Biomedical subjects

Dirk Wildemeersch

Publications and source records attributed to Dirk Wildemeersch.

8 recordsLinked to original sources

PubMed2004

Three-year efficacy and acceptability of the GyneFix 200 intrauterine system.

OBJECTIVE: This study was conducted to evaluate the efficacy of a "mini" version of the frameless intrauterine system (IUS; GyneFix), which has a copper surface area of approximately 200 mm(2). The small GyneFix version consists of four copper cylinders instead of six and is only 2 cm long. MATERIALS AND METHODS: A total of 392 insertions were performed in an open nonrandomized study in parous (76%) and nulligravid/nulliparous (24%) women in Belgium and China. This interim analysis reports on 13,699 women-months of use. All women were followed-up for a minimum of 12 months, up to 3 years and longer. RESULTS: Four pregnancies occurred with the GyneFix 200 IUS in this study, of which one occurred after unnoticed expulsion of the device, yielding a cumulative failure rate of 0.48 at 3 years. The cumulative removal rate for medical reasons was 1.65 at 3 years and the expulsion rate was 0.39. These low event rates resulted in a high continuation of use (93.92 at 3 years). Neither perforations nor pelvic inflammatory disease cases were encountered in this study. CONCLUSION: The present study suggests that the GyneFix 200 IUS is highly effective and probably as effective as the standard GyneFix IUS. This is attributed to the anchoring of the device to the fundus of the uterus, promoting its contraceptive action. The total surface area of the device, releasing a maximum amount of copper ions, is the fundamental difference between it and conventional IUDs and is probably essential in obtaining the high contraceptive efficacy seen in this study. The small total surface area of the GyneFix 200 IUS also minimizes menstrual bleeding and is an improvement over larger types of conventional IUDs, as indicated by the low removal rate for abnormal bleeding with the small GyneFix.

Adolescent↗

PubMed2004

The force required to remove the frameless 0-suture IUD anchoring system: comparison between pre- and postmenopausal women.

OBJECTIVE: The objective of this short communication is to measure and compare the force needed to remove the implanted "0-suture" GyneFix intrauterine contraceptive device (IUD) and the "0-suture" FibroPlant trade mark -LNG intrauterine system (IUS) from the uterus of pre- and postmenopausal women. STUDY DESIGN: A nonrandomized comparative study in 119 pre- and postmenopausal women. A dynamometer (Pesola) was used to measure the removal force in newtons. RESULTS: The results of this study show a mean removal force of 8.5 and 9.5 newtons, respectively (range, 3-11 and 4.5-11), in pre- and postmenopausal women, which is significantly different (p = 0.003). CONCLUSIONS: The force needed to remove the IUD/IUS anchored in the myometrium of the uterine fundus of pre- and postmenopausal women is higher than the removal force found in previous studies in which the IUD consisted of a slightly thinner anchoring thread (00 instead of 0 suture). The statistically significantly different removal force between the two groups has no clinical implications. The difference may reflect the increased compactness of the uterine tissue in the postmenopausal uterus.

Biomechanical Phenomena↗

PubMed2004

The reliability of the anchoring concept for suspension of bioactive substances in the human uterus evaluated by measuring the removal force: results after long-term use.

OBJECTIVE: The objective of the present study is to report on the force needed to remove the implanted GyneFix intrauterine contraceptive device (IUD) from the uterine cavity. This study is the first long-term study on the retrieval of the anchored IUD. STUDY DESIGN: A two-center, noncomparative study to measure the force needed to remove the IUD in 251 women. A dynamometer (Pesola, Switzerland) was used to measure the removal force in newtons. RESULTS: The results of this study show a mean removal force of 6.2 and 6.1 newtons, respectively (range, 0-10), in parous and nulligravid or nulliparous women (p = 0.62). There was no difference in removal force for those women with a duration of use either less than 60 months or longer than 60 months (median of 6 newtons in both groups; p = 0.22). CONCLUSIONS: The force needed to remove the GyneFix IUD suggests that the implantation technology used in the insertion of the device is reliable, provided the anchoring knot is properly inserted in the fundal myometrium. The results of this study indicate that early expulsion of the device could be explained by failure to implant the knot adequately (no implantation or partial implantation), which requires a degree of skill. The present study does not provide an explanation for the occurrence of late expulsion, although some speculations can be made.

Belgium↗

PubMed2004

GyneFix insertion.

Explore the source record for details and available documents.

Clinical Competence↗

PubMed2003

The 'frameless' intrauterine system for long-term, reversible contraception: a review of 15 years of clinical experience.

AIM: The development of the 'frameless' intrauterine system (IUS) is a response to the growing need to develop high-performing, long-acting, reversible, and acceptable contraceptives with a high continuation of use. METHODS: This is a review of 15 years of clinical experience in randomized controlled and non-randomized clinical trials. RESULTS: The IUS has a similar failure rate as the TCu380A Intrauterine device (IUD), considered the 'golden standard' IUD, which is attributed to the optimal target delivery of the copper ions in the upper part of the uterine cavity. Its performance is further optimized by the atraumatic design, which reduces partial and total expulsion and minimizes the side-effects and discomforts experienced with conventional 'framed' IUDs. The mini IUS is likely to further reduce the menstrual blood loss due to the very small size. The safety of the anchoring concept is beyond doubt as was demonstrated in all clinical studies covering 15,000 woman-years experience. CONCLUSIONS: Young nulliparous/nulligravid and parous women may significantly benefit from the advantages the 'frameless' IUS, which could be strategically important to help in reducing the increasing number of unintended pregnancies and induced abortions worldwide. Furthermore, the 'frameless' IUS has been shown to be highly effective for emergency contraception and for immediate postabortal insertion. The long lifespan of the IUS could constitute a cost-effective reversible alternative to irreversible female sterilization.

Female↗

PubMed2002

The effect on menstrual blood loss in women with uterine fibroids of a novel "frameless" intrauterine levonorgestrel-releasing drug delivery system: a pilot study.

OBJECTIVE: To evaluate the effect on menstrual blood loss, in women with uterine fibroids, of a novel "frameless" intrauterine drug delivery system (IUS), FibroPlant-levonorgestrel (LNG), releasing 14 microg of LNG per day. STUDY DESIGN: An open label, non-comparative ongoing pilot study. Fourteen insertions were performed in premenopausal women between 39 and 48 years of age for the treatment of menorrhagia. The effect on menstrual blood loss was evaluated using a simple visual assessment technique. Women were followed-up for at least 12 months (range 12-30 months). RESULTS: At the time of study analysis the total number of women-months was 283. All women, except one reported greatly reduced bleeding. In two women, the treatment failed although both reported reduced bleeding. One failure (patient no. 4) was due to the presence of a large endometrial polyp. This patient underwent hysterectomy. The other women (patient no. 1) had submucosal fibroids. She refused hysterectomy and is continuing treatment. In the other 12 patients, reduction of bleeding was appreciable after one month of treatment and tended to decrease further over the next months to stabilize afterwards. The mean bleeding score before treatment was 465 (185-960) and dropped to a mean score of 100 (range 5-300) after a minimum of 12 months of treatment which is highly statistically significant (P<0.001). In eight women, the bleeding reduced to very low scores. An effect on the size of the uterine fibroids could not be demonstrated. Significant spotting was rare after the first 3 months following insertion. Neither complications (e.g. infection, expulsion or perforation) nor pregnancies occurred. The FibroPlant-LNG IUS was well tolerated by all women involved in the study and no systemic hormonal side effects were reported. CONCLUSION: This study suggests that FibroPlant-LNG IUS is effective to significantly reduce the amount of menstrual blood loss in women with menorrhagia in the presence of intramural and subserosal fibroids and can avoid surgery. The strong endometrial suppression is the principal mechanism explaining the effect on menstrual blood loss of the IUS. The two failures probably explain that a successful treatment in women with endometrial abnormalities (e.g. polyps, submucous fibroids) is unlikely with the IUS. The low daily release rate of LNG from the FibroPlant-LNG IUS results in a low incidence of hormonal side effects. The simple design characteristics and revolutionary anchoring system account for minimizing the occurrence of complaints of pain and expulsion. The flexible fibrous delivery system adapts to cavities of every size even when severely distorted.

Adult↗

PubMed2002

Efficacy of a mini version of the frameless GyneFix intrauterine system (IUS) with effective copper surface area of 200 mm2. dirk.wildemeersch@contrel.be.

This study was conducted to evaluate the efficacy of a 'mini' version of the frameless intrauterine system (IUS) (GyneFix) that has a copper surface area of approximately 200 mm(2). The GyneFix-mini consists of four copper cylinders instead of six and is only 2 cm long. A total of 301 insertions were performed in an open nonrandomized pilot study in parous (77%) and nulligravid/nulliparous (23%) women in Belgium and China. This interim analysis reports on 4110 women-months of use. All women were followed-up for a minimum of 12 months. Two pregnancies occurred with the mini GyneFix IUS in this study. However, only one occurred with the device in situ. The cumulative removal rate for medical reasons (bleeding and pain) was 0.39 at 1 year. The expulsion rate was 1.04. These low event rates resulted in a high continuation rate (95.02 at 1 year). Neither perforations nor pelvic inflammatory disease cases were encountered in this study. This study indicates that only a minimal amount of copper, positioned in the upper part of the uterine cavity, is sufficient to provide a high contraceptive effect. This is made possible by anchoring the active contraceptive substance to the fundus of the uterus. The fact that 100% of the copper surface area of the frameless IUS is available for copper release is an additional advantage.

Adolescent↗

PubMedDate not supplied

Development of a miniature, low-dose, frameless intrauterine levonorgestrel-releasing system for contraception and treatment: a review of initial clinical experience.

A low-dose levonorgestrel (LNG)-releasing intrauterine system (IUS) (FibroPlant) has been clinically developed since 1997 for endometrial suppression during hormone replacement therapy in peri- and postmenopausal women, for the treatment of menorrhagia in women with normal uteri or with uterine fibroids, for contraception, for the treatment of endometrial hyperplasia, and for alleviating primary and secondary dysmenorrhoea. Results of preliminary studies confirm the promising nature of this all-round drug delivery system. The low dose of LNG released accounts for the low hormonal side-effect rate and virtual absence of amenorrhoea in premenopausal women. The system has not yet been evaluated in tamoxifen users (to protect the endometrium), or in women with rectovaginal endometriosis. However, early indications suggest that the system will also be suitable for these indications. The frameless drug delivery support of this LNG-releasing IUS has been optimized to reduce the size of the foreign body and to maximize tolerance and continuation of use while simultaneously providing for the maximum duration of action.

Contraception↗