Norplant Shipments Halted as Firm Addresses Shelf-Life Concerns
Aug. 17, 2000 (Washington) -- The maker of the Norplant birth control device has halted all shipments of the contraceptive, and is urging doctors not to use implants shipped since last October while the company investigates possible problems with shelf life.
In a letter to health care providers, Wyeth-Ayerst Laboratories says that routine quality testing in lots of the product with an expiration date of 2004 -- which were distributed beginning Oct. 7, 1999 -- found problems with "shelf-life stability." The company had distributed less than 22,000 of the devices. Earlier lots of the product have no such problems, the firm said.
The company says that it doesn't believe women with the implants in question are at greater risk for pregnancy. "The product is still within specifications," spokeswoman Audrey Ashby tells WebMD. But the firm is conducting more tests, to be completed in a month or two. In the meantime, it says, "for patients in whom the avoidance of pregnancy is ofgreat importance, use of a ... barrier method [such as condoms or adiaphragm] can be considered."
Women who had Norplant implanted after Oct. 7, 1999, should talk to theirdoctors.
More than a million American women have used Norplant since it became available in 1991, although experts say its use is now relatively uncommon in this country.
Ashby says it is not yet clear what is behind the quality concern with the product. But Larry Sasich, a pharmacist with the consumer advocacy group Public Citizen, tells WebMD that "any time there is a warning like this, there usually is a problem in the production or storage of the product."
Kate Thomsen, MD, medical director of the Planned Parenthood Federation of America, tells WebMD, "This is a very precautionary measure. They have not confirmed that there is a shelf-life issue. As far as they've told us, all of the Norplants are safe and effective. No one is recommending that women have this implant removed."
Similarly, Judith DeSarno, president of the National Family Planning and Reproductive Health Association, tells WebMD, "Wyeth is erring on the side of caution. Women are probably very safe with regard to unintended pregnancy."
But other reproductive health advocates are more alarmed. "If you've gone through the trouble of having it implanted, it might be discomfiting to know it may not be effective," Amy Allina, program director for the National Women's Health Network, tells WebMD. "Removal is not a simple procedure for many women, who've had it thinking that it will last for five years."
Planned Parenthood affiliates perform about 9,000 Norplant implants a year, Thomsen says, but the federation doesn't yet know how many of its patients got implants from the questionable lots.
Thomsen says she is concerned that shipments have been suspended, since "long-term birth control methods are sorely needed." Other popular long-term, reversible methods include the intrauterine device (IUD) and the hormone injection Depo-Provera.