A Hidden Side of Norplant
p.16
by Kristine M. Severyn, R.Ph., Ph.D.; copyright 1994

ON DECEMBER 6, 1990, USA Today proclaimed the soon-to-be-licensed 
Norplant "as perfect a method as you can have." [1] Three years later a 
Chicago Tribune headline read, "No panacea: Norplant suit charges 
failure to educate patients." [2] What happened during this time to 
dampen the initial enthusiasm for Norplant?

What Is Norplant?

The "Norplant System" is a birth control method involving surgical 
insertion of six flexible silastic 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. [3]

Levonorgestrel and its chemical relative norgestrel have been 
components of oral contraceptives for several years. [4] Since Norplant 
does not contain estrogen, which is associated with blood clotting and 
various cardiovascular disorders, [5, 6] 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." [7]

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 removal more difficult." After three 
days, keeping the wound clean and dry, she may resume normal 
activities. A typical insertion procedure takes about fifteen minutes. 
[3]

Difficulty in Norplant Removal and Class-Action Lawsuits

As expected (based on experience with other contraceptives8) 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." [9]

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 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 [10, 11, 12, 13] and proposed for 
women harmed by silicone gel breast implants. [14]


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 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. [15]


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 to "vigorously break up" adhesions. [16]

Conclusion

Three years of use in the United States have uncovered a hidden side of 
Norplant. Nearly all Norplant users experience side effects, forcing 
early implant removal in about 20 percent of them during the first year 
alone. Implant removal is difficult in some women, possibly involving 
multiple prolonged surgical attempts, including surgery under general 
anesthesia, leaving unsightly scars. Norplant has also not proven to be 
the solution to the moral and social problem of teenage out-of-wedlock 
pregnancy, as was predicted, nor does it protect against sexually 
transmitted diseases. For many women Norplant has been a 
disappointment, if not an abject failure.

Dr. Severyn is a registered pharmacist with a Ph.D. in 
biopharmaceutics. She lives in Dayton, OH, with her husband and three 
children, where she researches and writes on medical issues.

1. K. Painter, "As Perfect a Method as You Can Have," USA Today, Dec. 
6, 1990 (cover story).

2. H. M. Little, "No Panacea: Norplant Suit Charges Failure to Educate 
Patients," Chicago Tribune, Oct. 31, 1993, Sec. 6, p 1.

3. Norplant System prescribing information, Wyeth Laboratories, 
Philadelphia, PA 19101, Dec. 1990.

4. "Oral Contraceptives," in Drug Facts and Comparisons, Facts and 
Comparisons, St. Louis, MO, 1993, pp. 377-381.

5. 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.

6. L. Speroff, "The Formulation of Oral Contraceptives: Does the Amount 
of Estrogen Make any Clinical Difference?" Johns Hopkins Medical 
Journal 1982; 150:1970-1976.

7. "The Most Recent Innovation in Birth Control," Norplant System 
informational booklet. Wyeth Laboratories, Dec. 10, 1990.

8. K. H. Bacon, "U.S. Birth Control R&D Lags," Wall Street Journal, Feb. 13, 
1990.

9.  Jane Doe, Annrita Garcia, Mary Roe, and Leticia Walker v. 
Wyeth-Ayerst Laboratories, No. 93 L 11096 (Filed Nov. 5, 1993), Circuit 
Court of Cook County, IL.

10. "Dalkon Shield Fund Set at $2.5 Billion," Dayton Daily News 
(Associated Press), Dec. 12, 1987.

11. "IUD-Claims Fund Clears Way for Merger," Dayton Daily News 
(Associated Press) Mar. 17, 1988.


12. "IUD Manufacturer G. D. Searle and Co. Found Negligent," The 
Wanderer, Sep. 29, 1988.

13. "Costly Lawsuit," American Druggist (Teleflashes) Oct. 1988.

14. S. G. Boodman, "$4.75 Billion Proposed for Breast-Implant Cases," 
Washington Post Health, Sep. 21, 1993, p 7.

15. D. M. Twickler & B. E. Schwarz, "Imaging of the Levonorgestrel Implantable 
Contraceptive Device," American Journal of Obstetrics and Gynecology 
1992; 167(2):572-573.

16. E. Mechcatie, "Norplant Capsules Can Be Difficult to Remove; Other 
Problems Cited," Ob.Gyn. News, May l, 1993, p. 2; and E. Mechcatie, 
"Problems Cropping Up in Norplant Users," Family Practice News, May 1, 
1993.

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