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Norplant

Norplant is a form of birth control released in 1991 by Wyeth Pharmaceuticals, consisting of a set of six small, silicone capsules filled with levonorgestrel, a synthetic progestin used in many birth control pills. In 2002, Norplant was discontinued from production; limited supplies still remained until 2004. A similar product, featuring two rods instead of six, called Jadelle, is approved for US use but is not yet commercially manufactured in the United States. more...

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Insertion

Norplant is implanted under the skin in the upper arm of a woman, by creating a small incision and inserting the capsules in a fanlike shape. Insertion of Norplant usually takes 15 minutes and the capsules can sometimes be seen under the skin, although usually they look like small veins. They can also be felt under the skin. Once inserted, the contraceptive works within 24 hours and lasts up to five years.

Function and effectiveness

Norplant works by preventing ovulation, which means that no eggs are released for fertilization; by thickening the mucus of the uterus, which prevents sperm from entering; and by thinning the lining of the uterus, which makes implementation of an egg less likely. A small amount of the hormone is released through the capsules continuously, more during the first year and a half, but then at a level similar to most contraceptive pills afterward. According to studies completed, Norplant has been shown to be 99% – 99.95% effective at preventing pregnancy, and is one of the most reliable, though not the most available, forms of birth control around. It is important that women understand Norplant, however, does not protect against sexually transmitted diseases.

Contraindications

Norplant should not be used in women with liver disease, breast cancer, or blood clots. Women who believe they may already be pregnant or those with vaginal bleeding should first see a physician. However, since Norplant does not contain estrogen like some birth control pills, older women, women who smoke, and women with high blood pressure are not restricted from using the system.

Side effects

After three months of using Norplant, women will need to schedule a follow-up appointment to monitor blood pressure and discuss any concerns. Side effects may include irregular menstrual periods for the first approximately three months, including periods lasting longer than normal, bleeding or spotting between periods, or going with no period for the mentioned period of time. These changes are not serious. Less common side effects include weight gain or loss, headache, depression, acne, or excessive hair growth. Sometimes, mild pain or itching at the site of the implant will occur. Ovarian cysts may also occur, but usually do not require treatment.

Removal

Norplant can be removed with only minor inconvenience at any time by creating a second incision and withdrawing the capsules. Norplant is normally removed when the five year period is over and reinsertion of a new set is preferred, or if:

Pregnancy is desired
Differing birth control is preferred
Complications arise

Read more at Wikipedia.org

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Norplant effective but won't be back on market: Users can stop backup contraception - Called 'a Real Loss' for Women
From OB/GYN News, 9/1/02 by Norra MacReady

Norplant has gotten a reprieve--and an execution.

In a recent letter to health care professionals, Wyeth Pharmaceuticals announced that women using Norplant from batches distributed on or after October 20, 1999, can discontinue their backup methods of contraception, thanks to evidence indicating no loss of contraceptive effectiveness in those lots.

Wyeth suspended shipment of Norplant kits in August of 2000, when questions about their efficacy were first raised. But despite the findings that efficacy was unimpaired, the company also said that it will not reintroduce the Norplant system, which contains six implantable capsules, because of "limitations in product component supplies." Repeated calls to Wyeth seeking comment on the action were not returned by press time.

The latest Norplant kits still in use were made in 1999. Since they expire within 5 years, users will have to consider other methods of contraception by 2004. Wyeth will continue to pay for implant removal or for backup, barrier, or other nonhormonal methods of contraception until December 31, 2002.

Wyeth had sent letters to doctors in August and September 2000, warning that the batches had atypically low levels of levonorgestrel release on routine shelf-life stability tests. The letters advised doctors to stop inserting new implants and to have current Norplant users employ backup contraception. An investigation has revealed that those implants are as effective as the ones distributed earlier.

Clinicians were disappointed to hear that Norplant will not be reintroduced.

"I think it would be worthwhile to have an implantable product," said Dr. David F. Archer, director of the contraceptive research and development program at Eastern Virginia Medical School, Norfolk.

He suggested that Wyeth may have chosen to discontinue Norplant to make way for its two-capsule implant product called Jadelle or Norplant II. The product was approved by the Food and Drug Administration in 1996. Originally, the FDA stated that the implants were approved for 3 years of use, but the agency extended that period to 5 years in 2001. The product has yet to be marketed in the United States.

The departure of Norplant is "a real loss for American women," said Dr. David Grimes, vice president of biomedical affairs at Family Health International. "At present, there is no other subdermal [form of contraception] in the United States. Norplant was safe, effective, and worked extremely well."

Dr. Grimes, also of the University of North Carolina at Chapel Hill, estimated that at least one patient per week requests the implants, only to be told they are no longer available.

Norplant was "welcomed by women who didn't do well with other methods of birth control," added Dr. Felicia Stewart, codirector of the Center for Reproductive Health Research and Policy at the University of California, San Francisco. She suggested that Wyeth's decision may have reflected a perception of low demand.

According to the 1995 National Survey of Family Growth conducted by the Centers for Disease Control and Prevention, contraceptive implants were used by 0.9% of women aged 15-44 years, compared with birth control pills, which were used by 17.3% of women in that age range.

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