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Norplant

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Norplant

INDICATIONS

The NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM is indicated for the prevention of pregnancy and is a long-term (up to 5 years) reversible contraceptive system. The capsules should be removed by the end of the 5th year. New capsules may be inserted at that time if continuing contraceptive protection is desired.

In multicenter trials with the NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM, involving 2470 women, the relationship between body weight and efficacy was investigated. Tabulated below is the pregnancy experience as a function of body weight. Because NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM is a long-term method of contraception, this is reported over five years of use.

TABLE 1: Annual and Five-Year Cumulative Pregnancy Rates Per 100 Users by Weight Class

Weight class year 1 year 2 year 3 year 4 year 5 Cumulative
< 50kg
( < 110 lbs)
0.2 0 0 0 0 0.2
50-59 kg
(110-130 lbs)
0.2 0.5 0.4 2.0 0.4 3.4
60-69 kg
(131-153 lbs)
0.4 0.5 1.6 1.7 0.8 5.0
≥ 70 kg
( ≥ 154 lbs)
0 1.1 5.1 2.5 0 8.5
All 0.2 0.5 1.2 1.6 0.4 3.9

Typically, pregnancy rates with contraceptive methods are reported for only the first year of use as shown below. The efficacy of these contraceptive methods, except the IUD and sterilization, depends in part on the reliability of use. The efficacy of the NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM does not depend on patient compliance. However, no contraceptive method is 100% effective.

TABLE 2: Percentage Of Women Experiencing An Unintended Pregnancy During The First Year Of Typical Use And The First Year Of Perfect Use Of Contraception And The Percentage Continuing Use At The End Of The First Year. United States.

  % of Women Experiencing an
Unintended Pregnancy within the First Year of Use
% of Women
Continuing Use at One
Year 3
Method (1) Typical Use1
(2)
Perfect Use2
(3)
(4)
Chance 4 85 85  
Spermicides 5 26 6 40
Periodic abstinence 25   63
  Calendar   9  
  Ovulation Method   3  
  Sympto-Thermal 6   2  
  Post-Ovulation   1  
Cap 7  
  Parous Women 40 26 42
  NulliparousWomen 20 9 56
Sponge  
  Parous Women 40 20 42
  NulliparousWomen 20 9 56
Diaphragm7 20 6 56
Withdrawal 19 4  
Condom 8  
  Female (Reality) 21 5 56
  Male 14 3 61
Pill 5   71
  Progestin only   0.5  
  Combined   0.1  
IUD  
  Progesterone T 2.0 1.5 81
  Copper T380A 0.8 0.6 78
  LNg 20 0.1 0.1 81
Depo-Provera® 0.3 0.3 70
Levonorgestrel
Implants (Norplant® )
0.05 0.05 88
Female Sterilization 0.5 0.5 100
Male Sterilization 0.15 0.10 100
Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.9
Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998.
1.Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
2.Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
3.Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
4.The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5.Foams, creams, gels, vaginal suppositories, and vaginal film.
6.Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7.With spermicidal cream or jelly.
8.Without spermicides.
9.However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.

NORPLANT SYSTEM (levonorgestrel implants) gross annual discontinuation and continuation rates are summarized in Table 3.

TABLE 3: Annual and Five-Year Cumulative Rates per 100 Users

  year 1 year 2 year 3 year 4 year 5 Cumulative
Pregnancy 0.2 0.5 1.2 1.6 0.4 3.9
Bleeding Irregularities 9.1 7.9 4.9 3.3 2.9 25.1
Medical (excl. bleeding irreg.) 6.0 5.6 4.1 4.0 5.1 22.4
Personal 4.6 7.7 11.7 10.7 11.7 38.7
Continuation 81.0 77.4 79.2 76.7 77.6 29.5

DOSAGE AND ADMINISTRATION

The NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM consists of six Silastic® capsules, each containing 36 mg of the progestin, levonorgestrel. The total administered (implanted) dose is 216 mg. Implantation of all six capsules should be performed during the first 7 days of the onset of menses by a health-care professional instructed in the NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM insertion technique. Insertion is subdermal in the midportion of the upper arm about 8 to 10 cm above the elbow crease. Distribution should be in a fanlike pattern, about 15 degrees apart, for a total of 75 degrees. Proper insertion will facilitate later removal. (See section on Insertion/Removal.)

HOW SUPPLIED

The NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM Kit includes the following items:

1 NORPLANT SYSTEM (levonorgestrel implants), a set of six implants (capsules)
1 NORPLANT SYSTEM trocar 1 Package of skin closures
1 Scalpel 3 Packages of gauze sponges
1 Forceps 1 Stretch bandage
1 Syringe 1 Surgical drape (fenestrated)
2 Syringe needles 2 Surgical drapes

Store at room temperature away from excess heat and moisture.

NDC 0008-2564-01

References available upon request.

Instructions For Insertion And Removal

The NORPLANT SYSTEM consists of six levonorgestrel-releasing capsules that are inserted subdermally in the medial aspect of the upper arm.

The NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM provides up to 5 years of effective contraceptive protection.

The basis for successful use and subsequent removal of NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM capsules is a correct and carefully performed subdermal insertion of the six capsules. It is recommended that health-care professionals performing insertions or removals of NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM 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 deeply in the tissue. If the capsules are placed deeply, they will be more difficult to remove than correctly placed subdermal capsules.

Insertion Procedure

Insertion should be performed within seven days from the onset of menses. However, NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM capsules may be inserted at any time during the cycle provided pregnancy has been excluded and the possibility that ovulation and conception have already occurred has been considered. It is recommended that a complete history and physical examination, including a gynecologic examination, be performed before the insertion of NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM 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.

One NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM set consists of six capsules in a sterile pouch. The insertion is performed under aseptic conditions using a trocar to place the capsules under the skin.

Figure 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.

Equipment recommended for the insertion - Illustration

The plastic cover and tray are NOT STERILE.

Figure 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 so 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.

Have the patient lie on her back - Illustration

Figure 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.

Prep the patient’s upper arm - Illustration

Figure 4: Open the sterile NORPLANT SYSTEM (levonorgestrel implants) package carefully by pulling apart the sheets of the pouch, allowing the capsules to fall onto a sterile drape. Count the six capsules.

Open the sterile NORPLANT SYSTEM - Illustration

Figure 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 injecting a small amount of anesthetic. Then anesthetize six areas about 4 to 4.5 cm long, to mimic the fanlike position of the implanted capsules.

Anesthetize the insertion area - Illustration

Figure 6: Use the scalpel to make a small 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.

Use the scalpel to make a small incision - Illustration

Figure 7: The trocar has two 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.

The trocar has two marks - Illustration

Figure 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.

Advance the trocar gently - Illustration

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

Figure 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.

Remove the obturator and load the first capsule - Illustration

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

Gently advance the capsule - Illustration

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

Hold the obturator steady - Illustration

Figure 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.

The capsule should have been released under the skin - Illustration

Figure 13: Do not remove the trocar from the incision until all 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 degrees between capsules and keep the trocar from puncturing any of the previously inserted capsules.

Fix the position of the previous capsule - Illustration

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.

Figure 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 six have been properly placed.

A sterile gauze may be used -Illustration

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

Press the edges of the incision together - Illustration

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

Wrap gauze around the arm - Illustration

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 the NORPLANT SYSTEM (levonorgestrel implants). 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 usually take more time and may be more difficult and/or more painful than insertion. Capsules are sometimes nicked, cut, or broken during removal, or may be difficult to locate. The incidence of overall removal difficulties, including those that did not result in patient complaints (e.g., damage to the capsules), was 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 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. 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.

Figure 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.

Equipment needed for the removal - Illustration

Figure 18: Palpate the capsules to make sure that all six capsules have been located, marking their position with a sterile marker. If all six capsules cannot be located by palpation, they may be localized by ultrasound (7 MHz), X-ray, or compression mammography.

Palpate the capsules - Illustration

Figure 19: Once all six 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.

Apply a small amount of local anesthetic - Illustration

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

Make a 4-mm incision - Illustration

Figure 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.

Push each capsule gently towards the incision - Illustration

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

Gently open the tissue sheath - Illustration

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

Remove the capsule from the incision - Illustration

Figures 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, fertility rates return to levels comparable to those seen in the general population of women using no method of contraception, and a pregnancy may occur at any time. If the patient wishes to continue using the method, a new set of NORPLANT SYSTEM (levonorgestrel implants) capsules can be inserted through the same incision in the same or opposite direction.

NORPLANT®  (levonorgestrel implants) Figure 25 & 26 Illustration

Hints

Insertion
  • Counseling 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 anesthetic 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 degrees.
  • After insertion, make a drawing for the patient's file showing the location of the six capsules and describe any variations in placement. This will greatly aid removal.
Removal
  • Alternate removal techniques have been developed.
  • The removal of the implants will usually take more time and may be more difficult and/or more painful than the insertion. Capsules are sometimes nicked, cut, or broken during removal, or may be difficult to locate.
  • Before initiating removal, all capsules should be located by palpation. If all six capsules cannot be located by palpation, they may be localized by ultrasound (7 MHz), X-ray, or compression mammography.
  • Before removal, apply the anesthetic under the capsule ends nearest the original incision site.
  • 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.

Distributed by : Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101. Rev 03/05. FDA revision date: 5/21/2001

Last reviewed on RxList: 1/5/2009
This monograph has been modified to include the generic and brand name in many instances.

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