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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 Kits Expiring in 2004 Should Not Be Used
From OB/GYN News, 9/15/00 by Elizabeth Mechcatie

Shelf-life stability in question.

Norplant users affected by a recently reported problem with some of the devices should consider using a barrier method of contraception pending further investigation, according to the company that manufactures the contraceptive implant.

On August 10, the manufacturer, Wyeth-Ayerst Pharmaceuticals, issued a letter to Norplant providers advising them to stop inserting implants from kits with package expiration dates in the year 2004. During regular quality assurance monitoring, representative samples of these product lots "tested within product specifications, but at the lower end of the release rate specification for shelf-life stability," according to the letter.

Wyeth-Ayerst is currently conducting additional tests; until more information is available, the kits should be retained, the letter advised. The additional testing should be completed by October 10. In the meantime, the company has suspended all shipments of Norplant kits.

The letter advised that while additional testing is underway, the use of a concurrent barrier method of contraception should be considered for those patients "in whom the avoidance of pregnancy is of great importance." However, citing the 5-year cumulative pregnancy rate of Norplant as 3.9%, the company said that "at this time, we do not believe that there is an incremental risk of pregnancy with these lots."

Providers and patients should understand that this is "a very precautionary measure on the part of Wyeth and that they should remain calm" during the 2-month period the company is investigating the problem, Dr. Kate Thomsen, medical director of the Planned Parenthood Federation of America, said in an interview.

Planned Parenthood affiliates have advised patients affected by the advisory to use a barrier method of contraception during the investigation. Removal of the implants is not recommended, she added.

The affected kits were distributed beginning Oct. 7, 1999. Their lot numbers are: 3990729, 3990775, 3990776, 3993006, 3003127, 3003166, 3003544, and 3003355.

This warning does not apply to products shipped before October 7, 1999. These have an expiration date of 2002 and have consistently tested within specifications.

More information on this alert can be obtained by calling Wyeth-Ayerst at 1-800-934-5556. A copy of the Wyeth-Ayerst letter can be found at: wwwfda.gov/ medwatch/safety/2000/norpla.htm.

COPYRIGHT 2000 International Medical News Group
COPYRIGHT 2001 Gale Group

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