By BRIAN CLOWES
(Editor’s Note: Brian Clowes has been director of research and training at Human Life International since 1995. For an electronic copy of chapter 2 of The Facts of Life, “Abortifacients,” e-mail him at bclowes@hli.org.)
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Birth control implants are slowly becoming more popular as a method of birth control all over the world primarily because of heavy promotion by “family planners.” Implants have several advantages from the population control viewpoint. They do not require daily attention, they have a high effectiveness rate because the cause of most contraceptive failures (user error) is eliminated, and they are effective for a long period of time, from three to seven years.
There are three types of implants currently in use:
Norplant consists of six flexible tubes containing a total of 216 milligrams of the progestin levonorgestrel, and is effective for seven years after insertion. The Chinese call their version of Norplant “Sinoplant I.” All of the implants consist of silastic (silicone rubber), the same material used in heart valves and medical tubing.
Jadelle is the successor to Norplant, and is often referred to as “Norplant-2.” It consists of two flexible tubes containing a total of 75 milligrams of levonorgestrel, and is effective for five years after insertion. It was approved by the United States Food and Drug Administration (FDA) in 1996 but has never been used in this country. The Chinese also manufacture Jadelle, calling it “Sinoplant II,” which is effective for four years.
Merck’s Implanon contains 68 milligrams of the progestin etonogestrel, and is effective for three years. Merck also markets Nexplanon in Europe. Nexplanon is identical to Implanon but features radiopaque rods. Implanon is the only implant currently available in the United States.
The Checkered History of the First Implant. Norplant was developed and tested by embryologist Sheldon Segal of the Rockefeller Foundation, and its patent was originally owned by the Population Council. Wyeth Ayerst Laboratories of Philadelphia, a subsidiary of American Home Products Corporation, initially produced Norplant. The FDA approved it for use in December 1990, and it was formally introduced to the American public amid great fanfare two months later.
Just over a decade later (2002), one and a half million North American women had used Norplant. More than 50,000 of these women brought more than 200 lawsuits, including 70 class action suits, against Wyeth Ayerst. The legal complaints alleged inadequate warnings of side effects, prolonged menstrual bleeding, headaches, significant weight gain, personality disorders, hair loss, and depression.
Wyeth Ayerst reacted aggressively, and won three jury verdicts, more than 20 summary judgments, and the dismissal of 14,000 claims.
In 1999, it offered $1,500 cash settlements to the remaining 36,000 women who alleged that they had been injured by Norplant. Knowing that they would most likely not win their lawsuits, most of these women accepted the settlement offer. Norplant ceased distribution in the United States in 2002, but is still used in developing nations all over the world.
Norplant’s successor Jadelle was also developed by the Population Council and is manufactured by Finland’s Schering Pharmaceuticals. The FDA approved Jadelle in May 1996. Jadelle is not marketed in the United States, but is being used all over the world by the United States Agency for International Development (USAID) and other population control agencies.
Implantation and Extraction Procedures. Insertion and extraction procedures for all of the implants are similar. A physician begins the insertion procedure by making a 1/8 inch incision about six inches above the woman’s elbow. He then loads the capsules one by one into her arm in a fan-shaped pattern using an insertion tube. He uses local anesthetic for both the implantation and extraction procedures.
In many cases, removing the silastic tubes is more difficult than implanting them because the tubes become coated with fibrous tissue and gradually anchor into the surrounding tissue (i.e., they grow into the arm). This is a result of trauma caused by the implants being pushed into the tissue and a low-level inflammatory reaction to the tube’s foreign substance. In some cases, the tubes slowly scatter and migrate to other areas of the body, which is why Implanon was made to be more visible to X-rays.
How the Implants Work. The implants are members of the single synthetic hormone class of abortifacients which includes the “mini pill” and the Progestasert intrauterine device (IUD).
Once implanted, Norplant and Jadelle slowly release levonorgestrel (a low-dosage progestin used in many birth control pills), which is an abortifacient that prevents implantation of the developing human being in the uterus. Implanon and Nexplanon release etonogestrel, another low-dosage progestin.
All of these implants have a threefold mode of action. They inhibit ovulation, thicken the cervical mucus, and alter the endometrium (the lining of the uterus) so that its degree of receptivity to the blastocyst (early developing human being) is significantly decreased. A test of 41 women using Norplant for one year showed that 24 women experienced a suppressed uterine lining, 12 had an irregular uterine lining, and only five had normal (unchanged) uterine linings.
Thus, Norplant had a clearly abortifacient effect in up to 88 percent of the women tested. This means that a woman using an implant will occasionally ovulate and conceive — and experience an early “silent” abortion.
Dr. John Hildebrand, an expert in human reproduction, describes how the synthetic hormones in Norplant “. . . louse up the lining of the uterus. It produces exhaustion of the endometrium, depriving the lining of the uterus of the hormonal support that it needs. [The drug] disturbs all factors in the blood system. The drug is long acting because the body can’t digest these new analogs. The body sees this as an abnormal thing and tries to get rid of it. When it can’t, it sets up violent reactions inside us. In the sense that we are all different — that our enzymes are as individual as our fingerprints — nobody can be certain of the effects this drug will have.”
This is true of all implants, not just Norplant.
Side Effects. Although they naturally vary widely from woman to woman, the range of typical Norplant side effects include changes in the endometrium (uterine lining), odd menstrual bleeding patterns, spotting between menstrual periods, missed or prolonged menstrual periods, dizziness, sudden weight gain or loss, headaches, nervousness, nausea, hirsutism (abnormal body hair growth), and ironically, a decreased sexual appetite.
Since Jadelle releases exactly the same chemicals, we can expect its users to suffer the same side effects, but perhaps less frequently due to the lower dosage.
Inevitable Abuses
The patient information pamphlets for these implants also show that much more serious side effects include thrombosis (formation of blood clots which can lead to heart attacks and strokes), liver dysfunction, ectopic pregnancies, high blood pressure, and allergic/immune reactions.
One Texas survey showed that eight percent of Norplant users experienced pseudo tumor cerebri, a condition where increased fluid pressure in the brain crushes the optic nerve and causes partial or complete permanent blindness.
A study conducted in Singapore concluded that after one year of use, women “. . . may have an increased predisposition to thrombosis as evidenced by significant increase in platelet count and aggregability.” The results also show that Norplant acceptors may have an enhanced potential for hypercoagulation. Another study showed that there was a significant increase (58 percent) in bilirubin in women who used Norplant for a year, indicating that the abortifacient may cause serious liver dysfunction.
The FDA has warned that Norplant “should not be used by women who have acute liver disease, unexplained vaginal bleeding, breast cancer, or blood clots in the legs, lungs, or eyes.”
Groups that were already deeply involved in abortion, contraception, and population control predictably downplayed the side effects of the drug in their literature when concerns began to arise. The April 1990 issue of the International Planned Parenthood Federation (IPPF) newsletter Medical Bulletin stated that Norplant’s most serious side effects were weight gain and a “. . . greater risk that the pregnancy will be ectopic than if the user were not using Norplant.”
The article failed to mention impacts such as allergic/immune reactions, “migration” of the six polymer capsules, or most of the other side effects listed above.
In summary, the implants are all long-lasting and take reproductive control out of the hands of the user and put it into the hands of the doctors and health workers who are employed by health departments in developing nations. Thus it is inevitable that abuses occur on a wide scale, as described in the next article.
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