Population Council Research that makes a difference

Jadelle®

Jadelle, the two-rod levonorgestrel implant, is not currently available in the United States. However, in 1996 the US Food and Drug Administration approved the implant for use of up to three years. After reviewing additional data, the FDA changed its requirements and in 2002 approved Jadelle for up to five years' use in the United States. The implant has also been approved in Europe for five years' use.

Jadelle is licensed to Bayer Schering Pharma Oy outside of the United States.

The questions and answers below are intended to provide general information about Jadelle and should not serve as a substitute for a physician's advice.

General information

What is Jadelle? Jadelle is an implant system that provides effective, long-acting, reversible contraception for women. Two thin, flexible rods made of silicone tubing and filled with levonorgestrel, a synthetic progestin, are inserted just under the skin of a woman's upper, inner arm in a minor surgical procedure. Protection from pregnancy is provided within 24 hours, when insertion is performed during the first week of a woman's menstrual cycle. The woman rapidly returns to her normal fertility when the implants are removed. Because Jadelle contains no estrogen, the most common side effects are changes in menstrual bleeding patterns. Most other common side effects are similar to those experienced by women who use other hormonal contraceptives. 

How effective is Jadelle in preventing pregnancy? Jadelle is one of the most effective reversible contraceptives available. The cumulative pregnancy rate in clinical trials was 0.3 for three years and 1.1 percent for five years. Jadelle has a lower failure rate than the pill and most IUDs. Its efficacy is comparable to that of surgical sterilization. 

For how long is Jadelle effective? Jadelle is not currently available in the United States. However, in 1996 the United States Food and Drug Administration (FDA) approved the implant for use of up to 3 years. After reviewing additional data in 2003, the FDA changed their requirements and approved Jadelle use for up to 5 years, if it was sold in the US. The implant has also been approved in Europe for 5 years' use.

Who can use Jadelle? Almost any fertile woman without contraindications (see below) who wants to avoid pregnancy may use Jadelle. The method is suitable for women who are seeking continuous, yet reversible contraception; who want to space their children; who cannot use methods that contain estrogen; who do not want to be sterilized; and/or who desire a method that is convenient and not related to sexual intercourse. 

Who should not use Jadelle? Jadelle should not be used by women who are pregnant or who have any of these contraindications: active thrombophlebitis or thromboembolic disorders, such as blood clots in the legs, lungs, or eyes; undiagnosed abnormal genital bleeding; acute liver disease; noncancerous or cancerous liver tumors; known or suspected breast cancer; a history of idiopathic intracranial hypertension; or hypersensitivity to levonorgestrel or any of the other components of the rods (e.g., silicone elastomer). Women who have had previous blood clots or other thromboembolic disorders should consult with their health care providers about whether to use the method. 

Is Jadelle effective for women of differing weights? Yes. Even among heavier women, annual pregnancy rates for Jadelle users over three years and five years are well below those of oral contraceptives. A comparative five-year study of Jadelle and Norplant users showed no significant effect of weight on pregnancy risk. 

What do women like most about Jadelle? Discussions with women using Jadelle in various countries show they like the method's reliability, convenience, effectiveness, and reversibility. Other advantages mentioned are the method's long-term duration and the fact that the rods are placed in the arm. 

What do women dislike about Jadelle? The side effect that women like least is menstrual irregularity, which can mean heavy or prolonged bleeding, spotting, or no bleeding at all. This kind of irregular bleeding occurs because the method contains no estrogen. While such irregular bleeding is usually no cause for alarm, it can be troublesome for some women. In addition, women complain about side effects common to other hormonal methods, such as weight gain, headaches, acne, and mood changes. Some rod users are anxious about possible pain and complications from the insertion and removal procedures. Since the Jadelle system is not user-controlled, it is important that women be able to request removal and receive it promptly from competent providers. 

How does Jadelle work? Pregnancy is prevented in Jadelle users by a combination of mechanisms. The most important are the inhibition of ovulation and the thickening of the cervical mucus, making it impermeable to sperm. Other mechanisms may add to these contraceptive effects. 

What is Jadelle made of? The outer part of the Jadelle rod is silicone rubber tubing, similar to the material used in catheters and heart valves since the 1950s. It also is the same kind of material used in Norplant capsules, another contraceptive implant system. The rods release levonorgestrel, a synthetic progestin that has been used in combined oral contraceptives and in progestin-only pills for more than 30 years. What is "new" about the rods is their delivery system, which can provide contraceptive protection for up to five years. 

How do Jadelle rods differ from Norplant capsules? The Jadelle system consists of two rods, while the Norplant system has six capsules. Because there are fewer implants, Jadelle is easier to insert and remove than Norplant. Rods differ from capsules. Each Jadelle rod is 43 millimeters long and 2.5 millimeters in diameter, slightly longer (one centimeter) and slightly thicker (0.1 millimeter) than each Norplant capsule. Each rod contains 75 mg of levonorgestrel for a total of 150 mg, while the six Norplant capsules each contain 36 mg, for a total of 216 mg. Both the capsules and rods have outside sheaths composed of silicone rubber, but they are made differently. In the Norplant capsule, levonorgestrel crystals are packed within the rubber sheath, which is then sealed at each end. In the Jadelle rod, a core of mixed levonorgestrel and elastomer (a polymer having the elastic properties of natural rubber) is enclosed within the rubber sheath, which is then sealed at each end with medical adhesive. 

When was Jadelle approved? Jadelle was approved for marketing as a three-year method in the United States in 1996 and in Finland in 1997. In 2000, Finland approved the extension of use of the method to five years. In 2003, the FDA approved extension of use to five years. 

How many Jadelle users continue past the first year? In the clinical studies on which approval was based, cumulative continuation rates were 88.3 percent after the first year, 60.6 percent after three years, and 41.5 percent at five years. These figures may vary. Younger women have lower continuation rates; older women, whose families are completed, have higher continuation rates. 

Why do women discontinue using this method? Women discontinue using Jadelle because of side effects, because they want to become pregnant, or for other personal reasons. Studies conducted by the Population Council indicate that, over a three-year period, 14.1 per 100 women stopped using Jadelle because of menstrual irregularities and 14.7 per 100 women discontinued for other medical reasons; 9.7 per 100 women did not continue for the full three years because they were planning a pregnancy. Medical occurrences most frequently cited as reasons for removal were headaches, depression, weight gain, or hair loss.

Why is counseling important? Studies have shown that women who receive good counseling are more satisfied with the method they adopt and are more likely to continue using it. Contraceptive users who believe they have been fully and accurately informed about their choices will feel more confident about their methods and their providers. Inadequate counseling about Jadelle may result in early removals and loss of contraceptive protection. 

What topics should be covered in counseling? The Jadelle user should know the most important facts before the rods are inserted: how the method works, any discomfort she might feel following the insertion procedure, what side effects she might encounter, the likelihood of failure, how to recognize warning signs of possible complications, and when to have the rods removed. She should also learn how the method compares with other available contraceptives. Jadelle users should know that most insertions and removals are easily accomplished when performed by trained health care providers and are not painful for most women. 

Does the age of the user matter? Although women from ages 18 to 40 years participated in the clinical trials, women younger and older than those ages also can use Jadelle. If there are no contraindications, the rods may be used by women throughout their reproductive years. Several studies of Norplant use by teenagers in the United States have shown the method to be effective and well accepted. Although there are no studies specific to older women, women can use Jadelle as they approach menopause.

Insertion and removal

Should a woman undergo a physical exam before receiving Jadelle? It is recommended but not essential that a woman considering Jadelle undergo a medical examination. This may include giving a medical history and having a pelvic exam to ensure that she has no diseases or conditions that would make it unsafe for her to use this method. 

Can Jadelle be inserted at any time? To make sure the woman is not pregnant, Jadelle rods should be inserted within seven days after the onset of menstrual bleeding or immediately following an abortion. If Jadelle implants are inserted at any other time in the menstrual cycle, the possibility of a preexisting pregnancy must be ruled out and a nonhormonal contraceptive method (such as condoms, spermicides, or diaphragms) must be used for at least seven days following insertion to avoid pregnancy. If ovulation and conception have already occurred before Jadelle is inserted, pregnancy could occur during the month following insertion. 

How are the rods inserted? The rods are inserted under the skin of the inner side of the upper arm in a minor surgical procedure. In some countries, a pre-loaded disposable inserter (developed by Leiras) is available. Elsewhere, the rods are loaded in a reusable hollow needle called a trocar. In either technique, a local anesthetic is injected and the clinician makes a small incision-about 3 mm long-using either the disposable inserter or the trocar. The rods are placed subdermally in the shape of a V opening toward the shoulder. The procedure should take only a few minutes. Often the only pain is associated with the injection of the anesthetic. Usually the incision does not require stitches and is covered with a small adhesive bandage and protective gauze bandage. 

Who performs the insertions? The rods should be inserted by health care providers who have received training in the procedure. Generally, any trained physician, nurse, nurse-midwife, or other health care provider can perform the insertion. 

What kind of complications are possible? The needle providing the anesthetic may sting briefly. Rarely, women may have reactions to the anesthetic used. When the anesthetic wears off, there may be tenderness as well as discoloration, bruising, and/or swelling in the area of the insertion for a few days after placement. There have also been reports of arm pain, numbness, and tingling following placement. During Jadelle clinical trials, infection at the insertion site occurred in 0.4 percent of women over five years. Attention to aseptic technique and proper insertion and removal of Jadelle rods reduce the possibility of infection. In some women, hyperpigmentation occurs over the implantation site, but this effect is usually reversed following removal. During postmarketing use of Norplant, other cutaneous reactions reported include blistering, ulcerations, and sloughing. There have been reports of nerve injury with Norplant, most commonly associated with deep placement and removal. Expulsion of Norplant implants has been reported, more frequently when implant placement was shallow or too close to the incision or when infection was present. 

How should the insertion site be cared for? The insertion site should not be bumped for a few days and the area should be kept dry. Also, the woman should avoid heavy lifting for two to three days after the insertion. The protective gauze bandage should be left in place for three days and the small adhesive bandage should be left on for a day or two longer. Some women have reactions to the adhesive of the bandage. 

Are Jadelle rods visible? Since the incision is small, most women do not have a noticeable scar. The rods are usually comfortable and barely visible. When they are visible, the outline of the rods can be seen under the skin and they resemble colorless veins. 

Will the rods move around? The rods' location may shift. There have been rare postmarketing reports of movement of Norplant capsules. Most of the movement involved minor changes in the positioning of the implants, but some have involved significant displacement of up to several inches. Some of these reported displacements have been associated with pain and subsequent difficult removal of Norplant. 

Can a woman work after the insertion? Yes. She can resume her normal work and domestic activities, as long as she does not bump the site, avoids heavy lifting, and keeps the incision site dry for at least three days. The woman does not have to be concerned if pressure is put on the area during normal activities. After the incision has healed, the skin over the rods can be touched at any time. 

How soon after insertion can a couple have sexual relations? This depends on when in her menstrual cycle a woman has the rods inserted. If Jadelle rods are inserted during a woman's menses (to ensure she is not pregnant at the time of insertion), the couple may have sexual relations without a back-up contraceptive method 24 hours after the insertion. If the rods are inserted at any other time during the cycle, the possibility of a preexisiting pregnancy must be ruled out and a nonhormonal contraceptive method should be used for at least seven days following the procedure to avoid pregnancy. If a woman does get pregnant, the rods must be removed. 

When should the woman return to the clinic for a checkup? The follow-up schedule depends on the practice of the particular clinic or physician's office in which a woman receives the rods. She may be asked to return for periodic health checkups or to report on her experience with the rods. She should be encouraged to return to the same provider or clinic if she has any health problems that worry her; if she wishes to become pregnant; or if she is moving and needs the address of a clinic that provides Jadelle in her new area. Annual checkups offer an occasion to remind women when to have their rods removed, but are not required. 

How is Jadelle's protection reversed? One of the most important characteristics of Jadelle is its reversibility. The contraceptive action stops within two to three days after removal of the rods. The rods are removed during a clinical procedure under a local anesthetic, similar to the insertion process. An alternative form of contraception should be used as soon as the rods are removed, unless the woman desires pregnancy. 

When should Jadelle be removed? The rods should be removed at the end of the approved duration of use—either three or five years depending on where it is being used. The US Food and Drug Administration approved the implant for use of up five years, even though the product is not sold in the United States. The implant has also been approved in Europe for five years' use.  

However, the woman should be able to request and obtain removal of the rods at any time, for any reason. 

What happens if the rods are not removed after the approved period of use? Data have shown that women are protected for up to five years. If the rods are not removed at five years, the risks of pregnancy and of ectopic pregnancy increase. 

Who should remove the rods? Health care providers experienced in removals should perform the procedure. The rods can be removed at the same clinic or office where they were inserted or at another health facility that offers the method. Before insertion, a woman should confirm that she will have access to a competent provider at removal time. 

Is removal painful? Just as when the capsules are inserted, the health professional will apply a local anesthetic to prevent pain, but the anesthetic injection itself may hurt briefly. If the rods have been inserted properly, removal should be rapid and uncomplicated. When the anesthetic wears off, there may be some tenderness, discoloration, bruising, and swelling in the area for a few days. It is neither necessary nor recommended that general anesthesia be used for this procedure. 

Are removals more difficult than insertions? Yes. Although most removals are not difficult, the procedure usually takes longer than insertion. Some rods may be harder than others to locate and remove if they were inserted too deeply or if temporary swelling of the arm occurs during removal. A small incision about 4 mm long will be made, through which both rods are removed. If the clinician is unable to remove both rods during one procedure, the woman should return after her arm heals. Women should be informed of the possibility of needing a subsequent visit for removal and should not be alarmed if this is necessary. Clinicians should feel the insertion site to be sure they can locate both rods before attempting to remove them. If they cannot be felt, the rods can be located through x-ray, ultrasound, or compression mammography, all of which are painless procedures. Removal complications or difficulties were reported in 7.5 percent of more than 1,100 women who had Jadelle removed. Complications (some related to deep placement) included multiple or long incisions, bruising, displacement, pain, prolonged removal, incomplete removal requiring an additional visit or visits, broken implants, and fibrous pericapsular tissue. 

How should a woman care for the site after removal? As with insertion, it is important to avoid bumping the removal site for a few days. The area should be kept clean, dry, and bandaged until healed (3 to 5 days) so that the site does not become infected. 

How soon after removal can a woman become pregnant? The reversibility of protection afforded by Jadelle is one of the advantages of the method. Once the rods are removed, the contraceptive effect wears off within a few days. 

Can another set of rods be inserted when the old set is removed? Yes. If a woman wants to continue using Jadelle, a new set can be inserted when the old set is removed. Or a woman can use Norplant and then switch to Jadelle. The second set can be placed through the incision from which the earlier set was removed or in the other arm. If a woman does not want to continue with the rods and does not want to become pregnant, she should be offered another contraceptive method before she leaves the clinic.

Side effects and health considerations

What are the most common side effects reported with Jadelle use? The most common side effect of Jadelle use is irregular menstrual bleeding-most women can expect some variation in menstrual bleeding patterns. Irregularities vary from woman to woman and may include prolonged menstrual bleeding (more days than a woman would normally experience), heavy bleeding, prolonged spotting or spotting between periods, no bleeding at all, or a combination of these patterns. Other adverse reactions reported by 10 percent or more of women during five years of Jadelle use in clinical trials were application site reaction, discoloration, or pain; dizziness; headache; leukorrhea (whitish discharge from the vagina and uterine cavity); mastalgia (breast pain); nausea; pelvic pain; urinary tract symptoms; vaginitis (including genital pruritus and infections); and weight gain. Women using Jadelle have also experienced acne, appetite changes, contact dermatitis, hair loss, lesions or inflammation of the cervix, libido decrease, and nervousness. Preexisting conditions of acne or excessive growth of body or facial hair could worsen. Occasionally, an infection may occur at the implant site (treatable with an antibiotic), or there may be a brief incidence of pain or itching at the insertion site. Many of these adverse events associated with use of Jadelle are commonly experienced by users of other hormonal methods. 

Do most Jadelle users experience side effects? Yes, although it will frequently not be clear whether an adverse event was caused by the implants. All contraceptive methods have side effects and Jadelle is no exception. Bleeding irregularities (including spotting, longer or heavier periods than previously, or no bleeding) are reported by about 65 percent of rod users. A five-year clinical trial in seven countries showed that the two most frequent medical reasons, other than bleeding irregularities, leading to removal were headache and weight gain. About 19 per 100 women discontinued use of Jadelle because of bleeding problems. 

Are bleeding irregularities associated with Jadelle serious? A change in the menstrual bleeding pattern-the most frequently reported side effect-is to be expected with hormonal methods that do not contain estrogen. Most bleeding irregularities associated with Jadelle are not serious, although they may be troublesome for some users. If a woman experiences heavy bleeding, she should see her physician or health care provider to make sure the bleeding is not masking another condition. Because some rod users experience amenorrhea, missed menstrual periods cannot serve as the only means of identifying early pregnancy.

What kind of bleeding pattern can be expected? It is not possible to predict the kind of bleeding pattern a woman will have while using Jadelle. Many women can expect an altered menstrual bleeding pattern to become more regular after six to nine months. Both increased and reduced bleeding tend to diminish with time, although these irregularities can persist for some women throughout the three or five years. 

Is the lack of bleeding (amenorrhea) harmful? Sometimes a woman is concerned about amenorrhea-the absence of monthly bleeding. A woman's health or future fertility will not be harmed if she does not have her period while using Jadelle; there is no blood "buildup." Pregnancy tests should be performed whenever a pregnancy is suspected. Six weeks or more of amenorrhea after a pattern of regular menses may signal pregnancy. 

Does the use of Jadelle make women anemic? Despite the increased frequency of menstrual bleeding in some women using Jadelle, the amount of total blood loss is usually less than occurs during normal menses. In some studies, in fact, hemoglobin values of Jadelle users have been shown to increase. A few rare cases of severe blood loss have been associated with anemia. 

Should women be given estrogen to control bleeding and spotting? Jadelle is estrogen-free and many women and their health care providers choose the method for this reason. Although research has been conducted to test the effectiveness of a few treatments for bleeding irregularities, there is no evidence available to promote any specific treatment. 

Does Jadelle use affect lipid and carbohydrate metabolism? Serum lipoprotein levels were altered in three clinical studies involving 544 women using Jadelle. Levonorgestrel rod users had mean decreases from baseline in total cholesterol, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol of approximately 12 percent, 14 percent, and 10 percent, respectively. Triglyceride levels decreased about 25 percent from pretreatment values. Although these decreases were statistically significant, all mean values remained within the normal ranges. The long-term clinical effects of these changes have not been determined. Women who are being treated for hyperlipidemias should be followed closely if they elect to use Jadelle. Some progestins may elevate LDL levels, thereby making the control of hyperlipidemias more difficult. The effect of levonorgestrel-containing implants on carbohydrate metabolism appears to be minimal. During the Norplant postmarketing surveillance study, diabetes mellitus developed in Norplant users at the rate of 0.2 per 1,000 woman-years, a rate not significantly above that of control subjects who were not using hormonal contraception. While the clinical significance of these findings is unknown, diabetic patients should be carefully observed while using Jadelle. 

What are warning signs of possible problems? A woman using Jadelle should return to her health care provider or clinic immediately if she has severe lower abdominal pain (possible ectopic pregnancy), heavy vaginal bleeding (masking symptoms of cervical or endometrial cancer), delayed menstrual periods after several regular cycles (possible pregnancy), pus or bleeding at the insertion site (indication of infection), or expulsion of an implant (when placement is shallow). Of course, women also should seek immediate medical attention if they have sharp chest pain, coughing of blood, or sudden shortness of breath (possible clot in the lung); pain in the calf or arm (possible clot in the leg or arm); sudden partial or complete loss of vision (possible clot in the eye); crushing chest pain or heaviness in the chest (possible heart attack); sudden severe or persistent headache or vomiting, dizziness, or fainting, disturbances of speech or blurred vision, weakness or numbness in an arm or leg (possible stroke or other neurological problem); or sleep disorders, weakness, lack of energy, fatigue, or changes in mood (possibly indicating severe depression). The absence of menstrual periods after several regular cycles may be a sign of pregnancy. If a woman is not bleeding at her expected time or has lower abdominal pain or symptoms of pregnancy, she should visit the clinic without delay. Lower abdominal pain may indicate an ectopic pregnancy. A change in the frequency, pattern, severity, or persistence of headaches, or blurred vision, may be signs of papilledema, which in turn may indicate idiopathic intracranial hypertension. Women experiencing these symptoms should discuss them with their health care provider, who may screen them for papilledema and, if the condition is present, refer them to a neurologist for further diagnosis and care. This condition, which is seen most commonly in obese women of reproductive age in the general population, has been reported in postmarketing use of Norplant in the United States and the United Kingdom. However, a causal relationship is unclear. Jadelle rods should be removed from women experiencing papilledema. Contact lens wearers who experience visual changes or changes in lens tolerance while using Jadelle should be assessed by an ophthalmologist. Women who become significantly depressed while using Jadelle should discuss with their health care provider whether the rods should be removed. 

Are there other health considerations with Jadelle use? Women with certain health conditions can use Jadelle, provided they have regular checkups. If a woman has any of the following conditions, she should discuss them with her health care provider before using the rods: breast nodules, fibrocystic disease of the breast, or an abnormal breast x-ray or mammogram; diabetes; elevated cholesterol or triglycerides; high blood pressure; migraine or other headaches; epilepsy; mental depression; gallbladder, heart, or kidney disease; or a history of blood clots, heart attack, or stroke. 

Does Jadelle cause heart or vascular problems? There have been reports of superficial phlebitis in clinical trials of Jadelle and postmarketing reports of thrombophlebitis and superficial phlebitis coincident with Norplant use, more commonly in the arm of insertion. In such cases, the implants should be removed. Removal should also be considered in women who will be subjected to prolonged immobilization because of surgery or illness. There have also been reports of other thromboembolic disorders and cardiovascular problems (such as stroke, myocardial infarction, pulmonary embolism, and deep-vein thrombosis) coincident with Norplant use. In the Norplant postmarketing surveillance study, which observed more than 30,000 woman-years of Norplant use and comparable experience in women not using hormonal contraception, no myocardial infarctions occurred in either group. It is expected that this experience applies equally to Jadelle. An increased risk of thromboembolic and thrombotic disease (pulmonary embolism, superficial venous thrombosis, and deep-vein thrombosis) has been associated with the use of combination oral contraceptives. Combined oral contraceptives, which contain both estrogen and progestin, have been shown to increase both the relative and attributable risks of thrombotic and hemorrhagic strokes, although the risk is greatest among women over 35 years of age who are hypertensive (have high blood pressure) and also smoke. 

Does Jadelle use increase blood pressure? Increased blood pressure has been reported in users of combined oral contraceptives. The prevalence of elevated blood pressure increases with long exposure. Although no clinically significant rises in mean blood pressure occurred among Jadelle users in clinical trials, physicians should be aware of the possibility of elevated blood pressure in women using this method. In the Norplant surveillance study, the incidence of hypertension and borderline hypertension was moderately higher in Norplant users compared with women in the control groups. Because Norplant users had more frequent blood pressure measurements than controls, the results might partially reflect a reporting bias. 

Does Jadelle cause autoimmune diseases? Autoimmune diseases such as scleroderma, systemic lupus, and rheumatoid arthritis occur in the general population and more frequently among women of childbearing age. There have been rare reports of various autoimmune diseases, including the ones listed above, in users of the six-capsule Norplant implants; however, the rate of reporting is significantly lower than the expected incidences for these diseases in the general population. Studies have raised the possibility of antibodies being developed against silicone-containing devices; however, the specificity and clinical relevance of these antibodies are unknown. While it is believed that the occurrence of autoimmune diseases among Norplant capsule users is coincidental, health care providers should be alert to the earliest manifestations of such diseases in Jadelle users. In the Norplant postmarketing surveillance study, no significant difference in the risk of autoimmune disease was found between Norplant users and users of nonhormonal methods. 

Does Jadelle use increase the risk of gallbladder disease? Some studies have reported an increased lifetime relative risk of gallbladder disease in users of oral contraceptives and estrogens. More recent studies, however, have shown that the relative increased risk of developing gallbladder disease among oral contraceptive users is minimal. These recent findings may be related to the lower doses of estrogens and progestins in current pill formulations. In the Norplant postmarketing surveillance study, the relative risk of gallbladder disease was moderately higher in Norplant users in Chile and China compared with women in the control groups. 

Does Jadelle cause birth defects? Extensive epidemiological studies have revealed no increased risk of birth defects in the children of women who have used oral contraceptives before pregnancy. Studies also fail to suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb-reduction defects are concerned, when oral contraceptives are used inadvertently during early pregnancy. There is no evidence suggesting that the risk associated with Jadelle or Norplant use is different from the risk associated with oral contraceptives. There were no reports of birth defects for the live births that occurred during use of Jadelle in clinical trials. However, in postmarketing use of Norplant capsules, congenital anomalies have been reported in the offspring of women who used the method inadvertently during early pregnancy. A cause and effect relationship has not been established. If a woman becomes pregnant while using Jadelle, the rods should be removed immediately.

Can a smoker use Jadelle? Cigarette smoking increases the risk of heart attacks and strokes in users of combined oral contraceptives. This risk increases with age and with heavy smoking (15 or more cigarettes a day) and is quite marked women over 35 years old. While this is believed to be an estrogen-related effect, it is not known whether similar risk exists with progestin-only methods such as Jadelle. A woman who chooses to use Jadelle advised not to smoke. 

Does Jadelle protect against sexually transmitted diseases? No. This form of contraception does not protect against HIV/AIDS or other sexually transmitted diseases. If a woman who elects to use Jadelle thinks she might be at risk for STDs, she or her partner should use a condom in addition to the rods. 

Does Jadelle cause cancer at the incision site? In rare instances cancers have occurred at the site foreign-body intrusions or old scars. None have been reported in Norplant users or in clinical trials with Jadelle. In rodents, which are highly susceptible such cancers, the incidence decreases with decreasing size of the foreign body. Because of the resistance of humans to these cancers and because of the small size of the implants, the risk to users of Jadelle judged to be minimal. 

Can a woman use Jadelle if she is breastfeeding? Hormones are not considered the most appropriate contraceptives for breastfeeding women. However, studies have shown no significant effects on the growth or health of infants whose nursing mothers began using levonorgestrel implants five to seven weeks after childbirth. There is no experience to support the use of Jadelle earlier than six weeks after childbirth in lactating women.

Is sickle cell anemia a contraindication? Sickle cell anemia is not considered a contraindication for the use of Jadelle. However, the Population Council does not have relevant data from clinical trials since women who were anemic were not included in the Council’s studies with Norplant capsules or with Jadelle. One published study indicated that women with sickle cell anemia did not suffer adverse effects when using Norplant capsules. 

Do other drugs interact with Jadelle? Certain drugs may interact with the hormone delivered by Jadelle to make the rods less effective in preventing pregnancy. These include drugs used for epilepsy such as phenytoin (like Dilantin), carbamazepine, and oxcarbazepine. When considering Jadelle use, a woman should tell her health care provider if she is taking any of these or other medications. Rifampin is known to decrease the effectiveness of combination oral contraceptives; its effect on levonorgestrel concentrations is unknown. 

Is there a risk of ectopic pregnancy? The absolute risk of ectopic pregnancy (a fetus developing outside the uterus) during use of Jadelle is very low, because of the high effectiveness of the method. Ectopic pregnancies occur with Jadelle at a rate of less than 0.5 per 1,000 woman-years. Clinical and controlled postmarketing studies of Norplant users showed no increase in the rate of ectopic pregnancies per year as compared with women using IUDs, oral contraceptives, condoms, or no method at all. Physicians should be alert to the possibility of an ectopic pregnancy among women using Jadelle who become pregnant or complain of lower abdominal pain. Any patient who presents with lower abdominal pain must be evaluated to rule out ectopic pregnancy. 

Are ovarian cysts a problem for Jadelle users? Functional ovarian cysts or enlarged follicles occur in levonorgestrel implant users more frequently than they do in women who do not use Jadelle or Norplant. If follicles become enlarged, they may produce some discomfort in some women, although most users would not be aware of them unless they were found during a physical exam. In the majority of women affected, enlarged follicles will spontaneously disappear and do not require surgery. Rarely, they may twist or rupture, sometimes causing abdominal pain, so that surgery is required. 

Are there known long-term side effects? No studies of long-term health effects from either Jadelle or Norplant use have been conducted beyond five years. However, the drug contained in both types of implants—levonorgestrel—has been used in oral contraceptives for over 30 years. 

What is known about medium-term health effects of Jadelle use? The best evidence of medium-term health effects comes from the five-year Norplant postmarketing surveillance. The surveillance compared some 8,000 Norplant users with about 8,000 users of either IUDs or sterilization in eight developing countries. The women were followed for five years, even if they discontinued use of the method, switched to another, or became pregnant. Norplant was not associated with any material risk of major morbidity compared with the two control groups. For greater detail, see the section on the postmarketing surveillance in this monograph. 

Research and development

Why was Jadelle developed? The Population Council developed Jadelle to provide the same level of contraceptive protection as Norplant while using fewer implants, thereby making the method easier to insert and remove. 

Why are additional contraceptives needed? There is currently no reversible contraceptive that all women like and are able to use. A woman may try several methods until she finds the one that best suits her. Furthermore, a woman may switch methods several times during her reproductive lifetime because of changes in her age, health, economic security, marital status, lifestyle, and concept of ideal family size. All of these factors can have an impact on a woman’s decisions about contraception: when to use or stop using it, what kind to use, and when to switch to another method. Even with Jadelle as an option, there is a need for new contraceptives for groups of women whose needs are not met by available methods.

Where was Jadelle tested? Jadelle was studied in three multicenter trials beginning in 1990. The studies enrolled 1,393 rod users in seven countries. Almost half of the women studied were in the United States; other clinics were in Chile, the Dominican Republic, Egypt, Finland, Singapore, and Thailand. The studies provided data on blood levels, safety, and efficacy. The Council conducted clinical trials using an earlier version of the rods in five countries from 1983 to 1988, which has since been reformulated. 

Much of the information regarding characteristics of levonorgestrel implants comes from extensive studies of the six-implant Norplant. In addition, many countries have conducted preintroduction studies to obtain data on local experience with the Norplant method and to train providers in insertion, removal, and counseling techniques. Norplant capsules have been used in clinical trials and preintroduction studies involving over 55,000 volunteers in more than 40 countries. 

Where has Jadelle been approved? Regulatory agencies in the following countries have approved Jadelle: Finland, France, Iceland, Indonesia, Luxembourg, Netherlands, Norway, Spain, Sweden, Thailand, and the United States. However, the implant is not currently available in all of the countries where it has received regulatory approval. It is not on the market, for example, in the United States. 

Is there a risk of Jadelle being used coercively? There is a risk of any provider-controlled method being used coercively. The Population Council strongly advocates the voluntary use of any contraceptive and believes that women have the right to balanced and accurate information, trained and capable health care providers, aseptic conditions, and ability to discontinue the use of the contraceptive on request. Wherever provider-dependent methods are offered, providers should obtain women’s informed consent at the time the method is adopted, and users should have ready access to removal of the rods by competent health care providers.