Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: KEGG:D00950 (Norplant)
 815 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The efficacy and side effects of Norplant contraceptive implants (6 capsules) versus silastic rods were compared in 250 women for 4464 months of use. Both systems were found to be highly effective and well tolerated. There was only 1 pregnancy, and this occurred during the 27th month of use in a woman who had received the Norplant implants. 34 patients (14%) discontinued the study during the 3-year study period because of side effects. Irregular uterine bleeding (either prolonged or too frequent) accounted for 50% of these removals in both groups. Other reasons for removal included mood swings, excessive weight gain, headaches, and ovarian cyst. The total drop-out rate for all reasons was only 20%, indicating that the Norplant method is highly acceptable to US women. Many subjects indicated they were willing to tolerate the bleeding problems associated with Norplant in order to have a convenient longterm method of contraception. 4 of the 8 women who had the implants removed to become pregnancy had achieved this goal by 4 months after removal, indicating that restoration of fertility is not a problem. In general, the 2-rod system has the advantages of easier insertion technique and shorter insertion time, as well as ease of removal, compared to the 6-capsule system.
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PMID:Norplant contraceptive implants: rods versus capsules. 311 87

Norplant provides contraception over a five-year period through the gradual subcutaneous release of the progestogen levonorgestrel. It has been on the US market since 1991 and available in Great Britain since 1993. Already the subject of group legal actions in several US states, Norplant may soon be the target of lawyers in Britain for litigation. The lawyers allege that insertion of the implant under the skin of the upper arm by untrained doctors has led to painful and difficult removals and left women with scarred arms. Moreover, insufficient warning has been given about possible side effects such as mood swings and continuous vaginal bleeding. Hoechst Roussel, marketer of the implant in Britain, however, argues that only doctors trained in Norplant insertion and removal should attempt either procedure. Removal will be problematic only if preceded by a problem insertion. Hoechst Roussel recently advised gynecologists, in writing, not to attempt to extract the implant unless they are trained in the removal technique. By British law, the application of a drug product once approved for general release to general practitioners and family planning doctors cannot be restricted by a pharmaceutical company.
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PMID:Action against contraceptive implant threatened. 764 39

Focus group discussions were utilized to increase understanding of the factors associated with Norplant discontinuation among young, low-income women and identify counseling needs. The 15 participants--all of whom had requested Norplant removal after at least two months of use--were drawn from health clinics in three South Carolina cities. Group participants were 18-26 years old; the mean duration of Norplant use was 13.8 months. Norplant's convenience, effectiveness, long-term duration, and low cost were cited as the major advantages of the method, while prolonged bleeding, headaches, weight gain, hair loss, and mood swings were identified as the worst side effects. These side effects were the reason for requesting early Norplant removal. Although participants had been exposed to a combination of educational methods before Norplant insertion, they noted that the possibility of adverse side effects was minimized. Others felt they had been pressured to agree to Norplant insertion while still in the hospital following a delivery. The majority reported that medical staff responded negatively to their request for removal and were unsympathetic about Norplant-related side effects. As a result, these women developed a mistrust of the medical system. Since young, low-income women comprise a major target population for Norplant use, it is important to develop a counseling protocol that prepares them for side effects and suggests various coping strategies.
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PMID:A qualitative study of the perceptions of dissatisfied Norplant users. 773 Jul 70

During July 1991-July 1993 in Edinburgh, Scotland, 508 women 15-42 years old were inserted with the contraceptive subdermal implant Norplant. Physicians and trained family planning nurses counseled the women, which counseling included a detailed description of Norplant, its advantages and disadvantages (especially bleeding problems), and a description of the insertion and removal procedures. The women chose Norplant as an alternative to sterilization or other contraceptive methods with which they experienced problems. Two women were pregnant at the time of insertion. There were no method failures. 27 (9%) women were lost to follow-up. 71 (25%) women were very satisfied with Norplant, 30 of whom had regular cycles and 14 of whom had amenorrhea. At least 70% of all patients experienced changes in vaginal bleeding patterns. The 12-month and 18-month continuation rates were 84% and 80%, respectively. Leading reasons for removal of Norplant were bleeding problems (43%), weight gain (35%), and mood swings (21%). The combination of weight gain, mood swings, depression, and headache accounted for 56% of all removals. Major problems did not occur with either insertion or removal of Norplant. These findings suggest that Norplant is an effective and acceptable contraceptive method, despite the high incidence of bleeding changes.
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PMID:The introduction of a new contraceptive; two years experience with Norplant. 878 85

A retrospective study of 144 US women 14-21 years of age who requested and received the Norplant contraceptive implant system at the Mayo Clinic (Rochester, Minnesota) in 1990-93 analyzed the factors associated with duration of method use. Of the 124 women who reported past use of contraception, 94 (76%) had been pregnant at least once. The method most commonly used before Norplant was oral contraception (57%). The reasons for Norplant selection were its convenience (86%) and problems tolerating the pill (14%). Of the 130 Norplant users who either telephoned or made a clinic appointment after insertion, 60% reported side effects such as breakthrough bleeding, headache, and depression or mood swings. 64 women had the implants removed. The median duration of Norplant use was 29 months. The Kaplan-Meier estimate of the probability of the Norplant system remaining in place for at least 12 months was 83% and 63% for at least 24 months. Age, prior contraceptive use, and timing of insertion had no impact on duration of Norplant use. Multivariate analysis indicated that women with at least 1 prior pregnancy had a two-fold increased risk of Norplant removal compared to those who had never been pregnant. Larger studies are needed to identify additional factors associated with long-term use of injectable contraception among young women and to suggest interventions that would improve compliance with routine follow-up.
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PMID:Levonorgestrel contraceptive implants in female patients 14 to 21 years old. 944 73

More than 300 subscribers of Contraceptive Technology Update (CTU) completed the questionnaire for the 1994 Pill Survey. Most respondents (68%) were nurse practitioners followed by physicians (11%), registered nurses (9%), and physician assistants (4%). 92% of respondents considered oral contraceptives (OCs) (especially Ortho-Cept and Ortho Novum 7/7/7) as the leading hormonal contraceptive choice among adolescents and adults. Among teens, Depo-Provera was the second choice (4%). Among adults, Depo-Provera and the contraceptive implant, Norplant, fared equally as well (2% each). Headaches, mood swings, and weight gain continued to be complaints for all hormonal contraceptives. Progestins are potent depressants. Norplant produced the most complaints. About 20% of providers reported that at least 20% of their patients wanted Norplant implants removed because of significant side effects, especially irregular bleeding. Most Norplant users had the implants for no more than 12 months. The providers realized that they were providing insufficient counseling to Norplant users about irregular bleeding before insertion. A physician noted that some women experience infertility for as long as two to three years after their last Depo-Provera injection. Some providers discourage women from using Norplant based on the many complaints they have received from past users.
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PMID:Depo-Provera and Norplant implants prove no competition for no. 1 choice, OCs. The 1994 pill survey. 1228 3

A 1997 Contraceptive Technology Update survey of 145 US family planning practitioners found that oral contraceptives (OCs) remain the leading reversible contraceptive method, chosen by 85% of adult women and 78% of teenagers. Ortho Tri-Cyclen is the first choice among OC brands, presumably because of its recent US Food and Drug Administration endorsement for acne control. Ortho Tri-Cyclen is the first low-dose OC to be indicated for noncontraceptive use. 11% of adult women and 17% of teenagers preferred Depo-Provera in 1997, compared with 6% and 11%, respectively, in 1996. Another study, commissioned by the US Association of Reproductive Health Professionals, indicated 85% of current OC users are very satisfied with the method and 50% of former users still prefer it over other forms of birth control; 75% would advise a young woman to use OCs. Although weight gain, severe headaches, and mood swings may affect users of OCs, Depo-Provera, and Norplant, OC users are less likely to discontinue method use because of these side effects than users of implants and injectables.
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PMID:Oral contraceptives hold top position as leading choice for women. 1229 67

Legal action has been taken in several US cities against Wyeth-Ayerst's Norplant, claiming that labels were deceptive regarding the potential side effects and the difficulties possible with removal. All the lawsuits claimed suffering caused by removals. 25 women in Miami, Florida, filed suit for $50,000 each in damages due to difficult removal. 8 women from Maryland joined 600 women filing in Chicago, who seek $20,000 to $50,000 for damages due to difficult removals and scarring. The group of plaintiffs also have asked for an injunction preventing the company from selling Norplant to doctors without proper training. Wyeth-Ayerst reported that it requested label changes before the lawsuits were filed. The label now states that removals and insertions are possible, without designating the time allocation required; prior labels indicated a 15-20 minute period. The new label includes possible side effects of emotional instability, heart attack, stroke, migraine, arm pain, numbness and tingling. One Maryland woman requested removal because the capsules had shifted and one had moved from her upper arm to under her armpit. Removal required 3 stages totaling 3 hours and ultrasound detection. Another women gained 20 pounds and had a sore arm. Norplant was first introduced in the US in 1991 after 20 years of experience with use worldwide. The contraceptive is effective for 5 years after insertion of 6 capsules, with slow releasing hormones. Planned Parenthood of Maryland administers Norplant at 7 clinics throughout the state, by practitioners at several clinics, and by the Baltimore City health department in school-based clinics. City clinics since 1991 have made 198 insertions and 14 removals, with no problems with removals. School-based clinics have inserted 45 implants and no removals. Bayview Clinic in Baltimore has made 2000 insertions and 250 removals, with few difficulties. The chief of obstetrics and gynecology at Bayview said that it takes about 6 times before removal is perfected by even a trained doctor. The Population Council, which developed Norplant and licensed it to Wyeth-Ayerst, still supports it as one of the most effective, reversible methods of birth control.
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PMID:Norplant removals spur suits. Some recipients report problems. 1231 99

In response to the need of some women for long-acting, effective and safe contraceptives, the scientific community developed non-biodegradable progestational subdermal implants that act by making the cervical mucus viscous, with ovulation inhibition and thinning of the endometrial lining. The contraceptive protection is within 24 hours and the cumulative failure rate is low. Contraceptive implants require little or no motivation following adequate counselling. In current use are multirod implants (Norplant I and Norplant II Jadelle) and single rod implant (Implanon and Uniplant). Although menstrual symptoms associated with progestational regimens are the major compliance and acceptability factors within the first year of use, menstrual disturbance generally improves. Continuation rates for implant use are high among those who have had adequate pre-insertion counselling because the perceived advantages greatly outweigh the nuisance effects. Other side effects of implants are similar to those observed with hormonal pills--headache, weight changes, mood swings and abdominal bloating. Training of physicians and nurses in the art of insertion and removal techniques is a pre-requisite for a successful implant programme. This should also be backed by integration of implants into the national commodity logistics systems to ensure adequate local budgetary provision for contraceptive implant procurement rather than reliance on donor supply.
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PMID:Contraceptive implants. 1610 51