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The following article is copyright © African Technology Forum. All rights reserved. This article appeared in Volume 8, Number 1 of ATF. Select this link to see the table of contents for this issue. Select this link to order this issure of ATF .

Critics Challenge the Safety of Norplant

Muhonjia Khaminwa *

n the United States, the network of medical and legal professionals who organized against the manufacturers of silicon breast implants are mobilizing to bring attention to the possibility of similar harmful side effects from Norplant. Norplant is a steroid-based contraceptive that provides continuous contraception to women for at least five years. Lawyers and medical professionals are collecting data and case studies in preparation for lawsuits against the Finnish manufacturers of Norplant. Norplant rods are coated with silicon which is suspected to cause memory loss, muscle pain, depression, auto-immune disorders, infections, seizures, blindness, cancer, and heart attacks, according to a recent report published in the New York Times.

Norplant's developers maintain that their product is safe. According to Sandra Waldman, spokesperson for the Population Council, the developers of Norplant, there is no evidence of any health risk from silicon. She explains that unlike the breast implants, Norplant does not contain any liquids that can leak into the body, nor is there any silica in the coating of the rods. The rods for delivering the contraceptive are similar to the tubing of valves and shunts that have been implanted in cardiac and brain surgery patients over the last 30 years.

Norplant consists of six silicon rubber rods containing the synthetic steroid levonorgestrel. The rods are inserted under the skin on the upper arm of the patient. The insertion is a minor surgical procedure, requiring only local anesthetic. It takes about 10 to 15 minutes. Inserted properly, Norplant provides continuous contraception to women for at least five years. The rates of pregnancy while using Norplant are comparable to those of women who have been sterilized. The side effects of the drug include irregular menstruation, spotting between periods, amenorrhea, headaches, weight changes, depression, and acne.

Several years ago, Norplant achieved some notoriety after it was alleged that before being released in North America and Europe, the contraceptive was tested and developed on women in Bangladesh, often without their informed consent. Activists also questioned the enthusiasm with which population control programs were being aimed at the developing world. There has long been discussion about balancing the benefits of Norplant against the possibilities of gross abuse. Norplant must be implanted and removed by a trained medical practitioner. There is therefore the risk that women can be manipulated by unscrupulous authorities who may force them to have the product implanted in their bodies without their consent, or force them to continue using the product when they no longer want to. In the United States, with its history of an uneasy relationship with eugenics and racism, feminist activists were quick to raise the possibility that poor women might be forced to use Norplant.

Waldman pointed out that much of the controversy arose from the false assertion that Norplant had been developed and tested in Bangladesh. In fact, Norplant did not become available in Bangladesh until after all the testing and clinical trials had been completed. In 1983, Leira Pharmaceuticals, the Finnish manufacturers of the contraceptive, obtained regulatory approval from the government of Finland to produce the drug. Before the product became commercially available, the Population Council carried out clinical trials in four developing countries and four developed countries including the US and the Dominican Republic. In the mid-1980s, after the clinical trials were successfully concluded, the Council began to carry out pre-introduction studies in several countries including Bangladesh.

The Population Council acknowledged that there may have been cases where patients were not properly informed about the contraceptive before it was implanted, but points out that the Council was not responsible for the actual provision of the drug. In 1984, in response to a request from the United Nations Fund for Population Activities, the World Health Organization conducted a technical evaluation of Norplant. They concluded that Norplant is "an effective and reversible long-term method of fertility regulation [which is] particularly advantageous to women who wish an extended period of contraceptive protection." (Norplant Worldwide, a publication of the Population Council.)

The Population Council is a nonprofit organization based in New York City. Worldwide manufacturing rights for Norplant belong to Leira Pharmaceuticals. Under licensing agreements, Leira returns a percentage of sales as royalties to the Council. The agreement also provides for preferential pricing of Norplant for public sector agencies and governments who want to provide the contraceptive to women who would otherwise be unable to afford it. The product is currently available in 44 countries around the world.

The most common reason women give for having the implants removed before the medication has run its full course is the irregularities in their menstrual patterns. Research in China has shown that given adequate counseling about the expected menstrual changes, women are less likely to have the implants removed for those reasons. Once Norplant has been removed from the body, normal menstruation and fertility patterns resume within a couple of months.

In providing Norplant, the Population Council first carries out intensive country-specific pre-introduction studies. A training curriculum in both French and English is available. The Council trains a core group of physicians who then train others to properly implant the contraceptive and provide the necessary counseling and follow up medical care. There is a strong emphasis on making sure that the patient fully understands the implications of the contraceptive and the possible side effects. Six month checkups are necessary to make sure that no problems have resulted from the insertion. The testing procedure has identified patients who should not use Norplant due to pre-existing medical conditions. These include individuals with heart problems, low blood platelet count, hypertension, and thrombosis.

The Council also works with ministries of health to ensure that the marketing of Norplant is in line with other health initiatives the governments may be conducting.

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* Muhonjia Khaminwa is a Contributing Editor of ATF.

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