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Norplant and Implanon

Norplant is the name given to a series of rods or capsules that a doctor surgically inserts into a woman’s upper arm. The inserts release progestin into a woman’s bloodstream in order to prevent the ovaries from releasing eggs. However, this mechanism only works some of the time.[1]. The contraceptive device also thickens a woman’s cervical mucus, so that the movement of sperm is inhibited. Finally, Norplant also changes the lining of the uterus,[2] which can cause abortions of babies who are conceived. The implants can last for two or five years, depending upon which kind of insert is used. The rods or capsules must be surgically removed.

The effectiveness of Norplant in preventing pregnancy is about 99 percent, although this figure may decrease with time. Also, if the woman does not have the system inserted at the proper time in her menstrual cycle, she may be more likely to become pregnant during the initial weeks of use. Since the drug is placed inside the woman’s body, it does not have a high “typical” (or user) failure rate.

According to its patient package insert, its potential side effects include irregular menstrual bleeding (including prolonged bleeding or no bleeding), ruptured ovarian cysts, constant headaches, fainting, ruptured liver tumors, ectopic pregnancies, heart attacks, strokes, gallbladder disease, skeletal pain, nervousness, acne, blood clots, blindness, severe depression, birth defects, weight gain, excessive growth of body or facial hair, hair loss, coughing of blood, numbness, severe abdominal pain, yellowing of the eyeballs, and death. Because the contraceptive device is surgically inserted under the skin, some women experienced nerve injury and scarring, while others suffered from the implant unexpectedly being expelled from the skin.[3] When a woman breast-feeds while using Norplant, some of the hormones pass through the milk to the infant. Such babies are at an increased risk of respiratory and eye infections.[4] Despite all of these possible risks, population workers in developing nations are told to inform women that Norplant has “no known serious side effects.”[5]

The FDA approved Norplant in 1990, but within six years over fifty thousand women sued the makers of the drug.[6] In 1999 the makers of Norplant agreed to settle for a reported $50 million to compensate thirty-six thousand women for the complications they suffered from the contraceptive system. The drug company said the settlement “was purely a business decision,” and it did not admit any wrongdoing.[7] By 2002 the company stopped production of the drug, and it was phased out of the American market by 2004.

However, in 2006 the FDA approved a contraceptive method similar to Norplant, called Implanon. Instead of a series of small rods, Implanon users only need one plastic rod inserted under the skin of the inner upper arm. The insert contains a hormone (etonogestrel) that is released into the woman’s body over a three year period. It can be removed at any time but must be taken out after three years.

The implant is highly effective in preventing pregnancy: over 99 percent. To accomplish this, Implanon often stops the release of eggs from a woman’s ovary and changes the cervical mucus to keep sperm from reaching the egg. It also changes the lining of the uterus.[8] So if the first two methods fail, the baby can be aborted because he or she is unable to attach to the uterus. As with other hormonal methods of birth control, it is misleading to consider a drug to be 99 percent effective in “preventing” pregnancy when terminated pregnancies are considered prevention.

Implanon it is not without its potential side effects. Users may experience changes in bleeding or no bleeding at all, mood swings, weight gain, headache, acne, depression, nervousness, breast pain, viral infections, stomach pain, painful periods, back pain, nausea, dizziness, extra hair on the face and body, spotty darkening of facial skin, ovarian cysts, blood clots, heart attack, stroke, crushing chest pain, numbness, yellowing of the skin or eyes, and an increased risk of ectopic pregnancy. The insert can also break while inside the woman or be accidentally expelled from her skin. Other times the rod may be difficult or impossible to remove.[9]

These complications are not common, but the makers of the drug are required to warn all patients of the potential risks. The information packet included with the drug reminds women that they should call their healthcare provider right away if they faint, cough up blood, or become blind. Details are not given as to how she should make that phone call while unconscious or unable to see.

Even though Implanon is new in the United States, millions of women in other countries have used the product since 1998. Although the drug brought in $30 million in sales in 2005, the 2006 FDA approval is expected to stimulate much greater revenue.[10]

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[1]. Thomas Hilgers, “Norplant,” Linacre Quarterly (February 1993), 64–69.
[2]. W. Hadisaputra, et al., “Endometrial Biopsy Collection from Women Receiving Norplant,” Human Reproduction Supplement 2 (October 1996), 31–34; L. S. Wan, “A Review of the Endometrial Changes in Norplant Users,” Annals of the New York Academy of Sciences 828 (September 1997), 108–110.
[3]. Norplant System (levonorgestrel implants) Prescribing Information, Wyeth Pharmaceuticals, Inc. (March 2005), 6.
[4]. V. Schiappacasse, et al., “Health and Growth of Infants Breastfed by Norplant Contraceptive Implant Users: A Six-Year Follow-Up Study,” Contraception 66:1 (July 2002), 57–65.
[5]. “Guide to Norplant Counseling,” Supplement to Population Reports, Decisions for Norplant Programs, K-4, XX:3. (Baltimore: The Johns Hopkins Center for Communication Programs, November 1992).
[6]. Erica Johnson, “Medical device lawsuits,” CBC News (April 1, 2003).
[7]. “Norplant Makers to Settle,” CNNmoney.com (August 26, 1999).
[8]. Implanon Patient Insert, Organon USA, Inc. (July 2006), 1.
[9]. Implanon Patient Insert, 2.
[10]. John Bird, “Akzo Nobel/Organon: Contraceptive Hot Rods?” Pharmaceutical Business Review Online (July 19, 2006).