The "Norplant System" is a birth control method involving surgical insertion of six flexible matchstick-size rods into the inner upper arm of a woman. The rods (implants) contain levonorgestrel, a progesterone-type drug, which is released slowly to prevent pregnancy for up to five years.
Levonorgestrel and its chemical relative norgestrel have been components of oral contraceptives for several years. Since Norplant does not contain estrogen, which is associated with blood clotting and various cardiovascular disorders,, the drug's manufacturer, Wyeth-Ayerst, promotes Norplant "...as a particularly good option for a woman who...wants a form of hormonal contraception but does not wish to use estrogen-containing contraceptives."
How does it work?
Like other progestin-only methods of artificial contraception, Norplant appears to work in several ways.
- Norplant suppresses ovulation in at least half of the menstrual cycles.
- Hormonal indicators of ovarian activity suggest that ovulation may occur in some of the remaining cycles, but then Norplant makes cervical mucus thick and scanty, through which sperm cannot easily pass to fertilize ova.
- Norplant also suppresses the cyclic development of the endometrium (lining of the uterus) in over 50 percent of Norplant users.,,,
When Norplant works by making the endometrium (uterine wall) inhospitable to the fertilized ovum, the new human cannot implant and an early abortion occurs.
How is Norplant inserted?
As the woman lies on the doctor's examining table, the inside of her upper arm is prepared with antiseptic, and she receives six injections of local anesthetic "to mimic the fanlike position of the implanted capsules." Next, a scalpel is used to cut a 2-mm shallow incision in the woman's arm. Through this incision is inserted a large-bore needle, and the six implants are placed through this needle under the skin in a fan shape. "Correct and carefully performed subdermal insertion of the six capsules" is important because "failure to do so may result in deep placement...and could make re- moval more difficult." After three days, keeping the wound clean and dry, she may resume normal activities. A typical insertion procedure takes about fifteen minutes.
How was Norplant tested?
In Bangladesh, Norplant was used in a trial on women without their being given adequate information, thus making true informed consent impossible.
The Brazilian Ministry of Health gave permission for the testing of Norplant on Brazilian women in 1984 at a time when the country was under a military dictatorship and the public had no opportunity to participate in, or be informed about, government decisions. When the Committee for Studies of Human Reproductive Rights was formed in 1985 and evaluated Norplant trials, it found irregularities in their conduct and the trials were discontinued in January 1986.
A Norplant "acceptability" study was conducted in Communist China, where it has been goverment policy since 1982 for every urban couple to give birth to only one child. Mr. Irving Sivin, Norplant researcher for the Population Council, co-authored a report on this study of the implant on Chinese women. The article describes how "More than 90 percent of women had only one living child at admission...Less than one percent had three or more children... acceptors live in the largest urban centers of the People's Republic of China, where completed family size is low."
In 1986-87 attitudinal follow-up was evaluated in Egypt, the Dominican Republic, Indonesia and Thailand. Only those who had already been clients of a family planning clinic were included as subjects. This cannot be characterized as fair testing, since family planning clinic clients are already predisposed to taking active measures to avoid a baby. Thus, a study of their attitudes regarding the acceptability of Norplant and the use of this chemical would be biased.
Indonesia, which uses about two-thirds of the world's Norplant, has promoted it since 1987 as an essential part of the country's family planning program. Yet Ines Smyth of Oxford University has expressed concern about Indonesian women because of the possibility that the implant is not being removed on time or at all. Reporting Smyth's comments, journalist Dave Todd, wrote, "If the spent rubber-rod implants are not removed, they can continue to interfere with a woman's fertility, creating a serious risk of ectopic pregnancy in the fallopian tubes rather than the womb. That can lead to sudden death by massive internal hemorrhaging."
Dr. Olga Reyes of Ecuador wrote, "Dr. Jenny [Agyla] testified to me that she removed implants of poor Indian women in the rural province of Loja (southern part of Ecuador). So it is proved again that our poor population too is used as a lab-animal for research!"
These examples raise questions concerning the primary purpose of Norplant testing. Was the purpose to make certain that women would be safe from hazards to their health, or simply to garner favorable acceptance by governments for a chemical that would eliminate pregnancy for five years at a time?
But the U.S. Government approved this for American women, didn't it?
Yes, in December of 1990 the Food and Drug Administration (FDA), a division of the Department of Health and Human Services within the Public Health Service, approved Norplant for use by American women.
In August 1989 Hugh C. Cannon, Associate Commissioner for Legislative Affairs at the FDA, wrote to Congressman Robert K. Dornan that "the primary mechanism by which levonorgestrel [Norplant] prevents pregnancy has not been definitely established. Norplant does not act as an abortifacient."
However, in the same letter, Mr. Cannon wrote that levonorgestrel (Norplant) "alters the development of the endometrium which could interefere with nidation [implantation]."
In Mr. Cannon's December 13, 1989, reply to a request to define such terms as "conception," and "fertilization" he wrote, "We have not found it necessary to promulgate official definitions of words commonly used in the scientific community."
Apparently the federal government does not object to providing women a device that may kill preborn children, nor does it feel compelled to explain to women that the device may act in such a manner. This does not satisfy the tenets of fully informed consent.
(A "contraceptive" is intended to prevent pregnancy from occurring, not eliminate a baby after that child's life has begun.)
"Abortifacients" are chemicals or devices that act to cause an abortion, usually early in a pregnancy, but the scientific and medical communities and the federal government euphemistically refer to these as "contraceptives."
Does Norplant have any physical side effects for the woman who uses it?
Yes. They are:
1) An increase in the number of days of bleeding and spotting, with shorter cycle intervals.,
2) Changes in lipid metabolism, which is the body's mechanism for breaking down cholesterol, triglycerides and lipoproteins. This may affect blood pressure, risk of heart attack, and blood coagulation (clotting).
3) In approximately ten percent of women, large functional ovarian cysts have occurred, some of which required surgery to remove them.
4) Less common side effects include headaches; changes in liver function, carbohydrate metabolism, and immunoglobulin; and increased body weight and serum cholesterol.
5) A few users also report mood changes, frequent chest pains, acne, numbness in the implanted arm, increased body hair growth, uterine cramping, and excessive PMS symptoms.
6) For the diabetic, "there is likely to be a need for increased insulin requirements, and those with impaired carbohydrate metabolism may become overtly diabetic." More studies should be conducted "on diabetic women and others at risk"; and until then, "these conditions should be a relative contraindication."
According to Dr. Philip Darney, professor of obstetrics and gynecology, University of San Francisco Medical School, and Dr. Iris Litt of Standford University Medical Center, Norplant was not studied in teenagers before U.S. licensing. Therefore, safety and efficacy in this age group remains unknown. Despite this Dr. Litt suggested that Norplant may be desirable for teens because it "has the potential of delaying pregnancy until the higher-risk adolescent years have passed."
Incidence of side effects to Norplant in U.S. women (average age 28), as reported in Family Planning Perspectives, included the following:
1) "Nearly all users reported at least one side effect and four out of five reported menstrual changes."
2) "Ninety-five percent of the women surveyed said they experienced at least one side effect while using the implant, while 61 percent had experienced two or more."
3) "Forty-four percent of the women who had experienced any side effects said they had considered having the implant removed because of them..."
4) "Only 16 percent of women who had discontinued because of side effects said they would use the implants again." This suggests that the "convenience" is not worth the suffering.
Finally, an alarming comment by pediatrician DuBose Ravenel, M.D., brings another aspect of potential side effects to mind:
"Comments by Dr. Iris Litt, in the Journal of the American Medical Association address a much more fundamental issue-that of the effect of dissociating pregnancy prevention measures from prevention of STD's [venereal diseases]. Even assuming perfect pregnancy prevention (which is never true for any medical intervention), removal of fear of pregnancy in my opinion would cause a skyrocketing of sexual promiscuity and attendant STD's, including of course, [AIDS]. Note that the trials of Norplant have not included adolescent patients...I am afraid Norplant represents a 'time bomb' for a dramatic escalation of promiscuity, STD's and [AIDS]..."
Difficulty in Norplant removal, and class-action lawsuits
As expected (based on experience with other contraceptives) a class-action lawsuit was filed on behalf of women severely or permanently injured by Norplant. The amended complaint, filed on November 5, 1993, alleges that Wyeth-Ayerst failed to warn users "about the difficulty of [Norplant] removal," and as a result, women "...were damaged...and...will require continuing medical care due to the difficulty with removal of NORPLANT."
The suit alleges nine breaches by Wyeth, including "negligence" and "consumer fraud," and asks that Wyeth improve its warnings to women, and devise a "sufficient training program" for those who insert Norplant. The plaintiffs also ask that a compensation fund be established for these and other women, similar to the funds established several years ago for women damaged by intrauterine devices,,, and proposed for women harmed by silicone gel breast implants.
Four women's unfortunate experiences while using Norplant are detailed in the complaint. One woman suffered "interrupted and/or heavy and continual menstrual flow, nausea, weight gain (20 pounds), and severe headaches." Sixteen months after Norplant insertion, the physician, who unsuccessfully attempted to remove the rods, closed the incision and told her to return again. Three months later, and after two additional failed attempts to remove the rods, she was forced "to undergo surgery, under a general anesthetic...to remove the Norplant implants," and she now "has severe scarring..."
A second woman gained 18 pounds, developed menstrual irregularities, excessive hair growth, acne, and emotional side effects (irritability) during her 13-month use of Norplant. The implant-removal surgery lasted for more than two hours and required two separate incisions. Her arm was "bruised and sore," and "...left with two ugly scars." She continues to consult a dermatologist for the acne.
During a third woman's 17 months on Norplant she "experienced abnormally long menstrual cycles," which progressed to lack of menstrual cycles, "....hot flashes, headaches, and a numbness and pain in her left arm" so severe that "she could not pick things up with her left hand..." Although she sought removal of the Norplant rods 15 months after insertion, doctors were unsuccessful in removing them, even after nearly one and one-half hours of surgery. Two months later two more surgeons finally removed the implants through two separate incisions. She now has "severe scarring" after the two painful removal surgeries.
A fourth woman's Norplant experience included "excessive bleeding for two weeks" (after insertion), with "nausea, dizziness, weight gain...migraine headaches, diminished sex drive...[and] irritability" for the 13 months the Norplant rods were in her arm. Four months after insertion she complained to her doctor about the side effects, and was told twice to wait for two months (an additional four months). She finally demanded removal of the Norplant rods ten months after they were inserted.
Dependent on public assistance, she was told that the clinic lacked government funds for Norplant removal, and to wait three more months until the next fiscal year. During these three months she failed to find a physician who would remove the implants. When government funds became available, she returned to the clinic and underwent one and one-half hours of surgery to remove only two of the six implants. The next month she endured three more surgeries, one lasting three and one-half hours with eight injections of anesthetic, yielding removal of only one implant. Another surgical attempt failed to remove any of the three remaining implants. She was referred to a specialist who recommended surgery under general anesthesia. Nearly five months after she asked for Norplant removal, the fourth surgery removed the remaining three implants. She now has "severe scarring" and arm pain.
Considering that the approximately 800,000 U.S. women who currently use Norplant will ultimately seek removal of the implants, it is unknown how many other women will experience problems similar to those of the women in the lawsuit. One could reasonably expect that the longer the implants are in place, the more difficult they might be to remove due to adhesions and scar tissue formation. In fact, it has been recommended that when the implants cannot be felt in the woman's arm, or they migrate to deeper tissues, x-ray or ultrasound be employed to help locate the Norplant rods.
At a 1993 conference on contraception a Planned Parenthood physician reported that insertion of Norplant rods is usually uncomplicated, but that some health care providers have expressed difficulty in removing them. An obstetrics and gynecology professor recommended use of a curved hemostat [clamp] to "vigorously break up" adhesions.
Is the public being deceived about Norplant?
Norplant is manufactured by Wyeth-Ayerst Laboratories (a division of American Home Products), located in Philadelphia, Pennsylvania. In response to inquiries about the way Norplant works in the woman's body, Margaret Weber, M.D., Associate Director, Clinical Development, Medical Affairs Department, Wyeth-Ayerst, replied, "While it is true that progestins do alter the endometrial lining, this should be considered an irrelevant by-product of progestins..."
In her opinion, the fact that Norplant could cause early abortion is irrelevant to women who may use it.
Feminist columnist Anna Quindlen wrote of Norplant in 1990, describing it as a "contraceptive," but did not tell her readers exactly how Norplant works in a woman's body.
In 1991 the Catholic newspaper Our Sunday Visitor presented readers with a generally comprehensive article on Norplant but neglected to report that Norplant could cause early abortion.
In March 1991, McCall's magazine presented an in-depth article on Norplant, but did not note for their readers exactly how this implant system works in the bodies of those who use it.
In the case of teens who live with their parents, Planned Parenthood touts its policy to insert Norplant in the bodies of teens without requiring parental consent.
Is it true that Norplant would give government and others a way to coerce the poor and less fortunate into using birth control?
Professor George Annas, of Boston University School of Medicine, stated: "Norplant presents a special temptation to judges because it's so long lasting and doesn't require any cooperation after it's implanted, and can be monitored by a parole officer..."
Judge Howard Broadman, Tulare County Superior Court, California, ordered a 27-year-old woman to have Norplant implanted in her arm when she was convicted of child abuse.
Juvenile Court Judge Tom Rickoff, San Antonio, Texas, suggested that a 23-year-old woman, who had delivered a baby with methadone in his bloodstream be sterilized. After already losing custody of three children, she suggested Norplant be inserted instead. The judge agreed.
Judge Lawrence Page Haddock, Duval County Circuit Court (Florida), sentenced a girl who had smothered her newborn baby to two years in prison plus ten years of birth control.
Wyeth-Ayerst has established a $2.8 million fund to provide Norplant to poor women.
Past United States presidential candidate David Duke proposed, in the Louisiana state legislature, to pay poor mothers $100 per year to use Norplant. In Kansas, the legislature's offer was $500. Both measures failed in 1991. The Yuma County (California) Department of Social Services considered a plan to limit "unplanned" pregnancies by providing a $500 incentive to poor women not to have children.,
Legislation was even introduced in Ohio which would have required Norplant or tubal ligation for women, or vasectomy for men, if the family had a child and received welfare benefits for their support. Parents would have faced jail for refusing sterilization or Norplant.
And the feminist magazine Mirabella quoted Arthur Caplan, past director of the Center for Biomedical Ethics, University of Minnesota: "Today, a welfare mother is coerced into using Norplant. Tomorrow, the state is in the parent licensing business."
Introduction of Norplant has given U.S. courts and state legislatures a long-acting birth control device to force the poor to comply with govermnent wishes. The use of drugs as punishment or coercion violates medical ethics and is an affront to human dignity.
1. Norplant System prescribing information, Wyeth Laboratories, Philadelphia, PA 19101, 12/90.
2. "Oral Contraceptives," in Drug Facts and Comparisons, Facts and Comparisons, St. Louis, MO, 1993, pp. 377-381.
3. F. Murad and R. C. Haynes, "Estrogens and Progestins," in A. G. Gilman, L. S. Goodman, T. W. Rall, F. Murad (eds): Goodman and Gilman's The Pharmacological Basis of Therapeutics (New York: Macmillan, 1985), pp. 1412-1439.
4. L. Speroff, "The Formulation of Oral Contraceptives: Does the Amount of Estrogen Make any Clinical Difference?" Johns Hopkins Medical Journal 1982; 150:1970-1976.
5. "The Most Recent Innovation in Birth Control," Norplant System informational booklet. Wyeth Laboratories, 12/10/90.
6. "Hormonal Contraception: New Long-Acting Methods," Population Reports, Series K, #3, 3-4/87, pp. K58-K63.
7. R. Kleinman, ed., "Hormonal Contraception," International Planned Parenthood Federation, 1990, p. 97.
8. "Progestins," Facts and Comparisons, 1989, p. 104.
9. Segal, et al., "Norplant Implants: the Mechanism of Contraceptive Action," Fertility and Sterility, Vol. 56, #2, 8/91, pp. 273-277.
10. Norplant System prescribing information, Wyeth Laboratories, Philadelphia, PA 19101, 12/90.
11. Ubinig, "Research report Norplant, the five year needle: an investigation of the Norplant trial in Banhgladesh from the user's perspective." Issues in Reproductive and Genetic Engineering, 1990, Vol. 3, #3, pp. 211-228.
12. Cited in "Biomedical Research Practice-Informed Consent-Human Experimentation," Bioethics Research Notes, Vol. 3, 3/91, p. 6.
13. Gomes dos Reis AR: "Norplant in Brazil: Implantation Strategy in the Guise of Scientific Research," Issues in Reproductive and Genetic Engineering, Vol. 3, #2, 1990, pp. 111-118.
14. Gu Sujuan, Irving Sivin (Population Council) et al., "A Two Year Study of Acceptability, Side Effects and Effectiveness of Norplant and Norplant-2 Implants in the People's Republic of China," Contraception, Vol. 38, #6, 12/88, pp. 641-657.
15. Zimmerman, et al., "Assessing the Acceptability of Norplant Implants in Four Countries: Findings From Focus Group Research," Studies in Family Planning, Vol. 21, #2, 3-4/90, pp. 92-103.
16. Dave Todd, "Walking Time Bombs," Toronto Star, 12/28/91, p. H10.
17. Letter to American Life Lobby from Olga Reyes, M.D., Federacion Mundial de Medicos Que Respetan la Vida Humana, Quito, Ecuador, S.A., 1/24/91.
18. Letter to Honorable Robert K. Dornan from Mr. Hugh Cannon, FDA, 8/17/91.
19. Letter to Honorable Robert K. Dornan from Mr. Hugh Cannon, FDA, 12/13/89.
20. Paul Weckenbrock, R.Ph., "Norplant: What Is It? How Does It Work?" CCL Family Foundations, Vol. XVII, #4, 1-2/91, p. 1.
21. Darney, et al., "Acceptance and Perceptions of Norplant Among Users in San Francisco, USA," Studies in Family Planning, Vol. 21, #3, 5-6/90, pp. 152-160.
22. Paul Weckenbrock, op. cit.
25. Darney, et al., op. cit.
26. J. Konje, M.D., et al., "The Effect of Continuous Subdermal Levonorgestrel (Norplant) on Carbohydrate Metabolism," American Journal of Obstetrics and Gynecology, Vol. 166, #1, part 1, 1/92, pp. 15-19.
27. C. Allen, "Norplant-Birth Control or Coercion?" Wall Street Journal, 9/13/91, p. A10.
28. I. Litt, M.D., "Adolescent Medicine," Journal of the American Medical Association, Vol. 265, #23, 6/19/91, p. 3100-3101.
30. R. Turner, "Hormonal Implants Prove to Be Highly Acceptable, Although Nearly All Users Experience Side Effects," Family Planning Perspectives, Vol. 22, #5, 9-10/90, pp. 234-35.
32. Letter to Judie Brown from S. DuBose Ravenel, M.D., High Point Infant & Child Clinic, Inc., High Point, N.C., 6/17/91.
33. K. H. Bacon, "U.S. Birth Control R&D Lags," Wall Street Journal, 2/13/90.
34. Jane Doe, Annrita Garcia, Mary Roe, and Leticia Walker v. Wyeth-Ayerst Laboratories, No. 93 L 11096 (Filed 11/5/93), Circuit Court of Cook County, IL.
35. "Dalkon Shield Fund Set at $2.5 Billion," Dayton Daily News (Associated Press), 12/12/87.
36. "IUD-Claims Fund Clears Way for Merger," Dayton Daily News (Associated Press) 3/17/88.
37. "IUD Manufacturer G. D. Searle and Co. Found Negligent," The Wanderer, 9/29/88.
38. "Costly Lawsuit," American Druggist (Teleflashes) 10/88.
39. S. G. Boodman, "$4.75 Billion Proposed for Breast-Implant Cases," Washington Post Health, 9/21/93, p. 7.
40. D. M. Twickler & B. E. Schwarz, "Imaging of the Levonorgestrel Implantable Contraceptive Device," American Journal of Obstetrics and Gynecology 1992; 167(2):572-573.
41. E. Mechcatie, "Norplant Capsules Can Be Difficult to Remove; Other Problems Cited," Ob.Gyn. News, 5/l/93, p. 2; E. Mechcatie, "Problems Cropping Up in Norplant Users," Family Practice News, 5/l/93.
42. Letter to Judie Brown from Margaret E. Weber, M.D., Wyeth-Ayerst Laboratories, 5/3/91.
43. Anna Quindlen, "Norplant Inserts a Hope of Before-Conception Solutions," Miami Herald, 12/23/90, p. A12.
44. Elizabeth Sobo, "Norplant: Lab-Tested on Third World Women," Our Sunday Visitor, 2/3/91, p. 10.
45. Vivian Cadden, "The Five Year Contraceptive-Is It Right for You?" McCall's, 3/91, pp. 62, 64, 68.
46. "Clinics' Policy on Implant," Washington Post, 4/5/91, p. A3; "Minors Won't Need Consent for Norplant," USA Today, 4/5/91, p. 1.
47. Tamar Lewin, "Implanted Birth Control Device Renews Debate Over Forced Contraception," New York Times, 1/10/91, p. A13.
48. E. Mechcatie, "Calif. Judge Orders Child Abuser to Use Norplant," Ob. Gyn. News, 2/15-28/91, p. 8.
49. J. Kever and A. Villafranca, "Judge Orders Mom to Get Birth Control," San Antonio Light, 10/3/91, p. A1.
50. F. Barringer, "Sentence for Killing Newborn, Jail Term, Then Birth Control," New York Times, 11/18/90, p. 1.
51. "Funds Offered for Poor to Obtain Birth Control," Washington Times, 4/26/92, p. A2.
52. M. Schwartz, "Duke Presses Louisiana Birth Control," Washington Post, 5/29/92, p. A14; D. Saunders, "Norplant and Welfare," Richmond Times-Dispatch, 4/17/91, p. A13.
53. "YCD of Social Services Considering Plan to Aid in Birth Control," Wray (CO) Gazette, 6/5/91.
54. Ohio 119th General Assembly, House Bill 819, 1991-1992.
55. E. Hopkins, "Fertility Police," Mirabella, 6/91, pp. 102-106.