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Title: Important Reminder to Women Using Intrauterine Contraceptive System

"Important Reminder to Women Using Intrauterine Contraceptive System"

MONTREAL, CANADA -- December 11, 2006 -- Mirena®, a unique intrauterine system (IUS) for contraception, was approved in Canada five years ago. The Mirena® IUS provides 99.9% pregnancy protection for a five year period. As such, the first women who had the small T–shaped device inserted five years ago should now think of having the system either replaced or removed. Mirena® is the only IUS available in the country and is the most effective method of reversible contraception on the market. Since being launched in Canada, over 111,000 Mirena® have been sold.[i] "While the Mirena® system should be removed after five years of use, a new system can be inserted at the time of removal of the old one, if the patient wishes to continue using this method of contraception," said Dr. Robert Sabbah, obstetrician-gynaecologist, Scientific Director of the Department of Obstetrics and Gynaecology at Montreal's Sacré-Coeur Hospital and clinical professor at the Faculty of Medicine at the Université de Montréal. "Mirena® is proving to be a very useful, effective and safe method of contraception for the right type of women", he added. Mirena® works by slowly releasing levonorgestrel into the uterus at a rate of approximately 20 mcg per day. This small amount of levonorgestrel prevents pregnancy by reducing the normal monthly thickening of the lining of the uterus and by thickening the cervical mucus which prevents passage of sperm through the cervical canal (opening to the uterus).[ii] Mirena® can be removed at any time without affecting future fertility. Nearly 90% of women wishing to become pregnant conceive within 24 months after removal of the system.[iii] "Mirena® can help women who want to keep their family planning options open. While in Canada only approximately one to 2% of women turn to Mirena® for contraception, the rate of utilisation reaches as much as 11 million insertions worldwide," said Dr. Sabbah. Mirena® is inserted by a trained physician. Following the insertion procedure, Mirena® users only have to check on a monthly basis if the IUS is still properly in place and to book an annual check up with their physician, which can be done at the time of their regular Pap test. Mirena® also offers lighter and shorter menstrual periods and some women stop getting their periods altogether.[iv] After one year of use, Mirena® users experience a reduction in menstrual blood loss of between 74 and 97%.[v] 16.8% of Mirena® users have no bleeding or spotting at all.[vi] Excellent safety profile Clinical trials have shown that the Mirena® intrauterine system is one of the most effective forms of contraception available to women today. The contraceptive efficacy of Mirena® was studied in three clinical trials, in which a total of 2,379 women were enrolled, providing a total of 91,133 woman-months of experience. Since Mirena® does not require daily maintenance or rely on patient compliance, the unintentional pregnancy rate is extremely low. There were a total of eight pregnancies in the three clinical trials, giving a Pearl rate of 0.11.[vii] A result of 0.11 is extremely low and is comparable to sterilization. Mirena® is therefore an excellent alternative to surgical sterilization for women who seek long-term contraception.[viii] Developed by Raymond Pearl in 1933, the Pearl rate remains the most common method used in clinical trials to assess the effectiveness of birth control. Important safety information Mirena® must be inserted and removed by a trained physician since the insertion technique differs from that of an intrauterine device.[ix] Mirena® is intended for use in women of child-bearing age.[x] It is an option for every stage of a woman's reproductive life and should be considered by new mothers who are thinking about birth control after the baby is born. The IUS is also an option for women who are unsure about their desire to have more children but are looking for a worry-free, effective birth control without the permanence of sterilization. Mirena® does not protect against HIV infection (AIDS) and other sexually transmitted diseases. In clinical studies, the most common side-effect that occurred with Mirena® was a change in menstrual bleeding patterns. The changes included spotting, shorter or longer menstrual periods, irregular bleeding, infrequent or very light menstruation, absence of menstrual bleeding, heavy flow, back pain and painful menstruation.[xi] Other side effects might include cysts on the ovary, lower abdominal pain, headache, acne or breast tenderness, some or all of which occur with most other contraceptive methods.[xii] Adverse events are most common during the first months after insertion of Mirena® and their frequency subsides subsequently.[xiii] About Mirena® Mirena® intrauterine system (IUS) consists of a small polyethylene T-shaped frame made from soft flexible plastic. The vertical arm is surrounded by a cylindrical shaped reservoir that contains 52 mg of levonorgestrel. The levonorgestrel is released into the uterus at a rate of approximately 20 mcg per day. Mirena® has been used by more than 11 million women around the world and has been available in Europe for more than 10 years. ® Registered trademark Schering AG, Berlex Canada Inc. licensed user REFERENCES: [i] Mirena® (levonorgestrel-releasing intrauterine system). Health Canada approved product monograph [prescribing information]. Berlex Canada Inc., page 11 [ii] Mirena® (levonorgestrel-releasing intrauterine system). Health Canada approved product monograph [prescribing information]. Berlex Canada Inc., page 41 [iii] Mirena® (levonorgestrel-releasing intrauterine system). Health Canada approved product monograph [prescribing information]. Berlex Canada Inc., page 31 [iv] Mirena® (levonorgestrel-releasing intrauterine system). Health Canada approved product monograph [prescribing information]. Berlex Canada Inc., page 42 [v] Canadian Contraception Consensus No. 143 – Part 2 of 3, March 2004, Accessed at http://www.sogc.org/guidelines/public/143E-CPG2-March2004.pdf, Page 249 [vi] Mirena® (levonorgestrel-releasing intrauterine system). Health Canada approved product monograph [prescribing information]. Berlex Canada Inc., page 8 [vii] Mirena® (levonorgestrel-releasing intrauterine system). Health Canada approved product monograph [prescribing information]. Berlex Canada Inc., page 36 [viii] Canadian Contraception Consensus No. 143 – Part 2 of 3, March 2004, Accessed at http://www.sogc.org/guidelines/public/143E-CPG2-March2004.pdf, Page 252 [ix] Mirena® (levonorgestrel-releasing intrauterine system). Health Canada approved product monograph [prescribing information]. Berlex Canada Inc., page 13 [x] Mirena® (levonorgestrel-releasing intrauterine system). Health Canada approved product monograph [prescribing information]. Berlex Canada Inc., page 4 [xi] Mirena® (levonorgestrel-releasing intrauterine system). Health Canada approved product monograph [prescribing information]. Berlex Canada Inc., page 8 [xii] Mirena® (levonorgestrel-releasing intrauterine system). Health Canada approved product monograph [prescribing information]. Berlex Canada Inc., page 44 [xiii] Mirena® (levonorgestrel-releasing intrauterine system). Health Canada approved product monograph [prescribing information]. Berlex Canada Inc., page 8 SOURCE: Berlex

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