Women using Norplant need back-up contraception

Karen Schroeder, MS, RD

September 25, 2000 - Women who have received a Norplant System contraceptive device on or after October 20, 1999 are being urged to use an additional form of birth control. Routine laboratory testing by the product's manufacturer, Wyeth-Ayerst Laboratories, found that seven lots of the Norplant product release lower than normal levels of the hormone levonorgestrel, and therefore may not be delivering consistent, reliable contraception.

Women should check with their healthcare provider to see if their Norplant kit is one of the 22,000 that came from the suspect lots. If so, they should use a barrier or nonhormonal method of birth control such as condoms, spermicide, a diaphragm, or an IUD. Wyeth-Ayerst will reimburse women $100 for the cost of back-up birth control.

Testing is underway to determine if the abnormally low hormone levels are low enough to interfere with contraception. Wyeth-Ayerst plans to have a definitive answer by the end of October. Until this is clear, though, the company is not recommending removal of Norplant devices. "The implants do not present a safety risk and if they are deemed effective, they can continue to provide contraception for up to five years," explains a company spokesperson. However, if a woman would like to have the implant removed, she can receive $700 from the company to cover the cost. No pregnancies have been reported with this batch of implants.

The lots in question are: #3990729, #3990775, #3990776, #3993006, #3003127, #3003166, and #3003355. Although an official recall has not been ordered, doctors and wholesalers have been asked by the company to return kits that have yet to be used from these lots.

In the US, 100,000 women currently use Norplant, which was approved by the Food and Drug Administration in 1990. The Norplant System is composed of six silicone rubber capsules, each about the size of a matchstick, that are inserted into a woman's upper arm just under the skin. The implants steadily release a low dose of levonorgestrel, a form of the hormone progestin that is used in birth control pills. Norplant is effective within 24 hours of implantation and for up to five years. However, if a woman wishes to become pregnant or use a different form of birth control, the implant can be removed at any time and hormone levels will return to normal within two weeks. Because Norplant is not a barrier contraceptive, it offers no protection against sexually transmitted diseases.