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Back To Vidyya Norplant's Manufacturer To Pay Some Patients For Cost Of Backup Birth Control

Norplant's Effectiveness From 20 October 1999 Cannot Be Guaranteed

Wyeth-Ayerst, the maker of Norplant said last week that it cannot guarantee certain batches of the birth-control implants are effective. Because of this, the company has announced it will reimburse women who have questionable implants for the cost of backup birth control.

Women who have received Norplant implants from batches that were shipped to doctors on or after 10 October 1999 should use a nonhormone form of birth control as a backup.

Wyeth-Ayerst first wrote doctors last month telling them to stop inserting those implants, because laboratory testing for shelf-life stability suggested some might release less contraceptive hormone than they should, raising questions about effectiveness. Vidyya has been watching this story for you. For more information read 17 August 2000, 19 September 2000 issues.

In a second letter to thousands of doctors Wednesday, the company insisted additional tests still must be done to prove if those lower hormone levels really put women at risk of pregnancy. However the letter urged physicians to search their records and immediately notify patients who should use a backup.

In addition, the FDA has also advised women to call their doctors if they had Norplant inserted since Oct. 20 and specifically ask about backup birth control. Women should not wait to be notified but check for themselves.

Women who have Norplant should not use hormonal contraceptives, Back up methods to considure include: condoms, spermicide, a diaphragm or an IUD.

Wyeth-Ayerst said it will pay up to $100 to women who request financial assistance for the backup contraception. In addition, Wyeth-Ayerst will reimburse women $700 if they wish to have the questionable Norplant removed--a step the company is not recommending. There have been no reports of increased pregnancy rates among Norplant users.

Women and doctors may call the company at 1-800-364-9809 for information or financial assistance.

About 1 million American women and 5 million women worldwide have used Norplant, which consists of six hormone-filled capsules that are implanted in a woman's upper arm and slowly release enough hormone to provide contraception for five years.

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Editor: Susan K. Boyer, RN
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