 |
 |
|
|
|
|
DESCRIPTION
The goal of contraception (or birth control) is to prevent an unplanned pregnancy. The majority of methods of contraception enable sexually active couples to temporarily avoid pregnancy. Permanent birth control is accomplished through sterilization. Be sure you know and understand the different types of birth control available to you, the risks and benefits of each, and any side effects, so that you can make an informed choice.
Contraception Methods Compared
The information given on this page is given primarily for Norplant Hormone Implants, but these were discontinued in the United States in 2002. The reason I have continued to supply information about Norplant is that there may still be many women currently using this product even though it is no longer on the market.
A new implant system called Implanon using fewer hormonal inserts was approved July 2006 and is becoming available for use in the United States. Information regarding Implanon is also given here. The information given for Norplant is very similar to the information for Implanon.
I have also provided information and a link to a page about Jadelle, formerly known as Norplant II. This product was approved for use in the U.S. but currently is not on the market here. It is, however, used in Europe and many other countries throughout the world.
NORPLANT HORMONE IMPLANTS
OVERVIEW
Norplant (Levonorgestrel) is the first contraceptive implant and was approved by FDA in 1990. It is a hormone implant that consist of 6 small, soft capsules (the size of matchsticks) containing a synthetic progestin hormone long used in birth control pills. They are inserted surgically just under the skin of the upper arm of a woman in a fan-like arrangement. The implants, once in place, slowly and steadily release a low dose of progesterone-like hormone, which is called levonorgestrel. This substance goes into the bloodstream. No estrogen is used. The implants provide birth control for up to 5 years by slowly releasing the hormones in the capsules into the body. It is effective within 24 hours after insertion and must be removed by a qualified health care provider.
Each Norplant capsule is 2.4 millimeters (about one-tenth of an inch) in diameter and 34 millimeters (just under one-and-a-half inches) long, and holds 36 milligrams of powdered crystals of the progestin levonorgestrel. The tubes are made of Silastic, a silicone material long used in surgical implants such as heart valves and hip joints.
The hormone seeps through the permeable tubes into the bloodstream, initially at a rate of about 85 micrograms a day. The amount declines gradually to about 50 micrograms by nine months, 35 by 18 months, and about 30 micrograms at the end of five years. In comparison, birth control pills that contain levonorgestrel provide about 50 to 150 micrograms of the progestin a day, plus estrogen. (The only progestin-only contraceptive available in the United States contains 75 micrograms of norgestrel, a progestin similar to levonorgestrel.)
When the hormone supply dwindles, usually in about five years, a new implant can be inserted if desired. On the other hand, if a woman wishes to become pregnant earlier, she can have the implants removed at any time, and fertility is restored very soon. Blood levels of the progestin are undetectable within 5 to 14 days.
Studies are being done for Norplant II for male contraception to inhibit sperm formation (spermatogenesis) in men. See this NcIB Abstract about this study.
Because of contraception is automatic and does not depend on the user, the failure rate for Norplant is less than 1 percent for women who weigh less than 150 pounds. Women who weigh more have a higher pregnancy rate after the first two years.
In the studies, the contraceptive's effectiveness approached that of sterilization in the first year. Pregnancy rates were slightly higher in heavier women, increasing after the third year of use in those who weighed more than 69 kilograms (153 pounds). Nevertheless, the protection is still quite good. For example, among 100 women of all weights using the implant for five years, it is expected that four would become pregnant during that time. By contrast, of 100 women using the pill for the same time, at least 15 might be expected to become pregnant.
Norplant's effectiveness does not depend on patient compliance -- a feature shared by only one other type of reversible contraceptive -- the intrauterine device, or IUD. This particularly appeals some women for the convenience it affords. Unlike the pill, you don't have to remember to take it every day, and, unlike the diaphragm, there's no problem with sexual spontaneity.
Because Norplant is not a barrier contraceptive, however, it offers no protection against sexually transmitted diseases (STDs) such as AIDS, herpes, chlamydia, and gonorrhea. For optimum protection from both disease and pregnancy, couples may choose to use both Norplant and a condom.
Norplant hormones prevents pregnancy in three ways.
- It works by blocking ovulation and keeping the eggs from being released.
- By thickening the cervical mucus to prevent the sperm from getting to the egg and making penetration more difficult.
- And by changing the endometrium (lining of the uterus), making it thin and unsuitable for implantation of a fertile egg.
ADVANTAGES
Are very effective for contraceptive (over 99%); one of the most effective temporary forms of birth control available. Norplant and other hormone implants are considered the most effective method available today. If 10,000 women were using a hormone implant, only 9 may become pregnant within the first year. This is a 0.09% failure rate. To keep hormone implants most effective, be sure to replace them with a new set of implants after 5 years.
The hormone used in the implants, progestin, provides a birth control option for women who cannot take estrogen hormones that are used in oral contraceptives.
The implants require no daily routine. No maintenance is required on a daily basis or at a time of intercourse to prevent pregnancy. A yearly check-up visit at your health care provider is usually recommended.
Enjoyment of spontaneous sexual intercourse; freedom from concern once implants are in place. Easy to use and doesn't interrupt sex.
May prevent some health problems, like ovarian cancer, uterine cancer and Pelvic Inflammatory Disease (PID).
May reduce menstrual flow and cramps in some women.
Although they cannot be discontinued as easily as discontinuing a daily pill (oral contraceptives), they can be removed at any time by a trained health care provider.
They are effective for up to 5 years. There is no significant delay in restoration of fertility following removal.
Depression and premenstrual symptoms may improve (or worsen).
DISADVANTAGES
They require a minor surgical procedure with a local anesthetic for insertion. Some minor skin side effects may occur at the implantation site. Darkening of the skin over the implants may occur.
Depression and premenstrual symptoms may worsen (or improve).
Difficulty in finding a qualified health care provider that can remove the implants.
Some women experience problems when the implants are removed including a longer surgical time, pain, and scarring. Arm discomfort.
Side effects from the implants include menstrual irregularities, headaches, hair loss, breast tenderness and weight gain. The side effects tend to diminish with time. Implants are quite likely to cause irregular periods. If your bleeding pattern is bothersome to you, contact your health care provider. There are medications that may give you a more acceptable pattern of bleeding. As time goes on your periods may become more regular.
They should not be used in women who have a blood clotting disorder, heart problems, undiagnosed vaginal bleeding, liver problems or breast cancer.
Can be expensive. Up front costs are high since there is a one time payment, but overall costs for a 5 year period are comparable to oral contraceptives.
Will not protect against sexually transmitted diseases (STDs). A form of barrier protection will need to be used.
Can be seen by other people and can be felt when the skin is touched. Implants can make the skin over the implants a little darker.
SIDE EFFECTS
Women who cannot take birth control pills for medical reasons should not consider Norplant or any other hormone implant a contraceptive option. As with virtually any drug or medical device, Hormone implants are not entirely trouble free and may produce side effects in some women. The potential side effects of the implant include:These side effects may subside after the first year.
- Irregular menstrual bleeding.
- Headaches.
- Nervousness.
- Depression.
- Nausea.
- Dizziness.
- Skin rash and/or acne.
- Change of appetite.
- Breast tenderness.
- Weight gain.
- Enlargement of the ovaries or fallopian tubes.
- Excessive growth of body and facial hair.
Some Norplant users have also reported:These effects, however, may not be linked to use of the implant because the complaints are common among the general population and could stem from many other causes. There is no known biological reason to link the complaints specifically to use of the contraceptive.
- Breast discharge.
- Vaginal discharge.
- Inflammation of the cervix.
- Abdominal discomfort.
- Muscle and skeletal pain
By far, the most common side effect is menstrual cycle irregularity. To determine the percentage of women with menstrual irregularities is complex because it changes with time and age. Over a five-year period of use, about 45 percent of women will have irregular periods and another 45 percent will have normal periods. The remaining 10 percent will have long periods of time (three to four months) with no bleeding. This is an average. Basically what happens is you have more women with irregular periods in the first year and that tends to diminish with continuing use.
The bleeding irregularities result from the continuous hormone release. With the oral contraceptive pills, estrogen and progestin are taken for three weeks and withdrawn for one week, causing regular bleeding. Norplant, on the other hand, provides no cyclic withdrawal, and thus each individual creates her own bleeding pattern.
In the multi-center trials, more women had increases in their hemoglobin concentrations than decreases, indicating that they lost less menstrual blood when using Norplant. (Hemoglobin is the oxygen-carrying pigment of red blood cells that gives them their red color and serves to transport oxygen to tissues.) The reason for this, on average, even if the number of bleeding days increases in the first year of use, the total amount of blood lost may be less than would be lost without hormonal contraception.
Most women who use Norplant do not perceive bleeding as a problem. If women are interviewed about this issue and are asked what is the biggest complaint that they have about Norplant, the most common response is that it's the bleeding irregularities. But if they are asked if bleeding irregularities bother them, approximately 60 percent will respond with "No ". Some women experience spotting and a lighter flow with Norplant and sometimes they may have no discernible cycle at all.
Nevertheless, the major reason women give for discontinuing Norplant is bleeding problems, accounting for about 9 percent of those who stop in the first year. Another 5 percent stop for other medical reasons, from headaches to dizziness, and perhaps another 5 percent stop for other reasons, including to have a baby. Estimates are that about 60 to 65 percent of women continue with the implant longer than two years.
Norplant is NOT for Everyone:
More serious complications are possible as well, and Norplant is not recommended for everyone. As with oral contraceptives, women with acute liver disease or liver tumors (whether malignant or benign), unexplained vaginal bleeding, breast cancer, or blood clots in the legs, lungs or eyes should not use the implant.
Norplant contains only progestin, whereas most oral contraceptives contain both progestin and estrogen. Some side effects of the pill, such as eye disorders and increased risk of cardiovascular problems among women who smoke, are believed to be related to the estrogen component. Nevertheless, the FDA advises health care providers to consider the possible increased risks associated with oral contraceptives, including elevated blood pressure, thromboembolic disorders (blood clots obstructing blood vessels), and other vascular problems that might occur with use of the contraceptive implant.
Norplant will be most attractive to women who:On the other hand, the implant to be less popular among women who:
- Wish to use highly effective low-dose hormone contraception.
- Want long-term contraception after completing their family, but don't want sterilization.
- Want to delay childbearing for an extended period of time.
- Cannot use estrogens.
- Are unhappy with other forms of contraception.
- Are happy with their present form of contraception.
- Cannot or do not want to pay the up-front cost of Norplant.
- Will not tolerate irregular menstrual bleeding if it should occur.
- Do not want to use a method that requires a visit to a health-care professional to discontinue. Some women feel that they do not want to have to visit a health care provider when they decide to quit using Norplant and that they may want to discontinue it any time they choose. This is why some women like using the pill or barrier methods since they have more control over when they use them or not use them.
Surgical Insertion:
Successful use of the Norplant system depends on careful insertion of the capsules. Wyeth-Ayerst markets the implant as a kit with detailed instructions for insertion and removal, and, through the Association of Reproductive Health Professionals, offers health care provider training programs as well.
The firm describes the insertion as a minor, outpatient surgical procedure requiring only 10 to 15 minutes. The area is numbed with a local anesthetic, and a small incision, less than an eighth of an inch long, is made. Using a special instrument called a trocar, the health care provider places the six capsules just under the skin. The incision is then covered with protective gauze and a small adhesive bandage. Stitches are not required.
When the anesthetic wears off, there may be some tenderness or itching, and perhaps some temporary discoloration, bruising and swelling. Infection at the site of insertion has also been reported.
It takes a bit longer to remove the implant than to insert it. Removing them usually takes from 15 to 20 minutes, according to the distributor. As with insertion, a small incision is made under a local anesthetic. Then the health care provider removes the capsules and, again, the incision is covered with an adhesive bandage. Sometimes, some capsules may be more difficult to remove than others. When this happens, the woman may have to return a second time, after the area has healed, for removal of the remaining capsules.
The reason for suggesting the second visit is to let the health care provider know that if they have trouble removing the capsules that they shouldn't cut a big hole in the woman's arm and go fishing around looking for it them. If the anesthetic has caused the area to swell it may be difficult to feel the implant. The health care provider should Wait until the next week, or whenever the woman can come back in again, to be able to see the implants and take them out with minimal trauma to the woman.
If desired, a new set of implants can be inserted at the same time the old set is removed, either in the same arm and through the same incision, or in the other arm.
The price to the medical professional for a single Norplant system, which includes all the necessary apparatus for insertion and removal as well as the set of six capsules, has been set at $350 (prices may change over time). Fees for insertion and related costs, such as counseling and removal, vary, depending on the health care provider.
Some women may not want to get new implants later or may take a break from them for awhile if they may want to get pregnant in the near future or have concerns about hormone therapy and the risks associated with it (more with the pill and estrogen than with Norplant). They may want to research what other contraceptive alternatives may be available after the implants are removed. Some women who are satisfied with the implants would recommend Norplant for women planning on using hormone therapy anyway.
PRECAUTIONS
Health care providers and midwives consider certain precautions when deciding whether a woman can safely use Norplant or any other hormonal implants. If a woman has abnormal vaginal bleeding, the cause needs to be found before starting Norplant. There are other conditions a health care provider or midwife will evaluate. This include liver problems, breast cancer, blood clots and whether the client is pregnant.
GENERAL MEASURES
INSTRUCTIONS FOR USE
The implants are usually inserted during the first 7 days of a woman's menstrual cycle (ensuring she is not pregnant). However, they can be inserted anytime if pregnancy has been ruled out. Another form of birth control (non-hormonal) should be used for the remainder of the cycle.
A patient information booklet will be provided for you to read prior to the implants being inserted. Be sure any questions or concerns you have are answered or explained.
You can get Norplant implants from your health care provider, midwife, health department, or family planning clinic. Not all clinicians insert implants. Check in advance. You may qualify for free Norplant implants from the Norplant Foundation. Call 1-800-760-9030 for more information. They can also help you get your Norplant removed.1. To insert:
- The procedure will be done in a midwife's or health care provider's office. It should take about 15 minutes.
- A local anesthetic is injected into the upper arm (may cause some stinging) to numb the skin. Once the arm is numbed, there is rarely pain involved with the procedure.
- A small incision is made and one by one, the 6 capsules are placed under the skin in a fan shaped position. The implants will be on the inside of the upper arm.
- A protective bandage is placed over the incision which can be removed in a few days.
- There may be some discoloration, bruising, soreness or swelling in the incision area for a few days to a week.
- The implants start to work in less than 24 hours after it has been put in the arm.
- Take care of your arm right after the implants are inserted. Your health care provider or midwife will tell you how to take care of your arm. If you have pain after the insertion, see your health care provider. Once the site has healed, the skin can be touched over the implants and blood pressure can be taken on the arm. They will not break.
- It is normal to have a change in menstrual bleeding patterns while on the implants. Some women will spot daily or experience irregular spotting or very light bleeding. Some may have longer periods, prolonged spotting or heavy bleeding and others may not bleed at all. All of these changes are normal. Menstrual bleeding tends to become more regular after the first year or two of use, changes often stop happening, or happen less often. If a woman is concerned about being pregnant, she can get tested. However, pregnancy is very rare with hormonal implants.
- By the end of 5 years, the implants should be removed. Each set of implants lasts for up to 5 years. Norplant can also be removed any time before the end of 5 years. Once the implants are removed, pregnancy can occur right away.
- Be sure to tell any health care provider that you see that you have the implants since some medications and herbal supplements can make the implants less effective.
If you experience any of the Norplant hormone implant warning signs, contact your health care provider:
- Headaches can become more severe. Occasionally the implants need to be removed because of headaches.
- Acne or skin rashes.
- Weight changes. Some women gain weight.
- Nausea.
- Tender breasts or breast discharge.
- Mood changes or decreased sex drive.
- Growth or loss of facial or body hair.
- Slight darkening of the skin over the implant.
- Functional ovarian cysts. A cyst is a small sac filled with fluid. If cysts grow on the ovaries, they usually go away by themselves in 2 to 3 months. If they become large or painful, the you and your health care provider will need to discuss options about what should be done about them.
2. To remove:
- Again, the procedure will be done in a health care provider's office and should take less than 30 minutes.
- The capsules are located by being palpated (felt); a local anesthetic is injected.
- An incision is made and the capsules are withdrawn, one by one. If the capsules cannot all be removed on the first attempt, removal should be attempted later after the site has healed.
MEDICATION
Carbamazepine and phenytoin reduce the effectiveness of the hormone implants and may increase risk of pregnancy. Consult with your midwife or health care provider about nutritional and/or herbal supplements you may be taking. Some supplements may reduce the effectiveness of the implants.
Advise anyone who prescribes a medicine for you or before any anesthetic is used that you have the hormone implants.
IMPLANON IMPLANTS
Update Information:
A new contraceptive that is implanted in the upper arm and remains effective for three years will be made widely available in the United States early next year (2007), filling a gap in birth control options for women since Norplant was taken off the market in 2002.
The new contraceptive, called Implanon, is a matchstick-size device that health care providers inject into the underside of a woman's arm, where it releases a continuous dosage of the synthetic hormone progestin over three years. The device is 99 percent effective at preventing pregnancy.
Implanon, made by Organon of Roseland, N.J., joins the ranks of increasingly advanced birth control options on the market for women. In the past five years, new birth control devices have included a skin patch that is changed once a month, an intrauterine device that releases low-dose hormones and lasts five years, and a product called the NuvaRing, also made by Implanon, that is inserted into the vagina once a month and releases progestin.
Implanon won approval from the Food and Drug Administration in July 2006, nearly three years after Organon submitted an application to the agency. Implanon has been available in Europe and elsewhere since 1998 and has been used by about 2.5 million women, according to Organon.
The company has not announced what Implanon will cost, but a spokeswoman said the device would be competitive with other hormonal forms of contraception. Birth control pills cost $20 to $35 a month and often are covered by insurance. When Norplant was available, it cost about $500 for the initial implantation and $100 to $200 to remove the implants.
Norplant was taken off the market by manufacturer Wyeth Pharmaceuticals after women complained of uncomfortably heavy or irregular menstrual cycles and difficult removal .
Organon officials said they don't anticipate similar problems with Implanon, in part because Norplant involved the implantation of six small devices, compared with the one for Implanon. Also, Implanon uses a different form of progestin than Norplant.
Organon will be developing a nationwide training program to teach health care providers proper techniques for implanting and removing the device. Only health care providers who receive the training will be able to prescribe Implanon.
The Implanon device is loaded with 68 milligrams of progestin, which is released slowly and regularly during the lifetime of the device. Progestin stops the ovaries from releasing eggs and, at the same time, thickens cervical mucus, preventing sperm from fertilizing any released eggs.
Side effects can include irregular menstrual cycles and, in some cases, no monthly periods at all, as well as pain and swelling at the insertion site in rare cases.
The women most likely to show interest in Implanon are young people who aren't interested in having children for several years at least. Implanon does not affect long-term fertility, and after having the device removed, women should be able to get pregnant within a month.
You must see a health care provider to get hormone implants. After you are given a local anesthetic, insertion takes about 7 to 10 minutes and usually does not hurt. You will probably be given a date to return about one month after insertion to check out the insertion site and to answer any questions you may have.
Hormone implants is one of the most effective methods of contraception, but it does not protect against the transmission of sexually transmitted infections (STIs). Also, some women have experienced severe reactions to hormone implants. If you have a monogamous partner who has tested negative for STIs, you might want to try hormone implants. Also, teenagers using hormone implants have higher continuation rates and lower pregnancy rates than teenagers choosing to use birth control pills or hormone injections.
JADELLE IMPLANTS
Jadelle (a two-rod levonorgestrel implant) is not currently available in the United States. However, in 1996 the US Food and Drug Administration (FDA) approved the implant for use of up to 3 years. After reviewing additional data in 2002, the FDA changed its requirements and would allow Jadelle to be used for up to 5 years, if it was sold in the United States. The implant has also been approved in Europe for 5 years' use. Jadelle is currently available in both developed and developing nations around the world.
Jadelle is an implant system that provides effective, long-acting, reversible contraception for women. Two thin, flexible rods made of silicone tubing and filled with levonorgestrel, a synthetic progestin, are inserted just under the skin of a woman's upper, inner arm in a minor surgical procedure. Protection from pregnancy is provided within 24 hours, when insertion is performed during the first week of a woman's menstrual cycle. The woman rapidly returns to her normal fertility when the implants are removed. Because Jadelle contains no estrogen, the most common side effects are changes in menstrual bleeding patterns. Most other common side effects are similar to those experienced by women who use other hormonal contraceptives.
Jadelle is one of the most effective reversible contraceptives available. The cumulative pregnancy rate in clinical trials was 0.3 for three years and 1.1 percent for five years. Jadelle has a lower failure rate than the pill and most IUDs. Its efficacy is comparable to that of surgical sterilization.
Jadelle is not currently available in the United States. However, in 1996 the United States Food and Drug Administration (FDA) approved the implant for use of up to 3 years. After reviewing additional data in 2003, the FDA changed their requirements and approved Jadelle use for up to 5 years, if it was sold in the US. The implant has also been approved in Europe for 5 years' use.
For more information about Jadelle Implants, see:
NOTIFY YOUR MIDWIFE OR HEALTH CARE PROVIDER IF...
You are interested in hormone implants for contraception.
After implantation, unexpected side effects occur, such as severe abdominal pain.
Heavy vaginal bleeding develops.
You have had the hormone implants for about 5 years and they need to be replaced.
Mountain Rose Bulk Herbs
Mountain Rose Aromatherapy Oils
Mountain Rose Herbs, Aromatherapy Oils A-B
Mountain Rose Herbs, Aromatherapy Oils C-E
Mountain Rose Herbs, Aromatherapy Oils F-L
Mountain Rose Herbs, Aromatherapy Oils M-P
Mountain Rose Herbs, Aromatherapy Oils Q-Z
Mountain Rose Herbs, Aromatherapy Oils: Oil Blends & Resins
Mountain Rose Herbs, Aromatherapy Oils: Diffusers, Nebulizers, & Burners
Mountain Rose Herbs, Aromatherapy Oils: Oil Kits
Click Here To Visit Herbal Remedies Product Page
Press your "back" button to return to the last page.
