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Norplant, a form of hormonal birth control made by Wyeth, was first approved by the FDA in 1991. The Norplant system (levonorgestrel) contained six hormone-releasing cylinders implanted into a woman's upper arm to prevent pregnancy for up to five years. Trouble with the Norplant system began in late 2000. In August and September of 2000, Wyeth sent letters to health care officials informing them about many defective Norplant product lots.
According to Wyeth, Norplant systems with lot numbers beginning in October 1999 and expiring in 2004 did not contain enough of the progestin hormone to adequately prevent pregnancy. Doctors were told to stop providing Norplant to their patients. Those who had already received these defective Norplant lots were told to use a back-up barrier method of birth control, such as condoms.
As a result of these findings, Wyeth partnered with the FDA to learn more about the risk of conception while using Norplant. On July 26, 2002, Wyeth made another major announcement about Norplant. Data from their study found that women using the affected Norplant lots received adequate protection from unplanned pregnancies. Therefore, women with the affected lots would no longer require a back up method of contraception. The company also offered to pay for the removal of the Norplant system or continue to pay for back up forms of contraception until December 31, 2002.
Wyeth also made another major announcement at this time: they were voluntarily recalling Norplant permanently. While the company claimed the recall was due to limitations in component supplies, there were also Norplant side effect concerns at that time. Norplant could cause irregular and excessive bleeding, infection at the insertion site, capsule expulsion, migraine, and breast abnormalities. Other Norplant side effects include: nausea, dizziness, breast soreness, acne, weight gain, depression, skin discoloration, ovarian cysts, hair loss, and removal difficulties.
Wyeth is no longer paying for the cost of removing Norplant. Though this product is no longer available, some women received Norplant prior to the 2002 recall. If you have Norplant and notice any abnormal effects while using the Norplant system, it is important to speak with your health care provider. The cost of Norplant removal averages $100 to $200, but costs vary from region to region. If you would like to learn more about Norplant, please contact us to learn more about your legal rights and options.
More Norplant Resources
MedLine Plus Drug Information - Guide to prescription and over-the-counter medications provided by the United States Pharmacopeia.
Norplant Birth Control - Cost, experiences, complications and benefits of Norplant birth control system.