Norplant, the first new form of birth control approved for use in the United States in the past three decades, is scheduled to be implanted in a Utah woman March 16.
Dr. Matthew Peterson, a reproductive endocrinologist and assistant professor at the University of Utah Medical School, is one of 100 physicians nationwide trained to implant the birth-control device.The device, marketed by a Finnish pharmaceutical company under the trade name Norplant, is revolutionary because it is convenient, long-acting, effective and reversible.
After three decades in development and clinical trials, the contraceptive was approved earlier this month by the U.S. Food and Drug Administration. Peterson just received his first shipment from the U.S. distributor, Wyeth-Ayerst Laboratories, last week.
Peterson said his office has received about 20 calls about the device from patients, while 15 local doctors are already scheduled for implantation training.
Norplant consists of a synthetic chemical, levenorgestrel, which is encased in matchstick-size plastic capsules. Six rods are implanted on the underside of a woman's upper arm above the elbow.
The progestin-like hormone suppresses ovulation so eggs will not be released regularly, and thickens the cervical mucous, blocking the sperm's path to the egg.
The device is effective for five years and isn't visible to the eye in most patients, Peterson said. About the same levels of chemicals are released in a woman's body while using Norplant as if she were taking birth-control pills daily. But the new contraceptive is effective for women who can't take estrogen.
Based on 500,000 implants in 16 countries, officials say Norplant is one of the most effective forms of birth control short of sterilization as it reduces user error or negligence. During the first year of use, only 0.2 percent of the users became pregnant. During the second year, the pregnancy rate rose to 0.5 percent, and during the third to fifth year, it rose to about 1 percent.
The contraceptive will cost between $300 to $600 for the six rods, plus the doctor's fee for a minor surgical procedure, about $100. The contraceptive is more expensive in the United States than in other countries, because of the years of stringent clinical tests required to receive FDA approval.
If a woman should become pregnant while on Norplant, there is a high risk of ectopic pregnancy in which the ovum is fertilized and develops outside the uterus, Peterson said. Also, 82 percent of the women in clinical studies reported heavier bleeding during their menstrual cycle, 30 percent reported weight gain of one to 10 pounds and 30 percent reported headaches.
Yet, despite these side effects, the majority of women report a high degree of satisfaction with the contraceptive device.
In a California study, three-fourths of the women using Norplant termed convenience as the device's most attractive feature. In that same clinical trial, most users said they intended to have more children in the future and viewed the method as a temporary contraception.
When the capsules are removed, at the end of five years or earlier, studies report that 60 percent of women return to fertility within six months, and 75 percent at one year.
At a Park City meeting of obstetricians and gynecologists, Peterson termed the insertion operation as an "easy" technique. "Probably the hardest thing is to get all of these out of the little plastic containers. If you drop one of these, it can be an expensive insertion," he said.
Even before Norplant implantations were approved in the United States, the device proved controversial. Ethicists worried that women on welfare or drug addicts would be ordered by judges to use Norplant, as a court-ordered birth control.
And that worry has come true. A Tulare County superior court judge in California last month sentenced a convicted child-abuser with a one-year jail sentence and three years on probation with the implantable contraceptive. Darlene Johnson, 27, seven months pregnant with her fifth child, was convicted of beating her two daughters, ages 4 and 6.
Civil rights activists, as well as the group that developed Norplant, the Population Council in New York City, say that court-ordered medical decisions are a violation of individual rights. Birth-control choices should be personal decisions, they say.
GRAPHIC\ Norplant contraceptive device
Norplant is one of the first new contraceptives approved by the FDA since the pill in 1960.
Capsules are about the size of a match.Encased in plastic.
Used in 14 countries by 500,000 women.
First implantation in Utah scheduled for March 16.
Drug: Levonorgestrel -- Derived from testosterone that has a progestin-like action.
Operation takes 15 to 30 minutes and is effective for 5 years.
Capsules are implanted 8-10 cm above the elbow.
Less than one pregnancy per 100 women. The only more effective forms of birth control are tubal ligation or a vasectomy.
Six capsules are inserted in a fan-like configuration.