You need to read and understand this brochure before you decide to use Jadelle® implants. It tells you about the risks and benefits of Jadelle® implants. Discuss it with your health care provider. Ask him/her to explain anything you do not understand.

There is a more technical brochure about Jadelle® implants that was written for health care providers. If you would like to read that brochure too, ask your health care provider for a copy. You may need help to understand some of the information.

Before you decide to use Jadelle® implants or any other birth control method, compare it to other birth control methods. If you want to learn more about other methods, ask your health care provider. Another method may be better for you than Jadelle® implants.

Jadelle® implants differ from most other methods of birth control. Each of the two small, flexible silicone Jadelle implants contains a hormone. These implants must be inserted in your arm by a minor surgical procedure performed by a health care provider in the office. You should know that some health care providers have more experience than others in inserting Jadelle® implants. Be sure to ask your health care provider whether he/she has received instruction in how to insert Jadelle® implants and remove them.

You can decide to have Jadelle® implants removed at any time. You should know that removing Jadelle® implants may be more difficult than inserting them. It may take longer and involve more pain. It may leave scars. This risk does not exist with most other birth control methods.

Some women should not use Jadelle® implants. To find out whether you are one of these women, talk to health care provider and read this brochure carefully, especially the sections entitled "WHO SHOULD NOT USE JADELLE® IMPLANTS" and "OTHER CONSIDERATIONS BEFORE CHOOSING JADELLE® IMPLANTS."

Some women who use Jadelle® implants will have side effects. You should know the danger signs described in this brochure.

Each woman who considers using Jadelle® implants should understand the benefits and risks of this form of birth control as compared with other contraceptive methods. This leaflet will give you much of the information you will need to make a decision on whether to use Jadelle®, but it is not a replacement for a careful discussion with your health-care provider. You should discuss the information provided in this leaflet with him or her, both when choosing whether to use Jadelle® and during revisits. You should also follow your health-care provider's advice with regard to regular checkups while using Jadelle® implants.

Jadelle® implants are two thin flexible implants that are inserted just under the skin on the inner surface of your upper arm in a minor, outpatient surgical procedure. The implants contain the synthetic hormone levonorgestrel (a progestin). A similar product, NORPLANT® implants, consists of six capsules that are inserted under the skin and also contain levonorgestrel as the active ingredient. Levonorgestrel is also used in many birth control pills.

Immediately after insertion of Jadelle® implants, a low continuous dose of the hormone is released into your body. Pregnancy is prevented by stopping ovulation (so eggs will not be produced regularly), and thickening the cervical mucus (making it more difficult for the sperm to reach the egg). There may also be other effects that contribute to pregnancy prevention. Following removal, the effects reverse quickly and a woman can become pregnant as easily as if she had never used Jadelle® implants.

Jadelle® implants are one of the most effective reversible birth control methods. No method is 100% effective. The average annual pregnancy rate over a 5-year period for Jadelle® implants is less than 1%. That is less than one pregnancy for every 100 women during each year of use. Jadelle may be less effective in obese women. Over the five year period, the cumulative or total pregnancy rate is about 1%. In comparison, pregnancy rates during the first year of using other birth control methods are as follows:

Adapted from Hatcher RA et al., Contraceptive Technology, 17th Revised Edition. New York, NY: Irvington Publishers, 1998

Except for Jadelle® implants, NORPLANT® implants, sterilization, and the IUD, the effectiveness of contraceptive methods depends in part on how reliably they are used.

Jadelle® implants provide 5 years of protection against pregnancy but can be removed at any time. At the end of the fifth year, the implants will be less effective and must be removed; a new set may be inserted at the time of removal for continued protection if desired.

Some women should not use Jadelle® implants. You should not have the implants inserted if you have:

• Any chance that you may be pregnant.

• Liver disease, or liver tumors (either benign or cancerous)

• Unexplained bleeding between your periods.

• Breast cancer.

• Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes. Women who have had previous blood clots should consult with their health-care provider on whether to use Jadelle® implants.

• History of idiopathic intracranial hypertension.

• Hypersensitivity or allergy to levonorgestrel or silicone.

• A need for certain medications for seizures (epilepsy) or tuberculosis (TB) that could make Jadelle® less effective (see DRUG INTERACTIONS)

Tell your health-care provider if you or any family member has ever had:

• Breast nodules, fibrocystic disease of the breast, an abnormal breast X-ray or mammogram

• Diabetes

• Elevated cholesterol or triglycerides

• High blood pressure

• Gallbladder, heart, or kidney disease

• History of blood clots, heart attack, or stroke

• Clinical depression

• Migraine headaches

• History of scanty or irregular menstrual periods

Women with the above conditions may need to be checked more often by their health-care provider if they choose to use Jadelle® implants.

Be sure to inform your health-care provider if you smoke or are on any medications.

Jadelle® implants are inserted and removed by a minor surgical procedure in your healthcare providers office. You may experience pain, swelling, or bruising. Arm pain, itching, numbness and tingling may also occur following insertion or removal. Some women using NORPLANT® implants experienced infection, abscess, blisters, ulcers, peeling, scarring, or darkening of the skin at the insertion site, inflammation of blood vessels, or nerve injury. NORPLANT® implants occasionally come out of the skin or move to a slightly different position. These events could also occur with Jadelle® implants.

Removal may take longer than insertion and may be more difficult and/or cause more pain, especially if the implants are difficult to locate. Occasionally, additional incisions and/or office visits are required.

Most women experience some change in their usual monthly bleeding pattern. These menstrual changes vary from woman to woman and include:

• Prolonged bleeding or spotting (more days than you would usually experience)

• Bleeding or spotting between periods

• Heavy bleeding

• No bleeding at all for several months

• A combination of these patterns.

It cannot be predicted what kind of change you may experience. Contact your health-care provider if you experience heavy bleeding. Persistent heavy bleeding could lead to anemia. If you have regular periods and then miss a period, you should have a pregnancy test. If you are pregnant, Jadelle® implants must be removed.

If follicles (eggs and their surrounding cells) in the ovary develop while using Jadelle® implants, disappearance of the follicles is sometimes delayed, and the follicles may continue to grow beyond their normal size. These enlarged follicles (cysts) may produce abdominal pain in some women, although most women would not be aware of them unless they were found by chance on a physical exam. In most women, these cysts will disappear on their own and should not require surgery. Rarely, they may twist or rupture, and surgery is required.

The risk of having an ectopic pregnancy (a pregnancy that develops outside of the uterus) during Jadelle® use is less than the risk of ectopic pregnancy in women using no birth control method; however, if you become pregnant while using Jadelle®, that pregnancy is more likely to be ectopic than if you become pregnant using no birth control. Symptoms of an ectopic pregnancy include spotting and cramping pain. Contact your health-care provider if you suspect that you may be pregnant or if you experience abdominal pain.

Inflammation of blood vessels can occur with use of Jadelle® implants or NORPLANT® implants, usually in the same arm as the implants. This may occur with injury to that arm. There have also been reports of blood clots and cardiovascular problems (stroke, heart attack, blood clots in the lung, and deep-vein blood clots) with NORPLANT® implants use. (See also Risks Based on Experience With Combination Oral Contraceptives below.)

Combination oral contraceptives contain a progestin such as levonorgestrel and an estrogen, another type of hormone. Some rare but serious side effects have been associated with use of combination oral contraceptives. It is unknown whether the risks associated with combination oral contraceptive use may also be risks with a progestin-only birth control method like Jadelle® implants.

Blood clots and blockage of blood vessels can be serious. In particular, a clot in the veins of the legs can cause inflammation and risk of further clots. A clot that travels to the lungs can cause a sudden blocking of the vessel carrying blood to the lungs, resulting in respiratory collapse and even death. Rarely, clots occur in the blood vessels of the eye and may cause double vision, impaired vision, or even blindness. Any of these conditions can cause serious disability or death. Patients who develop blood clots in the legs, arms, lungs, or eyes should have the Jadelle® implants removed. In addition, patients restricted to bed rest or who have limited movement for a prolonged period due to surgery or other illness may be at increased risk of developing blood clots. Jadelle® implants may need to be removed in such patients.

The combination pill may increase the tendency to develop strokes (stoppage or rupture of blood vessels in the brain), angina pectoris, or heart attacks (blockage of blood vessels to the heart). Any of these conditions can cause death or serious disability. Smoking greatly increases the probability of suffering heart attacks and strokes. Use of combination oral contraceptives together with cigarette smoking greatly increases the risk of serious adverse effects on the heart and blood vessels. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age who smoke. It is not known whether a similar interaction occurs with Jadelle® implants. Therefore, women who use Jadelle® implants should not smoke.

An increase in blood pressure has been reported in combination oral contraceptive users. Elevated blood pressure occurs more often with long-term oral contraceptive exposure. A similar finding has been reported for women using NORPLANT® implants.

Combination pill users probably have a greater risk of gallbladder disease than nonusers. A similar finding has been reported for women using NORPLANT® implants.

In rare cases, the combination pill can cause dangerous liver tumors that can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with the pill and liver cancers. However, liver cancers are very rare. It is not known whether Jadelle can cause liver tumors.

Various studies give conflicting reports on the relationship between breast cancer and oral contraceptive use. Oral contraceptive use may slightly increase the chance of having breast cancer diagnosed, particularly after use at a young age. After stopping hormonal contraceptive use, the chances of getting breast cancer begin to go back down.

You should have regular breast examinations by a health care provider and examine your own breasts monthly. Tell your health care provider if you have a family history of breast cancer or if you have had breast nodules or an abnormal mammogram.

Women who currently have or have had breast cancer should not use hormonal contraceptives because breast cancer is usually a hormone-sensitive tumor.

Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives.

If any of these adverse effects occur following insertion of Jadelle® implants call your health-care provider immediately:

• Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)

• Pain in the calf or arm (indicating a possible clot in the leg or arm)

• Crushing chest pain or heaviness in the chest (indicating a possible heart attack)

• Sudden severe or persistent headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke or other neurologic problem)

• Persistent headaches, particularly if you are obese or have had recent weight gain (indicating possible idiopathic intracranial hypertension)

• Sudden partial or complete loss of vision (indicating a possible clot in the eye)

• Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your health-care provider to show you how to examine your breasts)

• Severe pain or tenderness in the stomach area or lower abdominal area (possibly indicating an ectopic pregnancy, a ruptured or twisted ovarian cyst, or a ruptured liver tumor)

• Sleep disorders, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)

• Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark-colored urine, or light-colored bowel movements (indicating possible liver problems)

• Heavy vaginal bleeding

• Delayed menstrual cycles after a long interval of regular cycles

• Arm pain

• Pus or bleeding at implant site

• Expulsion of an implant.

1. Physical Examination and Follow-Up Prior to insertion of Jadelle® implants, your health-care provider will inquire about your medical history and perform a physical exam, including a gynecologic exam. Be sure to have periodic checkups as advised by your health-care provider while the implants are in place.

2. Carbohydrate and Lipid Metabolism Blood sugar levels may be increased by progestin-only contraceptives such as Jadelle® implants. Diabetic patients should be observed carefully while using Jadelle® implants. Some progestins may increase lipid (eg, cholesterol, triglyceride) levels. Patients being treated for increased lipid levels should be followed closely while using Jadelle® implants.

3. Liver Function Jadelle® implants may need to be removed if yellowing of the skin or whites of the eyes occurs. Hormones may be poorly metabolized in patients with liver diseases.

4. Fluid Retention If you experience fluid retention (with swelling of the fingers or ankles, and possibly increased blood pressure) while using Jadelle® implants, contact your health-care provider.

5. Emotional Disorders Jadelle® implants may need to be removed if you become severely depressed.

6. Contact Lenses If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your health-care provider.

7. Idiopathic Intracranial Hypertension (pseudotumor cerebri, benign intracranial hypertension) An increase in intracranial pressure has been reported in rare cases in NORPLANT® implant users. Symptoms may include headache (associated with a change in the frequency, pattern, severity, or persistence. Of particular importance are visual disturbances and headaches that do not stop. Contact your health-care provider if you experience these symptoms, particularly if you are obese or have had recent weight gain. While it is unclear if this condition is caused by the implants, your health-care provider may recommend that Jadelle® implants be removed.

8. Use in Early PregnancyBirth defects have not been reported with Jadelle® use. There have been reports of birth defects when NORPLANT® implants were used unintentionally during early pregnancy, but a cause and effect relationship has not been established. You should check with your health-care provider about the risks of any medication taken during pregnancy. Do not have implants placed if you are pregnant or believe you may be pregnant.

9. While Breast-Feeding Women who are breast-feeding or intend to breast-feed should discuss this with their health-care provider when considering the use of Jadelle® implants. Studies have shown no significant effects on the growth or health of infants whose mothers used NORPLANT® implants beginning 5 to 7 weeks after childbirth.

10. Infections Infection at the implant site is uncommon. If infection does occur, contact your health-care provider for treatment. The implants may need to be removed if the infection continues.

11. Expulsion and Displacement (Movement) Expulsion of an implant (i.e., when an implant comes out of the insertion site/skin) may occur. If an implant is expelled, your health-care provider should replace it with a new sterile implant. If infection is present, it should be resolved before any implant is replaced. To avoid pregnancy when only one implant is in place, a back-up nonhormonal contraceptive method (such as condoms or spermicides) should be used.

12. After Jadelle® implants are inserted, they may move from the original position. Rarely, movement up to several inches has been reported with NORPLANT® implants. With NORPLANT® implants, movement accompanied by pain and discomfort has been reported. If movement of one or both Jadelle^® implants occurs, particularly if accompanied by pain and/or discomfort, notify your health-care provider.

Certain drugs may interact with the hormone delivered by Jadelle® implants to make them less effective in preventing pregnancy. Such drugs include drugs used for epilepsy, such as phenytoin (Dilantin^® is one brand), carbamazepine (Tegretol^® is one brand), oxcarbezepine (Trileptal is one brand), and phenobarbital . Certain other drugs, such as rifampicin, may also make Jadelle® implants less effective. You may need to use a different birth control method if you require drugs that can make Jadelle® implants less effective. Discuss this with your health-care provider.

If you are scheduled for any laboratory tests, tell your health-care provider that you are using Jadelle® implants. Certain blood tests are affected by synthetic hormones.

The most frequently reported side effects are menstrual cycle changes. SEE RISKS OF USING JADELLE^® IMPLANTS.

Women using Jadelle® implants have also experienced the following conditions.

• Acne

• Appetite changes

• Breast pain

• Contact dermatitis

• Dizziness

• Hair loss

• Headache

• Lesions or inflammation of the cervix

• Leukorrhea (whitish discharge from the vagina)

• Libido decrease (less interest in sex)

• Nausea

• Nervousness

• Pain, discoloration, or other skin reaction at implant site

• Pelvic pain

• Vaginal infection (due to yeast, trichomonas, bacteria), urinary tract symptoms, or genital pruritus (itching)

• Weight change, usually an increase

A woman who already has acne or excess hair on her face or body could experience worsening of these problems

The following additional complaints have been reported by NORPLANT® implant users.

• Migraine

• Mood swings

• Muscle and skeletal pain

• Pruritus (itching)

• Skin rashes

• Thrombotic thrombocytopenic purpura (TTP)

• Urticaria (hives)

Insertion and removal of Jadelle® implants should be performed by a health-care provider knowledgeable of the procedures.

Prior to insertion of Jadelle® implants, your health-care provider will ask about your medical history and perform a physical examination, including a pelvic exam. To make sure you are not already pregnant, Jadelle® implants should be inserted within 7 days after the onset of menstrual bleeding or immediately following termination of pregnancy. If Jadelle® implants are inserted at any other time during the cycle, pregnancy must be excluded, and a nonhormonal contraceptive method (such as condoms, spermicides, or diaphragms) must be used for at least 7 days following insertion. If ovulation and conception have already occurred before Jadelle® is inserted, pregnancy could occur during the month of insertion.

Jadelle® implants are inserted under the skin on the inner surface of your upper arm during a minor, outpatient surgical procedure under sterile conditions. A local anesthetic is used to numb a small V-shaped area in the upper arm, after which a small incision, less than 1/8 inch long, is made in the same area. The two implants are placed one at a time with a special instrument. The incision is covered with a small adhesive bandage and protective gauze. Because a local anesthetic is used, there should be little or no discomfort during insertion.

When the anesthetic wears off, there may be some tenderness in the area of the implants for a day or two. Some discoloration, bruising, and swelling may also be present for a few days after the procedure.

Following insertion, you can resume work and other activities. Be careful, however, not to bump the site or get the incision wet for at least 3 days. Also avoid heavy lifting for 2 to 3 days. The protective gauze should remain in place for 24 hours and a small adhesive bandage for 3 days.

Be sure to have periodic checkups as advised by your health-care provider while Jadelle® implants are in place.

The implants must be removed at the end of 5 years because they become less effective. They can be removed at any time before then, however, if you want to stop using the method for any reason. Removal will take longer than insertion.

Just as for insertion, your health-care provider will numb the area with a local anesthetic. Under sterile conditions, a small (1/8 inch) incision will be made through which the implants should be removed. The removal process takes more time than the insertion procedure. If the implants are too deep, they can be more difficult to remove. If both implants cannot be removed, additional visits and incisions may be required. A nonhormonal method of contraception (such as condoms, spermicides, or diaphragms) should be used until both implants are completely removed.

Avoid bumping the incision site for a few days. The area should be kept clean, dry, and bandaged until healed (3 to 5 days) to avoid infection. Bruising may occur at the implant site following removal.

If you want to continue using Jadelle® implants, a new set can be inserted at the same time the old set is removed. The second set can be placed in the same arm, and frequently through the incision from which the earlier set was removed, or in the other arm.

If you do not want to continue with Jadelle® implants and do not want to become pregnant, ask your health-care provider to recommend another birth control method.

Once the implants are removed, the effects reverse quickly and a woman can become pregnant as easily as if she had not used the method.

If you would like more information about Jadelle® implants, a copy of the Prescribing Information can be obtained from your health-care provider.

I have read this brochure and have discussed it with my health care provider. He/she has answered all my questions. I understand that there are risks as well as benefits from using Jadelle® implants. I understand that there are other forms of contraception that do not have the risks of Jadelle® implants, but may have different risks.

I also understand that this form is important. It demonstrates that I am making an informed and carefully considered decision to use Jadelle® implants. I have checked below those statements that I agree with:

_______I have been told how Jadelle® implants work to keep women from getting pregnant.

_______I have been told that the risk of getting pregnant while using Jadelle® implants is less than 1%. (This means that less than one woman out of every 100 who uses Jadelle® implants may get pregnant each year.)

_______I have been told that I can have Jadelle® implants taken out at any time and for any reason. I have also been told that, if I have trouble finding a health care provider to remove them, I can call (800) 934-5556 for help.

_______I understand that the Jadelle® implants are made of a hormone embedded in a flexible solid state silicone polymer.

_______I have been told that Jadelle® implants are implanted under the skin of my arm during an in-office surgical procedure.

________I have been told that the Jadelle® implants must be removed at the end of 5 years. The removal procedure is also an in-office surgical procedure and may cause more discomfort and scarring than the insertion procedure.

________I have been told about the side effects of Jadelle® implants, including that most women have changes in their menstrual bleeding. I have been told that the side effects may vary in severity from one woman to another.

________I have been told about warning signs that may indicate serious conditions and know that I should seek medical attention if any warning signs appear.

_______I have been told that I need to receive a medical checkup yearly and at any time I am having problems.

_______I have been told that Jadelle® implants do not protect me from HIV infection (AIDS) or any other sexually transmitted disease.

________I have considered all the information in this brochure and voluntarily choose to have Jadelle® implants inserted by:

_________________________
(Name of Health-Care Provider)

_________________________
(Patient Signature)

___________
(Date)

WITNESSED BY:

The patient above has signed this brochure in my presence after I counseled her and answered her questions.

_________________________
(Health-Care Provider Signature)

___________
(Date)

I have provided an accurate translation of this information to the patient whose signature appears above. She has stated that she understands the information and has had an opportunity to have her questions answered.

_________________________
(Signature of Translator)

___________
(Date)

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