Norplant (Levonorgestrel)

NORPLANT®

Wyeth-Ayerst

Levonorgestrel

Contraceptive Implant

Action And Clinical Pharmacology: Norplant consists of levonorgestrel implants, a set of 6 flexible closed capsules made of Silastic (dimethylsiloxane/methylvinylsiloxane copolymer) each containing 36 mg of the progestin levonorgestrel. Levonorgestrel, 18,19-Dinorpregn-4-en-20-yn-3-one,13-ethyl-17-hydroxy-,(17a)-(-)-, is a totally synthetic and biologically-active progestin which exhibits no significant estrogenic activity and is highly progestational. The absolute configuration conforms to that of D-natural steroids. Levonorgestrel is not subjected to a “first-pass” effect and is virtually 100% bioavailable. Plasma concentrations average 0.30 ng/mL over 5 years and are variable as a function of individual metabolism and body weight.

Diffusion of levonorgestrel through the wall of each capsule provides a continuous low dose of the progestin. Resulting blood levels are substantially below those generally observed among users of combination oral contraceptives containing the progestins, norgestrel or levonorgestrel. Because of the range of variability in blood levels and variation in individual response, blood levels are not predictive of the risk of pregnancy in an individual woman.

At least two mechanisms are active in preventing pregnancy: ovulation inhibition and thickening of the cervical mucus. Other mechanisms may add to these contraceptive effects.

Mean plasma levonorgestrel levels decrease below 0.1 ng/mL by 96 hours after removal of the implants and below the level of assay sensitivity (0.05 ng/mL) by 5 to 14 days. Once the implants are removed, the contraceptive effects cease quickly and women can become pregnant as rapidly as women who have not used the method. Circulating concentrations can be used to forecast the risk of pregnancy only in a general statistical sense.

No statistically significant increases have been reported in the ratio of total cholesterol to HDL-cholesterol

Indications And Clinical Uses: For the prevention of pregnancy and is a long-term (up to 5 years) reversible contraceptive product. Norplant should be removed by the end of the 5th year. A new Norplant may be inserted at that time if continuing contraceptive protection is desired.

Norplant is particularly suited for women who are seeking long-term (up to 5 years) reversible contraception, want to avoid daily contraceptive use or cannot use estrogen-containing contraceptives, or, do not want to undergo permanent sterilization.

In multiclinic trials, 402 subjects on Norplant were evaluated. In the first 5 years, a total of 1 271 woman-years of experience was accumulated. The annual and 5-year cumulative pregnancy rate per 100 women on Norplant is shown in Table I. Pregnancy rates did not differ appreciably by age, weight, or by parity of the women who participated in clinical trials comprised of 402 subjects.

The overall safety experience with Norplant is derived from evaluations on 2 470 subjects.

Contra-Indications: Active thrombophlebitis or thromboembolic disorders; undiagnosed abnormal genital bleeding; known or suspected pregnancy; acute liver disease; benign or malignant liver tumors; known or suspected carcinoma of the breast; history of idiopathic intracranial hypertension; hypersensitivity to levonorgestrel or any of the other components of Norplant.

Manufacturers’ Warnings In Clinical States: Warnings based on experience with Norplant:

Bleeding Irregularities: Most women can expect some variation in menstrual bleeding patterns. Irregular bleeding, intermenstrual spotting, prolonged episodes of bleeding and spotting, and amenorrhea occur in some women. Irregular bleeding patterns associated with the Norplant implant could mask symptoms of cervical or endometrial cancer. Overall, these irregularities diminish with continuing use. Since some Norplant users experience periods of amenorrhea, missed menstrual periods cannot serve as the only means of identifying early pregnancy. 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. If pregnancy occurs, the implants must be removed.

Although bleeding irregularities have occurred in clinical trials, proportionately more women had increases rather than decreases in hemoglobin concentrations, a difference that was highly statistically significant. This finding generally indicates that reduced menstrual blood loss is associated with the use of Norplant. In rare instances, blood loss did result in hemoglobin values consistent with anemia.

Ovarian Cysts (Delayed Follicular Atresia): If follicular development occurs with Norplant, atresia of the follicle is sometimes delayed and the follicle may continue to grow beyond the size it would attain in a normal cycle. These enlarged follicles cannot be distinguished clinically from ovarian cysts. In the majority of women, enlarged follicles will spontaneously disappear and should not require surgery. Rarely, they may twist or rupture, sometimes causing abdominal pain, and surgical intervention may be required.

Pregnancy: Ectopic Pregnancies: Clinical studies have demonstrated that ectopic pregnancies have occurred among Norplant users, at similar rates as with users of no method or of IUDs. The incidence among Norplant users was 1.3 per 1 000 woman-years. The risk of ectopic pregnancy may increase with the duration of Norplant use and possibly with increased weight of the user. Physicians should be alert to the possibility of an ectopic pregnancy among women using Norplant who become pregnant or complain of lower abdominal pain. The risk of ectopic pregnancies increases as the risk of pregnancy increases. Therefore, any patient who presents with lower abdominal pain must be evaluated to rule out ectopic pregnancy.

Use Before or During Pregnancy: There have been rare reports of congenital anomalies in offspring of women who were using Norplant inadvertently during early pregnancy. A cause and effect relationship is not believed to exist.

Breast-feeding: Steroids are not considered the contraceptives of first choice for breast-feeding women. Levonorgestrel has been identified in the breast milk. The health of breast-fed infants whose mothers began using the Norplant during the 5th to 7th week postpartum was evaluated: no significant effects were observed on the growth or development of infants who were followed to 12 months of age. No data are available on use in breast-feeding mothers earlier than this after parturition.

Foreign Body Carcinogenesis: Rarely, cancers have occurred at the site of foreign body intrusions or old scars. None has been reported in Norplant clinical trials. In rodents, which are highly susceptible to such cancers, the incidence decreases with decreasing size of the foreign body. Because of the resistance of human beings to these cancers and because of the small size of the implants, the risk to users of Norplant is judged to be minimal.

Thromboembolic Disorders: Patients who develop active thrombophlebitis or thromboembolic disease should have Norplant removed. Physicians should therefore be alert to the early manifestations of thromboembolic disorders (e.g., pulmonary embolism, stroke, retinal thrombosis, etc.). Norplant removal should also be considered in women who will be subjected to prolonged immobilization due to surgery or other illnesses.

Idiopathic Intracranial Hypertension: Idiopathic intracranial hypertension (pseudotumor cerebri, benign intracranial hypertension) is a disorder of unknown etiology which is seen most commonly in obese females of reproductive age. There have been reports of idiopathic intracranial hypertension in Norplant users. A cardinal sign of idiopathic intracranial hypertension is papilledema; early symptoms may include headache (associated with a change in frequency, pattern, severity, or persistence; of particular importance are those headaches that are unremitting in nature) and visual disturbances. Patients with these symptoms, particularly obese patients or those with recent weight gain, should be screened for papilledema and, if present, the patient should be referred to a neurologist for further diagnosis and care. Norplant should be removed from patients experiencing this disorder.

Precautions: General: Physical Examination and Followup: A complete medical history and physical examination should be taken prior to the implantation or re-implantation of Norplant and at least annually during its use. At each annual visit, examination should include those procedures that were done at the initial visit. These physical examinations should include special reference to the implant site, blood pressure, breasts, liver, abdomen, extremities and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate diagnostic measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have benign breast nodules should be monitored with particular care.

Sexually Transmitted Diseases: Norplant does not protect against sexually transmitted diseases (STDs) including HIV/AIDS. For protection against STDs, it is advisable to use latex condoms along with Norplant.

Autoimmune Diseases: Autoimmune diseases such as scleroderma, systemic lupus erythematosus 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 above, in Norplant users; however the rate of reporting is significantly less than the expected incidence for these diseases. Studies have raised the possibility of developing antibodies against silicone-containing devices; however, the specificity and clinical relevance of these antibodies are unknown. While it is believed that the occurrence of autoimmune disease among Norplant users is coincidental, healthcare providers should be alert to the earliest manifestations.

Carbohydrate and Lipid Metabolism: An altered glucose tolerance characterized by decreased insulin sensitivity following glucose loading has been found in some users of combination and progestin-only oral contraceptives. Diabetic patients, or those with a family history of diabetes, should be observed closely to detect any alterations in carbohydrate metabolism. Young diabetic patients whose disease is of recent origin, well-controlled, and not associated with hypertension or other signs of vascular disease such as ocular fundal changes, should be closely observed. The effects of Norplant on carbohydrate metabolism appear to be minimal. In a study in which pretreatment serum glucose levels were compared with levels after 1 and 2 years of Norplant use, no statistically significant differences in mean serum glucose levels were evident 2 hours after glucose loading. The clinical significance of these findings is unknown but diabetic and prediabetic patients should be carefully observed while using Norplant.

Women who are being treated for hyperlipidemias should be followed closely if they elect to use Norplant. Some progestins may elevate LDL levels and may render the control of hyperlipidemias more difficult.

Liver Function: If jaundice develops in any women while using Norplant, consideration should be given to removing the implants. Steroid hormones may be poorly metabolized in patients with impaired liver function.

Fluid Retention: Steroid contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.

Emotional Disorders: Consideration should be given to removing Norplant in women who become significantly depressed since the symptom may be drug related. Women with a history of depression should be carefully observed and Norplant removal considered if depression recurs to a serious degree.

Contact Lenses: Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. Temporary or permanent cessation of wear may be advised.

Insertion and Removal: To be sure that the woman is not pregnant at the time of implant placement and to assure contraceptive effectiveness during the first cycle of use, it is advisable that the Norplant insertion be done during the first 7 days of the cycle or immediately following an abortion. However, Norplant capsules may be inserted at any time during the cycle provided pregnancy has been excluded and a nonhormonal contraceptive method is used for the remainder of that cycle following insertion. Insertion is not recommended before 6 weeks postpartum in breast-feeding women.

Insertion and removal are not difficult procedures but instructions must be followed closely. It is strongly advised that all healthcare professionals who insert and remove Norplant be instructed in the procedures before they attempt them. A proper insertion just under the skin will facilitate removals. Proper Norplant insertion and removal should result in minimal scarring. If the implants are placed too deeply, they can be harder to remove. There have been infrequent reports of the use of general anesthesia during the removal procedure; it is generally not required. Before initiating the removal procedure, all Norplant capsules should be localized via palpation. If all 6 capsules cannot be palpated, they may be localized via ultrasound (7 MHz) or X-ray (soft tissue). If all implants cannot be removed at the first attempt, removal should be attempted later when the site has healed. Bruising may occur at the implant site during insertion or removal. Other cutaneous reactions that have been reported include blistering, ulcerations and sloughing. There have been reports of arm pain, numbness and tingling following these procedures. In some women, hyperpigmentation occurs over the implantation site but is usually reversible following removal. See Dosage for Insertion and Removal Instructions.

Infections: Infection at the implant site, including cellulitis, has been uncommon. Attention to aseptic technique and proper insertion and removal of the Norplant implants reduces the possibility of infection. If infection occurs, suitable treatment should be instituted. If infection persists, the implants should be removed.

Capsule Expulsion and Displacement: Expulsion of implants was uncommon. It occurred more frequently when placement of the implants was extremely shallow, too close to the incision, or when infection was present. Replacement of an expelled implant must be accomplished using a new sterile implant. Contraceptive efficacy may be inadequate with fewer than 6 implants. If infection is present, it should be treated and cured before replacement.

There have been reports of capsule displacement (i.e., movement) most of which involve minor changes in the positioning of the capsules. However, infrequent reports of significant displacement (a few to several inches) have been received. Some reports have been associated with pain or discomfort. In the event that capsule movement occurs, the removal technique may need to be modified, such as additional incisions or visits.

Provisions for Removal: Women should be counselled that they can request removal of the implants at any time for medical or personal reasons. The removal should be done on request or at the end of 5 years of usage by personnel instructed in the removal technique.

Drug Interactions: Reduced efficacy (pregnancy) has been reported for Norplant users taking phenytoin and carbamazepine. These drugs may increase the metabolism of levenorgestrel through induction of microsomal liver enzymes. Norplant users should be warned of the possibility of decreased efficacy with use of drugs exhibiting enzyme-inducing activity such as those noted above and rifampicin. For women receiving long-term therapy with hepatic enzyme inducers, another method of contraception should be considered.

Drug/Laboratory Test Interactions : Certain endocrine tests may be affected by Norplant use: sex hormone binding globulin concentrations are decreased, thyroxine concentrations may be slightly decreased and triiodothyronine uptake increased.

Adverse Reactions: The following adverse reactions have been associated with Norplant and a slightly different version (more inert filler) subdermal levonorgestrel implant during the first year of use (combined database of 2 470 women): many bleeding days or prolonged bleeding 27.6%, spotting 17.1%, amenorrhea 9.4%, irregular (onsets of) bleeding 7.6%, frequent bleeding onsets 7%, scanty bleeding 5.2%, pain or itching near implant site (usually transient) 3.7%, infection at implant site 0.7%, removal difficulties including damage to capsules 13.2%.

In interpreting the frequency, one should remember that users may have employed several descriptors for the same condition. This means that frequencies for related descriptions cannot simply be added to obtain total rates.

Controlled clinical studies suggest that the following adverse reactions occurring during the first year are probably associated with Norplant use. These adverse reactions have also been reported postmarketing: headache, nervousness/anxiety, nausea/vomiting, dizziness, adnexal enlargement, dermatitis/rash, acne, change of appetite, mastalgia, weight gain, hirsutism, hypertrichosis and scalp hair loss.

In addition, the following adverse reactions have been reported with a frequency of 5% or greater during the first year and are possibly related to Norplant use: breast discharge, cervicitis, musculoskeletal pain, abdominal discomfort, leukorrhea, vaginitis.

The following adverse reactions have been reported postmarketing with an incidence of less than 1% and are possibly related to Norplant use: emotional lability, idiopathic intracranial hypertension (IIH, pseudotumor cerebri, benign intracranial hypertension), dysmenorrhea, migraine, arm pain, numbness, tingling, depression.

The following adverse reactions have been reported postmarketing with an incidence of less than 1%. These events occurred under circumstances where a causal relationship to Norplant is unknown. These reactions are listed as information for physicians: congenital anomalies, pulmonary embolism, superficial venous thrombosis, deep-vein thrombosis, myocardial infarction, thrombotic thrombocytopenic purpura (TTP), stroke, pruritus, urticaria, asthenia (fatigue/weakness).

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Overdosage can result if more than 6 capsules of Norplant are in situ. All implanted Norplant capsules should be removed before inserting a new set. Overdosage may cause fluid retention with its associated effects and uterine bleeding irregularities. tag_DosageDosage

Dosage And Administration: Norplant implants consist of 6 Silastic capsules each containing 36 mg of the progestin levonorgestrel. Thus, the total administered (implanted) dose is 216 mg. Implantation of all 6 capsules should be performed during the first 7 days of the onset of menses by a healthcare professional instructed in the Norplant insertion technique. Insertion is subdermal, through a 2 mm incision, in the mid-portion of the upper arm about 8 to 10 cm above the elbow crease. Distribution should be in a fanlike pattern, about 15° apart, for a total of 75°. Proper insertion will facilitate later removal.

Instructions for Insertion and Removal: Norplant consists of 6 levonorgestrel-releasing capsules that are inserted subdermally in the medial aspect of the upper arm.

Norplant provides up to 5 years of effective contraceptive protection.

The basis for successful use and subsequent removal of Norplant capsules is a correct and carefully performed subdermal insertion of the 6 capsules. It is recommended that healthcare professionals performing insertions or removals of Norplant capsules avail themselves of instruction and supervision in the proper technique prior to attempting these procedures. During insertion, special attention should be given to the following: asepsis, correct subdermal placement of the capsules, careful technique to minimize tissue trauma.

This will help to avoid infections and excessive scarring at the insertion area and will help keep the capsules from being inserted too deeply in the tissue. If the capsules are placed too deeply, they will be more difficult to remove than correctly placed subdermal capsules.

Insertion Procedure: Insertion should be performed within 7 days from the onset of menses. However, Norplant capsules may be inserted at any time during the cycle provided pregnancy has been excluded and a nonhormonal contraceptive method is used for the remainder of that cycle following insertion. It is recommended that a complete history and physical examination, including a gynecologic examination be performed before the insertion of the Norplant capsules. Determine if the subject has any allergies to the antiseptic or anesthetic to be used or contraindications to progestin-only contraception. If none are found, the capsules are inserted using the procedure outlined below.

Norplant consists of 6 capsules in a sterile pouch. The insertion is performed under aseptic conditions using a trocar to place the capsules under the skin. See package insert for illustrations.

Fig. 1: The following equipment is recommended for the insertion: an examining table for the patient to lie on; sterile surgical drapes, sterile gloves (free of talc), antiseptic solution; local anesthetic, needles and syringe; #11 scalpel, #10 trocar, forceps; skin closure, sterile gauze and compresses.

The plastic cover and tray are not sterile.

Fig. 2: Have the patient lie on her back on the examination table with her left arm (if the patient is left-handed, the right arm) flexed at the elbow and externally rotated such that her hand is lying by her head. The capsules will be inserted subdermally through a small 2 mm incision, and positioned in a fanlike manner with the fan opening towards the shoulder.

Fig. 3: Prep the patient’s upper arm with antiseptic solution; cover the arm above and below the insertion area with a sterile cloth. The optimal insertion area is in the inside of the upper arm about 8 to 10 cm above the elbow crease.

Fig. 4: Open the sterile Norplant package carefully by pulling apart the sheets of the pouch, allowing the capsules to fall onto a sterile cloth. Count the 6 capsules.

Fig. 5: After determining the absence of known allergies to the anesthetic agent or related drugs, fill a 5 mL syringe with the local anesthetic. Since blood loss is minimal with this procedure, use of epinephrine-containing anesthetics is not considered necessary. Anesthetize the insertion area by first inserting the needle under the skin and releasing a small amount of anesthetic. Then anesthetize 6 areas about 4 to 4.5 cm long, to mimic the fanlike position of the implanted capsules.

Fig. 6: Use the scalpel to make a small, shallow incision (about 2 mm) just through the dermis of the skin. Alternatively, the trocar may be inserted directly through the skin without making an incision with the scalpel. The bevel of the trocar should always face up during the insertion.

Fig. 7: The trocar has 2 marks on it. The first mark is closer to the hub and indicates how far the trocar should be introduced under the skin before the loading of each capsule. The second mark is close to the tip and indicates how much of the trocar should remain under the skin following the insertion of each implant.

Fig. 8: Insert the tip of the trocar through the incision beneath the skin at a shallow angle. Once the trocar is inserted, it should be oriented with the bevel up toward the skin to keep the capsules in a superficial plane. It is important to keep the trocar subdermal by tenting the skin with the trocar as failure to do so may result in deep placement of the capsules and could make removal more difficult.

Advance the trocar gently under the skin to the first mark near the hub of the trocar. The tip of the trocar is now at a distance of about 4 to 4.5 cm from the incision.

Do not force the trocar. If resistance is felt, try another direction.

Fig. 9: When the trocar has been inserted the appropriate distance, remove the obturator and load the first capsule into the trocar using the thumb and forefinger.

Fig. 10: Gently advance the capsule with the obturator towards the tip of the trocar until you feel resistance. Never force the obturator.

Fig. 11: Hold the obturator steady and bring the trocar back until it touches the handle of the obturator.

Fig. 12: The capsule should have been released under the skin when the mark close to the tip of the trocar is visible in the incision. Release of the capsule can be checked by palpation. It is important to keep the obturator steady and not to push the capsule into the tissue.

Fig. 13: Do not remove the trocar from the incision until all 6 capsules have been inserted. The trocar is withdrawn only to the mark close to its tip. Each succeeding capsule is always inserted next to the previous one, to form a fanlike shape. Fix the position of the previous capsule with the forefinger and middle finger of the free hand and advance the trocar along the tips of the fingers. This will ensure a suitable distance of about 15° between capsules and keep the trocar from puncturing any of the previously inserted capsules.

Leave a distance of about 5 mm between the incision and the tips of the capsules. This will help avoid spontaneous expulsions. The correct position of the capsules can be ensured by feeling them with the fingers after the insertion has been completed.

Fig. 14: After placement of the sixth capsule, a sterile gauze may be used to apply pressure briefly to the insertion site to ensure hemostasis. Palpate the distal ends of the capsules to make sure that all 6 have been properly placed.

Fig. 15: Press the edges of the incision together and close the incision with a skin closure. Suturing the incision should not be necessary.

Fig. 16: Cover the insertion area with a dry compress and wrap gauze around the arm to ensure hemostasis.

Observe the patient for a few minutes for signs of syncope or bleeding from the incision before she is discharged.

Advise the patient to keep the insertion area dry and avoid heavy lifting for 2 to 3 days. The gauze may be removed after 1 day, and the butterfly bandage as soon as the incision has healed, i.e., normally in 3 days.

Removal Procedure: Described below is a removal procedure which was developed and used during the clinical trials for Norplant. As with many surgical procedures, variations of the technique have appeared and some have been published. No one particular procedure routinely appears to have any advantage over another.

It is recommended that removals be prescheduled so that preparations for carrying out the procedure can be facilitated.

Removal of the capsules should be performed very gently and will take more time than insertion. Capsules are sometimes nicked, cut, or broken during removal. The incidence of overall removal difficulties, including damage to capsules, has been 13.2%. Less than half of these removal difficulties have caused inconvenience to the patient. If the removal of some of the capsules proves difficult have the patient return for a second visit. The remaining capsule(s) will be easier to remove after the area is healed. It may be appropriate to seek consultation or provide referral for patients in whom initial attempts at capsule removal prove difficult. If contraception is still desired, a barrier method should be advised until all capsules are removed.

The position of the patient and the asepsis are the same as for insertion.

Fig. 17: The following equipment is needed for the removal: an examining table for the patient to lie on; sterile surgical drapes, sterile gloves (free of talc), antiseptic solution; local anesthetic, needles and syringe; #11 scalpel, forceps (straight and curved mosquito); skin closure, sterile gauze and compresses.

Fig. 18: Locate the implanted capsules by palpation, possibly marking their position with a sterile skin marker. If all 6 capsules cannot be palpated, they may be localized via ultrasound (7 MHz) or X-ray (soft tissue).

Fig. 19: Once all 6 capsules are located, apply a small amount of local anesthetic under the capsule ends nearest the original incision site. This will serve to raise the ends of the capsules. Anesthetic injected over the capsules will obscure them and make removal more difficult. Additional small amounts of the anesthetic can be used for the removal of each of the capsules, if required.

Fig. 20: Make a 4 mm incision with the scalpel close to the ends of the capsules. Do not make a large incision.

Fig. 21: Push each capsule gently towards the incision with the fingers. When the tip is visible or near to the incision, grasp it with a mosquito forceps.

Fig. 22: Use the scalpel, forceps, or gauze to very gently open the tissue sheath that has formed around the capsule.

Fig. 23 and 24: Remove the capsule from the incision with the second forceps.

Fig. 25 and 26: After the procedure is completed, the incision is closed and bandaged as with insertion. The upper arm should be kept dry for a few days.

Following removal, a return to the previous level of fertility is usually prompt and a pregnancy may occur at any time.

If the patient wishes to continue using the method, a new Norplant can be inserted through the same incision in the same or opposite direction.

Hints: Insertion: Counselling of the patient on the benefits and side-effects of the method prior to insertion will greatly increase patient satisfaction.

Correct subdermal placement of the capsules will facilitate removal.

Before insertion, apply the anaesthetic just beneath the skin so as to raise the dermis above the underlying tissue.

Never force the trocar.

To ensure subdermal placement, the trocar with bevel up should be supported by the index finger and should visibly raise the skin at all times during insertion.

To avoid damaging the previous implanted capsule, stabilize the capsule with your forefinger and middle finger and advance the trocar alongside the finger tips at an angle of 15°.

After insertion, make a drawing for the patient’s file showing the location of the 6 capsules and describe any variations in placement. This will greatly aid removal.

Removal: Alternate removal techniques have been developed.

The removal of the implanted capsules will take a little more time than the insertion.

Before initiating removal, all capsules should be located by palpation. If all 6 capsules cannot be palpated, they may be localized via ultrasound (7 MHz) or X-ray (soft tissue).

Before removal, apply the anesthetic under the capsule ends nearest the original incision site.

If one of the capsules has moved away from the incision, in order to facilitate finding it, use the straight mosquito clamp first to pull the capsule closer to the incision. Then change to the curved mosquito forceps to make the tip of the capsule visible and remove the surrounding connective tissue. When the capsule has been freed this way, re-grasp it with the straight forceps and pull it out gently.

It may facilitate removal of the capsule if you grasp the proximal tip with the straight mosquito clamp which is then turned 180° with the handle facing the patient’s shoulder.

It is usually not helpful to enlarge the incision for easier removal.

If the removal of some of the capsules proves difficult, interrupt the procedure and have the patient return for another visit. The remaining capsule(s) will be easier to remove after the area is healed.

It may be appropriate to seek consultation or provide referral for patients in whom initial attempts at capsule removal prove difficult.

Fig. 27: Occasionally, a Norplant capsule may have a U or V shape due to faulty insertion. To remove such a disfigured insert, one may have to make a second incision at the tip of the capsule (see Fig. 27). Grasp the tip with the curved forceps, clean the connective tissue and remove the capsule with the straight forceps in the usual fashion.

If extreme force is applied on the capsule when grasping during removal, it may break. If this happens, the capsule fragments can be removed by pushing them with a finger towards the incision or by making a second incision at the opposite end of the capsule.

It is important to line up all the fragments after removal and compare them with an intact capsule to ensure that all the pieces have been removed.

If the removal of some of the capsules proves difficult, interrupt the procedure and have the patient return for a second visit 4 to 6 weeks later. The remaining capsule(s) will be easier to remove after the area is healed.

Availability And Storage: Each subdermal implant contains: levonorgestrel 36 mg. Each Norplant system consists of 6 capsules and is available as a Norplant System Kit.

Each Norplant System Kit contains: 1 Norplant System (subdermal 36 mg levonorgestrel implants), a set of 6 implants; 1 Norplant System Trocar (10G´2.75²); 1 scalpel; 1 forceps; 1 syringe (6 cc); 1 syringe needle (22G´1.5²); 1 syringe needle (18G´1²); 1 package of skin closures; 3 packages of gauze sponges; 1 stretch bandage; 1 surgical drape (fenestrated); 2 surgical drapes; 1 patient labelling leaflet; 1 patient folder; 1 prescribing information leaflet. Nonmedicinal ingredients: polydimethylsiloxane. Store between 15 and 30°C. Protect from excess heat and moisture.

NORPLANT® Wyeth-Ayerst Levonorgestrel Contraceptive Implant

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