Food and Drug Administration
U.S. Department of Health and Human Services
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T00-42 Print Media: 301-827-6242
September 13, 2000
Consumer Inquiries: 888-INFOFDA
Wyeth-Ayerst Laboratories, of Philadelphia, Pa, the maker of The Norplant System, a 5-year contraceptive implant, is advising doctors to inform patients who had the product inserted since October 20, 1999 to use an additional (backup) method of contraception. The company is issuing an update of a letter sent on August 10, 2000 that advised health care professionals to discontinue inserting kits from specific lots. Laboratory stability testing showed the product from certain lots may not release enough of the hormone levonorgestrel to deliver effective ongoing contraception. Therefore, the contraceptive efficacy of these lots cannot be assured.
Any patient who received a Norplant system from the specified lots should use a backup non-hormonal method of contraception such as a condom, spermicide, diaphragm, or IUD (an IUD is an intrauterine device, which also provides long term contraception).
Wyeth-Ayerst is working with the FDA to assure that patients who may have these implants are aware of the potential reduction in contraceptive protection. The update sent September 13, 2000 requests that doctors search their records and immediately notify patients about this potential concern.
The Norplant System consists of 6 silicone capsules containing the hormone levonorgestrel. The capsules are implanted in a woman's upper arm and are intended to provide contraceptive protection for 5 years.
The lots distributed since October 20, 1999 have an expiration date in January or February, 2004. The following lot numbers of The Norplant System are affected: #3990729, #3990775, #3990776, #3993006, #3003127, #3003166, and #3003355.
The affected lots are currently undergoing additional laboratory testing to determine the amount of hormone released from the product and to determine the effect of that release on contraceptive protection.
FDA advises patients who have had implants inserted after October 20,1999 to contact their doctors about using a nonhormonal backup contraceptive method. Products which contain hormones, such as birth control pills and injectable contraceptives, should not be used as backup contraceptive methods by women who have The Norplant System in place.
Patients with further questions about the use of backup methods, financial assistance or removal of implants can contact The Norplant System Information Line at 1-800-364-9809.
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