Five-year clinical experiences with NOVA T 380 copper IUD.

In an open, single-group, phase III clinical trial of 5 years, the clinical performance of NOVA T 380 was investigated in three centers. The device having a higher copper surface of 380 mm(2) is a modification of NOVA T. A total of 400 voluntary women were enrolled in the study. The mean age was 31.4 years (SD 5.5) with the minimum of 18 and the maximum of 44 years. At the end of the study, 211 women had passed the 60-month visit. Cumulative discontinuation rates at the end of the first and the fifth year calculated by Kaplan-Meier estimates, were respectively as follows: pregnancy 0.5 and 1.9, expulsion 1.3 and 4.1, bleeding 4.4 and 14.0, pain 1.3 and 4.2, removal for other medical reason 1.4 and 6.4, planning pregnancy 0.8 and 13.5, and removal for other personal reason 2.4 and 11.9 per 100 users. Neither ectopic pregnancies nor episodes of pelvic inflammatory diseases (PIDs) occurred. One perforation was recorded; the calculated rate is 0.3 per 100 women (first year). The continuation rate was 88.3 and 52.5 at 1 and 5 years, respectively. In conclusion, the 5-year performance of NOVA T 380 was good compared to other "high-loaded" copper devices. Safety was acceptable over the entire study period.

Return to fertility in nulliparous and parous women after removal of the GyneFix intrauterine contraceptive system.

OBJECTIVE: To evaluate the return to fertility following removal of the GyneFix intrauterine implant system in women wishing to conceive. STUDY DESIGN: A retrospective study was performed on a sample of healthy, sexually active nulligravid/nulliparous and parous women. The participants were 18-41 years of age, with no apparent infertility problem, living in a stable relationship and planning to become pregnant. Women who changed their mind and did not wish to become pregnant immediately after intrauterine device (IUD) removal were excluded from the study. Women were evaluated in terms of rates of conception and fertility outcome. A total of 128 women were evaluated. RESULTS: The study shows that 119 out of 128 (93%) past users of GyneFix have conceived, accounting for a net cumulative pregnancy rate of 88% at 12 months and 99% after 2 years' observation. No statistical differences in pregnancy rates were found for age and duration of use of the IUD. A strong significant difference in pregnancy rate was shown (p = 0.007) between parous and nulligravid/nulliparous women. Seventy-seven women (66.9%) gave birth to a term infant. There were no stillbirths. Twenty-five women (21.8%) are pregnant at the time of writing. Five (4.4%) spontaneous abortions occurred and in eight women (6.9%) the pregnancy was terminated. There were no ectopic pregnancies. CONCLUSION: The results obtained compare favorably with those obtained in previous studies conducted following the removal of copper IUDs. The use of the frameless IUD does not affect future fertility in nulligravid/nulliparous and parous women wishing to become pregnant following removal of the device. Nulliparous women conceive significantly earlier than parous women.

Immediate postabortal insertion of the frameless IUD: review of current experience.

Experience with the frameless Gynefix intrauterine device (IUD) for immediate postabortal insertion is growing. Reports confirm that the design characteristics of the frameless IUD (fixed, frameless and flexible) are responsible for the low expulsion, high effectiveness and high continuation rates. Insertion is easy and safe in the hands of trained providers and appears to be as reliable and effective as when inserted at interval. The results suggest that the frameless IUD may be an important new and affordable option to prevent repeat abortion.

What does society expect from health policy makers in reproductive health?

Family planning, and preventive measures generally, are very important for the health of a society. Despite this, official policy in Hungary has not given them enough support and recognition in recent years. The latest "act for the protection of the fetus," issued some years ago, dealt mainly with abortion; shortly thereafter, the health insurance stopped subsidizing the cost of contraceptives. Nowadays, patients must pay full price not only for condoms, but for pills, IUDs and even sterilization. The cost of preventing unwanted pregnancies became high; for many today, the reliable, modern methods are almost unaffordable. This situation is more than strange in a country with such high numbers and rates of induced abortion. Another problem is that service providers have too few resources. In the wake of the political and fiscal changes that have taken place since the early 1990s, the state does not have enough money to meet the need for this type of preventive work. There are still few non-governmental organizations (NGOs) operating in Hungary: those that there are do not yet have the financial strength to sponsor these initiatives. In light of these circumstances, decision makers concerned to reverse the disturbing demographic trends should concentrate on changing the health policy.

GyneFIX. The frameless intrauterine contraceptive implant--an update for interval, emergency and postabortal contraception.

This article reviews the clinical experience with the GyneFix intrauterine implant system for interval, emergency and post-abortal contraception. The relatively high rate of unintended pregnancies and abortions in the world signifies that greater access to contraception is necessary. Unwanted pregnancies and abortions could be avoided by widening the range of effective and acceptable contraceptive methods for use in situations where current methods are far from optimal. High effectiveness, protection against sexual transmitted infections, long duration of action, reversibility and safety are some of the most important attributes of contraceptives valued by women. The development of the frameless intrauterine device is a response to the need to develop contraceptives with high user continuation rate. GyneFix has the lowest failure rate of all copper IUDs currently available. Its performance is further optimised by the atraumatic frameless design which minimises the side effects and discomfort experienced with conventional IUDs. GyneFix could, therefore, be a useful new contraceptive option in looking at ways to reduce the number of unwanted pregnacies and induced abortions.

A decade of experience with TCu200.

This paper summarizes ten years of experience with 2766 interval insertions of the TCu200 device. One hundred and twenty months of use were completed by 572 patients and the cumulative woman-months of use were 159,664. For evaluating the overall performance, gross cumulative and yearly specific life-table termination and continuation rates were calculated as suggested by Tietze [2]. The cumulative pertinent rates at the end of the ten-year follow-up period were as follows: pregnancy 10.2; expulsion 6.3; bleeding/pain 32.3; and removal for other medical reasons 19.4. The gross annual rates for the same conditions at the end of the first year of use were: 1.8, 2.4, 4.2, and 2.0, while in the tenth year they were: 0.6, 0.1, 4.4, and 2.8, respectively. The continuation rate was 89.1 at the end of the 12th month and 33.2 at the end of the 10th year. Based on this evaluation, the TCu200 IUD has a good overall performance and a longer lifespan than was previously expected.

Two-year clinical experience with Nova-T 380, a novel copper-silver IUD.

In 1992, an open single-group phase III clinical trial was started at three centers to investigate the clinical performance of the high copper surface area Nova-T 380, a modification of Nova-T. This report presents the interim results of the first two years of use. A total of 400 women volunteers were enrolled in the study. The mean age was 31.4 years (SD 5.5) with a minimum of 18 and a maximum of 44 years. At the cut-off date, 259 women had passed the 24-month visit. Gross cumulative life-table rates at the end of the first and second years, respectively, calculated by the Kaplan-Meier method, were as follows: pregnancy 0.5 and 1.6, expulsion 1.6 and 2.8, bleeding 4.7 and 8.7, pain 1.3 and 2.3, removal for other medical reasons 1.7 and 3.9, planning pregnancy 1.1 and 6.0, removal for other personal reasons 0.5 and 1.5, per 100 users. No ectopic pregnancies or PIDs occurred. The continuation rates were 89.0 and 75.5 at 12 and 24 months, respectively. The first two-year performance of the Nova-T 380 was good. Bleeding problems were in the same range as with devices with smaller copper surface areas. No unexpected serious adverse events were encountered.

Preventing abortion and repeat abortion with the Gynefix intrauterine implant system--preliminary results.

The provision of immediate post-abortal contraception is important to reduce the number of unplanned pregnancies and the number of repeat abortions. Immediate post-abortal insertion of an IUD has many advantages and is an acceptable and safe method. However, side-effects and expulsion of conventional IUDs remain a problem. In an attempt to minimize these problems, the frameless intrauterine implant (IUI) was developed. Clinical studies conducted over the past 12 years have shown the validity of the anchoring concept. The design characteristics of the IUI (fixed, frameless and flexible) are responsible for the low expulsion, high effectiveness and high tolerance rates. This communication is the first report of clinical experience with the post-abortal version of Gynefix (Gynefix PT) in a limited number of women with pregnancies of less than 10 weeks' duration. This experience suggests that immediate post-abortal insertion of Gynefix PT is easy, safe and the implant appears to be as reliable and effective as interval insertion of the interval version. We conclude that the immediate post-abortal insertion of Gynefix PT is an important novel approach to reducing the incidence of repeat abortions.

The GyneFix implant systems for interval, postabortal and postpartum contraception: a significant advance in long-term reversible contraception. International Study Group on Intrauterine Drug Delivery.

Intrauterine contraception has a number of important advantages over other forms of contraception and remains, therefore, an important method of birth control. However, side-effects and other drawbacks have reduced its overall acceptance. Also misconceptions and lack of updated scientific knowledge among the potential users and providers are major obstacles to the widespread use of intrauterine contraception. Ideally, an intrauterine device (IUD) should prevent pregnancy effectively, be well tolerated, not become displaced or expelled over time, cause a minimum of side-effects, be long-lasting, have a strictly local effect, and be easy to insert and remove. A group at the University of Ghent, Belgium, the International Study Group on Intrauterine Drug Delivery, has developed, since 1985, a totally new concept in order to improve current intrauterine contraceptive efficacy and enhance tolerance, by creating a harmonious relationship between the uterine cavity and the contraceptive 'foreign body'. The new concept (GyneFix) consists of a non-biodegradable suture thread made of surgical 00 monofilament polypropylene on which six copper tubes are threaded, providing a total surface area of 330 mm2. The upper and lower tubes are crimped onto the thread to keep the tubes in place. The upper extremity of the thread is provided with a knot which serves as an anchor. The knot is implanted in the myometrium of the uterine fundus with a specially designed insertion instrument, thereby permanently securing the device in the uterine cavity. Since the initial clinical investigations, over 10,000 woman years of experience and up to 10 years' follow-up in international multicenter, non-comparative and comparative clinical trials have been collected. The clinical material also included a large number of nulligravid and nulliparous women. Due to the design characteristics of the GyneFix and its anchoring in the uterine fundus, an optimal tolerance and almost complete absence of expulsion were obtained. The constant release of copper ions in the upper part of the uterine cavity results in the high effectiveness of the anchored device. The effectiveness is higher than in the high-load conventional copper IUDs which have a risk of becoming displaced, partially or totally expelled in 10% or more (nulliparous women), resulting in a significant number of accidental pregnancies. The absence of frame and, as a consequence, its flexibility, explain the low incidence of side-effects and the very low incidence of complications, such as pelvic inflammatory disease and ectopic pregnancies. This new concept could be a major step forward in the acceptance of intrauterine contraception worldwide and increase its popularity. This article reviews the experience with the new concept for interval, postabortal and postpartum contraception.

Interval and postabortal contraception with the frameless GyneFix.

Intrauterine contraceptive devices (IUDs) have not suffered from the same negative influences in the developing world as in the first world. The method has too many basic advantages to be gainsaid including, most importantly, that it has the lowest lifetime cost of any effective method of contraception, and that user compliance is not an issue once the device is in place. However, the global community is not immune from trends that are seen in selected industrialized countries. Today, better methods of contraception are requested and the discomforts associated with earlier models of IUD, which were once acceptable, are less so today. Faced with the side-effects of oral contraception and the high cost in developing countries, many women who have completed their families undergo surgical sterilization as the only long-term method available to them, notwithstanding severe cultural and economic reservations about doing so. The development of the frameless device is a response to the growing need to develop high-performing, long-acting, reversible and acceptable contraceptives with a high continuation of use and to respond to the urgent need to reverse the legacy of neglect of immediate postabortal family planning.

Screening for breast and cervical cancer in Europe. Hungary.

PIP: In Hungary, the incidence of breast cancer, the fourth leading cause of death among women, almost doubled in every age group during the period 1970-94. Hungary has instituted a mass screening project in response to this situation. Screening for breast cancer is combined with screening for tuberculosis, and manual breast examination is now a routine part of every gynecological examination. Women are also being trained to examine their own breasts for changes. Treatment for breast cancer consists of total or partial mastectomy with removal of the axillar lymph nodes if necessary. Radiotherapy and adjuvant chemotherapy are also available. Data on cervical cancer gathered in 1988 indicate that morbidity is 26.7-28.3/100,000 and that the death rate has not changed in the past 25 years. The incidence of cervical cancer has increased dramatically, however, in the population aged between 15 and 39 years and over 80 years. Gynecologists usually provide routine screening for cervical cancer using oncocytology or, where available, colposcopic examination. Women must be informed about the importance of screening for early detection and treatment of cancer.^ieng

The frameless GyneFix intrauterine implant: a major improvement in efficacy, expulsion and tolerance.

The CuFix (GyneFix), conceived in 1985, was developed to minimize three major problems frequently associated with discontinuation of IUD use: expulsion, bleeding and pain. Since the initial clinical investigations, over 10,000 woman years of experience and up to 8 years of follow-up in international multicenter, non-comparative and comparative clinical trials, including a large proportion of nulligravid/nulliparous women, have been collected. Based on new clinical information about the GyneFix from a long-term multicenter clinical trial, conducted in young nulligravid/nulliparous and parous women, the importance of this new contraceptive is discussed. The following conclusions were reached: The unique design characteristics of the GyneFix (frameless, flexible and fixed to the fundus of the uterus) have resulted in optimal tolerance and almost complete absence of expulsion. The result is enhanced effectiveness (comparable to OCs and male/female sterilization) and a high rate of continued use. The GyneFix reduces the IUD failure rate to a minimum and is, therefore, a welcome reversible alternative to OCs and female surgical contraception. Framelessness and flexibility explain the absence of side-effects and adverse events caused by dimensional incompatibility between the frame of conventional IUDs and the uterine cavity and may also explain the absence of PID and ectopic pregnancies in any of the clinical studies. The GyneFix is a promising new, highly effective and safe, contraceptive option for parous women and an equally effective and well-accepted method for nulliparous women.

IUD expulsion solved with implant technology.

In an attempt to minimize the problem of IUD expulsion, implantation technology has been developed and tested. The trials have extended from 1985 until the present time for interval as well as for immediate postabortal and post-placental insertion and fixation of the CuFix IUD (Gyne-Fix). The present article reports on an ongoing study with GyneFix interval insertion, with an improved inserter, in 820 women, observed up to 3 years, of whom 213 (25.9%) are nulligravid/nulliparous. The cumulative expulsion rate is 0.6 per 100 women-years at 3 years and is not significantly higher in the nulligravid/nulliparous group. The cumulative pregnancy rate is 0.6 and the cumulative removal rate for medical reasons 3.2 at 3 years. The total experience in this multicenter study covers approximately 14,000 woman-months. It is concluded that the design characteristics of the GyneFix (fixed, frameless, and flexible) explain the low expulsion, high efficacy and high acceptability rates. The implantation technology is very effective and the improved inserter allows easy insertion and optimal anchoring.

Immediate postplacental insertion and fixation of the CuFix postpartum implant system.

Since promising results were obtained with the CuFix interval implant system in international clinical trials conducted worldwide, a modification of the device adapting it for immediate postplacental insertion and fixation (IPPIF) seemed a logical approach to solve the expulsion problem of IUDs inserted at that particular time. Seventy-three insertions were performed at three university centers, during 1990 and 1991, both by skilled and unskilled investigators. The results of this multicenter study show the excellent retainability of the modified IUD supporting the validity of the anchoring principle. The insertion procedure is easy, requiring minimal training, and the insertion technique appeared to be safe.

PIP: Physicians inserted the CuFix postpartum (CuFixPP) implant system, an IUD, to a depth of 1.3 cm in the fundal myometrium in 73 healthy women soon after vaginal delivery (10-30 minutes) at either the University Hospital in Gent, Belgium; the University Medical School in Debrecen, Hungary; or Alexandra Hospital of the University of Athens in Greece. Since previous international clinical trials showed unacceptably high rates of expulsion of CuFixPP, researchers conducted this trial to test the IUD after having it modified for immediate postplacental insertion and fixation. None of the physicians had received training in the insertion procedure of this experimental IUD. The cumulative expulsion rate at 12 and 18 months was 3.1. The cumulative pregnancy rate at 12 and 18 months stood at 1.5. The sole reasons for removal at 12 and 18 months were bleeding/pain and planned pregnancy (7.4 at 12 and months and 10.8 at 18 months; 9 at 12 months and 12.2 at 18 months, respectively). Physicians experienced difficulty removing the IUD in 4 cases. The removals did not cause noticeable bleeding. No complications occurred. These findings revealed that, with further modifications, the CuFixPP IUD holds considerable promise as a simple and effective method of postpartum contraception, which can easily be inserted by nurses or midwives, especially in developing countries.

New abortion law in Hungary.

In December 1992, the Hungarian Parliament revised the abortion law. The new law is in some ways more liberal than the former one. A woman can now have an abortion on demand within the first 12 weeks of pregnancy, if she is in a "crisis situation". A compulsory consultation has also been introduced with a nurse who informs the women on issues of contraception, maternity allowance, etc. Under certain circumstances abortion is legal beyond the first trimester. These include for example misdiagnoses of the pregnancy, if the women is under 18 years, or in case of genetical or teratogenic risks. Abortion performed for medical reasons is free of charge. In other cases the fee is HUF 5000, the equivalent of US $60, which can be reduced according to the economical status of the family. In one way the new law can be considered more restrictive; previously, an abortion was free of charge for women who became pregnant with an IUD, whereas now the woman has to pay the abortion fee.

Return to fertility after removal of a levonorgestrel-releasing intrauterine device and Nova-T.

In a European randomized multicenter study, the efficacy and safety of an intrauterine contraceptive device releasing 20 microgram levonorgestrel/24 hours (LNG-IUD) have been evaluated and compared to the Nova-T. Because the LNG-IUD has a strongly suppressive effect on the endometrium and in some women affects ovarian function, the return to fertility after removal of the IUD was studied. Two-hundred-nine women (71 in the Nova-T and 138 in the LNG-IUD group), who had their IUDs removed because of planning pregnancy, were followed at least 24 months or until termination of pregnancy. For the Nova-T, the cumulative conception gross rate was 71.2/100 women after 12 months (79.7 after 24 months) and for the LNG-IUD 79.1 (86.6 after 24 months). The difference between the devices is not statistically significant, and in spite of the endometrial suppression during use of LNG-IUD, there is no delay of return to fertility and in both groups 96% of the pregnancies occurred during the first year after removal of the device. Eighty-four % of the pregnancies in the Nova-T group and eighty-six % in the LNG-IUD group ended in live births. The results suggest that the endometrium recovers quickly, normal ovulations are established and the fertility seems to be unaffected after use of an LNG-IUD.

One-year clinical experience with FlexiGard.

In 1988, a clinical study with a new copper-containing IUD, the FlexiGard, was initiated at the Family Planning Center of the UMSD, Debrecen, Hungary. The aim of this trial was to measure the overall performance of the device with special attention to its frameless design and anchoring system. In one year (from May 1988 through May 1989), 344 FlexiGard devices were inserted in parous women during the first seven days of their menstrual cycle. This report summarizes the one-year results. By the end of the 12 -month follow-up period, 3484 woman-months of use (WMU) were accumulated. The number of women who completed the one-year follow-up period was 264. During this period, 33 cases were terminated for different reasons. The net continuation rate is 89.7 at the end of the first year of use. The device was well retained by the uterus (cumulative expulsion rate 1.5 at 12 months). The cumulative removal rate for bleeding/pain is 4.4 at 12 months and the cumulative pregnancy rate 0.6 at 12 months. The results confirm those of previously conducted multicenter studies with the device. This new generation intrauterine copper contraceptive (ICC) is well tolerated, which is attributed to its design characteristics. Besides, the device is highly effective, and its insertion is easy and safe. Removal of the ICC is equally easily accomplished.

PIP: During May 1988-May 1989, an obstetrician-gynecologist inserted the new frameless copper-releasing IUD, Flexigard, in 344 18-45 year old women attending the Family Planning Center at the University Medical School in Debrecen, Hungary. The physician was able to examine 336 patients during at least 1 follow-up visit during the 12 months, for a lost-to-follow-up rate of only 2.3% which is lower than the recommended 10%. At the end of 12 months 264 women continued to use Flexigard. The number of cumulative woman months of use stood at 3484. The net termination rate was 10.3 at 12 months. The leading reason for removal was bleeding/pain (cumulative removal rate= 4.4). The only personal reason for removal was planning a pregnancy (6 cases, rate = 1.9). The 12-month net continuation rate was 89.7. The low expulsion rate was only 1.5 which was probably due to the anchoring system which allows the upper part of the IUD to penetrate no more than 1 cm into the fundal myometrium. The 12-month cumulative pregnancy rate was 0.6. In conclusion, the design characteristics of Flexigard made it well tolerated. Further, it proved to be very effective, and insertion and removal were easy and safe.

Clinical experiences with MLCu250 and MLCu375 IUD.

The paper summarizes the author's ten-year experience with 1446 interval insertions of the MLCu250 standard-type device, and makes comparison between the first two-year results of this and the MLCu375 IUD. The 120th month was completed by 106 MLCu250 users, and the cumulative woman-months of use (wmu) were 78,078. At the end of the second year, 976 patients were at risk in this group, representing a total of 28,097 wmu. From the initial 224 MLCu375 IUD cases, 160 (2,151 wmu) and 93 (3634 wmu) were eligible for life-table calculation at the end of the first and the second year, respectively. The overall performance was evaluated by net and gross cumulative and yearly specific rates as suggested by Tietze. These figures are detailed by the article. Based on this evaluation, two statements are made: (1) the MLCu250 standard-type device has a good overall performance and a longer life span than was previously expected; (2) the first two-year results with the MLCu375 are more favorable (lower termination rates, higher continuation) than the MLCu250.