Doctors Choice Norplant 1990

Norplant

Norplant consists of six flexible, slender capsules that are inserted just under the skin on the inside of the upper arm. They can be felt by the fingers and sometimes their outline may be visible. Norplant delivers levonorgestrel, a progestin commonly used in contraceptive pills, via a system that was invented more than 25 years ago. The porous, silicone capsules allow the levonorgestrel to enter the bloodstream slowly, providing the body with a continuous low dose of progestin day after day. This results in hormone levels that are lower than those from a daily minipill. Because Norplant is a hormone method, it has some of the same side effects as birth control pills. It also may cause bleeding disturbances—at least for the first months of use.

Norplant is effective for 5 years. The capsules then must be removed and replaced, if desired, by a new set.

The main advantages of Norplant are: (1) There is nothing to take and no prescription to refill every month. (2) It is almost as effective as sterilization, yet the contraceptive effect disappears soon after the capsules are removed. (3) A pelvic examination is not necessary with Norplant, although it is recommended. (4) Except in women with thin arms, the capsules are not visible, so only you

IN A NUTSHELL

NORPLANT

Norplant is a birth control method that uses six tiny capsules that contain a progestin. They are placed just under the skin on the inside of the upper arm. In most women they are barely visible.

The capsules are porous, which means they allow small, regular amounts of progestin to pass into the body and prevent pregnancy. They hold enough progestin to last for 5 years.

Before the capsules are inserted, the skin is made numb in that part of your arm. Then the capsules are inserted with an instrument like a fat ballpoint pen.

The most common side effect is irregular bleeding. This irregularity varies from woman to woman. Some have prolonged menstrual bleeding during the first months afterwards or untimely bleeding or spotting between periods, no bleeding at all, or a combination of these.

With Norplant, there is nothing to remember and no prescription to refill every month. It is extremely effective, yet after it is removed, your periods start again and you can get pregnant almost right away.

Although having Norplant inserted is expensive, it costs less than 5 years of most other types of contraceptives.

Norplant does not protect you against STDs, including AIDS.

know you are using a contraceptive. (5) Although the up-front cost is high, when compared to the expense of 5 years of other methods, it is much cheaper than most.

Norplant's greatest disadvantage is that having it inserted and removed is expensive. In addition, the removal procedure can be uncomfortable, and the bleeding irregularities can be annoying to some women.

When Norplant is inserted, there is an initial surge of hormone that gradually diminishes until the capsules are delivering only a little bit of progestin every day. This means that only a tiny amount of hormone is necessary to produce a good contraceptive effect. The low dose of progestin and the absence of estrogen make Norplant a very safe contraceptive method.

Like the minipill, the progestin in Norplant prevents pregnancy by thickening the cervical mucus so it is difficult for sperm to pen etrate. It also inhibits ovulation so eggs are not produced regularly, and it makes the womb inhospitable to a fertilized egg.

The Norplant tubes are made of the same silicone used for other medical devices such as some heart valves. Tubing made of this material has been used safely in surgical procedures since the 1950s. The Norplant capsules are tiny and contain 100 times less silicone than do silicone gel breast implants.

The six capsules are placed under the skin through a single small puncture-type incision that is about 1/8 inch wide, using an instrument that resembles a fat ballpoint pen with a sharp tip (Figure 9.1). The procedure generally takes 10 to 20 minutes and is done with a local anesthetic injected near the area. No stitches are required. If you are right-handed, the capsules are inserted in the left arm; if you are left-handed, the right arm is used. A health care provider who inserts Norplant should be specially trained before he or she performs this procedure.

The capsules can be removed at any time; fertility returns almost immediately afterwards. At the end of the fifth year, the method begins to become less effective, so if you want to continue with it, the old capsules must be replaced with new ones.

This system of long-lasting hormonal implants has been used in

Pictured larger than actual size

FIGURE 9.1 Norplant Capsules in Place in Upper Arm.

Pictured larger than actual size

FIGURE 9.1 Norplant Capsules in Place in Upper Arm.

other countries since 1983, and was approved in the U.S. in late 1990. More than three million women around the world have now used Norplant. Women like this method because they do not have to remember to take a pill every day or interrupt their lovemaking to insert something.

Norplant does not protect against sexually transmitted diseases.

EFFECTIVENESS AND REVERSIBILITY

Norplant is a highly reliable form of birth control, because there are no pills to forget or prescription to renew. Yet normal fertility returns very soon after the capsules have been removed.

Failure Rate

Although its hormone dose is extremely small, the failure rate for Norplant during the first 12 months after insertion is just under 1 percent. Over a 5-year period of use the failure rate is a bit more than 1 percent.

The implants begin releasing hormone directly into the bloodstream immediately after insertion. If you get the implants during the first 7 days of your menstrual cycle, no backup method is needed. If the insertion takes place at any other time during your monthly cycle, you will need backup contraception during the first 24 hours.

Reversibility

When the Norplant capsules are removed, it is possible to conceive quite soon, so you must start on another method of birth control the same day if you do not want to get pregnant. This is in contrast to women who discontinue oral contraceptives containing estrogen and progestin, who sometimes find that several months or more may elapse before they are ovulating regularly again and are able to conceive.

NORPLANT AND SILICONE

The silicone in Norplant has been used for many years in a variety of medical replacements for body parts. Recent studies involving thousands of patients have not found that silicone increases the risk of autoimmune disorders. The most recent study on thousands of women with breast implants was published in the New England Journal of Medicine in June, 1994.

Before these studies, a huge class-action lawsuit against the maker of silicone breast implants was won. Because of its success, lawyers began to advertise for clients who ever received a medical device containing silicone or had a problem with Norplant. Some lawyers are irresponsibly telling women who have had no problems with Norplant to have their implants removed and to sue the manufacturer.

It is hoped that the current false alarms being raised by lawyers who are seeking financial gain will not frighten women away from a very effective contraceptive.

HEALTH EFFECTS

Health effects of Norplant may include:

Irregular Bleeding. The most common side effect of progestin-only contraceptives is a change in menstrual bleeding, such as heavy or irregular bleeding, spotting between periods, prolonged episodes of bleeding and spotting, or no bleeding at all. Although a period may last for more days than usual, the total blood loss is usually less than before. With Norplant, amenorrhea (no monthly periods) is most likely to occur during the first year of use, because progestin amounts are slightly higher then. Menstrual periods sometimes return in the second year as the daily progestin amount drops a little. If the irregularity in your periods bothers you a lot, you may want to switch to another method.

Headaches. Some women experience an increase in the number or severity of headaches. Some may start having migraines. Usually this reaction disappears after a few months, but if it does not, it may be necessary to remove the implant.

Breast Tenderness. This occurs in a few women and occasionally can be very painful. Although pregnancy is unlikely, a pregnancy test should be done, just to be sure.

Mood Changes and Depression. If depression, anxiety, and other mood changes persist beyond the first months and are severe, removing the implant may be necessary.

Drug Interactions. Like progestin-only pills, Norplant can be made less effective by some commonly prescribed drugs that speed up liver activity, which may lead to breakthrough bleeding or even pregnancy. Drugs that may affect Norplant's performance include prescription headache pills which contain barbiturates (Fiorinal, Fioricet, Esgic), the tuberculosis antibiotic rifampin, the oral anti-fungal drug griseofulvin (Fulvicin, Grifulvin, Grisactin), and the antiseizure drugs containing carbamazepine (Tegretol), phenytoin (Dilantin), primidone (Mysoline), or phenobarbital. If you take such medications regularly, Norplant may not be recommended. The possibility of a drug interaction should be discussed with your physician. There are too few women taking these drugs while using Norplant to study for definite answers. If you already are using Norplant and must take such medications, you may want to add the extra protection of a condom or spermicide.

When you are using a hormonal method, you should always remind your health care provider of this fact when discussing any prescription.

Ovarian Cysts. Functional ovarian cysts (enlarged follicles) are uncommon but sometimes occur in Norplant users just as they may occur in women who do not use Norplant. They may produce some discomfort, but usually disappear on their own. If you should experience severe abdominal pain or unusually heavy or painful periods, however, get in touch with your physician.

Inflammation or Infection at the Insertion Site. These complications can occur after any minor or major surgical procedure. Any pus or bleeding at the insertion site should be brought to the attention of your health care provider.

Acne. Acne is the most common skin reaction in Norplant users. If you are particularly concerned about this possibility, ask your health care provider to prescribe the progestin-only pill Ovrette so you can see what happens to your skin under the influence of levonorgestrel. If Ovrette gives you acne, so will Norplant. However, there are a number of prescription medications that treat acne successfully.

Other Side Effects. Other, less common side effects include unwanted hair growth, nervousness, nausea, dizziness, change in appetite, and hair loss. These reactions may disappear after several months or become much less noticeable. Many women report a small weight gain when using Norplant, but usually less than with an injectable contraceptive.

IS NORPLANT RIGHT FOR YOU?

This method of birth control is especially appealing to some women because it provides continuous protection against pregnancy for 5 years without any special effort.

Good Candidates

All women. Norplant is suitable for almost all women who are seeking continuous, highly effective yet reversible, contraception. Progestin implants are particularly appropriate for women who cannot use methods that contain estrogen. For women of all ages, Norplant is desirable because they do not have to remember to take a pill every day or to renew their prescriptions. When a pregnancy is wanted, Norplant is easily reversible. An older woman can use Norplant comfortably as she approaches menopause.

Breastfeeding women. Like all hormonal contraceptives, Norplant is not the first choice for the breastfeeding woman, but if she prefers to use a hormonal method, she should choose one with no estrogen, such as Norplant. (For more information on breastfeeding and birth control, see Chapter 17.)

Women with diabetes or a history of heart disease. Women with these problems should not use a birth control method that contains estrogen, so Norplant is a good choice, because it is a progestin-only method.

Women Who Are Not Good Candidates

Women who have active thromboembolic disorders, such as blood clots in their legs, lungs, or eyes. Women who have had these problems should talk to their health care providers about whether to use Norplant.

Women with unexplained vaginal bleeding. The irregular bleeding that goes along with Norplant may obscure any unusual bleeding that can be a symptom of cancer of the reproductive tract. If a woman already has unusual bleeding, she should not start on Norplant until the explanation for that bleeding has been found.

Women with acute liver disease, or liver tumors. The hormones are metabolized by the liver so you need a good, working liver to handle this drug.

Women who smoke. Smoking greatly increases the probability of a heart attack or stroke for anyone. This risk is strongly aggravated by the use of combined (estrogen-progestin) oral contraceptives. While this is believed to be an estrogen-related effect, it also may be linked to the progestin. Even though Norplant does not contain estrogen, a woman who chooses to use it is advised not to smoke.

Women who cannot tolerate irregular bleeding. If having regular periods is important to you, Norplant and other progestin-only methods are not good choices.

CHOOSING NORPLANT

Because Norplant requires minor surgery for insertion and removal, you will want to learn as much as you can about this method before you use it.

Finding a Practitioner

Although the procedure for inserting Norplant capsules is very simple, it is important that it be performed correctly. If the capsules are inserted too deeply, they are more difficult to remove later. The U.S. distributor of Norplant, Wyeth-Ayerst Laboratories, has trained over 25,000 health care providers to insert the capsules. These include doctors, nurse-midwives, nurse-practitioners, and other medical professionals. You should be able to find a practitioner who has been trained in the technique by calling Wyeth's Norplant hotline: 1-800-934-5556. Your local Planned Parenthood affiliate, a nearby woman's health clinic, or the obstetrics/gynecology service of your local hospital may also provide Norplant.

When asking about a practitioner, be sure you are clear about wanting someone who has been trained and has had experience in inserting the capsules. The more often providers perform this procedure, the more skilled they become, and this means a faster, more comfortable experience for you. And the capsules will be placed exactly where they should be.

If you are concerned about the privacy of any birth control method you might use, you should be aware that the Norplant capsules can be felt and sometimes can be seen under the skin of your upper arm.

Norplant Counseling

If you have doubts about any aspects of Norplant, do not hesitate to ask questions. Before your appointment, write down any anxieties you have so you do not forget to have them resolved. Do not be reluctant to ask how often the practitioner has inserted

Norplant capsules. There is nothing wrong with being nervous about the insertion procedure or about the possible side effects this method could have. It is only sensible to clear up any questions you have about Norplant before the capsules have been inserted, no matter how "dumb" you think your questions are. A good health care provider will not mind answering questions.

The more you know about Norplant and its effects beforehand, the more at ease you will be with any reaction you experience. You should not be reluctant to contact your practitioner afterward, especially about changes in your body or menstrual pattern, if you are not entirely comfortable with them. Do not have the implants inserted until you are sure you understand what the side effects of this method are and exactly what happens during the procedure.

The Procedure

To avoid the risk of placing the capsules in a woman who is pregnant, providers are advised to implant the capsules during the first 7 days of the menstrual cycle or immediately after an abortion.

The site usually selected for the implants is on the inner side of the arm, a few inches above the bend of the elbow. If there is some reason this is not a good place for you, discuss this with the practitioner. Most practitioners will draw a mark on your arm showing where the capsules will be placed in a fan-shaped pattern. A local anesthetic is injected before the capsule insertion and the injection may sting for a second or two. After the area is numb, a tiny incision is made and, using a special needle, the capsules are placed one at a time under the skin so they do not touch each other and the progestin can diffuse easily from each one.

The insertion process takes 10 to 20 minutes. There are no stitches. After the anesthetic wears off, the insertion area will feel sore and may be bruised and swollen for a few days. Some women feel a little tingling or numbness afterwards.

The incision is covered by a small gauze pad and adhesive tape that should be left in place for a few days. Keep that part of your arm dry and protected from dirt until it heals. Try not to bump it and do not lift anything heavy for several days.

Because the incision is so tiny, it seldom leaves a detectable scar. The implants are comfortable and barely visible. Although you may be aware of them, almost no one else will notice their existence.

The capsules do not move around and, because they are flexible, they cannot break, no matter how vigorously you use your arm. After the incision is healed, you can treat that arm as you normally would. You can put pressure on the area or touch the skin without concern. You can swim, play sports, carry packages, and do heavy work.

LIVING WITH NORPLANT

Warning Signs of Possible Problems

Serious problems are rare, but you should call your health care provider immediately if you develop severe lower abdominal pain, heavy vaginal bleeding, migraine or other severe headaches, visual disturbances, or if a capsule works its way out through the skin. It is unusual for a capsule to come out spontaneously. If it does, it may be the result of being inserted not quite deep enough or because of an infection at the site. Call your health care provider.

Pain in the implant arm, or pus or bleeding at the site of the implant may indicate an infection, and you should see your provider right away.

You should also check with your physician or nurse if you have a delayed period after a number of regular menstrual cycles, because this could be a sign of pregnancy.

Dealing with Menstrual Irregularity

Irregular or heavy menstrual periods, spotting between periods, or no periods at all are common among users of progestin implants, especially during the first year. There is no harm if you do not menstruate; the blood does not accumulate in your uterus. What happens is that the lining of the uterus does not thicken and become filled with blood every month as it otherwise would, so there is little or no blood to be shed. The absence of menstrual periods does not mean you are pregnant, nor does it mean you will have problems becoming pregnant after your implants are removed. If you are worried that you might be pregnant, take a pregnancy test to put your mind at rest. If your periods do not return after a year, you probably will have few, if any, bleeding days each month while you are using Norplant.

If such menstrual irregularity bothers you, talk to your health care practitioner. Most bleeding irregularities associated with Norplant use are not serious, although in rare cases persistent spotting could be an indication of a cervical infection or malignancy. Spotting does not mean you cannot have intercourse and it does not make you anemic. Although the spotting may be continuous, you are probably losing less, rather than more, blood than usual. Prolonged, heavy bleeding can result in anemia, however.

Removing and Replacing Capsules

When you have Norplant inserted, your practitioner will probably give you a booklet for writing down the date the capsules were inserted, by whom and where, and when they should be removed. You should store this somewhere for future reference. If you keep a calendar, you can record this information and then carry it forward to your new calendar every year so you know when you must have your implants removed.

Norplant capsules should be removed after 5 years because after this time they gradually become less effective. They also can be taken out at any earlier time and for any reason.

As with the insertion, you should make sure that the nurse or doctor who will be doing the removal has been trained to perform the procedure.

Removal can be more difficult than the insertion. The incision for removal may need to be a bit longer than the original. A local anesthetic is injected at the end of the capsules. If you still feel some pain, tell your practitioner so you can be given extra anesthetic. Because they are visible with either x-rays or ultrasound, Norplant capsules are easily located. On rare occasions, a second visit is needed to get out all the capsules.

After the removal procedure, you will have some swelling and bruising similar to the aftereffects of the insertion. These will wear off in a few days. If your arm is very uncomfortable, ask your provider about taking something to ease the pain.

As soon as the capsules are removed, you will need to have another set inserted or start using another method if you want to avoid pregnancy.

COST

The Norplant implant alone costs $365. The practitioner's fee for the insertion procedure is additional and will vary, depending on whether it is done by a private physician or in a publicly funded clinic, and can range from $50 to $400. If you keep your capsules for the full 5 years, the cost averages out to approximately $80 to $150 a year.

Most or all of the cost of a Norplant insertion—the implant plus the insertion—is covered by Medicaid in many states, as well as by some health insurance plans. HMOs charge their usual modest co-payment for the exam and insertion.

If the removal procedure is not covered by insurance, low-income women may be able to obtain funding through the Norplant Foundation. For more information about financial help for removing Norplant, call 1-800-760-9030.

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