Birth Control Testing and Health

A Popular Birth Control Pill Advertisement

Your family needs daily attention.
Your birth control shouldn't.

(mindfully.org note: 
   Image of a woman in a bath tub with a child and another woman playing with them.)  

So that you can focus on living in the moment-as a wife, a mother, a woman-now there's [Unnamed Birth Control Pill]: the reliable, 5 .year contraception you don't have to think about. With one simple visit to your doctor's office, you'll have long-term birth control that's over 99% effective-without the daily nuisance of pills, condoms or diaphragms. [Unnamed Birth Control Pill] is an advance in intrauterine contraception that has been used for over 10 years by more than 2 million women in Europe. [Unnamed Birth Control Pill] is also estrogen free arid may even cause shorter, lighter periods. And if fat any point you decide to have another child, [Unnamed Birth Control Pill] is rapidly reversible whenever you choose. To find out more, tear out this ad and discuss it with your doctor.

Mindfully.org note: levonorgestrel is a progestin. Products containing this include BIPHASIL* tablets; E-GEN-C TABLETS; LOGYNON ED TABLETS; MICROVAL® Tablets; MIRENA; NORDETTE® tablets; NORDIOL® tablets; and TRIPHASIL® tablets. See http://home.intekom.com/pharm/index/index_G_levonorgestrel.shtml for more on these.  

[Unnamed Birth Control Pill]® (levonorgestrel-releasing intrauterine system)

PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES

Rx only

INDICATIONS AND USAGE:
[Unnamed Birth Control Pill]® is indicated for intrauterine contraception for up to 5 years. Thereafter, if continued contraception is desired, the system should be replaced. RECOMMENDED PATIENT PROFILE: [Unnamed Birth Control Pill]® is recommended for women who have had at least one child, are in a stable, mutually monogamous relationship, have no history of pelvic inflammatory disease, and have no history of ectopic pregnancy or condition that would predispose to ectopic pregnancy.

CONTRAINDICATIONS: 
[Unnamed Birth Control Pill]® insertion is contraindicated when one or more of the following conditions exist: 1. Pregnancy or suspicion of pregnancy. 2. Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity. 3. Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless there has been a subsequent intrauterine pregnancy. 4. Postpartum endometritis or infected abortion in the past 3 months. 5. Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear. 6. Genital bleeding of unknown etiology. 1. Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled. 8. Acute liver disease or liver tumor (benign or malignant). 9. Woman or her partner has multiple sexual partners. 10. Conditions associated with increased susceptibility to infections with microorganisms. Such conditions include, but are not limited to, leukemia, acquired immune deficiency syndrome (AIDS), and I.V. drug abuse. 11. Genital actinomycosis (See WARNINGS). 12. A previously inserted IUD that has not been removed. 13. Hypersensitivity to any component of this product. 14. Known or suspected carcinoma of the breast. 15. History of ectopic pregnancy or condition that would predispose to ectopic pregnancy.

WARNINGS: 

1. Ectopic Pregnancy: 
In large clinical trials of [Unnamed Birth Control Pill]®, half of all pregnancies detected during the studies were ectopic. The per-year incidence of ectopic pregnancy in the clinical trials was approximately 1 ectopic pregnancy per 1000 users per year. The rate of ectopic pregnancies associated with [Unnamed Birth Control Pill]® use is not significantly different than the rate for sexually active women not using any contraception. Clinical trials of [Unnamed Birth Control Pill]® excluded women with a history of ectopic pregnancy. [Unnamed Birth Control Pill]® is not recommended for use in women with a history of ectopic pregnancy or conditions that increase the risk of ectopic pregnancy. Women who choose [Unnamed Birth Control Pill]® must be warned about the risks of ectopic pregnancy. They should be taught to recognize and report to their physician promptly any symptoms of ectopic pregnancy. Women should also be informed that ectopic pregnancy has been associated with complications leading to loss of fertility. 

2. Intrauterine Pregnancy: 
In the event of an intrauterine pregnancy with [Unnamed Birth Control Pill]®, the following should be considered. a) Septic abortion: In patients becoming pregnant with an IUD in place, septic abortion-with septicemia, septic shock, and death may occur. If pregnancy should occur with a [Unnamed Birth Control Pill]® in place, [Unnamed Birth Control Pill]® should be removed. Removal or manipulation of [Unnamed Birth Control Pill]® may result in pregnancy loss. b) Continuation of pregnancy: If a woman becomes pregnant with [Unnamed Birth Control Pill]® in place and if [Unnamed Birth Control Pill] cannot be removed or the woman chooses not to have it removed, she should be warned that failure to remove [Unnamed Birth Control Pill]® increases the risk of miscarriage, sepsis, premature labor and premature delivery. She should be followed closely and advised to report immediately any flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge or leakage of fluid. c) Long-term effects and congenital anomalies: When pregnancy continues with [Unnamed Birth Control Pill]® in place, long-term effects on the offspring are unknown. Because of the intrauterine administration of levonorgestrel and local exposure to the hormone, the possibility of teratogenicity following exposure to [Unnamed Birth Control Pill]® cannot be completely excluded. Clinical experience with the outcomes of pregnancies is limited due to t he small number of reported pregnancies following exposure to [Unnamed Birth Control Pill]®. Congenital anomalies have occurred infrequently when [Unnamed Birth Control Pill]® has been in place during pregnancy. In these cases the role of [Unnamed Birth Control Pill]® in the development of the congenital anomalies is unknown. As of September 1999, 32 live births following exposure to [Unnamed Birth Control Pill]® were reported retrospectively. All but 2 of the infants were healthy at birth. One infant had pulmonary artery hypoplasia and another infant had cystic hypoplastic kidneys. (A sibling of this infant had renal agenesis with no [Unnamed Birth Control Pill]® exposure.) 

3. Sepsis: 
As of 1999, four cases of Group A streptococcal sepsis (GAS) out of an estimated 1.3 million [Unnamed Birth Control Pill]® users were reported. All four women experienced the symptom of severe pain within hours of insertion, and this was followed by sepsis within a few days (of insertion). All recovered with treatment. Since death from GAS is more likely if treatment is delayed, it is important to be aware of these rare but serious infections. Aseptic technique during [Unnamed Birth Control Pill]® insertion is essential. (GAS sepsis can also occur postpartum, after minor surgery, in wounds and in association with other IUDs.) 

4. Pelvic Inflammatory Disease (PlD): 
[Unnamed Birth Control Pill]® is contraindicated in the presence of known or suspected PlD or in women with a history of PlD unless there has been a subsequent intrauterine pregnancy. Use of IUDs has been associated with an increased risk of PlD. The highest risk of PlD occurs shortly after insertion (usually within the first 20 days thereafter) (see Insertion Precautions). A decision to use [Unnamed Birth Control Pill]® must include consideration of the risks of PlD. a) Women at increased risk for PlD: PlD is often associated with a sexually transmitted disease, and [Unnamed Birth Control Pill]® does not protect against sexually transmitted disease. The risk of PlD is greater for women who have multiple sexual partners, and also for women whose sexual partner(s) have multiple sexual partners. Women who have ever had PlD are at increased risk for a recurrence or re-infection. b) PlD warning to [Unnamed Birth Control Pill]® users: All women who choose [Unnamed Birth Control Pill]® must be informed prior to insertion about the possibility of PlD and that PlD can cause tubal damage leading to ectopic pregnancy or infertility, or in infrequent cases can necessitate hysterectomy, or can cause death. Patients must be taught to recognize_ and report to their physician promptly any symptoms of pelvic inflammatory disease. These symptoms include development of menstrual disorders (prolonged or heavy bleeding), unusual vaginal discharge, abdominal or pelvic pain or tenderness, dyspareunia, chills, and fever. c) Asymptomatic PlD: PlD may be asymptomatic but still result in tubal damage and its sequelae. d) Treatment of PlD: Following a diagnosis of PlD, or suspected PlD, bacteriologic specimens should be obtained and antibiotic therapy should be initiated promptly. Removal of [Unnamed Birth Control Pill]® after initiation of antibiotic therapy is usually appropriate. Guidelines for PlD treatment are available from the Centers for Disease Control (CDC), Atlanta, Georgia. Adequate PlD treatment requires the application of current standards of therapy prevailing at the time of occurrence of the infection with reference to prescription labeling. Actinomycosis has been associated with IUDs. Symptomatic women with IUDs should have the IUD removed and should receive antibiotics. However, the management of the asymptomatic carrier is controversial because actinomycetes can be found normally in the genital tract cultures in healthy women without IUDs. False p ositive findings of actinomycosis on Pap smears can be a problem. When possible, confirm the Pap smear diagnosis with cultures. 

5. Irregular Bleeding and Amenorrhea: 
[Unnamed Birth Control Pill]® can alter the bleeding pattern. During the first three to six months of [Unnamed Birth Control Pill]® use the number of bleeding and spotting days may be increased and bleeding patterns may be irregular. Thereafter the number of bleeding and spotting days usually decreases but bleeding may remain irregular. If bleeding irregularities develop during prolonged treatment, appropriate diagnostic measures should be taken to rule out endometrial pathology. Amenorrhea develops in approximately 20°I° of [Unnamed Birth Control Pill]® users by one year. The possibility of pregnancy should be considered if menstruation does not occur within six weeks of the onset of previous menstruation. Once pregnancy has been excluded, repeated pregnancy tests are not necessary in amenorrheic subjects unless indicated by other signs of pregnancy or by pelvic pain. 

6. Embedment: 
Partial penetration or embedment of [Unnamed Birth Control Pill]® in the myometrium may decrease contraceptive effectiveness and can result in difficult removals. 

7. Perforation: 
An IUD may perforate the uterus or cervix, most often during insertion although the perforation may not be detected until some time later. If perforation occurs, the IUD must be removed and surgery may be required. Adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses and erosion of adjacent viscera have been reported with IUDs. It is recommended that postpartum [Unnamed Birth Control Pill]® insertion be delayed until uterine involution is complete to decrease perforation risk. There is an increased risk of perforation in women who are lactating. Inserting [Unnamed Birth Control Pill]® immediately after first trimester abortion is not known to increase the risk of perforation, but insertion after second trimester abortion should be delayed until uterine involution is complete. 

8. Ovarian Cysts: 
Since the contraceptive effect of [Unnamed Birth Control Pill]® is mainly due to its local effect, ovulatory cycles with follicular rupture usually occur in women of fertile age using [Unnamed Birth Control Pill]®. Sometimes atresia of the follicle is delayed and the follicle may continue to grow. Enlarged follicles have been diagnosed in about 12% of the subjects using [Unnamed Birth Control Pill]®. Most of these follicles are asymptomatic, although some may be accompanied by pelvic pain or dyspareunia. In most cases the enlarged follicles disappear spontaneously during two to three months' observation. Surgical intervention is not usually required. 

9. Breast Cancer: 
Women who currently have or have had breast cancer should not use hormonal contraception because breast cancer is a hormone-sensitive tumor. 

10. Risks of Mortality: The available data from a variety of sources have been analyzed to estimate the risk of death associated with various methods of contraception. The estimates of risk of death include the combined risk of the contraceptive method plus the risk of pregnancy or abortion in the event of method failure. The findings of the analysis are shown in the following table: Annual Number of Birth-Related or Method-Related Deaths Associated with Control of Fertility per 100,000 Nonsterile Women, by Fertility Control Method According to Age

AGE GROUP
METHODS 15-19 20-24 25-29 30-34 35-39 40-44
No Birth Control
Method/Term 4.1 5.4 4.8 6.3 11.7 20.6
No Birth Control
Method/AB 2.1 2.0 1.6 1.9 2.8 5.3
IUD 0.2 0.3 0.2 0.1 0.3 0.6
Periodic Abstinence 1.4 1.3 0.7 1.0 1.0 1.9
Withdrawal 0.9 1.7 0.9 1.3 0.8 1.5
Condom 0.6 1.2 0.6 0.9 0.5 1.0
Diaphragm/Cap 0.6 1.1 0.6 0.9 1.6 3.1
Sponge 0.8 1.5 0.8 1.1 2.2 4.1
Spermicides 1.6 1.9 1.4 1.9 1.5 2.7
Oral Contraceptives 0.8 1.3 1.1 1.8 1.0 1.9
Implants/Injectables 0.2 0.6 0.5 0.8 0.5 0.6
Tubal Sterilization 1.3 1.2 1.1 1.1 1.2 1.3
Vasectomy 0.1 0.1 0.1 0.1 0.1 0.2

Harlap S. et al. Preventing pregnancy, protecting health: 
a new look at birth control choices in the US. 
The Alan Guttmacher Institute. 1991:1-129.

PRECAUTIONS

PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.

1. Patient Counseling: Prior to insertion, the physician, nurse, or other trained health professional must provide the patient with the Patient Package Insert. The patient should be given the opportunity to read the information and discuss fully any questions she may have concerning [Unnamed Birth Control Pill]® as well as other methods of contraception. Careful and objective counseling of the user prior to insertion regarding the expected bleeding pattern, the possible interindividual variation in changes in bleeding and the etiology of the changes may have an effect on the frequency of removal due to bleeding problems and amenorrhea. The patient should be told that some bleeding such as irregular or prolonged b leeding and spotting, and/or cramps may occur during the first few weeks after insertion. If her symptoms continue or are severe she should report them to her health care provider. She should also be given instructions on what other symptoms require her to call her physician. She should be instructed on how to check after her menstrual period to make certain that the thread still protrudes from the cervix and cautioned not to pull on the thread and displace [Unnamed Birth Control Pill]®. She should be informed that there is no contraceptive protection if [Unnamed Birth Control Pill]® is displaced or expelled. Patient Evaluation and Clinical Considerations: a) A complete medical and social history, including that of the partner, should be obtained to determine conditions that might influence the selection of an IUD for contraception (see CONTRAINDICATIONS). A physical examination should include a pelvic examination, a Pap smear, and appropriate tests for any other forms of genital disease, such as gonorrhea and chlamydia laboratory evaluations, if indicated. Special attention must be given to ascertaining whether the woman is at increased risk of ectopic pregnancy or PlD. [Unnamed Birth Control Pill]® is contraindicated in these women. b) The health care provider should determine that the patient is not pregnant. The possibility of insertion of [Unnamed Birth Control Pill]® in the presence of an existing undetermined pregnancy is reduced if insertion is performed within 7 days of the onset of a menstrual period. [Unnamed Birth Control Pill]® can be replaced by a new system at any time in the cycle. [Unnamed Birth Control Pill]® can be inserted immediately after first trimester abortion. c) [Unnamed Birth Control Pill]® should not be inserted until 6 weeks postpartum or until involution of the uterus is complete in order to reduce the incidence of perforation and expulsion. d) Patients with certain types of valvular or congenital heart disease and surgically constructed systemic-pulmonary shunts are at increased risk of infective endocarditis. Use of [Unnamed Birth Control Pill]® in these patients may represent a potential source of septic emboli. Patients with known congenital heart disease who may be at increased risk should be treated with appropriate a ntibiotics at the time of insertion and removal. Patients requiring chronic corticosteroid therapy or insulin for diabetes should be monitored with special care far infection. e) [Unnamed Birth Control Pill]® should be used with caution in patients who have a coagulopathy or are receiving anticoagulants. f.) Use of [Unnamed Birth Control Pill]® in patients with vaginitis or cervicitis should be postponed until proper treatment has eradicated the infection and until it has been shown that the cervicitis is not due to gonorrhea or chlamydia (see CONTRAINDICATIONS). 2. Insertion Precautions: Because the presence of organisms capable of establishing PlD cannot be determined by appearance, and because IUD insertion may be associated with introduction of vaginal bacteria into the uterus, strict asepsis should be observed at insertion. Administration of antibiotics may be considered, but the utility of this treatment is unknown. The uterus should be carefully sounded prior to [Unnamed Birth Control Pill]® insertion to determine the degree of potency of the endocervical canal and the internal os, and the direction and depth of the uterine cavity. In occasional cases, severe cervical stenosis may be encountered. Do not use excessive force to overcome this resistance. Syncope, bradycardia, or other neurovascular episodes may occur during insertion or removal of [Unnamed Birth Control Pill]®, especially in patients with a predisposition to these conditions or cervical stenosis. If decreased pulse, perspiration, or pallor are observed, the patient should remain supine until these signs have disappeared. 3. Continuation and Removal: [Unnamed Birth Control Pill]® must be replaced every 5 years because contraceptive effectiveness after 5 years has not been established. a) User complaints of pain, odorous discharge, bleeding, fever, genital lesions or sores should be promptly responded to and prompt examination recommended. (See WARNINGS regarding amenorrhea). b) If examination during visits subsequent to insertion reveals that the length of the threads has changed from the length at time of insertion, and the system is v erified as displaced, it should be removed. A new system may be inserted at that time or during the next menses if it is certain that conception has not occurred. If the threads are not visible, location of the [Unnamed Birth Control Pill]® should be verified, for example with X-ray, ultrasound, or gentle probing of the uterine cavity. If the [Unnamed Birth Control Pill]® is in place with no evidence of perforation, no intervention is indicated. If expulsion has occurred, it may be replaced within 7 days of a menstrual period after pregnancy has been ruled out. c) Since [Unnamed Birth Control Pill]® may be displaced, patients should be reexamined and evaluated shortly after the first postinsertion menses, but definitely within 3 months after insertion. Symptoms of the partial or complete expulsion of any IUD may include bleeding or pain. However, the system can be expelled from the uterine cavity without the woman noticing it. Partial expulsion may decrease the effectiveness of [Unnamed Birth Control Pill]®. As menstrual flow usually decreases after the first 3 to 6 months of [Unnamed Birth Control Pill]®. use, increase of menstrual flow may be indicative of an expulsion. d) In the event a pregnancy is confirmed during [Unnamed Birth Control Pill]® use, the following steps should be taken: • Determine whether pregnancy is ectopic and take appropriate measures if it is. • Inform patient of the risks of leaving [Unnamed Birth Control Pill]® in place or removing it during pregnancy and of the lack of data on long-term effects on the offspring of women who have had [Unnamed Birth Control Pill]® in place during conception or gestation (see WARNINGS). • If possible, [Unnamed Birth Control Pill]® should be removed after the patient has been warned of the risks of removal. If removal is difficult, the patient should b e counseled and offered pregnancy termination. • If [Unnamed Birth Control Pill]® is left in place, the patient's course should be followed closely. e) Should the patient's relationship cease to be mutually monogamous, or should her partner become HIV positive, or acquire a sexually transmitted disease, she should be instructed to report this change to her clinician immediately. The use of a barrier method as a partial protection against acquiring sexually transmitted diseases should be strongly recommended. Removal of [Unnamed Birth Control Pill]® should be considered. f) [Unnamed Birth Control Pill]® should be removed for the following medical reasons: menorrhagia and/or metrorrhagia producing anemia; acquired immune deficiency syndrome (AIDS); sexually transmitted disease; pelvic infection; endometritis; symptomatic genital actinomycosis; intractable pelvic pain; severe dyspareunia; pregnancy; endometrial or cervical malignancy; uterine or cervical perforation. g) If the retrieval threads are not visible, they may have retracted iota the uterus or have been broken, or [Unnamed Birth Control Pill]® may have been broken, perforated the uterus, or have been expelled. Location of [Unnamed Birth Control Pill]® may be determined by sonography, X-ray, or by gentle exploration of the uterine cavity with a probe. h) Removal of the system should also be considered if any of the following conditions arise for the first time: migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia; exceptionally severe headache; jaundice; marked increase of blood pressure; severe arterial disease such as stroke or myocardial infarction. 4. Glucose Tolerance: Levonorgestrel may affect glucose tolerance, and the blood glucose concentration should be monitored in diabetic users of [Unnamed Birth Control Pill]®.

DRUG INTERACTIONS: The effect of hormonal contraceptives may be impaired by drugs which induce liver enzymes. The influence of these drugs on the contraceptive efficacy of [Unnamed Birth Control Pill]® has not been studied. CARCINOGENESIS: Long-term studies in animals to assess the carcinogenic potential of levonorgestrel releasing intrauterine system have not been performed. See WARNINGS section. PREGNANCY: Pregnancy Category X. See WARNINGS section. NURSING MOTHERS: levonorgestrel has been identified in small quantities in the breast milk of lactating women using [Unnamed Birth Control Pill]®. In a study of 14 breastfeeding women using a [Unnamed Birth Control Pill]® prototype during lactation, mean infant serum levels of levonorgestrel were approximately 7°I° of maternal serum levels. Hormonal contraceptives are not recommended as the contraceptive method of first choice during lactation. PEDIATRIC USE: Safely and efficacy of [Unnamed Birth Control Pill]® have been established in women of reproductive age. Use of this product before menarche is not indicated. (See RECOMMENDED PATIENT PROFILE.) GERIATRIC USE: [Unnamed Birth Control Pill]® has not been studied in women over age 65 and is not currently approved for use in this population. INFORMATION FOR THE PATIENT: See Patient Package Labeling. Return to Fertility: About 80°/° of women wishing to become pregnant conceived within 12 months after removal of [Unnamed Birth Control Pill]®. ADVERSE REACTIONS: The most serious adverse reactions associated with the use of [Unnamed Birth Control Pill]® are discussed in the WARNINGS section. Others are presented in the PRECAUTIONS section. Other adverse events reported by 5% or more subjects include: abdominal pain, breast pain, nausea, decreased libido, leukorrhea, acne, nervousness, abnormal pap smear, headache, depression, dysmenorrhea, sinusitis, vaginitis, hypertension, weight increase, back pain, upper respiratory infection, skin disorder. Other reported adverse reactions occurring in less than 3°I° of patients include: failed insertion, migraine, vomiting, anemia, cervicitis, dyspareunia, hair loss, eczema. HOW SUPPLIED: [Unnamed Birth Control Pill]® (levonorgestrel-releasing intrauterine system), containing a total of 52 mg levonorgestrel, is available in a carton of one sterile unit NDC# 50419-421-01. Each [Unnamed Birth Control Pill]® is packaged in a thermoformed blister package with a peelable lid, together with an insertion tube which is then heat sealed into a secondary pouch. [Unnamed Birth Control Pill]® is supplied sterile. [Unnamed Birth Control Pill]® is sterilized with ethylene oxide. Do not resterilize. For single use only. Do not use if the inner package is damaged or open. Insert before the month shown on the label.

STORAGE AND HANDLING: Store at 25°C (77°F), with excursions permitted between 15°-30°C (59-86°F) [See USP Controlled Room Temperature]

DIRECTIONS FOR USE: NOTE: Health care providers are advised to become thoroughly familiar with the insertion instructions before attempting insertion of [Unnamed Birth Control Pill]®.

© 2001, [Unnamed Company], Inc.
All rights reserved.
Manufactured for:
[Unnamed Company], Montville, NJ 07045
Manufactured in Finland