13.07.2014

Ways to get pregnant on implanon

It is not known if IMPLANON is as effective in very overweight women because clinical studies did not include many overweight women. The following chart shows the chance of getting pregnant for women who use different methods of birth control.
Talk to your health care provider about using IMPLANON if you have diabetes, high cholesterol or triglycerides, headaches, gallbladder or kidney problems, history of depressed mood, high blood pressure, allergy to numbing medicines (anesthetics) or medicines used to clean your skin (antiseptics). Immediately after the IMPLANON implant has been placed, you and your health care provider should check that the implant is in your arm by feeling for it. If you become pregnant while using IMPLANON, you have a slightly higher chance that the pregnancy will be ectopic (occurring outside the womb) than do women who do not use birth control. The use of IMPLANON may also increase your chance of serious blood clots, especially if you have other risk factors, such as smoking. IMPLANON does not protect against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases. Implanon should be inserted between Day 1 (first day of menstrual bleeding) and Day 5 of the menstrual cycle, even if the woman is still bleeding.
Implanon should preferably be inserted on the day after the last active tablet of the previous combined oral contraceptive or on the day of the removal of the vaginal ring or transdermal patch.
Contraceptive implant or intrauterine system (IUS): Insert Implanon on the same day as the previous contraceptive implant or IUS is removed.
First Trimester: Implanon should be inserted within 5 days following a first trimester abortion or miscarriage. Second Trimester: Insert Implanon between 21 to 28 days following second trimester abortion or miscarriage. The basis for successful use and subsequent removal of Implanon is a correct and carefully performed subdermal insertion of the single, rod-shaped implant in accordance with the instructions. Prior to inserting Implanon carefully read the instructions for insertion as well as the full prescribing information. The woman is not pregnant nor has any other contraindication for the use of Implanon [see Contraindications (4)]. Until the presence of the implant has been verified, the woman should be advised to use a non-hormonal contraceptive method, such as condoms.
Immediate replacement can be done after removal of the previous implant and is similar to the insertion procedure described in section 2.2 Insertion of Implanon.
The new implant may be inserted in the same arm, and through the same incision from which the previous implant was removed. Single, off-white, soft, flexible, ethylene vinylacetate (EVA) implant, 4 cm in length and 2 mm in diameter containing 68 mg etonogestrel. The following information is based on experience with either Implanon, other progestin-only contraceptives, or experience with combination (estrogen plus progestin) oral contraceptives. Implanon should be inserted subdermally so that it will be palpable after insertion, and this should be confirmed by palpation immediately after insertion. Implant removal may be difficult or impossible if the implant is not inserted correctly, is inserted too deeply, not palpable, encased in fibrous tissue, or has migrated. There have been reports of migration of the implant within the arm from the insertion site, which may be related to a deep insertion. After starting Implanon, women are likely to have a change from their normal menstrual bleeding pattern. In clinical studies of Implanon, reports of changes in bleeding pattern were the most common reason for stopping treatment (11.1%). Bleeding patterns observed with use of Implanon for up to 2 years, and the proportion of 90-day intervals with these bleeding patterns, are summarized in Table 2. As with all progestin-only contraceptive products, be alert to the possibility of an ectopic pregnancy among women using Implanon who become pregnant or complain of lower abdominal pain. There have been postmarketing reports of serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using Implanon. Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, Implanon should not be used prior to 21 days postpartum.
Consider removal of the Implanon implant in case of long-term immobilization due to surgery or illness. Use of Implanon may induce mild insulin resistance and small changes in glucose concentrations of unknown clinical significance. Women who are being treated for hyperlipidemia should be followed closely if they elect to use Implanon. In clinical trials with Implanon, the etonogestrel levels in blood decreased below sensitivity of the assay by one week after removal of the implant. A woman who is using Implanon should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated health care.
Sex hormone-binding globulin concentrations may be decreased for the first 6 months after Implanon insertion followed by a gradual recovery. In clinical trials including 942 women who were evaluated for safety, change in menstrual bleeding patterns (irregular menses) was the most common adverse reaction causing discontinuation of use of Implanon (11.1% of women). Other adverse reactions that were reported by at least 5% of subjects in clinical trials of Implanon are listed in Table 4. Implant site complications were reported by 3.6% of subjects during any of the assessments in clinical trials.
The following additional adverse reactions have been identified during post-approval use of Implanon. General disorders and administration site conditions: edema, fatigue, implant site reaction, pyrexia. Complications related to insertion or removal of the implant reported include: bruising, slight local irritation, pain or itching, fibrosis at the implant site, paresthesia or paresthesia-like events, scarring and abscess. Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins, and may decrease the effectiveness of Implanon. Teratology studies have been performed in rats and rabbits using oral administration up to 390 and 790 times the human Implanon dose (based upon body surface) and revealed no evidence of fetal harm due to etonogestrel exposure.
Studies have revealed no increased risk of birth defects in women who have used combination oral contraceptives before pregnancy or during early pregnancy.
Based on limited clinical data, Implanon may be used during breastfeeding after the fourth postpartum week.


No studies were conducted to evaluate the effect of hepatic disease on the disposition of Implanon. No studies were conducted to evaluate the effect of renal disease on the disposition of Implanon.
The effectiveness of Implanon in women who weighed more than 130% of their ideal body weight has not been defined because such women were not studied in clinical trials. Implanon (etonogestrel implant) is a progestin-only, soft, flexible implant preloaded in a sterile, disposable applicator for subdermal use. The contraceptive effect of Implanon is achieved by suppression of ovulation, increased viscosity of the cervical mucus, and alterations in the endometrium.
After subdermal insertion of the etonogestrel implant, etonogestrel is released into the circulation and is approximately 100% bioavailable. The pharmacokinetic profile of Implanon from 1 of 3 pharmacokinetic studies is shown in Figure 24. In the subgroup of women 18 to 35 years of age at entry, 6 pregnancies during 20,648 cycles of use were reported.
One Implanon package consists of a single implant containing 68 mg etonogestrel that is 4 cm in length and 2 mm in diameter, which is pre-loaded in the needle of a disposable applicator. Counsel women that Implanon does not protect against HIV infection (AIDS) or other sexually transmitted diseases. Counsel women that the use of Implanon may be associated with changes in their normal menstrual bleeding patterns so that they know what to expect. Implanon® does not protect against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases. Implanon is a hormone-releasing birth control implant for use by women to prevent pregnancy for up to 3 years. When the Implanon implant is placed correctly, your chance of getting pregnant is very low (less than 1 pregnancy per 100 women who use Implanon for 1 year).
If you and your health care provider cannot feel the IMPLANON implant, use a non-hormonal birth control method (such as condoms) until your health care provider confirms that the implant is in place.
In studies, about one out of ten women stopped using the implant because of an unfavorable change in their bleeding pattern.
In rare cases, implants have been reported to be found in a blood vessel, including a blood vessel in the lung. To reduce the risk of neural or vascular injury, the implant should be inserted at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus. At the latest, Implanon should be inserted on the day following the usual tablet-free, ring-free, patch-free or placebo tablet interval of the previous combined hormonal contraceptive.
Both the healthcare provider and the woman should be able to feel the implant under the skin after placement. Information concerning the insertion and removal of Implanon will be sent upon request free of charge [1-877-Implanon (1-877-467-5266)]. The implant should be inserted subdermally just under the skin [see Warnings and Precautions (5.1)]. If the needle is not inserted to its full length, the implant may protrude from the insertion site and fall out.
After insertion of the implant, the grooved tip of the obturator will be visible inside the needle (Figure 11).
By palpating both ends of the implant, you should be able to confirm the presence of the 4-cm rod (Figure 12). After insertion of the implant, the grooved tip of the obturator will be visible inside the needle. Locate the implant by palpation and mark the distal end (end closest to the elbow), for example, with a sterile marker (Figure 13). Be sure to inject the local anesthetic under the implant to keep it close to the skin surface. Starting at the distal tip of the implant, make a longitudinal incision of 2 mm towards the elbow. Grasp the implant with forceps (preferably curved mosquito forceps) and gently remove the implant (Figure 16). An implant that has been deeply inserted or has migrated may not be palpable and therefore imaging procedures, as described below, may be required for localization. If the implant is located in the chest, surgical or endovascular procedures may be needed for removal; healthcare providers familiar with the anatomy of the chest should be consulted. Removal of deeply inserted implants should be conducted with caution in order to prevent injury to deeper neural or vascular structures in the arm and be performed by healthcare providers familiar with the anatomy of the arm.
Failure to insert Implanon properly may go unnoticed unless it is palpated immediately after insertion. To reduce the risk of neural or vascular injury, Implanon should be inserted at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus. There also have been rare postmarketing reports of implants located within the vessels of the arm and the pulmonary artery, which may be related to deep insertions or intravascular insertion. Although ectopic pregnancies are uncommon among women using Implanon, a pregnancy that occurs in a woman using Implanon may be more likely to be ectopic than a pregnancy occurring in a woman using no contraception.
Use of Implanon in women with active liver disease or liver cancer is contraindicated [see Contraindications (4)]. Consideration should be given to removing Implanon in patients who become significantly depressed. Based on in vitro data, when the implant is broken or bent, the release rate of etonogestrel may be slightly increased. Expulsion or migration of the implant, have been reported, including rarely to the chest wall. In women on long-term treatment with hepatic enzyme inducing drugs, it is recommended to remove the implant and to advise a contraceptive method that is unaffected by the interacting drug. There is no evidence that the risk associated with Implanon is different from that of combination oral contraceptives. The use of Implanon in women with active liver disease is contraindicated [see Contraindications (4)]. Serum concentrations of etonogestrel are inversely related to body weight and decrease with time after implant insertion.


The implant is off-white, non-biodegradable and 4 cm in length with a diameter of 2 mm (see Figure 22). Read this Patient Information leaflet carefully before you decide if Implanon is right for you. The implant is a flexible plastic rod about the size of a matchstick that contains a progestin hormone called etonogestrel. Your healthcare provider can insert a new implant under your skin after taking out the old one if you choose to continue using Implanon for birth control.
It is not known if Implanon is as effective in very overweight women because studies did not include many overweight women. You may need special tests to check that the implant is in place or to help find the implant when it is time to take it out. Removal of the implant may be very difficult or impossible if the implant is not where it should be. Call your health care provider right way if you think you are pregnant or have unexplained lower stomach (abdominal) pain. The implant should be inserted subdermally just under the skin, avoiding the sulcus (groove) between the biceps and triceps muscles and the large blood vessels and nerves that lie there in the neurovascular bundle deeper in the subcutaneous tissues. Please note that the Implanon rod is not radiopaque and cannot be seen by X-ray or CT scan.
Once the implant has been localized in the arm, the implant should be removed according to the instructions in Dosage and Administration (2.3), Procedure for Removal of an Implant that is Palpable, and the use of ultrasound guidance during the removal should be considered. Implanon should be inserted subdermally just under the skin, avoiding the sulcus (groove) between the biceps and triceps muscles and the large blood vessels and nerves that lie there in the neurovascular bundle deeper in the subcutaneous tissues. In cases where the implant has migrated to the pulmonary artery, endovascular procedures may be needed for removal. If the implant is located in the chest, healthcare providers familiar with the anatomy of the chest should be consulted. In studies, 2.3% of the users reported weight gain as the reason for having the implant removed. Therefore, a woman should re-start contraception immediately after removal of the implant if continued contraceptive protection is desired. In rare cases implants have been found within the vasculature including the pulmonary artery.
It is therefore possible that Implanon may be less effective in overweight women, especially in the presence of other factors that decrease serum etonogestrel concentrations such as concomitant use of hepatic enzyme inducers.
Each implant consists of an ethylene vinylacetate (EVA) copolymer core, containing 68 mg of the synthetic progestin etonogestrel, surrounded by an EVA copolymer skin. After removal of the implant, etonogestrel concentrations decreased below sensitivity of the assay by 1 week.
Each conception was likely to have occurred shortly before or within 2 weeks after Implanon removal.
Your healthcare provider will insert the implant just under the skin of the inner side of your upper arm. If you do not want to get pregnant after your healthcare provider removes the Implanon implant, you should start another birth control method right away. Implanon also thickens the mucus in your cervix and this change may keep sperm from reaching the egg. Special procedures, including surgery in the hospital, may be needed to remove the implant.
By holding the obturator fixed in place on the arm and fully retracting the cannula, the implant will be left in its correct subdermal position.
If a partial implant (less than 4 cm) is removed, the remaining piece should be removed by following the instructions in section 2.3. Deep insertions of Implanon have been associated with paraesthesia (due to neural injury) and migration of the implant (due to intramuscular or fascial insertion), and in a very few cases with intravascular insertion. Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event. The bleeding pattern experienced during the first three months of Implanon use is broadly predictive of the future bleeding pattern for many women. The percentages of patients having 0, 1-7, 8-21, or >21 days of spotting or bleeding over a 90-day interval while using the Implanon implant are shown in Table 1.
During the first months after insertion of Implanon, when maternal blood levels of etonogestrel are highest, about 100 ng of etonogestrel may be ingested by the child per day based on an average daily milk ingestion of 658 mL. With these 6 pregnancies, the cumulative Pearl Index was 0.38 pregnancies per 100 women-years of use. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
If the implant is not removed, then the effects of IMPLANON will continue for a longer period of time.
Tell your doctor at least 4 weeks before if you are going to have surgery or will need to be on bed rest, because you have an increased chance of getting blood clots during surgery or bed rest. Occasionally in post-marketing use, implant insertions have failed because the implant fell out of the needle or remained in the needle during insertion. The USER CARD should be filled out and given to the patient after insertion of the Implanon implant so that she will have a record of the location of the implant in the upper arm and when it should be removed. Other problems related to insertion and removal include pain, irritation, swelling, bruising, scarring, infection, injury to the nerves or blood vessels, and breaking of the implant. Abnormal bleeding should be evaluated as needed to exclude pathologic conditions or pregnancy. The health of breast-fed infants whose mothers began using Implanon during the fourth to eighth week postpartum (n=38) was evaluated in a comparative study with infants of mothers using a non-hormonal IUD (n=33). The implant must be removed by the end of the third year and may be replaced by a new implant at the time of removal, if continued contraceptive protection is desired. Use a back up birth control method and call your health care provider right away if the implant comes out.



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