Norplant Recall - EFFECTIVE IMMEDIATELY

Normally I do my recall notices at the end of the month, but there has been a recall that needs immediate attention. Makers of the Norplant birth control implant are notifying physicians and clinics across the country, that the recently manufacturered batch may be ineffective and to not use any Norplants shipped after October of 1999. Additionally for those women who have had the implant since October, the manufacturer is recommending a back-up method of contraception.

WYETH-AYERST Pharmaceuticals, which is a division of American Home Products Corp., issued the notice last week regarding Norplants that were shipped from October 13, 1999. The story was first reported by the Milwaukee Journal Sentinel Thursday, August 17, 2000. "We recommend taking this precaution while we further evaluate the shelf life stability of these lots of Norplant and any potential clinical relevance of these findings," Philip J. de Vane, vice president of clinical affairs and North American medical director for Wyeth-Ayerst, said in a letter that was supposedly posted on the FDA's website. After searching the FDA site, I was unable to locate this letter, so wherever they put it, it doesn't seem to be a top priority issue.

At any rate, approximately 1 million women in the United States use this method of contraception, and another 5 million are estimated to use it in other countries around the world. Its method is to release synthetic hormones into the bloodstream on a continual basis to serve as a birth control device. The implant takes about 10 minutes to insert surgically under the skin of a woman's forearm, and is supposed to last for about five years. The pharmaceutical company is stating that they are doing additional testing and will have more information in a month or two, but again, are urging women to use a backup method of birth control until final results are available.

Planned Parenthood has issued a statement regarding this recall. "While we don't want to be alarmists, we do want to make sure patients have all of the information they need to make decisions which guard their health," said Bonnie McEwin, vice president of communications for Planned Parenthood.

The best advice to women who have a Norplant device, as always, is to contact your doctor immediately. Whether you chose to remove the implant or just use a backup in the meantime, is your decision, but make this decision with proper medical advice and information. If an unwanted pregnancy is not something you can cope with at this time, the gamble is just not worth it and the heartache that could result is far outweiged by a quick doctor visit.

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