Norplant: Birth Control at Arm's Reach 
by Marian Segal

The newest birth control option for women is literally at arm's reach. The
Norplant contraceptive, approved by the Food and Drug Administration last 
December and marketed since February, is implanted just under the skin of 
the inner arm, right above the elbow. Developed by the Population Council of
New York, this birth control alternative is distinctly different from 
methods previously available. 

New Form, Old Content 

Norplant consists of a familiar ingredient in a new package. Six silicone 
rubber capsules about the size of matchsticks contain a synthetic progestin 
hormone long used in birth control pills. The flexible tubes are inserted in
a fan-like arrangement and can be felt but not easily seen. 

Once in place, they steadily release a low dose of hormone into the 
bloodstream. Effective within 24 hours after insertion, Norplant can
continue to prevent pregnancy for up to five years. 

The hormone usually inhibits ovulation so that eggs are not produced
regularly, and causes the mucus of the cervix to thicken, making it more
difficult for sperm to reach the egg. Other ways that Norplant may provide
contraceptive effects have been proposed but not proven.

Experimental Attitude 

Jennifer Collier, a 28-year-old New York law student, entered a study of
Norplant at the Robert Wood Johnson Institute in New Brunswick, N.J., in the
spring of 1984 and is now on her second implant, inserted last June.

"It sounded like a really neat invention, so I decided to try it," says 
Collier. She had been dissatisfied with the weight gain and irritability she
experienced using oral contraceptives. With Norplant, she says, she isn't 
troubled with either of those side effects. Collier describes the implant as
visible, "but not terribly obvious. No one has noticed it unless they were
looking for it, probably partly because of where it's inserted."

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. 

Population Council Project

Norplant has been marketed in other countries for several years. According
to the Population Council, more than half a million women in 46 countries 
have used the implant since it was first approved in Finland--where it is 
manufactured--in 1983. It now has regulatory approval in 17 other countries 
as well, including Sweden, Indonesia, the Dominican Republic, Thailand, 
China, Peru, and the United States. Norplant's U.S. distributor is the
Philadelphia-based pharmaceutical firm Wyeth-Ayerst Laboratories. 

"The first implants were tested in 1968," says Population Council vice
president Wayne Bardin, M.D., "and then the council began to develop and
test implants that released a whole variety of progestins. By 1974, we came 
up with what is now the Norplant implant, using levonorgestrel. The first 
clinical trial of that was begun in 1975."

FDA approval of the implant was based on the results of clinical studies
involving 2,400 women in the United States, Finland, Sweden, Denmark, 
Jamaica, Brazil, Chile, and the Dominican Republic. 

In the studies, the contraceptive's effectiveness approached that of
sterilization in the first year. (See chart below or whatever.) 

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 to Collier 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 spontaneity," she says.

Because Norplant is not a barrier contraceptive, however, it offers no
protection against sexually transmitted diseases 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.

The Drawbacks 

As with virtually any drug or medical device, Norplant isn't entirely 
trouble-free. Side effects that women have reported with the implant during 
the first year include irregular menstrual bleeding, headache, nervousness, 
depression, nausea, dizziness, skin rash, acne, change of appetite, breast
tenderness, weight gain, enlargement of the ovaries, and excessive growth of
body or facial hair.

Some Norplant users have also reported breast discharge, vaginal discharge, 
inflammation of the cervix, abdominal discomfort, and muscle and skeletal 
pain. These effects, however, cannot 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.

By far, the most common side effect is menstrual cycle irregularity. "To
give the percentage of women with menstrual irregularities is complex," says
Bardin, "because it changes with time." He says that 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. "That's an 
average," says Bardin. "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," explains 
Lisa Rarick, M.D., a medical officer in FDA's division of endocrine and 
metabolism drug products. "Norplant, on the other hand," says Rarick, 
"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.) Bardin says that this is because, 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.

He says that most women who use Norplant don't perceive bleeding as a 
problem. "To illustrate," he says, "if you say, 'What is the biggest
complaint that women have about Norplant,' it's bleeding irregularities. But
if you ask all women if bleeding irregularities bother them, something like 
60 percent say 'no.' "

Collier says she has spotting and a lighter flow with Norplant. "Sometimes, 
I have no discernible cycle at all," she says, but maintains that "although 
of course I'd rather have regular periods, the effects are not that bad." 

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, according to FDA's Rarick. 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. She estimates that about
60 to 65 percent of women continue with the implant longer than two years.

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,
FDA advises physicians 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." 

Bardin suggests that Norplant will be most attractive to 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.

On the flip side, Bardin expects the implant to be less popular among women 
who:

  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 puts them at the mercy
of the clinic and they want to be able to stop it any time they want," says 
Bardin. "That's why they like pills and barrier methods--it's under their 
control," he says.) 

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 physician 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 physician 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--usually from 
15 to 20 minutes, according to the distributor. As with insertion, a small
incision is made under a local anesthetic. Then the physician 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, Bardin says, is to let the
physician know that "if you have trouble removing, don't cut a big hole in
the woman's arm and go fishing around looking for it [the capsule]." If the 
anesthetic has caused the area to puff up, for example, it may be difficult 
to feel the implant. "Wait until the next week or whenever she can come in
again," says Bardin, "and you'll be able to see it and take it out with 
minimal trauma."

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. Fees for insertion and 
related costs, such as counseling and removal, vary, depending on the 
physician.

Collier says that this will probably be the last Norplant she'll have, at 
least for a while, as she plans to get pregnant eventually. She's not sure
if she would come back to the implant later. "Hormone therapy and the risks 
associated with it--more with the pill and estrogen than with 
Norplant--concern me," she says. "I'll just have to see what else might be
available when that time comes." For now, Collier is pleased with Norplant
and would recommend it to any woman, "especially," she says, "if they're
going to be on hormone therapy anyway." 

Marian Segal is a member of FDA's public affairs staff.