Norplant: Birth Control : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

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."

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.