Norplant

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Norplant
Background
B.C. type	Hormonal Progesterone implant
First use	1983 (Finland) 2006 (Discontinued)
Failure rates (per year)
Perfect use	0.05-1%
Typical use	0.05-1%
Usage
Duration effect	5 years
Reversibility	Provided correctly inserted
User reminders	Following product discontinuation, alternative method required after 5 years
Clinic review	3 months following insertion
Advantages
Benefits	No further user contraceptive action needed
Disadvantages
STD protection	No
Periods	Initial irregular light spotting
Weight gain	Yes
Medical notes
Insertion by untrained doctors had higher rates of local scarring and resultant difficulties in removal.

Norplant is a form of birth control first approved in 1983 in Finland where it was manufactured by Leiras Oy Pharmaceuticals, consisting of a set of six small, silicone capsules filled with levonorgestrel, a synthetic progestin used in many birth control pills.[1] Norplant production is being phased out; USAID's contract for Norplant runs until December 2006.[2]

Norplant was approved by the FDA in 1990 and released in the United States in 1991 by Wyeth Pharmaceuticals. Norplant distribution in the United States ended in 2002; limited supplies still remained in the US 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called Jadelle, is approved for US use but is not yet commercially manufactured in the United States.[3] Norplant was withdrawn from the UK market in 1999, [4] and from the US in 2002.

Contents 1 Insertion 2 Function and effectiveness 3 Contraindications 4 Side effects 5 Removal 6 Pulled from the market 7 Footnotes

[edit] 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.

[edit] 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 implantation 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 people understand Norplant, however, does not protect against sexually transmitted diseases.

[edit] 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.

[edit] 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, heavy bleeding, or going with no period for the mentioned period of time. Common side effects include weight gain, nervousness, anxiety, nausea, vomiting, mastalgia, dizziness, dermatitis/rash, hirsutism, scalp-hair loss, headache, depression, and acne. Sometimes, pain, itching or infection at the site of the implant will occur. Ovarian cysts may also occur, but usually do not require treatment, although they can cause pain even if benign.

Plaintiffs in the more than 50,000 lawsuits against Wyeth-Aherst claim the contraceptive device causes a wide range of adverse side effects, from routine hormonal side effects already mentioned to more infrequently reported serious effects, such as strokes and blindness.

Later studies demostrated cases of neurotoxicity with symptoms being displayed by extremity numbness and digit function difficulty, emotional distress, dizziness and other symptoms as outlined in the Science News article published in 1995.^{[citation needed]}

[edit] Removal

Norplant can be removed 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
• Different birth control is preferred
• Complications arise

Removal can be uncomplicated, but removal difficulties have been reported with a frequency of 6.2%, based on 849 removals. Removal difficulties include: multiple incisions, capsule fragments remaining, pain, multiple visits, deep placement, lengthy removal procedure, or other.[5]

[edit] Pulled from the market

Norplant distribution ceased in the United States in July 2002 because of limitations in component supplies and serious side effects.[6] Women who currently have the implants will need to find a new method of contraception once they expire.

More than 50,000 women filed lawsuits, including 70 class actions, against Wyeth and/or its subsidiaries, or doctors who prescribed Norplant.^[1]

[edit] Footnotes

1. ^ Erica Johnson. "Medical device lawsuits", CBC news, April 1,2003.