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
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
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.