Clinical experience with a novel anchored, frameless copper-releasing contraceptive device for intra-caesarean insertion.

OBJECTIVES: The primary objective of the study was to determine the expulsion rate of the newly developed frameless GyneFix Caesarean Section (Gyn-CS®) device, specifically developed to minimise expulsion when inserted immediately after delivery of the placenta during caesarean section. Secondary objectives included evaluation of side effects, patient's satisfaction with the method and continuation of use. METHODS: A prospective, non-randomised clinical trial was conducted at a single university hospital research centre in Istanbul, Turkey, with follow-up at 4-6 weeks and again at 3 months. The majority of participants (∼80%) were planned for elective caesarean delivery. RESULTS: The study analysed 100 Gyn-CS devices inserted immediately after delivery of the placenta in a group of multiparous women undergoing planned or emergency caesarean section. One expulsion occurred early in the study, which was subsequently attributed to improper anchoring of the device. No serious adverse events (e.g. pelvic inflammatory disease or perforation) were reported. At the last follow-up visit, at approximately 90 d, 89 Gyn-CS devices were still in place (one participant was lost to follow-up). CONCLUSION: The study confirms that intra-caesarean implantation of the newly designed frameless Gyn-CS to the uterine fundus is a simple procedure that has no timing restraints, high patient acceptance and minimal risk of expulsion and displacement, while affording all the contraceptive benefits of a conventional copper-releasing intrauterine device. In addition, by preventing a shortened interpregnancy interval, the Gyn-CS can promote proper healing of the laparotomy wound. As insertion is easy, safe and quick, the Gyn-CS could significantly increase the use of immediate postplacental delivery intrauterine contraception, thus serving to reduce the number of unintended follow-on pregnancies.

Cost-effectiveness of screening for active cases of tuberculosis in Flanders, Belgium.

OBJECTIVE: To assess the cost-effectiveness of the tuberculosis screening activities currently funded by the Flemish government in Flanders, Belgium. METHODS: After estimating the expenses for 2013-2014 of each of nine screening components - which include high-risk groups, contacts and people who are seeking tuberculosis consultation at a centre for respiratory health care - and the associated costs per active case of tuberculosis identified between 2007 and 2014, we compared the cost-effectiveness of each component. The applied perspective was that of the Flemish government. FINDINGS: The three most cost-effective activities appeared to be the follow-up of asylum seekers who were found to have abnormal X-rays in initial screening at the Immigration Office, systematic screening in prisons and contact investigation. The mean costs of these activities were 5564 (95% uncertainty interval, UI: 3791-8160), 11 603 (95% UI: 9010-14 909) and 13 941 (95% UI: 10 723-18 201) euros (€) per detected active case, respectively. The periodic or supplementary initial screening of asylum seekers and the screening of new immigrants from high-incidence countries - which had corresponding costs of €51 813 (95% UI: 34 855-76 847), €126 236 (95% UI: 41 984-347 822) and €418 359 (95% UI: 74 975-1 686 588) - appeared much less cost-effective. Between 2007 and 2014, no active tuberculosis cases were detected during screening in the juvenile detention centres. CONCLUSION: In Flanders, tuberculosis screening in juvenile detention centres and among new immigrants and the periodic or supplementary initial screening of asylum seekers appear to be relatively expensive ways of detecting people with active tuberculosis.

Results of a 5-year contraceptive trial in parous and nulliparous women with a new LNG-IUS.

OBJECTIVE: To report on the contraceptive performance and continuation of a new T-shaped LNG-IUS, releasing 20 µg of levonorgestrel/day, in both parous and nulliparous nulliparous women after 5 years of use. MATERIALS AND METHODS: An observational prospective contraceptive study conducted in parous and nulliparous women up to 48 years of age. RESULTS: The study was conducted in a sample size of 356 women of whom 67.1% were parous and 32.9% were nulliparous with mean age of 35.1 (range 15-48). The total cumulative observation period was 27 269 woman-months. Only one accidental pregnancy was observed and two expulsions were reported with no partial expulsions. There were 12.7% medical removals for abnormal bleeding, pain and other medical reasons, mostly not related to the use of the LNG-IUS, and 13.3% removals in women wishing to become pregnant. The discontinuation rate at 5 years amounts to 25.7% including women with pregnancy wish, who used the LNG-IUS for an average of 44 months. There were no serious adverse events (e.g. perforation, pelvic inflammatory disease). CONCLUSION: The LNG-IUS used in this study is highly effective and well tolerated resulting in a high continuation of use. The only two expulsions that occurred during the study is remarkable. The ease and safety of insertion together with optimal retention is considered an advance in intrauterine contraceptive device technology.

Why perimenopausal women should consider to use a levonorgestrel intrauterine system.

OBJECTIVE: The use of a levonorgestrel intrauterine system (LNG-IUS) is useful in preventing pregnancy and for the treatment of menstrual disturbances. A smooth or symptom-free transition to and through menopause is possible when LNG-IUS is combined with estrogen therapy. Unfortunately the majority of physicians are generally unaware of this usefulness combined hormonal therapy in the pre-, peri- and postmenopausal women. DESIGN AND METHOD: Based on long-term clinical experience with LNG-IUS in the form of Femilis®, 104 women where followed from the premenopause through the menopausal transition into the postmenopause. These perimenopausal women received supplemental 17 ß-estradiol by gel or patch, or orally as estradiol valerate. Patients received one or two separate Femilis insertions at 5 year intervals. Main outcome measures included acceptability and continued use of the combined regimen for the treatment of climacteric symptoms and for prevention of cardiovascular disease, osteoporosis and other adverse effects caused by estrogen deprivation. RESULTS: The average age at insertion was 48 years (range 28-58) and the total duration of use was 137 months (range 80-161). The Femilis LNG-IUS was well tolerated as the number of removals for LNG-IUS-related reasons was low. The LNG-IUS was well retained in the uterine cavity as no expulsions were observed. Seven women were lost to follow-up. Eighty-six women (82%) opted for replacement of an LNG-IUS at expiry after 5 years and continued with the estrogen therapy. CONCLUSION: Intrauterine progestogen delivery for endometrial suppression in combination with estrogen therapy in the symptomatic perimenopausal women is highly practical as it combines the benefits of prevention of endometrial proliferation and treatment of menorrhagia and hyperplasia, if present. In addition, the contraceptive effect of locally administered LNG is highly desirable as many perimenopausal women run considerable risk of unintended pregnancy. For these reasons, the author views this regimen as one of the most effective, safest and best accepted route resulting in high patient compliance. It is important to convey this message to general practitioners as well as women.

Current status of frameless anchored IUD for immediate intracesarean insertion.

Immediate postpartum intrauterine device (IUD) insertion deserves great attention as it can provide immediate, timely and convenient contraception plus the added benefit of preventing repeat unintended pregnancies. Although women post vaginal delivery can benefit from immediate post-placenta contraception, women undergoing Cesarean section clearly need contraception, as an inter-delivery interval shorter than 18 months places them at a high risk for uterine rupture. The main drawback of currently available framed IUD devices for immediate postpartum insertion of an IUD is their high expulsion and displacement rates when inserted immediately postpartum after both vaginal and Cesarean delivery. Current research suggests that a brief window of opportunity exists of 10 minutes for insertion of conventional IUDs after which time expulsion rates both immediately and over time are greatly enhanced. This paper summarizes the current research conducted to overcome the expulsion problems associated with conventional T-shaped devices as well as through the use of an anchored frameless device. In the 1970s and 1980s, attempts were made to solve the expulsion problem by modifying existing devices, such as adding absorbable sutures (Delta-T) or additional appendages. These attempts proved to be clinically unsuccessful as the catgut suture added to the transverse arms did not provide sufficient resistance to prevent downward displacement and expulsion. An anchoring technique to suspend a copper IUD to the fundus of the uterus was developed in Belgium in the 1980s and has been the subject of extensive ongoing clinical research since 1985. Recently the frameless copper releasing anchor IUD, GyneFix, has been tested for postplacental insertion. Initially, the anchor was modified by the inclusion of a biodegradable cone which was added below the anchoring knot. Clinical studies confirmed the adequacy of this approach suggesting that it was technically possible to anchor an IUD immediately following Cesarean section as well as after vaginal delivery with minimal incidence of expulsion. However, it was found that removal of the IUD was difficult in a number of women who requested early removal, due to the slow disintegration time of the cone. Based on these prior experiences, a new approach for anchoring of a frameless IUD immediately after delivery of the placenta was invented and developed specifically for use immediately post-Cesarean delivery. Beyond providing convenient and timely contraception the intended use allows a woman adequate time to recover from both the surgery and the burden of childbirth, while ensuring adequate future contraception. It is anticipated that it will also have an added benefit of allowing a greater number of women to have follow-on vaginal deliveries. The anchoring procedure is conducted under direct vision. It can be performed immediately after placental removal without the burden of timing restraints. It consists of the precise placement of the anchor of the frameless IUD immediately below the serosa of the uterus, followed by fixing the anchoring knot in place with a very thin absorbable suture. Early stage studies have confirmed the suitability and ease of use of this approach with additional clinical trials currently being conducted. The anchoring technique is easy, quick, safe and effective with no expulsions at 12 months. The method is considered a major advance, suitable for general use due to its simplicity requiring limited training.

Evaluation of pigtail macaques as a model for the effects of copper intrauterine devices on HIV infection.

BACKGROUND: Long-acting, hormonal contraception may increase HIV risk. Copper intrauterine devices (IUDs) could serve as non-hormonal alternatives. We pilot a pigtail macaque model for evaluating HIV susceptibility factors during copper IUD use. METHODS: Frameless and flexible GyneFix(®) copper IUDs were surgically implanted into three SHIVSF 162p3 -positive macaques via hysterotomy and monitored for up to 4 months. Four macaques served as non-IUD controls. RESULTS: All animals retained the devices without complications. No consistent change in vaginal viral RNA or inflammatory cytokines was seen. Two animals had altered menstrual cycles and experienced marked thinning of vaginal epithelium after IUD insertion. Histological examination of uterine tissue at necropsy revealed endometrial ulceration and lymphocytic inflammation with glandular loss at sites of direct IUD contact. CONCLUSIONS: Although the need for insertion surgery could limit its usefulness, this model will allow studies on copper IUDs and SHIV shedding, disease progression, and HIV susceptibility factors.

Potential health benefits of continuous LNG-IUS combined with parenteral ERT for seamless menopausal transition and beyond--a commentary based on clinical experience.

OBJECTIVE: To comment on the acceptability and potential health benefits of the continuous use of the levonorgestrel-releasing intrauterine system (LNG-IUS), combined with estrogen substitution, for seamless transition through the menopause, in women with climacteric symptoms. DESIGN AND METHOD: Evaluation of the recent hormone replacement therapy literature and the acceptability of the combined parenteral estrogen and intrauterine LNG-IUS regimen in a group of approximately 100 women, above 48 years of age, using LNG-IUS for contraception, who developed climacteric symptoms requiring estrogen substitution. MAIN OUTCOME MEASURES: acceptability and continued use of the method for the treatment of climacteric symptoms and for prevention. RESULTS: The combination of intrauterine progestogen delivery to suppress the endometrium, in combination with systemic estrogen, is highly acceptable resulting in a high continuation of use due to the absence of side effects and erratic bleeding in the large majority of women. CONCLUSION: The study suggests that parenteral estrogen replacement therapy combined with intrauterine progestogen delivery for endometrial suppression in the perimenopause is highly practical and beneficial, providing enhanced quality of life. There are strong arguments to categorize the regimen as probably the most effective, safest and best accepted route resulting in high patient compliance as well as potentially providing maximal benefits for peri- and postmenopausal women.

Assessment of a Novel Fixation Method of a Frameless Intrauterine Contraceptive Device Inserted during Cesarean Delivery as a Means of Preventing Displacements and Expulsions: A Prospective Observational Study.

The primary objective of this study was to assess the novel fixation method of a frameless copper-releasing intrauterine device inserted following placental delivery during cesarean section and analyze its impact in reducing device displacement and expulsion during and after uterine involution. We hypothesized that the dual-anchoring technique could reduce the risk of intrauterine device displacement and expulsion during and after the uterine involution. The study was conducted at the Gazi University Medicine Faculty Hospital in Ankara, Turkey. Twenty-one pregnant women were enrolled. Insertion was performed following placental removal. To confirm the proper placement and good retention of the device, the distance between the fundal serosa (S) and device anchor knot (A) was measured (S-A) during follow-ups, by ultrasound. There were significant differences in the S-A, as observed by ultrasound at discharge and at 6 weeks post-delivery, which is consistent with the tissue contractions associated with uterine involution. Notwithstanding the uterine involution, no device displacements or expulsions occurred, which indicated a good retention of the frameless device. This innovative retention method of the frameless intrauterine device ensures a well-tolerated, long-term contraception, allowing for immediate contraception and proper pregnancy spacing for cesarean scar healing, and overcomes the issue of expulsion encountered with conventional intrauterine systems.

COVID-19 contact tracing in Belgium: main indicators and performance, January - September 2021.

BACKGROUND: Contact tracing is one of the main public health tools in the control of coronavirus disease 2019 (COVID-19). A centralized contact tracing system was developed in Belgium in 2020. We aim to evaluate the performance and describe the results, between January 01, 2021, and September 30, 2021. The characteristics of COVID-19 cases and the impact of COVID-19 vaccination on testing and tracing are also described. METHODS: We combined laboratory diagnostic test data (molecular and antigen test), vaccination data, and contact tracing data. A descriptive analysis was done to evaluate the performance of contact tracing and describe insights into the epidemiology of COVID-19 by contact tracing. RESULTS: Between January and September 2021, 555.181 COVID-19 cases were reported to the central contact center and 91% were contacted. The average delay between symptom onset and contact tracing initiation was around 5 days, of which 4 days corresponded to pre-testing delay. High-Risk Contacts (HRC) were reported by 49% of the contacted index cases. The mean number of reported HRC was 2.7. In total, 666.869 HRC were reported of which 91% were successfully contacted and 89% of these were tested at least once following the interview. The estimated average secondary attack rate (SAR) among the contacts of the COVID-19 cases who reported at least one contact, was 27% and was significantly higher among household HRC. The proportion of COVID-19 cases who were previously identified as HRC within the central system was 24%. CONCLUSIONS: The contact-tracing system contacted more than 90% of the reported COVID-19 cases and their HRC. This proportion remained stable between January 1 2021 and September 30 2021 despite an increase in cases in March-April 2021. We report high SAR, indicating that through contact tracing a large number of infections were prospectively detected. The system can be further improved by (1) reducing the delay between onset of illness and medical consultation (2) having more exhaustive reporting of HRC by the COVID-19 case.

Intrauterine contraceptives that do not fit well contribute to early discontinuation.

BACKGROUND: To shed additional light on various aspects of intrauterine contraception discussed recently in a comprehensive review article and on the continued development of frameless copper intrauterine devices (IUDs). CONTENT: An essential feature of intrauterine contraceptives is their long duration of action. However, this only applies in the absence of side effects. The importance of dimensional compatibility of the IUD or intrauterine system (IUS) with the uterine cavity should be stressed: IUD/IUS designs that fit will lead to high acceptability, a prerequisite with regard to continuation of use. Dimensional incompatibility, on the other hand, is a cause of cramping pain, erratic bleeding or menorrhagia, dislocation or expulsion and, as a result thereof, pregnancy. The size of the intrauterine foreign body, in relation to that of the uterine cavity, determines its acceptability and influences menstrual bleeding. Abnormal and heavy menstrual bleeding is an issue which has not been fully resolved. It is the most common cause of discontinuation of this contraceptive modality. The size of the IUD can be reduced without jeopardizing its effectiveness provided the effective copper surface is sufficiently large. CONCLUSION: Properly designed and fitting IUDs and IUSs are associated with fewer side effects and greater user satisfaction. This, in turn, could increase usage of intrauterine contraception and thus reduce further the number of unintented pregnancies and induced abortions.

Intrauterine drug delivery for contraception and gynaecological treatment: novel approaches.

This chapter describes the development of new intrauterine drug delivery products, which are designed to provide improved methods for the prevention and treatment of gynaecological conditions, improvements to birth control methods, and higher levels of safety, user acceptability, compliance, and quality of life for women. The development of frameless intrauterine systems is such an attempt to improve on the performance and acceptability of established intrauterine contraception, potentially solving major problems encountered with conventional IUDs (e.g., expulsion, abnormal or excessive bleeding, and pain). However, the performance of frameless devices depends on proper anchoring of the device, which requires specific technical skills not required for the insertion of conventional IUDs. Moreover, current research paves the way for new developments. The frameless copper and LNG-releasing IUDs/IUSs and framed LNG-IUS are the beginning of a series of innovative developments in this field. New compounds, such as progesterone antagonists and selective progesterone receptor modulators (SPRMs), could be incorporated into polymeric drug delivery platforms for use in the uterus, cervix, or vagina, or subdermally. It is likely that current and new hormone-releasing intrauterine systems could also be useful for bleed-free contraception in HIV-positive (HIV+ women). It is hoped that this work will contribute to the increase in worldwide use of intrauterine contraception and to non-surgical treatment of frequently occurring women's health problems.

Review of clinical experience with the frameless LNG-IUS for contraception and treatment of heavy menstrual bleeding.

OBJECTIVE: Review the clinical experience with the frameless FibroPlant levonorgestrel intrauterine system (FP-LNG-IUS). STUDY DESIGN: An open, prospective non-comparative contraceptive 5-year study; a 1-year MBL study in women with heavy menstrual bleeding (HMB), using a PBAC and a 2-year MBL study in women with HMB and with normal menstruation using the quantitative alkaline hematin method. A literature review on perforation rate with the frameless GyneFix and FibroPlant. RESULTS: 304 insertions were performed with the FP-LNG-IUS. The total observation period was 11,299 woman-months. Only one pregnancy occurred. There were two expulsions and two uterine perforations at insertion during the first year. In the first 1-year MBL study, the median MBL decreased by more than 90%. In the second 2-year MBL study, MBL reduced drastically and 80% had amenorrhoea after 24 months. The ferritin values increased significantly. On a total of approximately 17,000 insertions, the perforation rate was between 1.2 and 2.0/1000 insertions. CONCLUSION: The frameless FP-LNG-IUS is an effective and well-tolerated long-acting reversible contraceptive and is also highly effective for the treatment of HMB. The perforation rate is similar to traditional copper and levonorgestrel-releasing intrauterine devices and systems. Strict adherence to the manufacturer's insertion instructions is recommended.

Considerations on a new, frameless copper-releasing intrauterine system for intracesarean insertion and its future clinical significance: A review.

Family planning is a system for attaining the desired number of children and enabling a desired spacing between pregnancies. Family planning can be achieved through both the use of contraceptive methods and the treatment of infertility. A woman's ability to limit her pregnancy has a significant effect on her health.While family planning reduces the rate of unintented pregnancies, it also reduces the number of unsafe abortions. Contraception is an important component of family planning and reproductive health. Among various contraceptive methods, intrauterine devices (IUDs) are very popular because of some of the features of IUDs including being affordable, simplicity of insertion, long duration of action and reversibility. Modern, frameless, copper IUDs contain more copper and their copper content is contained in the solid tubular sleeves rather than in the wire which increases efficacy and lifespan. Immediate postpartum intrauterine device insertion (IPPI) during cesarean section can be considered in women who desire long acting, reversible contraception. Fertility returns instantly after removal of the device and pregnancy rate is not affected. IPPI is a very attractive method, especially for women who have undergone cesarean and require an interval of contraception before getting pregnant again. However, IPPI needs more clinical attention due to many aspects. The advantages remain including the prevention of unintended short interval pregnancies and, by providing an optimal timeframe for post-cesarean uterine recover, can reduce the incidence of the next cesarean delivery. With the publication of international IPPI studies, it will take a place in the range of globally available contraceptive methods, which in this author's opinion, it deserves.

The Femilis LNG-IUS: contraceptive performance-an interim analysis.

OBJECTIVE: To provide an update on the experience with the Femilis levonorgestrel-releasing intrauterine system (LNG-IUS) used for up to five years by parous and nulliparous women, particularly with regard to its contraceptive performance. STUDY DESIGN: An interim, open, prospective non-comparative study of the Femilis LNG-IUS releasing 20 microg of levonorgestrel/day. RESULTS: Two-hundred and eighty insertions were carried out in women with a mean age of 35.7 years (range 17-48), 60% of whom were parous and 40% nulliparous. Twenty-four women with uterine pathology (e.g., fibroids, menorrhagia) were included in the study. The cumulative gross discontinuation life table rates were determined. The total observation period was 8,028 woman-months. The LNG-IUS was easy to insert in 95.7% of the cases, and no perforations occurred. No pregnancies were observed and only one expulsion took place (rate 0.4/100 women at five years). The cumulative total use-related discontinuation rate was 14.7/100 at five years. There were nine removals because of pain, six of which were in nulliparous women. Four women requested removal of the IUS for bleeding problems. Fourteen removals were done for 'other' medical reasons among which mood disturbances (five cases) were the most frequent, and 12 for non-medical reasons. Fifteen removals were requested for pregnancy wish. Twelve of these women became pregnant within one year and all had uneventful pregnancies. The Femilis LNG-IUS was equally well accepted by nulliparous as by parous women. Most women with heavy menstrual bleeding prior to insertion, whether associated with fibroids or not, reported much less bleeding, scanty bleeding or even no bleeding at all after insertion. CONCLUSION: This study suggests that the Femilis LNG-IUS, which releases 20 microg LNG/d, is a highly effective, well tolerated and well retained contraceptive both in parous and nulliparous women. The shorter crossarm of the LNG-IUS has simplified its insertion technique, which may contribute to its safety. This could promote use by non specialist providers and enhance the application of the method.

New frameless and framed intrauterine devices and systems - an overview.

There is a need for new, improved birth control methods which are easier to use, with less side effects and which avoid daily action, such as the pill. Perfect use requires consistent daily use or use at every act of intercourse. Long-acting methods eliminate the need for specific action at the time of coitus, or for daily action. Developing a new contraceptive is a major challenge. It is generally estimated that it takes 10-15 years to develop a new method and bring it to the market, at a cost of 200-300 million US dollars, and the industry is reluctant to take the risk of such long-term investment. However, both risk and investment can be reduced by taking small steps. Slight improvements of existing contraceptives could result in a giant step forward. The development of frameless intrauterine systems (IUS) is an attempt to improve the performance and acceptability of intrauterine contraception. Both the frameless GyneFix IUD and the frameless FibroPlant levonorgestrel (LNG)-IUS possess features which may solve the main problems encountered with conventional IUDs (e.g., expulsion, abnormal or excessive bleeding and pain). The performance of frameless devices, however, is dependent on correct anchoring of the device, which requires technical skill. Becoming a proficient GyneFix(R) or FibroPlant provider is easily acquired if the provider follows the procedural instruction strictly. For the less technically skilled provider, the Femilis LNG-IUS, using the new, simplified insertion technique, could be an excellent contraceptive option. It is usually not necessary to provide pain relief for insertion of an IUD/IUS, particularly in parous women. IUD providers should, however, realize that no woman likes to suffer from the insertion of an IUD. Severe discomfort may create a negative attitude towards the method. If the woman is anxious and fears pain (as most nulliparous women do), probably the most convenient, safe and effective method is to use local (intracervical) anesthesia using a dental syringe which can be applied with minimal risk in the office. In some women, the use of misoprostol 400 microg, 3 h prior to fitting of the IUD/IUS, may be useful to dilate the cervical canal. The popularity of the IUD could be much improved if attention is given to this aspect of IUD insertion.

Intra-cesarean insertion and fixation of frameless intrauterine devices.

Various contraceptive methods are available to postpartum women including hormonal and nonhormonal barriers, as well as injectable forms. Of all the available birth control methods, intrauterine devices (IUD) are felt by many to be the near-ideal form of contraception, and are recommended by advocacy groups, physicians, and gynecological organizations worldwide. Immediate postpartum IUD insertion deserves greater attention because it can provide immediate contraception, prevents repeat unintended pregnancies, and may serve to reduce the incidence or need for secondary cesarean delivery; however, insertion of conventional T-shape IUDs immediately post placenta delivery is limited by their high expulsion and displacement rates. Anchoring of frameless-design IUDs that lack conventional cross-arms to the uterine fundal surfaces has been medically and commercially available throughout Europe for many years. The placement technique is simple, has minimal patient discomfort, and high long-term patient acceptance due to its high degree of uterine compatibility as a consequence of its small size and segmented design. Frameless-design IUD implantation appears to represent a major advance, suitable for general use, due to its lack of timing restraints and its simplicity of attachment, which only requires limited training.

Intrauterine levonorgestrel delivery with frameless fibrous delivery system: review of clinical experience.

The concept of using a frameless intrauterine device (IUD) instead of the conventional plastic framed IUD is not new. Frameless copper IUDs have been available since the late 1990s. They rely on an anchoring system to retain in the uterine cavity. The clinical experience with these IUDs suggests that frameless IUDs fit better as they are thin and, therefore, do not disturb or irritate the uterus. High tolerance and continuation rates have been achieved as complaints of pain are virtually nonexistent and the impact on menstrual blood loss is minimal. Conventional levonorgestrel-releasing intrauterine systems (LNG-IUSs) are very popular as they significantly reduce menstrual bleeding and provide highly effective contraception. However, continuation of use remains problematic, particularly in young users. Total or partial expulsion and displacement of the LNG-IUS also occur too often due to spatial incompatibility within a small uterine cavity, as strong uterine contractions originate, attempting to get rid of the bothersome IUD/IUS. If not expelled, embedment ensues, often leading to chronic pain and early removal of the IUD/IUS. Several studies conducted recently have requested attention to the relationship between the LNG-IUS and the endometrial cavity. Some authors have proposed to measure the cavity width prior to inserting an IUD, as many uterine cavities are much smaller than the currently existing LNG-IUSs. A frameless fibrous drug delivery system fits, in principle, in all uterine cavities and may therefore be preferable to framed drug delivery systems. This review examines the clinical performance, acceptability, and potential of the frameless LNG-IUS (FibroPlant®) when used for contraception, treatment of heavy menstrual bleeding, dysmenorrhea, and endometrial suppression in women using estrogen replacement therapy, endometrial hyperplasia, and other gynecological conditions. The review concludes that FibroPlant LNG-IUS offers unique advantages in reducing side effects.