Pain assessment by pupil dilation reflex in response to noxious stimulation in anaesthetized adults.

BACKGROUND: In response to noxious stimulation, pupillary dilation reflex (PDR) occurs even in anaesthetized patients. The aim of the study was to evaluate the ability of pupillometry with an automated increasing stimulus intensity to monitor intraoperative opioid administration. METHODS: Thirty-four patients undergoing elective surgery were enrolled. Induction by propofol anaesthesia was increased progressively until the sedation depth criteria (SeD) were attained. Subsequently, a first dynamic pupil measurement was performed by applying standardized nociceptive stimulation (SNS). A second PDR evaluation was performed when remifentanil reached a target effect-site concentration. Automated infrared pupillometry was used to determine PDR during nociceptive stimulations generating a unique pupillary pain index (PPI). Vital signs were measured. RESULTS: After opioid administration, anaesthetized patients required a higher stimulation intensity (57.43 mA vs 32.29 mA, P < .0005). Pupil variation in response to the nociceptive stimulations was significantly reduced after opioid administration (8 mm vs 28 mm, P < .0005). The PPI score decreased after analgesic treatment (8 vs 2, P < .0005), corresponding to a 30% decrease. The elicitation of PDR by nociceptive stimulation was performed without changes in vital signs before (HR 76 vs 74/min, P = .09; SBP 123 vs 113 mm Hg, P = .001) and after opioid administration (HR 63 vs 62/min, P = .4; SBP 98.66 vs 93.77 mm Hg, P = .032). CONCLUSIONS: During propofol anaesthesia, pupillometry with the possibility of low-intensity standardized noxious stimulation via PPI protocol can be used for PDR assessment in response to remifentanil administration.

Safety and comfort of long-term continuous combined transdermal estrogen and intrauterine levonorgestrel administration for postmenopausal hormone substitution - a review.

OBJECTIVE: To review the endometrial safety and patient acceptability of long-term use of continuous transdermal estrogen substitution combined with intrauterine release of levonorgestrel (LNG) in postmenopausal women. DESIGN: One-hundred and fifty-three women who utilized the regimen for 2 IUD cycles were followed-up for a period of 10 years. Histology of the endometrium was evaluated at the end of this period to assess endometrial safety and the acceptability of the method was assessed based on the replacement rate of the LNG-IUS and continuation of ET. RESULTS: The regimen, administered over a 10-year period, was very well tolerated and the IUD was retained well and no expulsions occurred. The dominant endometrial histologic picture was that of inactive endometrium characterized by glandular atrophy and stroma decidualization (Kurman classification 5b). No cases of endometrial hyperplasia were found. CONCLUSION: The low systemic absorption of LNG could be desirable, thus allowing for maximization of the beneficial effects of ET on organ tissues (e.g. cardiovascular tissues and breast). Repeat LNG-IUS is associated with high patient satisfaction. If started before the age of 60, this regimen could be advised for lifelong prevention of cardiovascular disease and other prevention measures. The LNG-IUS was shown to effectively oppose the secondary effects of systemic estrogen on the endometrium tissue resulting in strong suppression during the entire period of EPT.

Comparison of expulsions following intracesarean placement of an innovative frameless copper-releasing IUD (Gyn-CS®) versus the TCu380A: A randomized trial.

OBJECTIVE: The intent of this study (primary outcome measure) is to assess the expulsion rate of a newly developed copper releasing frameless intrauterine IUD GyneFix® Cesarean Section (Gyn-CS®) at 3 months' follow-up, compared to the TCu-380A IUD, inserted immediately postplacental expulsion following cesarean section delivery. STUDY DESIGN: This is a randomized trial from one hospital research center in Istanbul, Turkey. Eligible pregnant women, the majority undergoing elective cesarean delivery (n=106), and the remaining emergency cesarean section cases (n=34), received intracesarean insertion of Gyn-CS or TCu380A insertion. Follow-up ended with a 3 month-visit. The Zeynep Kamil University Hospital Ethics Committee approved this study. RESULTS: The study explores the retention of 140 insertions, 70 Gyn-CS and 70 TCu380A. There were two follow-up visits after discharge from hospital at 6 weeks and 3 months. A single Gyn-CS expulsion occurred after approximately 6 weeks likely a consequence of improper anchoring. Expulsion was more common in the TCu380 A IUD group (11.4% vs 1.4%, p=.039). There were 4 removals for medical reasons in the Gyn-CS patients and 4 in the TCu380A patients, respectively, with 4 non-medical removals occurred, 2 in each group. No serious adverse events (e.g., PID, perforation) were reported. At the study conclusion of 3 months, 61 Gyn-CS (88%) and 54 TCu380A (79%) IUDs remain in place. CONCLUSION: This immediate postplacental study in cesarean section patients suggests that the anchoring technique employed resulted in the excellent retention of Gyn-CS. Insertion was easy, safe and quick requiring minimal physician training. The possibility of direct visualization of the anchor by ultrasound at insertion and follow-up allows the surgeon to verify the position of the IUD serving to enhance provider and patient confidence and assurance. IMPLICATIONS: The frameless anchored intrauterine IUD is effective in minimizing displacement and expulsion. The results of this study suggest that the Gyn-CS IUD is appropriate for wider intracesarean use.

Endometrial safety after 5 years of continuous combined transdermal estrogen and intrauterine levonorgestrel delivery for postmenopausal hormone substitution.

OBJECTIVE: To investigate endometrial histology and thickness of the endometrium after long-term use of continuous transdermal estrogen substitution combined with intrauterine release of levonorgestrel (LNG) in postmenopausal women. DESIGN: A 5-year non-comparative prospective clinical trial. SUBJECTS: Out of 182 symptomatic postmenopausal women using estrogen substitution therapy (EST) combined with a novel T-shaped LNG-releasing intrauterine system (Femilis Slim LNG-IUS), to prevent endometrial proliferation and bleeding, only those women (n=102) who used two consecutive LNG-IUSs, were isolated with the aim to study the long-term effects on the endometrium. The mean age of the women was 57 years (range 47-71). The majority of women received percutaneous 17beta estradiol, 1.5mg daily, or an equivalent dose by patch or orally, on a continuous basis. MAIN OUTCOME MEASURES: Endometrial histology and ultrasonographic evidence of endometrial suppression, after a period of approximately 5 years of use. The mean duration of use of the regimen was 70 months (range 25-98). RESULTS: The dominant endometrial histologic picture was that of inactive endometrium characterized by glandular atrophy and stroma decidualization (Kurman classification 5b). No cases of endometrial hyperplasia were found. On transvaginal ultrasound, this corresponds with a thin endometrium (< or = 5 mm). CONCLUSION: The results of this 5-year study in 102 postmenopausal women using EST demonstrates that the LNG-IUS effectively opposes the estrogenic effect on the endometrium resulting in strong suppression during the entire period of EST. Due to its high efficacy and absence of systemic effects on organ tissues (e.g., breasts), target delivery in the uterine cavity could be a preferred route to administer a progestagen in women using EST.

Management of patients with non-atypical and atypical endometrial hyperplasia with a levonorgestrel-releasing intrauterine system: long-term follow-up.

OBJECTIVES: Levonorgestrel (LNG), delivered locally into the uterine cavity has a profound effect on the endometrium. The aim of the study was to use a LNG intrauterine system to treat non-atypical and atypical endometrial hyperplasia in women and to evaluate the long-term cure (remission) rate. METHODS: Each of the 20 women in the study, of whom eight were diagnosed with atypical hyperplasia, received a LNG-IUS, releasing 20 microg LNG/day. The study is a non-comparative study with long-term follow-up (range 14-90 months). RESULTS: All women developed a normal endometrium, except one asymptomatic woman with atypical hyperplasia who still had focal residual non-atypical hyperplasia at 3 years follow-up in the presence of a thin (< 4 mm) endometrium. CONCLUSION: Continuous intrauterine delivery of LNG appears to be a promising alternative to hysterectomy for the treatment of endometrial hyperplasia and could enhance the success rate when compared with other routes of progestagen administration as well as intrauterine progesterone delivery. The significant reduction of the PR expression observed during treatment with the LNG-IUS appears to be a marker for the strong antiproliferative effect of the hormone at a cellular level resulting in an inhibition of estrogen bioactivity and endometrial suppression.

Use of a frameless LNG-IUS as conservative treatment for a pre-malignant uterine polyp in a premenopausal woman - a case report.

Prevention of progression to invasive carcinoma in patients with a premalignant endometrial lesion using longterm treatment with levonorgestrel (LNG) releasing intrauterine systems (IUS) remains controversial, especially when manifest cellular atypia has been found in the endometrial biopsy specimen. We present a case of a 44-year old premenopausal woman with a premalignant uterine polyp who declined hysterectomy and was followed-up for more than 12 years after the first LNG-IUS was inserted. Endometrial atrophy installed, no pathology was detected and hysterectomy was thereby successfully avoided. The positive experience in this case should encourage further studies as literature data indicate that conservative treatment of premalignant endometrial pathology is a real option with a high success rate for women who have a contra-indication for surgery, refuse the classical approach for personal reasons or want to preserve their fertility.

Miniature, low-dose, intrauterine drug-delivery systems.

The safety of systemically administered sex steroids continues to be a major focus of researchers. The negative results of the Women's Health Initiative study (WHI), and follow-up reports published in JAMA, evaluating the safety of estro-progestogen in postmenopausal women, elicited an unprecedented reaction in the press by women and doctors alike. From these publications, it is clear that research should focus on new progestogens and on alternative administration routes to minimize adverse drug effects. One approach to the improvement of safety, efficacy, and acceptability of steroid hormones, including patient compliance, is to develop long-acting implantable methods that deliver the lowest possible dose to the key target tissues. This therapeutic concept of "minimal intervention" has been known for several decades, but the practical applications of the method were lacking. Intrauterine drug-delivery systems can be developed to achieve minimal intervention fertility control without influencing normal ovarian function and/or causing adverse hormonal effects. With hormone replacement therapy in postmenopausal women, research suggests that progestogens delivered directly to the uterine mucosa could reduce side effects and minimize reversal of the beneficial effect of estrogens. Various "frameless" and "framed" intrauterine systems are currently being clinically evaluated. They are less troublesome than the available intrauterine systems and could therefore be suitable for use in the majority of women for contraception and treatment purposes (e.g., menorrhagia, hormone replacement). These systems require a single short office procedure, and have a low morbidity, which is undeniably linked with more invasive methods and systemic hormonal contraceptives. Due to the technological progress miniature, low-dose, long-term intrauterine drug-delivery systems offer enhanced effectiveness, reduced side effects, and optimal user compliance. Although there is minimal absorption in the systemic circulation, they deserve the status of a locally acting method that should be regarded as fundamentally advantageous, if effective, to systemically applied medications that may have potentially inherent ill side effects.

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.

Double-blind trial of prostaglandin F2alpha and oxytocin in the induction of labour.

In a random double-blind trial in 28 pregnant women at term, labour was induced with either prostaglandin F2alpha or oxytocin given by intravenous infusion. The results showed that prostaglandin F2alpha was as active as oxytocin and induction was successfully carried out in 24 patients; 3 patients had a caesarean section because of an obstructed labour and 1 patient on oxytocin did not have regular contractions after 10-hours' infusion although she delivered spontaneously 2 days later. No difference was found in the induction--delivery interval in the 8 patients in each group who had early amniotomy (first 90 minutes). No adverse effects were noted in either mother or the child. The authors recommend that to avoid side-effects the dosage of 20 mug prostaglandin F2alpha per minute should not be exceeded and that, although no cardiotocographic abnormalities were noted, this method of control should be used.

Endometrial suppression with a new 'frameless' levonorgestrel releasing intrauterine system in perimenopausal and postmenopausal women: a pilot study.

OBJECTIVE: A novel intrauterine drug delivery system, FibroPlant-levonorgestrel (LNG), derived from the frameless GyneFix intrauterine device (IUD) is described and the preliminary results in 30 symptomatic climacteric and postmenopausal women are discussed. The treatment with the FibroPlant-LNG intrauterine system (IUS) was instituted to suppress the endometrium during estrogen substitution therapy (EST) to prevent endometrial proliferation and bleeding. The purpose of the study was to evaluate the clinical and ultrasonographic effect of this new intrauterine progestin delivery system. METHODS: Two dosage forms were tested: the first 11 women received a 3-cm long coaxial fibrous delivery system, delivering approximately 10 microg per day of LNG; the remaining 19 women in the study received a 4-cm long delivery system, delivering approximately 14 microg per day. The calculated duration of release of the two systems is approximately 5 years. Twenty-two women were perimenopausal at the start of the treatment. Women in this study were observed for a duration of at least 1 year. Most postmenopausal women received percutaneous 17beta-estradiol (Oestrogel), 1.5 mg daily on a continuous basis. RESULTS: All postmenopausal women in the two groups reported amenorrhea during the entire study period (up to two and a half years follow-up). Endometrial atrophy in these women was confirmed by vaginal ultrasound examination. Seventeen of the 22 perimenopausal women reported amenorrhea at the first or second follow-up visit at 1 and 3 months following insertion of the IUS, respectively. The remaining had infrequent scanty bloody discharge needing a panty liner, at the most, for protection. There were no complications in this study (e.g. infection, expulsion or perforation). The FibroPlant-LNG IUS was very well tolerated by all the women and no systemic hormonal side effects were reported. There were no removals for medical reasons. CONCLUSION: The results of this pilot study suggest that the frameless FibroPlant-LNG IUS is safe, well tolerated and effective in suppressing the endometrium during EST. No differences could be clinically distinguished between the two dosages. Compliance was optimal. The fact that the IUS also acts as a potent contraceptive is of added importance.

Performance and acceptability of intrauterine release of levonorgestrel with a miniature delivery system for hormonal substitution therapy, contraception and treatment in peri and postmenopausal women.

OBJECTIVE: To evaluate the performance and acceptability of a novel intrauterine drug delivery system, FibroPlant-levonorgestrel (LNG), delivering approximately 14 microg per day. SUBJECT AND DESIGNS: A 1-year prospective clinical trial in 141 peri and postmenopausal women, including women with heavy or postmenopausal bleeding and women needing contraception. The majority received percutaneous 17beta-estradiol (Oestrogel), 1.5 mg daily. Clinical results and ultrasonographic effects were evaluated. RESULTS: Eighty-three insertions were done in perimenopausal women and 58 in postmenopausal women followed-up for 8-38 months. Fifty-two perimenopausal (64%) and virtually 100% of the postmenopausal women developed amenorrhoea, with occasional slight spotting. Eleven women with heavy bleeding, five of them with single or multiple intramural and subserosal fibroids of 3-6 cm or more, were all successfully treated, except one. There were no pregnancies. CONCLUSION: This study of 1432 women-months of use suggests that the frameless FibroPlant-LNG IUS is safe, well tolerated and effective in suppressing the endometrium during EST. The fact that the IUS also acts as a contraceptive, and significantly reduces menstrual bleeding, as demonstrated in earlier studies, is of added importance.

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.

Endometrial safety with a low-dose intrauterine levonorgestrel-releasing system after 3 years of estrogen substitution therapy.

OBJECTIVE: To evaluate the pharmacodynamic effects of a novel intrauterine drug delivery system, FibroPlant-levonorgestrel (LNG), on the endometrium in 24 postmenopausal women using estrogen substitution therapy (EST) to suppress climacteric symptoms. DESIGN: A 3-year non-comparative prospective clinical trial. SUBJECTS: The treatment with the FibroPlant-LNG intrauterine system (IUS), releasing 14 microg of LNG per day, was part of a regimen for estrogen substitution therapy in symptomatic postmenopausal women to prevent endometrial proliferation and bleeding. The majority of women received percutaneous 17 beta estradiol, 1.5 mg daily, or an equivalent dose by patch or orally, on a continuous basis. OUTCOME MEASURES: Menstrual pattern, endometrial histology and ultrasonographic evidence of endometrial suppression, after 3 years of use. RESULTS: The endometrial histology specimen showed profound endometrial suppression with glandular atrophy and stroma decidualization in all women. On transvaginal ultrasound, this corresponds with a thin endometrium (<5 mm) and clinically with a "bleed-free" menstrual pattern or amenorrhoea. CONCLUSION: The results of this 3-year study in 24 postmenopausal women using EST suggest that the FibroPlant-LNG IUS is effective in causing strong suppression of the endometrium during the entire period of EST. Target delivery in the uterine cavity could be the preferred route of administering a progestin to oppose estrogen stimulation of the endometrium.

Assessment of menstrual blood loss in Belgian users of the frameless copper-releasing IUD with copper surface area of 200 mm2 and users of a copper-levonorgestrel-releasing intrauterine system.

OBJECTIVE: This study was conducted to evaluate the effect of a miniaturized frameless copper IUD (GyneFix 200 small) and a copper-levonorgestrel (GynePlant) intrauterine system (IUS) on the amount of menstrual blood loss (MBL). METHODS: In 60 Belgian women using GyneFix 200 and 21 using GynePlant, MBL was assessed with the visual assessment technique. RESULTS: MBL scores in GyneFix 200 users did not change from baseline during the mean observation period of 31 months. In GynePlant users, mean MBL scores decreased by at least 50% in all but one user. CONCLUSION: The impact of copper IUDs on MBL can be minimized by reducing the surface area of the foreign body. Reduction of MBL, without causing amenorrhea, can be obtained by adding levonorgestrel.

Assessment of menstrual blood loss in women with ideopathic menorrhagia using the frameless levonorgestrel-releasing intrauterine system.

OBJECTIVE: This study was conducted to evaluate the effect of a "low-dose" levonorgestrel (LNG)-releasing intrauterine system (IUS) on the amount of menstrual blood loss (MBL) in women with ideopathic menorrhagia. METHODS: Menstrual blood loss was assessed with the visual assessment technique in 12 Belgian FibroPlant-LNG users with menorrhagia. In addition, ferritin levels were measured. RESULTS: The median MBL, evaluated by the visual scoring technique, decreased by more than 90%. The ferritin levels increased significantly during treatment with the levonorgestrel system. CONCLUSION: This study confirms previous MBL studies conducted with the FibroPlant-LNG IUS demonstrating the efficacy of the LNG-IUS to significantly reduce the amount of MBL in women with menorrhagia. The strong endometrial suppression is the principal mechanism explaining the effect on MBL. The therapeutic effect of this contraceptive method is highly desirable, particularly in women with heavy bleeding or anemia, as other treatment modalities are less effective, more costly, more invasive or inaccessible. The simple design characteristics and anchoring system account for minimizing the occurrence of complaints of pain and expulsion.

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.

PIP: Obstetrician/gynecologists in Brussels and Gent, Belgium, inserted the FlexiGard 330 copper releasing IUD in 514 women and followed 405 of them to determine the ability of ultrasound to evaluate the anchoring concept of this frameless and flexible IUD. The ultrasonic equipment consisted of a Pie Data Medical 400 scanner with a 3.5 MHz focused linear array transducer. They inserted the IUD's small anchoring knot into the fundus at a depth of 1 cm. They measured the distance between the serosal surface of the uterus and the upper border of the first copper sleeve (S-S distance). The expulsion rate was just .78%. Improper insertion techniques, unintentional yanking of the tail, or genital touching during sexual foreplay accounted for the 4 expulsions. Ultrasound located the IUD in all the patients who still retained the IUD. The mean S-S distance at insertion was 12.6 mm (10 mm in normal uteri and 32 mm in uteri with muscular tissue tumor) compared to 12.7 mm at last follow-up (10 mm in normal uteri and 28 mm in uteri with muscular tissue tumors). The .1 mm difference was not statistically significant. Therefore the IUDs did not migrate (some cases had the IUD for 5 years). The IUDs did not penetrate the uteri. This study showed that ultrasound is effective in determining whether the FlexiGard 330 IUD was properly inserted and whether it remains in the proper position later. The physicians suggested that vaginal ultrasound examination or use of a sector transducer rather than a linear ultrasound transducer are preferable in cases of retroverted uteri.

Contraception and treatment in the perimenopause with a novel "frameless" intrauterine levonorgestrel-releasing drug delivery system: an extended pilot study.

The objective of the study was to evaluate the contraceptive performance, acceptability, side effects, and adverse events of a novel "frameless" intrauterine drug delivery system (IUS), FibroPlant-levonorgestrel (LNG) releasing 14 microg of LNG/day, in perimenopausal women. An ancillary objective was to evaluate the effect of the new IUS on menstrual blood loss in women with or without fibroids. The study, consisting of 109 women, suggests that FibroPlant-LNG IUS is an effective contraceptive. No pregnancies occurred with the FibroPlant-LNG IUS. The total use-related discontinuation rate at 1 year is low (1.9) and results in a high rate of continuation of use (98.1). In addition, the FibroPlant-LNG IUS demonstrated a high level of effectiveness in reducing bleeding in women with excessive menstrual flow even when medium or large fibroids were present. However, an effect on the size of the fibroids could not be demonstrated. Patient satisfaction with the method is high, which is a prerequisite for continuance of the method, and may be linked with the advantageous design characteristics of the FibroPlant-LNG IUS, the virtual absence of hormonal side effects, and the low incidence of irregular bleeding and spotting even during the first 3 months after insertion of the FibroPlant IUS. Counseling remains important though to explain to women about the possible occurrence of changes in their menstrual pattern that may sometimes be annoying but harmless. It is concluded that many women over age 40 years could substantially benefit from the advantages of this intrauterine drug delivery technology which provides contraception and treatment of a possible associated condition such as menorrhagia. The treatment also creates the opportunity to pass through the transitional perimenopausal period smoothly and to benefit fully from the advantages hormone replacement therapy offers in terms of treatment of short-term symptoms and long-term prevention by gradually replacing the waning estrogens.

Performance of the frameless GyneFix and the TCu380A IUDs in a 3-year multicenter, randomized, comparative trial in parous women.

This study was conducted to evaluate a new and improved inserter (GyneFix) for the anchoring of the Frameless IUD in the uterine cavity. Previous studies conducted with a prototype inserter (Flexigard) did not show fully the advantages of the new anchoring concept because of the shortcomings of the Flexigard inserter and the complexity of the insertion technique. The GyneFix IUD was compared with the TCu380A IUD in six centers in China in approximately 300 women in each group. Only parous women were included in the study. The data from this 3-year, ongoing study demonstrate that the shortcomings of the inserter have been corrected, resulting in better performance and a much reduced rate of failed insertion/expulsion of the frameless and anchored device. The cumulative expulsion rate with the GyneFix IUD was 3.0 at 3 years (annual rates 2.67, 0.33, and 0.0, respectively) compared with a cumulative expulsion rate of 7.38 at 3 years with TCu380A (annual rates 4.63, 1.76, and 1.04, respectively). This difference is statistically significant. The majority of the expulsions with the anchored IUD occurred early in the study, indicating improper anchoring technique. The study also shows that both devices are highly efficacious. No pregnancies occurred with the GyneFix IUD (cumulative pregnancy rate 0.0 at 3 years) versus one pregnancy with TCu380A (cumulative pregnancy rate 0.34 at 3 years). The total use-related discontinuation rate at 3 years was significantly lower with the GyneFix IUD (8.34) than with the TCu380A IUD (14.13) and results in a higher rate of continuation with the GyneFix IUD compared to the TCu380A IUD (90.73 vs 85.25). Neither perforations nor pelvic inflammatory disease cases were encountered with either device in this study, demonstrating the safety of the anchoring system.

Assessment of menstrual blood loss in Brazilian users of the frameless copper-releasing IUD with copper surface area of 330 mm2 and the frameless levonorgestrel-releasing intrauterine system.

OBJECTIVE: This study was conducted to evaluate the effect of two types of IUDs on the amount of menstrual blood loss (MBL): the frameless copper-releasing intrauterine device (IUD) with copper surface area of 330 mm2 (GyneFix; Contrel Research, Ghent, Belgium) and the frameless levonorgestrel (LNG)-releasing intrauterine system (IUS) releasing 14 microg per day (FibroPlant-LNG; Contrel Research). Heavy and abnormal MBL is the main reason for discontinuation of intrauterine devices. METHODS: In 20 Brazilian women using GyneFix 330 and 32 using FibroPlant-LNG, respectively, MBL was measured by the quantitative alkaline hematin technique. In addition, ferritin levels were measured in GyneFix 330 and FibroPlant-LNG users. RESULTS: MBL with GyneFix 330, measured over a 24-month period, increased but was less when compared with TCu380A. Ferritin levels with GyneFix 330 were not affected in contrast with TCu380A. In FibroPlant-LNG users, mean MBL decreased by about 90% and ferritin levels increased significantly. CONCLUSIONS: The authors confirm earlier reports that, especially for women with low body iron stores and heavy menstrual bleeding, there is an order of preference for IUD use to minimize MBL. The choice should first be a progestin-releasing IUS, then a copper IUD, which has the least effect on menstrual bleeding, such as the frameless GyneFix IUD.

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.