO TALK TO YOUR DOCTOR.

To find an Australian gynaecologist in your area who performs NovaSure, go to

novasuredoctorfinder.com.au

WHAT IS NOVASURE ENDOMETRIAL ABLATION?NovaSure endometrial ablation is a 5-minute procedure that can lighten or end your heavy period. No pills. No hormonal side effects. No incisions. For 90% of women, menstrual bleeding is dramatically reduced or stopped.2

DO HEAVY PERIODS AFFECT YOUR LIFE? It is estimated that heavy menstrual bleeding affects 1 in 5 women.1 That means thousands of women are living with heavy periods, yet research shows only one-quarter of them seek treatment.1 Many women begin to experience heavy and/or irregular bleeding in their 30s and 40s, as they begin to get closer to menopause.

Studies show heavy periods have a greater impact than just heavy bleeding. They can affect women in a number of ways:

Whilst heavy menstrual bleeding is the 6th most common reason for a specialist referral,4 the vast majority of women do not seek medical help due to embarrassment or the false belief that their bleeding is normal.1

Ask for a referral to a gynaecologist to ensure you are fully assessed and diagnosed to help determine the cause of your bleeding, which is critical for treatment success.5

• Many feel tired and nauseated

• Many experience bad cramps

PHYSICAL

• More than 60% have had to miss social or athletic events2

• About 80% report avoiding sex1

• 33% have been forced to miss work2

• 77% have depression or moodiness1

• 75% feel anxious2

• 57% report a lack of confidence during their period2

• One-time procedure

• The treatment is fast - it usually takes less than 5 minutes

• It is typically performed under general anaesthesia as a day procedure in Australia and New Zealand

• 90% of women returned to normal, light or no periods at all2

• 40% reported their periods stopped completely2

• Most women experience mild or no pain during or after the procedure3

• There are no incisions (cuts into your body)

• It can be performed at any time during your cycle, even if you’re bleeding

• You don’t need to prepare by taking any pretreatment hormonal therapy

BENEFITS OF THE NOVASURE PROCEDURE:

“My periods took a turn for the worse when I was 47. After a year of heavy and agonising periods, enough was enough. I had the NovaSure procedure 4 years ago. It was “easy as pie”. I only needed to take one day off work and the best part is I haven’t had a period ever since! So see your doctor, take action, there’s a simple solution.” Chris, Sydney


SOCIAL

EMOTIONAL

Your doctor slightly opens your cervix (the opening to the uterus), inserts a slender wand, and extends a triangular mesh device into the uterus

The mesh expands, fitting to the size and shape of your uterus

Precisely measured radio frequency energy is delivered through the mesh for about 90 seconds

The mesh device is pulled back into the wand, and both are removed from the uterus

1

2

3

4

THE NOVASURE PROCEDURE

NO PART OF THE NOVASURE DEVICE REMAINS INSIDE YOUR BODY AFTER THE PROCEDURE.

HOW DOES NOVASURE WORK?NovaSure is an endometrial ablation procedure that can reduce or stop heavy menstrual bleeding.2 It works by permanently removing the endometrium, or the lining of the uterus (the part that causes the bleeding), with a quick delivery of radio frequency energy.

The NovaSure procedure is quick and simple. It requires an anaesthetic; a choice of local or general anaesthetic based on individual needs and doctors advice (although general is typically used in Australia and New Zealand), and can be performed either in the hospital or as day surgery.

It is a minimally invasive procedure that does not require incisions and can typically be performed in less than 5 minutes. The NovaSure procedure can be done at any time during the menstrual cycle and does not require hormonal pretreatment. Patients can go home the same day and are back to work typically in 1 or 2 days.

ARE WOMEN SATISFIED WITH THE NOVASURE PROCEDURE?In a clinical study, 12 months after the NovaSure procedure:

• 95% of patients were satisfied with the results3

• 97% said they would recommend the NovaSure procedure to a friend3

Over 2 million women worldwide have been treated with NovaSure endometrial ablation.13

“This procedure changed my life - I am active again and have more energy. I feel less stress and anxiety and more self confidence. My message to other women is don’t suffer silently! I would encourage all women with heavy bleeding to speak to their physician about treatment options that make a difference to their life.” Heidi, Australia


CHOOSING THE RIGHT TREATMENT FOR YOUThere are a number of treatment options available. The chart below highlights some advantages and disadvantages of the most common options. Please consult your doctor to discuss which treatment may be right for you.

Non-hormonal Hormonal

Medication (E.g. Ibuprofen or Tranexamic Acid)

Minimally Invasive Surgery (E.g. NovaSure Endometrial Ablation)

Major Surgery (Hysterectomy) Oral Contraceptives

(E.g. The Pill)

Hormone-ReleasingIntrauterine Device or IUD

(E.g. Mirena®)

Nonsteroidal anti-inflammatory drugs (NSAIDs) are painkillers generally available over the counter.

Tranexamic acid is an antifibrinolytic agent that helps block the breakdown of blood clots.17 A prescription is required.

Quick, simple and effective procedure that removes the lining of the uterus.

Surgery to removethe uterus - a permanent option for women not responsive to other treatments.

Low doses of female hormones (oestrogen and/or progestin) such as birth control pills.

Device inserted into the uterus that releases a steady amount of progestins, which can help control bleeding.

• NSAIDs are suitable for milder menorrhagia18

• NSAIDs can relieve painful menstrual cramps20

• NSAIDs and tranexamic acid only need to be taken at the time of the bleeding20

• Some NSAIDs can reduce the amount of blood volume by up to 45%18

• Tranexamic acid is shown to reduce the amount of blood flow during each period by 40-60%21

• 9 in 10 women return to normal or lower than normal bleeding2

• Typically takes less than 5 minutes3

• Performed as day surgery• Local or general anaesthetic can

be used• Can be done at any time during

the cycle without hormonal pretreatment

• Recovery in 1 to 2 days• Removes lining but leaves

uterus intact• 97% of women had not needed a

hysterectomy after 5 years4

• Eliminates problem bleeding

• Permanent

• Reduces bleeding in about one-third of women16

• Taken by mouth or injection

• Contraceptive• Fertility restored

when use is ceased

• 39% efficacy after 5 years6

• Does not require taking pills• Contraceptive• Fertility restored when IUD is

removed

• NSAIDs and tranexamic acid are associated with gastrointestinal side effects including nausea, vomiting, diarrhea, and dyspepsia, as well as disturbances in color vision18

• NSAIDs are less effective than tranexamic acid18

• Tranexamic acid can cause nausea and leg cramps19

• Patients on tranexamic acid also run the risk of developing deep venous thrombosis (DVT)18

• Only appropriate for women who do not want any (more) children

• Surgical risks associated with minimally invasive procedures

• Cannot be reversed• After an ablation your uterus is

not able to properly support fetal development so some form of birth control is required

• Involves major invasive surgery

• Risks of complications associated with major surgery

• Requires general or regional anaesthesia

• 2 to 8 week recovery time

• May result in early onset of menopause/possible need for future hormone treatment14

• Non-reversible – lose fertility

• May take up to 3 months before they start working10

• About 50% of patients experience side effects16

• Hormonal side effects can include depression, acne, headache, weight gain, breast tenderness, increased risk of cervical cancer11

• Must remember to take them

• 77% of women eventually progress to a surgical solution12

• Must be removed and replaced every 5 years

• 70% of women experience intermenstrual bleeding/spotting6

• 50% of women experience hormonal side effects8

• Hormonal side effects may include: depression, acne, headaches, nausea, weight gain, and hair loss7

• May take up to 6 months before it starts working9

• 42% of women require surgery within 5 years6

MOST COMMON TREATMENT OPTIONS FOR MENORRHAGIA

Desc

riptio

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vant

ages

Disa

dvan

tage

s

Note: Dilation and Curettage (D&C) is excluded from the treatment list due to its limited efficacy. It is generally not offered as a treatment option in Australia or New Zealand.22


Many women who’ve had the NovaSure procedure say they are no longer missing out on as many social and athletic outings because of heavy periods. They report improved energy levels, better moods, and a boost in self-confidence. And many also had a significant reduction in painful periods and PMS symptoms like irritability.2

Most women who have had the NovaSure procedure have lighter periods or no periods at all. In a clinical study, 9 in 10 women returned to normal or light periods and 4 in 10 stopped bleeding altogether.2

Answered “Always,” “Frequently,” or “Sometimes” Before NovaSure After NovaSure

Do you lack confidence due to your period? 57% 16%

Do you have a problem working due to your period? 66% 10%

Do you spend less time at work or other activities? 61% 9%

Do you feel anxious due to your period? 75% 24%

Do your periods cause you to miss social activities? 63% 9%

Do your periods cause you to miss athletic activities? 66% 9%

Are you unable to work outside your home due to your periods? 33% 6%

Do you have less energy or a total lack of energy? 84% 24%

Do you experience painful periods? 57% 21%

Do you have PMS symptoms? 65% 36%

WHAT CAN I EXPECT FROM THE NOVASURE PROCEDURE?

IMPACT ON QUALITY OF LIFE2


FREQUENTLY ASKED QUESTIONS ABOUT NOVASUREIs the NovaSure procedure right for me?

Your gynaecologist can decide if NovaSure is right for you. Women with heavy or long-lasting periods who do not want any (more) children may be candidates. Your physician may perform diagnostic tests to help understand the cause for your heavy periods.

Can I still become pregnant after the NovaSure procedure?

Because NovaSure treats the lining of the uterus, your chances of getting pregnant after the procedure will be reduced. However, it is still possible to fall pregnant. A pregnancy after an ablation is very dangerous for both the mother and the foetus as the uterine lining would not be able to properly support foetal development. It’s very important to talk to your physician about what birth control you will use after the NovaSure procedure.

Are there any risks I should know about?

Your physician will explain the risks of all treatment options. Some of the risks associated with endometrial ablations making a hole in the uterus, bleeding, infection, bradycardia, injury to organs within the abdomen or around the uterus or complications leading to serious injury or death. These problems are very rare and reported at a rate of less than 0.05%.14

Tell your physician if you have a cardiac pacemaker or any other electrical device in your body.

When will I know what my periods will be like after the NovaSure procedure?

Every woman is different. But plan to give your body about 3 months to fully heal on the inside and resume a normal cycle. Then you and your physician should be able to tell what your cycle and your periods will be like from that point on.

WHAT TO EXPECT: AFTER THE PROCEDUREAs with any medical procedure, your doctor will give you specific post-operative instructions to follow. The information in this brochure is intended only to describe what many women typically experience and should not be regarded as a substitute for your doctor’s advice.

Remember, every woman is different!

The first 24 hours

• Right after the procedure and for the next day or so, some women experience slight cramping. Others don’t feel any discomfort. Most cramps can be relieved with over-the-counter pain medicines such as ibuprofen

• Some women may feel nauseous or vomit as a result of anaesthesia

• Watery and/or bloody discharge may begin

• You may feel tired and need to rest

Just in case...

Very few patients experience complications following the NovaSure procedure. But you should call your doctor right away if you develop:

• A fever higher than 38°C (100.4°F)

• Worsening pelvic pain that isn’t relieved by ibuprofen or other medication

• Nausea, vomiting, shortness of breath, or dizziness

• Bowel or bladder problems

• A greenish vaginal discharge (reddish, yellowish, or brownish is normal)


WHAT TO EXPECT: THE NEXT FEW WEEKSHow you’ll feel

Most women will feel back to normal within a day or two of the procedure. Any cramps should subside, and the lingering effects of any anaesthesia should be gone. If it makes you more comfortable, you can continue to take over-the-counter pain medicine. Some women may still feel tired from time to time for a while afterwards. If this does happen, don’t worry - any remaining symptoms should disappear as soon as your body is fully healed.

Returning to normal activities

After the first 24 hours, your doctor will probably give you approval to return to most light-to-moderate activities. As a rule, your body’s comfort level will tell you how much you’re ready to do. For heavier activities, such as vigorous exercise or heavy lifting, your doctor may want you to wait a little longer. If you feel tired or start to get cramps, you may need to slow down a bit.

What to avoid

Though you may feel better shortly after your procedure, it will take your body a few weeks to fully heal on the inside. Your doctor may tell you to limit certain activities (such as taking a bath, swimming, or sex) for a week or two to avoid risk of infection. Be sure to follow instructions no matter how well you may feel. If your symptoms persist you should contact your doctor immediately.

A word about discharge after the Novasure procedure:

You may have a watery and/or bloody discharge after your NovaSure procedure. It could start anywhere from immediately after the procedure to a couple of weeks afterwards. The discharge might last only briefly or continue for up to a couple of months. It could even come and go, and may increase after certain activities.

Why? It’s because the inside of your uterus, which has been treated to stop your heavy bleeding, is healing. This is quite normal and can be expected with any endometrial ablation procedure.

What does the discharge look like? It may be watery, bloody, or the two mixed together. Reddish, brownish, or yellowish discharge is normal. As you heal, it may even change in appearance. When you are fully healed, the discharge should stop completely.

When to call your doctor: If your discharge is greenish in colour or if it is bright red for a long time. These could be signs of an infection.

WHAT TO EXPECT: THE NEXT FEW MONTHS AND BEYONDYour periods after the Novasure procedure

Okay, so the big question: how long until you know what your periods will be like, or if you’ll even get them at all? Of course, it’s different for every woman, and we know you’re eager to see and enjoy your results. But you should plan to give your body about 3 months to fully heal and resume its normal cycle. After that, you and your doctor should be able to tell how well the procedure has worked for you.

What about PMS?

Another benefit many women enjoy after the NovaSure procedure is some relief of PMS symptoms. In the NovaSure clinical trial, approximately 50% of women reported a reduction in PMS and painful periods (dysmenorrhea).2

Don’t forget birth control, even if your periods stop completely

Because NovaSure treats the lining of the uterus, your chances of getting pregnant after the procedure will be reduced. However, it is still possible to fall pregnant. And a pregnancy after an ablation is very dangerous for both the mother and the foetus as the uterine lining would not be able to properly support foetal development. So if you haven’t already, be sure to talk to your doctor about birth control.


* The average treatment time is 90 seconds, and the entire NovaSure® procedure typically takes less than 5 minutes to complete.3

References: 1. National Women’s Health Resource Center. Survey of Women Who Experience Heavy Menstrual Bleeding. Hologic data on file; 2005. 2. Cooper J, Gimpelson R, Laberge P, et al. A Randomized, Multicenter Trial of Safety and Efficacy of the NovaSure® System in the Treatment of menorrhagia.J Am Assoc Gynecol Laparosc. 2002;9(4):418-428. 3. NovaSure® Instructions for Use. Bedford, MA: Hologic, Inc. 4. Gallinat A. An Impedance-Controlled System for Endometrial Ablation: Five-Year Follow-up of 107 Patients. J Reprod Med. 2007;52(6):467-472. 5. Istre O et al. Treatment of menorrhagia with levonorgestrel intrauterine system versus endometrial resection. Fertil Steril 2001;76:304-9. 6. Hurskainen R, et al. Clinical Outcomes and Costs With the Levonorgestrel-Releasing Intrauterine System or Hysterectomy for Treatment of Menorrhagia: Randomized Trial Five-Year Follow-up. JAMA. 2004;291(12):1456-1463. 7. Mirena Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2007. 8. Backman T, et al. Length of use and symptoms associated with premature removal of levonorgestrel intrauterine system: a nation-wide study of 17,360 users. BJOG 2000; 107:335-9. 9. Busfield RA, et al. A Randomised Trial Comparing the Levonorgestrel Intrauterine System and Thermal Balloon Ablation for Heavy Menstrual Bleeding. BJOG. 2006;113(3):257-263. 10. ACOG Committee on Practice Bulletins. ACOG Practice Bulletin: Management of Anovulatory Bleeding. Int J Gynecol Obstet. 2001;72(3):263-271 11. Yasmin Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2007. 12. Cooper KG, et al. Five-Year Follow-up of Women Randomised to Medical Management or Transcervical Resection of the Endometrium for Heavy Menstrual Loss: Clinical and Quality of Life Outcomes. Br J Obstet Gynaecol. 2001;108(12):1222-1228. 13. Decherney AH, et al. Current Obstetric & Gynecologic Diagnosis & Treatment, ninth edition. New York, NY: McGraw-Hill Medical; 2003. 14. ACOG Committee on Practice Bulletins. ACOG Practice Bulletin: Endometrial Ablation. Obstet Gynecol 2007;109(5)1233-48. 15. Hologic Data on File, 2009. 16. Cooper KG, et al. A randomised comparison of medical and hysteroscopic management in women consulting a gynaecologist for treatment of heavy menstrual loss. Br J Obstet Gynecol 1997;104:1360-66. 17. Mayo Clinic. Tranexamic Acid. Available at www.mayoclinic.org/drugs-supplements/tranexamic-acid-oral-route/description/drg-20073517. Accessed February 2016. 18. Panesar K, “Managing Menorrhagia”, US Pharmacist. 2011;36(9):56-61. 19. PubMed Health, Informed Health Online. Treatment options for heavy periods, June 2013. Available at www.ncbi.nlm.nih.gov/pubmedhealth/PMH0072477/. Accessed February 2016. 20. Mayo Clinic. Menorrhagia (heavy menstrual bleeding). Available at www.mayoclinic.org/diseases-conditions/menorrhagia/basics/treatment/con-20021959. Accessed February 2016. 21. Munro M G, Abnormal Uterine Bleeding, Cambridge University Press. First published 2010. ISBN 978-0-521-72183-7. 22. Decherney AH, et al. Current Obstetric & Gynecologic Diagnosis & Treatment, ninth edition. New York, NY: McGraw-Hill Medical; 2003.

PP-01910-AUS-EN Rev.001 © 2016 Hologic, Inc. All rights reserved. Hologic, NovaSure and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. Views and opinions expressed herein by third parties are theirs alone and do not necessarily reflect those of Hologic. This information is not intended as a product solicitation or promotion where such activities are prohibited. Because Hologic materials are distributed through websites, eBroadcasts and tradeshows, it is not always possible to control where such materials appear. Mirena is a trademark of Bayer. All other trademarks are property of their respective owners.

Hologic (Australia) Pty Ltd, Level 4, 2-4 Lyon Park Rd, Macquarie Park NSW 2113. Tel. +61 2 9888 8000. ABN 95 079 821 275.

“I want to shout it from the roof-tops and say to women, ‘please don’t suffer in silence’, there is an alternative without the need for major surgery! I only wish I had known about this procedure sooner, I certainly wouldn’t have suffered as long as I did...” Gaynor, United Kingdom

IT’S TIME TO TAKE BACK MY LIFE.


do heavy periods affect your life? - wear white again · my life would improve if i could decrease...

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