PubMed Health⌕ Search

Biomedical subjects

D Wildemeersch

Publications and source records attributed to D Wildemeersch.

At least 37 records · Page 2Linked to original sources
PubMed2000

Contraception with a novel 'frameless' intrauterine levonorgestrel-releasing drug delivery system: a pilot study.

OBJECTIVE: To evaluate the contraceptive performance, acceptability, side-effects and adverse events of a novel 'frameless' intrauterine drug delivery system, the FibroPlant levonorgestrel intrauterine system, releasing 14 microg of levonorgestrel/day. An ancillary objective was to evaluate the effect of the new intrauterine system on menstrual blood loss. STUDY DESIGN: This was an open-label, non-comparative, ongoing pilot study. Fifty-four insertions were performed by the first author in fertile women between 16 and 51 years of age for contraception. Eighteen of these women were fitted with the FibroPlant levonorgestrel intrauterine system for the treatment of excessive bleeding as well as for contraceptive purposes. Of these women, 12 had medium-to-large-sized uterine fibroids in addition to heavy menstrual flow. The follow-up period of the trial was between 6 and 16 months. RESULTS: At the time of study analysis the total number of woman-months was 464 and 21 women had had the FibroPlant levonorgestrel intrauterine system in place for more than 1 year. No pregnancies occurred. All women reported greatly reduced bleeding; however, no cases of amenorrhea resulting from endometrial suppression were encountered. Significant spotting was rare after the first 3 months following insertion. No complications (e.g. infection, expulsion or perforation) occurred. The FibroPlant levonorgestrel intrauterine system was well tolerated by all women involved in the study and no systemic hormonal side-effects were reported. CONCLUSIONS: Although the average age of the study subjects was 40 years, this preliminary study suggests that the FibroPlant levonorgestrel intrauterine system is an effective contraceptive. The FibroPlant levonorgestrel intrauterine system is also highly efficacious in controlling bleeding in women presenting with excessive menstrual flow. Effective endometrial suppression is the principal mechanism underlying both the contraceptive effect and the effect on menstrual blood loss. The low release rate oflevonorgestrel results in an absence of hormonal side-effects. The unique 'frameless' design characteristics of the intrauterine system facilitate insertion and minimize pain and discomfort. These factors, together with the low incidence of amenorrhea, appear to be a significant step forward from the 'framed' Nova-T levonorgestrel intrauterine system (Mirena).

Adolescent↗
PubMed2000

Intrauterine contraception in the year 2001: can intrauterine device use be revived with new improved contraceptive technology?

Intrauterine contraception is the most cost-effective reversible method of contraception today. The method is becoming increasingly attractive to women due to the development of new technologies that not only enhance the performance of the intrauterine device (i.e. efficacy is now close to 100%), but also reduce the rate of expulsion (in the case of the 'frameless' GyneFix intrauterine device (IUD)) and the number of removals for medical reasons. This is important, since the demand for intrauterine devices is likely to increase drastically in the coming years. The size of the intrauterine foreign body with the mini GyneFix has been reduced six-fold since the development of the Lippes Loop, resulting in an almost total absence of incompatibility problems. Furthermore, intrauterine contraception is entering a new phase with the development of intrauterine systems (IUSs) that deliver potent progestins. The Mirena intrauterine system, which releases levonorgestrel, has been shown to drastically reduce menstrual bleeding. The FibroPlant levonorgestrel IUS has been clinically developed since 1997 and is a further development of the 'frameless' anchoring IUD concept. The majority of women presenting with excessive bleeding can be treated by insertion of the IUS, resulting in greatly reduced menstrual blood loss. This is a very important result from both a health and a quality-of-life point of view. The fact that the IUS is also a potent contraceptive is extremely interesting. We believe, therefore, that these new technologies will lead to a re-appraisal of the IUD and could revive the use of intrauterine contraception in all parts of the world, including those regions where IUD use is presently very low.

Female↗
PubMed2000

Immediate post-abortal insertion of the frameless GyneFix IUD: initial experience in China.

The promising results obtained with the frameless GyneFix IUD for interval insertion led to the belief that the technology could be useful for immediate post-abortal application to reduce the number of induced and repeat abortions. IUDs have many advantages and the method is acceptable and safe. However, side effects and expulsion of conventional IUDs remain a problem. In an attempt to minimise these problems, the frameless GyneFix IUD was developed. Clinical studies conducted over the past 14 years have shown that the principles on which the device is based are valid. An increasing bulk of clinical evidence shows that the design characteristics of the device (fixed, frameless and flexible) are responsible for the low expulsion, high effectiveness, and high tolerance and continuation rates.1 Experience with the frameless IUD in China since 1989 confirms the international experience with the device. The present communication is a second report from China with the GyneFix IUD. In the present study the GyneFix IUD is inserted immediately following termination of pregnancy of less than 10 weeks amenorrhea. It is concluded that immediate post-abortal insertion of the frameless IUD is easy and safe, and appears to be as reliable and as effective as when it is inserted at interval. The GyneFix IUD could, therefore, constitute an important new option in the prevention of abortion.

Abortion, Induced↗
PubMed2000

Rethinking the status quo.

Even when a medical device appears to have been refined, tested and used extensively there is invariably scope for further improvement. Input from outside the relevant specialist field can encourage a rethink of the status quo. The resultant enhancements can benefit the doctor and patient as well as offer the manufacturer a marketing opportunity to increase sales and profitability. This design story describes innovation in intrauterine contraceptive device technology.

Equipment Design↗
PubMed1999

Performance of the frameless IUD (Flexigard prototype inserter) and the TCu380A after six years as part of a WHO multicenter randomized comparative clinical trial in parous women.

The clinical performance of the new Frameless IUD was compared with the TCu380A, the most widely used copper IUD in the world today. Insertions of the Frameless IUD were conducted with a prototype inserter (Flexigard). We report on the 6-year results from a randomized comparative clinical trial conducted at the Shanghai Institute of Planned Parenthood Research, as part of an international multicenter WHO clinical trial, involving 200 women, respectively recruited for use of each device. The cumulative 6-year pregnancy rates were 0.0 per 100 women for the Frameless IUD and 3.3 for TCu380A. Termination due to partial expulsion was significantly less for the Frameless IUD as compared with TCu380A (0.0 and 4.3 per hundred women, respectively). Complete expulsion, bleeding, pain, bleeding and pain and other medical reasons for termination did not differ significantly between the two devices. The net cumulative continuation rates at six years per 100 women were 80.8 for TCu380A, and 83.0 for the Frameless IUD. Both Frameless IUD and TCu380A are highly effective, safe and acceptable contraceptive devices, because of low pregnancy rates (per 100 women), and low termination rates due to expulsion, pain, bleeding, and bleeding and pain. Due to its anchoring, the Frameless IUD is significantly more effective than the TCu380A IUD as regards proper retention of the IUD in the uterine cavity. This may also explain its lower failure rate.

Adult↗
PubMed1999

GyneFix-LNG: preliminary clinical experience with a copper and levonorgestrel-releasing intrauterine system.

A novel intrauterine contraceptive drug delivery system derived from the conventional GyneFix intrauterine implant system is described and the preliminary results in 22 women are discussed. The first objective of the development of the GyneFix-levonorgestrel system was to reduce menstrual bleeding, whether or not related to the effect of copper, by combining a shortened version of the standard GyneFix implant, having a copper surface area of 200 mm2, with a system for the sustained intrauterine delivery of levonorgestrel. The results of this initial observational study indicate that the GyneFix-levonorgestrel system, apart from being well tolerated, is safe and effective. The levonorgestrel component appears to have a beneficial effect on the amount of bleeding. A study on menstrual blood loss will be carried out to substantiate this assumption.

Adolescent↗
PubMed1999

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.

Abortion, Induced↗
PubMed1998

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.

Abortion, Induced↗
PubMed1997

Intrauterine contraception in adolescent women. The GyneFix intrauterine implant.

Pregnancy rates among adolescents have not decreased over the last 10 years, despite numerous efforts. To solve this important health problem, the major strategy recommended is to encourage contraceptive use among sexually active teenagers. An important means of obtaining this is by promoting methods that are not dependent on daily administration in order to avoid noncompliance. One such method (Norplant) has already shown to be much more effective than the combination pill in preventing pregnancy in adolescent women. The frameless intrauterine implant system (fixed, frameless, and completely flexible) has been studied since 1985 in women between 14 and 50 years of age. The results in young nulligravid women confirm its very high effectiveness (cumulative pregnancy rate at 36 months: 1.4%), its low expulsion rate (cumulative rate at 36 months: 0.9%) and its optimal tolerance (cumulative removal rate for medical reasons at 36 months: 2.4%), resulting in a high acceptance of the implant and a high continued use. The system (GyneFix) offers long-term protection (5 years), and its insertion, with or without anesthetic, is easily accomplished in the office. The GyneFix should therefore be recommended as an excellent alternative for birth control pills for young women with low risk for STDs, especially when compliance is a problem, without an increased risk for complications and without systemic side effects. Removal of the device is accomplished by traction on the tail. It can also be used for emergency contraception and for insertion immediately after termination of pregnancy.

Adolescent↗
PubMed1997

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.

Abortion, Induced↗
PubMed1997

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.

Abortion, Induced↗
PubMed1996

[Intrauterine copper contraceptive implants].

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 women 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. The following conclusions were reached: 1. The unique design characteristics of 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. GyneFix reduces the IUD-failure rate to a minimum and is, therefore, a welcome reversible alternative to OCs and female surgical contraception. 2. Frameless 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. 3. Insertion of GyneFix, with or without local anaesthesia, is easily accomplished in the office of a few minutes. Removal is easy, quick and painless. 4. GyneFix is an equally effective and well accepted method fro nulliparous women.

Equipment Design↗
PubMed1995

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.

Adult↗
PubMed1995

European Society of Contraception oral contraceptives survey update: birth control methods in "Europe of the 12".

The European Society of Contraception developed a survey to examine birth control methods in the 12 countries++ of the European Community. Responses to those questions relating to prescribing++ practices of oral contraceptives (OCs) are presented herein. The survey was sent to 400 physicians. One hundred two responded, most from France, Belgium, and the United Kingdom. The responses revealed that the most popular OCs are modern combined formulations containing low doses of ethinyl estradiol and progestogens such as norgestimate, desogestrel, gestodene, and levonorgestrel. More than half of physicians prescribe a particular formulation because of its tolerability and 20% because of its hormonal content. More than 90% prescribe OCs to healthy, nonsmoking women over 40. However, three fourths will not prescribe OCs to smokers over 35. Half of physicians recommend mammography for their older OC patients. Half also recommend cholesterol screening, but 8% only for women over 30. Most physicians are no longer reluctant to prescribe OCs to their diabetic patients: 61% prescribe OCs for women with non-insulin-dependent diabetes, 56% for those with insulin-dependent diabetes, and 85% for those with a history of gestational diabetes. Despite recent studies showing no relation between past OC use and cardiovascular disease, 42% of physicians said that their greatest OC-related health concern is cardiovascular disease. One third cited noncompliance as their greatest concern. These results reveal inhomogeneous prescribing practices for OCs among European physicians. ¿Over-screening¿--not prescribing the pill because of perceived (but not necessarily real) health risks--may be depriving many women of the contraceptive and noncontraceptive benefits of OCs. Complete and accurate information--as promoted by the European Society of Contraception--is one way to combat such overscreening.

Adult↗
PubMed1992

The FlexiGard 330 ICC, an ultrasound evaluation.

The FlexiGard 330 intrauterine copper contraceptive (ICC) was studied by ultrasound in 405 patients immediately following insertion and at each follow-up visit, for up to 5 years. The present study confirms the validity of the anchoring concept for the suspension of bioactive substances in the uterine cavity. The major conclusion from the study is that the anchor is non-migrating even when observed over a long period of time. Ultrasound examination is the method of choice to evaluate proper insertion technique as well as proper positioning of the device at follow-up.

Evaluation Studies as Topic↗
PubMed1988

The Copper-Fix (Cu-Fix): a new concept in IUD technology.

The Copper-Fix (Cu-Fix) is a thread-type copper-bearing device designed to overcome the most common IUD-related problems: bleeding and pain. Two distinctive features--virtual absence of a frame and provision of an anchoring system--make this new intrauterine device the first radical departure from current IUD technology. The Cu-Fix 390 was inserted at intervals in 382 women, and 4851 woman-months of experience had been accumulated at 18 months. The device was exceedingly well retained by the uterus (expulsion rate 0.6 at 18 months) and the removal rate for bleeding/pain was low (3.1 at 18 months). Serious complications did not occur; the pregnancy rate amounted to 0.3 at 18 months, with a continuation rate of 87.6%, which includes an 8.1% removal rate for pregnancy wish. Cardinal event rates were not influenced by the age or gravidity status of the recipient.

Adult↗
PubMed1983

Hysterectomy in six European countries.

Gynaecologists have been criticized in recent years because of their attitude towards hysterectomy; it is often stated that they are too ready to consider hysterectomy to be indicated and that hysterectomies are carried out too frequently. In order to obtain insight into the incidence of hysterectomy, 2066 women between 40 and 70 yr of age, composing a sample covering 6 European countries, were asked whether they had undergone this operation. Of the total sample, 11.4% had been hysterectomized, the highest percentage being found in Italy (15.5%) and the lowest in France (8.5%). The most important factor that influenced the relative frequency of hysterectomy was age: the percentage of women who had undergone hysterectomy increased with age up to 55-59 yr, but fell thereafter. Another significant factor was civil status; there were fewer divorcees or widows at the moment of operation than married or never-married women. The relationship between the incidence of hysterectomy and age is a parabolic one. To explain this curve the authors postulate that two trends must have played a rôle: firstly; a greater need for hysterectomy with increasing age and, secondly a decrease in the reluctance of the gynaecological profession to perform a hysterectomy and/or of women to undergo this operation. Statistical analysis confirms the existence of this second trend over the period 1960-1975. The chances of a young woman losing her uterus before her 70th year went up linearly to 19.8% in 1975. By extrapolation a figure of 21% is obtained for 1980. Satisfaction with the result of the operation was lowest in Italy and Germany; satisfaction was also lowest in rural areas.

Adult↗