Serum ferritin was measured in 4 groups of long-term users of NORPLANT implants. The users were divided according to their own subjective perception of bleeding: a random sample of 46 one year active users; 30 active users who had increased bleeding; 39 women who had increased bleeding and had the implants removed; 28 active or terminated users who had reduced bleeding. These four groups were compared with a control group of 68 new acceptors of any method at the same clinic who met the criteria for use of NORPLANT. The mean age, parity, years of schooling and family income were similar for the 5 groups. Mean hematocrit for all NORPLANT groups were significantly higher than the control group. About half of the NORPLANT subjects and controls with normal hematocrit had ferritin levels below 11 ng/ml. The proportion of subjects with ferritin less than 11.0 ng/ml were: Group 1) 48%; 2) 63%; 3) 77%; 4) 36% and

METHODS

57%. Mean iron stores for all NORPLANT users did not differ significantly from those of a demographically similar control group. Significant differences were, however, observed in two subgroups of NORPLANT users. Those women who had increased bleeding and requested implant removal had lower mean ferritin levels and those who perceived decreased bleeding as a result of NORPLANT use had higher ferritin concentration.

A study was conducted to evaluate the effect of NORPLANT use on hemoglobin levels (HB), packed cell volume (PCV) and menstrual bleeding patterns. NORPLANT insertions were performed on 50 healthy volunteers in Ilorin, Nigeria, between January-March 1986. Whole blood samples were collected at admission, 6-month and 12-month follow-up visits, and each acceptor was asked to keep a daily bleeding calendar. Mean age of the acceptors was 32.8 years with a mean parity of 5.3 live births. Almost 50% of the acceptors indicated that they did not want any more children. After 12 month's follow-up, there were a total of three discontinuations, two for excessive menstrual bleeding and one due to husband's objection. Mean HB and PCV values remained relatively unchanged from admission to 12 months. Nearly 50% of the women experienced at least one episode of 8 or more days of continuous bleeding during the first six months of use, and about 20% reported amenorrhea of 90 or more days. Despite the incidence of menstrual bleeding irregularities, acceptability of the NORPLANT method was high as indicated by a 1-year continuation rate of 93.7 per 100 users. Clinically more important was the finding that despite a high proportion of women reporting menstrual pattern changes, HB and PCV levels remained unchanged.

OBJECTIVE

To investigate the relationship between endometrium laminin (LN) expression and irregular uterine bleeding in Norplant users.

METHODS

Eighteen endomerium samples obtained during day 10-14th from Norlant users for 1/2, 1 or>> 2 years respectively with irregular bleeding were studied morphologically and immunohistochemically for LN expression. Six normal proliferative endometria and 18 connterpacts with regular bleeding were used as control.

RESULTS

In Norplant users, endometrial glands decreased in numbers and asynchromized in appearance. The LN expression on basal lamina of glandular epithelium and vascular endothelium was lower in those with irregular bleeding as compared with regular bleeders (P < 0.05).

CONCLUSIONS

The decline of LN expression may related to irregular bleeding in Norplant users.

Norplant is a subcutaneous contraceptive with levonorgestrel. From March to October 1993. Norplant was implanted in 58 women and its side effects were observed for a period of six months. No pregnancy occurred during the study period. Almost all the women experienced irregular menstruations or amenorrhea. The most frequent side effect was weight gain in 21 women (36.2%) followed by headache (13.7%), hair loss (8.6%) and emotional changes (8.6%). However, they were usually mild and 86.2% of the women showed complete satisfaction at the end of study. Norplant was removed in 6 women for its side effects. Younger women appeared to tolerated better than older women. There was a significant relationship between the frequency of side effects with Norplant and those with previous use of birth control pills.

OBJECTIVE

To study the side-effects and reasons for the discontinuation of Norplant.

METHODS

The study was based on the analysis of the medical records of 265 Norplant users, who obtained Norplant from two clinics of the Family Planning Association of Pakistan and who were followed for 5 years.

RESULTS

The most common reason (29.4%) for the discontinuation of Norplant was menstrual disturbances, followed by medical problems (4.1%), desire for more children (3.1%) and family problems (3.1%). The major side-effects were weight gain, breast tenderness, headache and dizziness. Only 7.7% of users mentioned any change in sexual behavior and 69.6% of the complaints leading to Norplant removal developed within 6 months of insertion.

CONCLUSIONS

The extent and nature of the side-effects experienced by Pakistani women using Norplant are similar and comparable to those reported from other countries.

Two-hundred-eight women attending family planning clinics in New York City who received the Norplant contraceptive system during the first sixteen months of Norplant implants insertions were evaluated. Within this clinic population, Norplant implants were a popular contraceptive choice and were removed from 64 of the 208 recipients. Reasons for removal included bleeding, weight gain, and headache, and were consistent with those found in the clinical trials. Prior satisfaction with oral contraceptives did not predict success or failure with Norplant implants. The rate of follow-up visits to the family planning clinics was low. However, evidence exists that these women did not lose contact with the medical center and continued to receive health care.

We present the experience from Instituto Nacional de Perinatología (INPer) with the use of subdermal contraceptive implants Norplant from 1995 to 1997. The purpose was to Know the sociodemographic characteristics and evaluate contraceptive efficacy, adverse effects and tolerance on the users of Norplant. We carried out a prospective, observational trial in the Family Planning Clinic, during the period january 1o, 1995 through december 31, 1997. Women with desire of long term hormonal contraception, and without contraindications for the use of progestins were eligible for the study. The follow up consisted in visits every 6 months, and in some cases we obtain the information by telephonic interviews. One hundred an two women were included in the study; the median age of the subjects was 21.6 years, the median number of pregnancies were 2.0. In 53% of the subjects an obstetric risk factor was present such as adolescence (25.5%), social (8.8%), and others. Seventy-four women were followed up, and accumulated 1,064 months of observation. (Average 14.4 months). Menstrual irregulaties (83%), and headache (30%) were the most frequent adverse effects. The continuity rate was 81%, and during the study no pregnancy was observed. The principal causes for the extraction of the implants were menstrual irregulaties and headache. The contraceptive subdermal implants Norplant, constitutes and excellent choice because of its high efficacy, safety and good tolerance.

Four hundred and seven Norplant insertions were performed over a 2 year period, from January 1998 to December 1999. The clients were followed up over a period of 36 months ending in June 2002. The overall complication rate was 22.6%, and the cumulative continuation rate was 84.0%. Menstrual bleeding disturbances were the most common reported complication in 50 (12.3%) clients. However, there was no significant change in packed cell volume among those clients. Desire for pregnancy was the most common reason for discontinuing Norplant use in 24 (5.9%) cases. Norplant was inadvertently inserted in a client who was pregnant, 3 months after her last confinement. The implants were removed after 8 week use, and the pregnancy was carried to term. There was no fetal abnormality. Thirty-one (7.6%) clients were lost to follow-up.

This report describes the two-year experience of 250 acceptors of NORPLANT implants and 100 TCu-380-Ag IUD acceptors in Assiut, Egypt. The two-year net continuation rate was 67.9 per 100 for implant users and 52.3 per 100 for IUD users. The most important cause for NORPLANT removal was the disruption of menstrual rhythm. However, by the end of the second year, three-quarters of NORPLANT users had monthly menstrual periods and about 60 percent described the amount of blood loss as average, 15 percent as decreased, 15 percent as increased and 10 percent as variable. About 88 percent of the NORPLANT acceptors rated their experience with the contraceptive as good or excellent.

The contraceptive device Norplant, not yet commercialized in Belgium, has been studied prospectively on 198 women, which were followed for up to 42 months per patient. All together, 2,643 months of use were surveyed. Norplant consists of 6 silastic capsules, liberating levonorgestrel, a synthetic progestagen. The pregnancy protection lasts for 5 years. Insertion site is the inner part of the upper arm. The Pearl Index was 0.46% women-years (only one pregnancy occurred); the continuity rate was high (86% after 1 year and 60% after 2 years). The main side effects were menstrual disturbances and abnormal intermenstrual blood loss. No other important side effects have been found. There is no absolute contra-indication to the use of Norplant.

Testing for HIV antibody at the antenatal clinic in Siriraj Hospital started on 1 July 1991. It was found that the percentage of HIV seropositive pregnant women rapidly increased from 1.2% in 1992 to 1.9% in 1993. During those 2 years, 487 seropositive women were admitted for delivery or abortion; 23.8% were adolescents and 47.0%, young adults. Prevention of HIV transmission from mother-to-baby was birth control; 95 women (19.5%) chose to abort their pregnancy. After termination of all pregnancies by abortion or delivery, 83% requested sterilization, 12.9% accepted Norplant, 1.8% the pill and only 2.3% refused anything at all. Condoms were used regularly for prevention of HIV infection by 29.4% of men although Thai men generally do not accept them for birth control. Seropositive Norplant users had more bleeding than general Norplant users but treatments were the same.

OBJECTIVE

To compare the contraceptive efficacy, tolerability and bleeding patterns of Implanon and Norplant.

METHODS

One hundred healthy female volunteers received either Implanon (75 cases) or Norplant (25 cases) for 4 years, followed up with complain, bleeding patterns, hemoglobin, blood pressure, weight. Record the time of insert and remove.

RESULTS

There were no pregnancies during the study. Per 90-day reference period, the average number of bleeding-spotting days with Implanon decreased from 33 day in the first period to 21 day in the last year, and Norplant decreased from 31 day to 20 day. The average bleeding number of times was 2.25 of Implanon and 2.99 of Norplant per reference period (P < 0.05). The mean insert time was 11 second of Implanon and 103 second of Norplant. The mean remove time was 27 second of Implanon and 102 second of Norplant (P < 0.001).

CONCLUSIONS

Both contraceptive systems demonstrated excellent contraceptive efficacy and were well tolerated. Because of its single-rod design, Implanon was significantly quicker to insert and remove than the multiple-capsule system.

The object of this study was to review the experience of Norplant implants insertion at the University of Colorado Health Sciences Center with specific attention to the potential impact of source of care and/or clinic site of of insertion. Norplant implants were inserted at four different office sites, namely, adolescent-teen, resident, certified nurse midwife, and faculty physician. The charts of all patients who had Norplant implants inserted between April 1991 and September 1992 were reviewed and we attempted to contact each patient by telephone to assess clinical course and acceptability of Norplant contraceptive. We were able to contact 254 of 414 women (61%) who had Norplant implants inserted. The average length of time since Norplant implants insertion was 13.2 months. The only significant demographic difference between groups was that the adolescent-teen patients were younger, of lower parity, less educated, and were more likely to be single than the other three groups. The overall removal proportion was 14.6%, and removal proportions were not significantly different between any of the four groups. The primary reason for removal was unacceptable bleeding (32% of removers). Only 59% of patients returned for follow-up care. Faculty physician patients were significantly more compliant with follow-up compared to adolescent-teen and resident patients (p < 0.01). Patient retention of Norplant contraceptive is unrelated to age or the clinic setting in which the device was inserted. Since similar side effects are experienced by retainers and removers, it is unclear what other factors prompt women to seek removal. Particularly in the teen and resident groups, follow-up is poor.

Sustained-release progestin contraceptives are a new approach to meeting a worldwide need for more effective and acceptable birth control. These contraceptive systems provide low, stable levels of synthetic progestins for periods of months to several years. Unlike earlier injectable and oral contraceptives, they do not cause peaks in progestin levels beyond those required for effective contraception, nor do they employ estrogens. For these reasons, sustained-release progestin systems are without some of the health risks attributed to birth control pills, and they are more effective, as well as easy to use, and completely reversible. They share common side effects, the most frequent of which is irregular menstrual bleeding caused by the erratic shedding of hypotrophic endometrium. Despite this and other minor side effects, most users find the sustained-release systems acceptable alternatives to other methods of contraception. Permanent or biodegradable subdermal implants, injections, intrauterine and intracervical devices, and vaginal rings are all employed as delivery systems for contraceptive progestins. The Norplant (Wyeth Ayerst, Radnor, PA) system, consisting of six silastic tubes filled with levonorgestrel and implanted under the skin, was recently approved by the US Food and Drug Administration and is already used by more than a half million women worldwide. The other sustained-release systems are in various stages of development, at least several years away from general use. When these new methods complete clinical trials, women will be able to choose from among implants, injections, or pellets with various durations of action, all providing convenient, highly effective contraception with low risk to health.

Norplant contraceptive implants are silastic implants containing levonorgestrel. This study describes our experience with 100 acceptors of NORPLANT implants in Singapore. No pregnancies occurred during the first year of use. The majority found the method's ease of use to be the most attractive feature. Disruption of menstrual rhythm appeared to be the least liked feature. However the incidence of these menstrual irregularities appeared to diminish with time. Implant users have tolerated this early disruption of their menstrual rhythm well and the continuation rate at the end of the year was 97%. Thus it appears that Norplant is a safe, effective and acceptable method of contraception.

Among 600 women in Bangladesh who initiated use of Norplant, 38% still had their implant at the end of its 5-year life span. To evaluate the contraceptive effectiveness, safety and acceptability of the implant, researchers recruited 200 women from each of 3 clinics in Dhaka who began using the method in 1985. Most of the participants were young (mean age 27), had had little or no formal education and had had an average of 3.4 live births. Participants were followed up at 1, 3, and 6 months after insertion, then every 6 months after insertion, then every 6 months until removal. The 5-year study was completed by 228 (38%) participants; 31 were lost to follow-up. 2 pregnancies were reported during the study; these were believed to have occurred prior to insertion of Norplant. Of the 340 removals during the course of the study, 45% were requested because of menstrual problems, 15% because of other side effects or medical reasons, 20% because the women desired the pregnancy and 20% for other personal reasons. Most of the women (86%) who completed the study planned to continue using a contraceptive method; of these, one-third planned to use Norplant again.