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Norplant® Implants PDF Print E-mail
Written by Allen Lawrence, M.D.   


About Norplant® Implants

What Is Norplant® and How Does it Work?

Norplant® is a long-acting hormonal method consisting of six match-size, flexible capsules made of Silastic, a soft rubber-like material. Norplant® is placed just under the skin of a woman's upper arm. A low dose of the synthetic progestin, levonorgestrel, is then continuously released for up to five years. Levonorgestrel is also used in some combined oral contraceptives and one type of mini pill. Norplant® prevents pregnancy by inhibiting ovulation and by thickening the cervical mucus.

Some researchers believe that Norplant® may also work by preventing a fertilized egg from attaching to the lining of the uterus. The implants release small amounts of its hormone into the bloodstream. The bloodstream carries the hormone to the pituitary gland in the brain and to the uterus and cervix. Generally, the pituitary stops the ovaries from developing eggs. The hormone also keeps sperm outside the uterus by thickening the cervical mucus and thinning the lining of the uterus.

It is essential to be sure that you are not already pregnant. Although there is no evidence that the Norplant® Implants will hurt a developing baby, most experts believe it's best not to expose it to hormones. Be sure you use some form of birth control until the insertion is done. Norplant® can be inserted immediately when an old set of implants are removed. It can be inserted at any time of the month if you are using the pill or IUD. It also can be inserted right after an abortion or childbirth if you are not breast-feeding. If you are breast-feeding, you can use Norplant® six weeks after childbirth.

It is important to remember: Norplant® does not protect against STDs, condoms should always be used.


How Effective Is Norplant®?

Norplant® is one of the most effective reversible methods of birth control available in the U.S. It becomes effective within 24 hours of insertion. It protects against pregnancy for five years. It is best inserted within 7 days of the start of any menstrual period. Of every 100 women who use Norplant® for five years, fewer than four will become pregnant - this is less than one per year. Norplant® is greater than 99% effective in preventing pregnancy. Norplant® is actually slightly more effective than sterilization, but the contraceptive effect of Norplant® disappears in a few hours after the implants are removed.


How Are Norplant® Inserted?

Norplant® is inserted by a health care provider using local anesthesia. The procedure usually takes ten to twenty minutes. The capsules are inserted in a fanlike pattern through a single incision in the inner part of the upper arm. Once the capsules are in place, the incision is closed. A pressure bandage is applied to prevent bleeding and should be left on overnight. The area will probably be tender, bruised, or slightly swollen for a day or two. Sutures are generally not necessary. There will be a slight scar that is usually not noticeable. Norplant® is effective within 24 hours of insertion.


Can You See the Capsules Once They've Been Placed under the Skin?

The implanted capsules usually are not visible. They are flexible, should not move, and cannot break inside the woman's arm.


How Effective Are the Implants?

Norplant® inserts are one of the most effective birth control methods in use today. During the first year after insertion, there is only one pregnancy per 500 users. The system becomes less effective toward the end of its useful life, so it is extremely important to have the capsules replaced at the 5-year mark.

Continuation rates have been high in clinical studies and field trials of Norplant® use. Recently published data for the U.S. show a continuation rate of 85 percent after the first year. Cumulative continuation rates in seven different studies averaged 80 percent in the first year. In another study, the rate approached 49 percent at four years. Population Council indicate that the most common side effects causing women to terminate implant use in a five-year period are as follows: menstrual irregularities (17.4 percent); headache (1.9 percent); weight changes (1.7 percent); mood changes (1.1 percent); and depression (0.9 percent).


Who can use Norplant® Implants?

Norplant® implants may be used by almost any woman in her fertile years who wants to avoid getting pregnant. It 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. There have been no differences in reactions to Norplant® implants based on a woman's race, age, or ethnic group.


Who Are the Best Candidates for Norplant® Implants?

Women Who:

  1. Want continuous, long-acting birth control
  2. Do not want to take a pill daily or put a contraceptive (diaphragm or condom) in place before having vaginal intercourse
  3. Want a more spontaneous sex life
  4. Do not want to use a method that contains estrogen
  5. Women who can put up with some irregular bleeding and spotting

Does the Age of the User Matter?

If there are no contraindications, Norplant® implants may be used by women throughout their reproductive years. A young woman can start using this method once her period becomes regular, which is usually about two years after the onset of her menses. Older women can use Norplant® implants as they approach menopause.


How and When Should Norplant® Be Removed?

The capsules are removed by a health care provider by using local anesthesia in a procedure taking 10 to 30 minutes. Norplant® must be removed after five years, although it may be removed earlier should you so desire because you either want to get pregnant, or you simply don't like the method. Removal is often more difficult than insertion, sometimes requiring 2 sessions before all 6 capsules are removed. Two visits are necessary when swelling of the surrounding tissue becomes an impediment to the doctor and a discomfort to you. If you wish to continue to use Norplant®, a new set of capsules can be inserted when the old ones are removed. Within twenty-four hours after the capsules has been removed, your protection from pregnancy ends. It is essential to either be abstinent or use an alternative method of contraception to protect against unwanted pregnancy.


What Are the Benefits of Norplant®?

Few, if any, serious complications occur with Norplant®, probably because they don't contain estrogen, and they release their hormonal contents slowly, thereby avoiding hormonal surges. Further benefits are:

  • Convenient, requires no action prior to intercourse
  • No need to remember to use
  • Lasts up to five years but can be removed sooner
  • Safe for most women
  • Very effective
  • Doesn't interrupt sex
  • Contains no estrogen, hence no estrogen side effects
  • Can stop menstrual cycle
  • Decrease in menstrual cramps and pain
  • Decrease anemia due to menstruation
  • Reduced risk of PID, endometrial and ovarian cancers

  • What Are the Disadvantages of Norplant®?

    The following is a list of factors that should be considered in making your decision to use Norplant® Implants.

  • Must be prescribed and inserted by a health care provider
  • Initial expenses are high
  • May alter menstrual cycle, cause irregular bleeding
  • May cause decrease in bone density
  • Does not protect against sexually transmitted diseases (STDs)
  • Long term lipid effects are unknown
  • May result in missed periods or decrease the amount of menstrual flow (some women consider this an advantage)
  • May be very difficult to remove
  • Increased Risk of Tubal Pregnancy
  • You may experience weight gain and breast tenderness
  • Increased Risk of Ovarian Cysts
  • Menstruation may stop entirely while on Norplant® if amenorrhea greater than 6 weeks, must check for pregnancy.
  • Contraindications - Don't Use Norplant® Implants If You:
  • Suspect you are pregnant (uterine or tubal) or trying to get pregnant
  • If you are breast-feeding
  • If you have abnormal or unexplained vaginal bleeding
  • Take anti-seizure medication or the antibiotic rifampin
  • If you have active thromboembolic disease (blood clots) or thrombophlebitis
  • If you have known or suspected breast cancer
  • If you have known or suspected cancer of the cervix, uterus or vagina
  • If you have acute liver disease, benign or malignant tumors of the liver
  • If you have diabetes mellitus, especially uncontrolled insulin dependent
  • If you have diabetes along with severe heart, coronary artery or kidney disease
  • If you have severe elevation of blood cholesterol or triglycerides
  • If you have significant or frequent migraine headaches
  • If you have a history of idiopathic intracranial hypertension
  • If you are a heavy smoker, more than ½ pack daily
  • If you have history of an allergic reaction to levonorgestrel, other hormones, dyes or preservatives

  • What Are the Risks, Hazards, Side Effects and Complications Associated With Norplant®?

    To be on the safe the manufacturer's of Norplant® rely on the exact same warnings that are used for birth control pills which contain estrogen. Norplant®, however, does not contain any estrogen so the chances of any or some of these problems occurring are minimal. For completeness sake we are listing all of the so called "potential" risks, hazards and side effects even though it is very unlikely that they may occur.

    Studies show, however, that there are some common side effects and problems which can or may occur. Between 60 and 100 percent of Norplant® users are likely to experience some kind of menstrual change, especially in the first few months. These changes can include bleeding for a longer time than usual per cycle (27.6 percent), spotting between periods (17.1 percent), frequent bleeding onsets (7.0 percent), infrequent or light bleeding (5.2 percent), or no bleeding at all (9.4 percent).

    It is important to note that even with these irregular patterns of increased bleeding, women using Norplant® implants lose less blood than women with normal menstrual cycles. Studies show that Norplant® implant users have higher hemoglobin levels than nonusers do. This could prove beneficial for women prone to anemia. Some additional side effects listed are:

     

    Headache

    Dizziness/fainting

    Rash

    Appetite Changes

    Nervousness

    Nausea/vomiting

    Generalized itching

    Weight gain

    Breast pain/discharge

    Breast tenderness

    Hair loss or growth

    Ovarian enlargement

    Pain arms, legs, groin

    Shortness of breath

    Abdominal pain

    Facial hair growth

    Fluid retention in hands, ankles or feet

    Elevated blood sugar

    Elevated blood pressure

    Elevated liver enzymes

    Hepatitis

    Vision and/or speech problems

    Acne

    Thrombophlebitis

    Retinal Thrombosis

    Pain or itching at insertion point

    Cervical, vaginal infection, vaginal discharge

    Painful menstruation

    Numbness or tingling

    Mood changes, nervousness, anxiety, depression, frustration, anger, or emotional outbursts


    The majority of these side effects are mild and generally do not require removal of the Norplant® inserts, on occasion, however, one or more of these symptoms may cause sufficient discomfort to necessitate early removal of the Norplant® inserts.


    How Does Norplant® Implants Affect the Body's Chemistry?

    Extensive clinical pharmacology research has shown no adverse effects of progestin implant use on other hormonal patterns, the endometrium, lipoproteins, adrenal function, thyroid function, and a variety of other physiological indicators in healthy women. These studies also have given no indication of cardiovascular, respiratory, central nervous system, or other serious problems, nor is there any evidence of increased risk of cancer or increased risk to unborn children associated with Norplant® use in otherwise healthy women.


    Does Norplant® Cause Autoimmune Diseases or Arthritis?

    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 above, in Norplant® users; however, the rate is significantly less than the rate among the general population of women of reproductive age. It is believed that the occurrence of autoimmune diseases among Norplant® users is coincidental, and it cannot be positively stated that Norplant® protects against these conditions. It is essential in all cases that women using Norplant®, just as those women using birth control pills, should have regular routine medical checkups.


    Should Women Who Smoke Use Norplant® Implants?

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


    What Other Medicines Can Interact with Levonorgestrel?

  • Bromocriptine (Parlodel)
  • Carbamazepine (Atretol, Depitol, Epitol, Tegretol)
  • Phenytoin (Dilantin, Di-Phen, Diphenylan)
  • Rifabutin (Mycobutin)
  • Rifampin (Rifadin, Rimactane)
  • Barbiturate medicines for inducing sleep or treating seizures (convulsions)

  • Remember to tell your doctor or pharmacist about all other medicines you are taking, including non-prescription medicines. If you are a frequent user of beverages with caffeine or alcohol; if you smoke; or if you use illegal drugs, these may affect the way Norplant® works. Check before stopping or starting any new medications.


    What Do I Need to Watch for While I Using Norplant® Inserts?

    It is suggested that you have regular check ups to monitor your progress and overall status while using Norplant®. Generally a complete checkup every 6 to 12 months is recommended.

    Tobacco smoking increases the risk of getting a blood clot or having a stroke while you are using levonorgestrel, especially if you are more than 35 years old. Smoking is strongly recommended against.

  • If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye doctor immediately.
  • Levonorgestrel implants do not protect you against HIV infection (AIDS) or other sexually transmitted diseases.
  •  

    How Do I Get to Use the Norplant® Implants?

    You must see a clinician to find out if you can use Norplant®. The clinician will discuss your medical history with you. You will be given a physical exam, including:

  • Blood pressure check
  • Breast exam
  • Pelvic exam
  • Pap test (to check for cancer of the cervix).
  • Menstrual history
  • Norplant® Seems So New, How Do I Know If it Is Safe?

    Norplant® has been tested for 20 years in 46 countries, where it has been used by over 500,000 women. Norplant® has also been studied extensively in the U.S. Long-term side effects of Norplant® use are not yet known. However, the drug contained in Norplant®, levonorgestrel, has been used in oral contraceptives and Norplant® for more than 20 years and so far, no significant medical problems have been identified.

     

     


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