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News1994September › Writs fly over 'safe' norplant › September 1994

Writs fly over 'safe' norplant

Norplant, the new miracle contraceptive that is supposed to be much safer than the Pill, may not be very safe after all

Norplant, the new miracle contraceptive that is supposed to be much safer than the Pill, may not be very safe after all. Over 400 women in the US are suing the American supplier Wyeth-Ayerst Laboratories after suffering permanent injury when doctors

Jewel Klein, a Chicago lawyer representing some of the women, said the actions were merely the beginning, and that many more suits would follow when other women tried to have the rods removed. The women, she said, had suffered lengthy and repeated procedures to remove the rods, and had experienced "excruciating pain".

About three million women around the world have the six matchstick sized rods fitted under their skin, including 900,000 in the US alone. Wyeth-Ayerst has said removal was a simple, 20-minute procedure that would not require stitches. However they reckoned that about 6 per cent of women could suffer complications on removal; at

the current rate, this would translate into 180,000 women suffering permanent injury.

Norplant has been used in the US since 1990 when it gained FDA approval; the UK granted it a licence in October 1993. It has been hailed as such a miracle contraceptive that demand is far outstripping supply in the UK, according to family planning clinics in Derbyshire (BMJ, 23 July 1994).

Some of the women wanted the rods removed because they wished to

conceive, while others were suffering serious side effects. Virtually all women who have been fitted with Norplant have complained of some side effect, according to one study (Drug and Therapeutics Bulletin, 17 March 1994). In another study of 205 women, almost half were considering having the implants removed because of adverse reactions. Side effects have included irregular bleeding, weight gain, breast tenderness, nausea or dizziness.

But the greatest damage can be done when the rods are taken out, it appears. The rods are usually removed under local anesthetic, although some of the American women filing law suits had to have general anesthesia before all the rods could be removed. They have complained of permanent scarring after repeated attempts by doctors to remove the rods. Lawyers fear that doctors have not gained enough experience at removing the rods because they are supposed to stay under the skin for five years. So far, only 15 per cent of users have had the implants removed.

These experiences are contrary to the research findings of the manufacturer Roussel, which claims Norplant is far safer than the contraceptive Pill because it releases much lower levels of hormone which never pass through the liver.

Leading pediatricians and endocrinologists in India have come out against the use of Depo-Provera (DMPA, injectable depot medroxy progesterone) as a contraceptive among breastfeeding mothers.

The drug was recently approved by the Indian authorities for use as a

contraceptive for private marketing. The manufacturer Upjohn, the Drugs Controller of India and the World Health Organization have all stated that it can be safely taken by breastfeeding women, insofar as the drug is not carried in the milk to the baby.

However, doctors from the Departments of Endocrinology and Pediatrics at New Delhi (The Lancet, 9 July 1994) say that it is not safe for the mother. Studies have shown that bone mineral density is lower in breast-feeding mothers, and tests have shown that DMPA can have a similar effect in causing bone loss. Indian women tend to suffer from calcium deficiency anyway, and so the use of DMPA in this high-risk group will only heighten the dangers of bone disease such as osteoporosis.

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