Levoplant Warnings

Clinical trials have demonstrated the contraceptive efficacy of Levonorgestrel (Levoplant) for three years of use. The serum levonorgestrel concentration is lower at the end of the implant use and it is inversely related to the user's body weight.
Expulsion of an implant may occur before the incision has healed if the implants have been inserted very near the skin surface or too close to the incision or when the insertion site is infected. An expelled implant must always be replaced with a new, sterile implant.
Breakage of Levonorgestrel (Levoplant) at or near removal occurred at a rate of 16% over 4 years in the pivotal clinical trial.
Reports have been published on slight displacement of similar levonorgestrel implants, most of which have involved minor changes in the position of the implants. Infrequent reports on significant displacement (a few to several centimetres) have been received. Some of these cases have been associated with pain or discomfort. In the event of displacement, the removal technique may have to be modified and may involve additional incisions or visits.
Altered serum lipoprotein levels have been observed in clinical trials on levonorgestrel implants. Although statistically significant decreases in total cholesterol, HDL (high-density lipoprotein) and LDL (low-density lipoprotein) and triglycerides have been detected, all mean values have remained within the normal ranges. The long-term clinical significance of these changes has not been determined.
The effects of levonorgestrel implants on clotting factors have varied. In patients with a history of thromboembolic disease, Levonorgestrel (Levoplant) should only be used if other contraceptive methods are unsuitable and after careful assessment of the risk-benefit ratio. Thromboembolic and cardiovascular undesirable effects have been reported in users of other levonorgestrel implants. Cases of stroke, myocardial infarction, pulmonary embolism and deep venous thrombosis have been reported in users of other levonorgestrel implants. Patients who develop thrombotic or embolic disease should have their Levonorgestrel (Levoplant) implants removed. Thrombophlebitis and superficial phlebitis have occurred more commonly in the arm of insertion. Some cases have been associated with trauma to that arm. Special caution should be observed in prescribing Levonorgestrel (Levoplant) for patients with recognized risk factors for or any predisposition to arterial disease.
If a sustained hypertension develops during the use of Levonorgestrel (Levoplant) implants, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, the use of Levonorgestrel (Levoplant) implants should be discontinued.
If a patient has a history of or develops focal or crescendo type migraine or exhibits worsening of such migraine during the use of Levonorgestrel (Levoplant), the situation should be carefully assessed.
Contact lens wearers who develop loss of vision or changes in lens tolerance should be assessed by an ophthalmologist. The patient may be advised to stop wearing contact lenses for a while or completely.
Altered glucose tolerance and insulin sensitivity in oral glucose tests have been reported in users of levonorgestrel implants in some studies. The clinical significance of these findings is unknown but diabetic patients using Levonorgestrel (Levoplant) should be carefully monitored. A gain in weight is possible during the use of Levonorgestrel (Levoplant).
If cholestatic hepatitis or jaundice develops in a patient with Levonorgestrel (Levoplant), the implants must be removed. A mild or moderate transient rise in total serum bilirubin is usual at the start of the implant use. A slightly increased risk of cholelithiasis has been reported during the use of other levonorgestrel implants of similar type. Levonorgestrel metabolism may be slower than normal in patients with impaired liver function.
Removal of Levonorgestrel (Levoplant) should also be considered in women who become significantly depressed, since the symptom may be hormone-related. Women with a history of depression should be carefully monitored and removal of Levonorgestrel (Levoplant) should be considered if clear symptoms develop.
Steroid hormones may cause some degree of fluid retention, which may result in weight gain. The use of Levonorgestrel (Levoplant) should be considered carefully in patients with conditions that might be aggravated by fluid retention, and their condition should be monitored closely during the use of Levonorgestrel (Levoplant).
Idiopathic intracranial hypertension has been reported on rare occasions in users of levonorgestrel implants. Evidence is based on isolated reports only. This diagnosis should be considered if persistent headache and/or visual disturbances occur in a woman with Levonorgestrel (Levoplant), particularly if the patient is obese or has recently gained weight. If idiopathic intracranial hypertension is diagnosed, Levonorgestrel (Levoplant) should be removed.
Levonorgestrel (Levoplant) implants affect the menstrual bleeding pattern in most women. Irregular, prolonged and intermenstrual bleeding, spotting and amenorrhea have been reported. In general, such irregularities decrease with continuing use. Significant blood loss leading to anemia is rare, and average concentrations of hemoglobin normally rise slightly in Levonorgestrel (Levoplant) users.
Since some users of Levonorgestrel (Levoplant) experience periods of amenorrhea, missed menstrual periods should not be relied on as the sole means of diagnosing pregnancy. A pregnancy test should be performed whenever pregnancy is suspected. Six or more weeks of amenorrhea after a period of regular menses may indicate pregnancy. The implants must be removed if pregnancy occurs.
Ectopic pregnancy occurs rarely with levonorgestrel implants: at a rate less than 1 per 1,000 woman-years. If a woman using Levonorgestrel (Levoplant) presents with lower abdominal pain or is found to be pregnant, she should be examined to exclude ectopic pregnancy.
Follicles develop during the use of Levonorgestrel (Levoplant) but their atresia may be delayed and they may continue to grow beyond the normal size. In most women, such enlarged follicles will disappear spontaneously. In rare cases, however, they may twist or rupture, causing abdominal pain. Even in the presence of symptoms, conservative management is indicated but ectopic pregnancy must be excluded. Surgical intervention is rarely warranted.
In some rare cases, autoimmune diseases such as scleroderma, LED (lupus erythematosus disseminata) or rheumatoid arthritis have been reported in users of levonorgestrel implants. No causal relationship to implants containing levonorgestrel has been established. Both during pregnancy and during the use of sex steroids, the following conditions have been observed, without confirmed relationship to the use of progestogens: cholestatic icterus and/or itching, cholelithiasis, hemolytic-uremic syndrome, herpes gestationis, and hearing loss associated with otosclerosis.
Even though there is no clear causal connection between the use of oral contraceptives and breast cancer, a meta-analysis of epidemiological studies reported that there is a slightly increased relative risk (RR=1.24) of having breast cancer diagnosed in women who are currently using combined oral contraceptives (COCs). The increased risk gradually disappears during the course of 10 years after cessation of COC use. The risk of having breast cancer diagnosed in progestogen-only contraceptive users is possibly of a similar magnitude to that associated with COCs.