A decade of experience with the TCu220C

Thiéry, Michel; Pas, H. Van Der; Kets, H. Van

doi:10.1007/bf01849306

Cited by 12 publications

(4 citation statements)

References 7 publications

(9 reference statements)

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“…Depending on the available Cu surface area, currently manufactured TCuIUDs, are indicated for short-term usage of 3 years (200, 220, 250 mm 2 ) or for long-term of 5, 8 or 10 years (300, 375, & 380 mm 2 ) (Kulier et al 2007). However, in practice, effective contraception was reported for TCu220C and TCu380A for at least 10 and 20 years respectively (Sivin 2007;Thiery et al 1985).…”

Section: Introductionmentioning

confidence: 97%

“…CuIUDs gained popularity because, they are non-hormonal, highly effective, inexpensive, long-lasting (use of single device reported for 20 years), rapidly reversible and safe contraceptives (Hov et al 2007;Hubacher et al 2001;Sivin 2007;Thiery et al 1985). Currently, there are over 150 million IUD users (about 15 % of the world's women of reproductive age) around the world (Hubacher et al 2006, WHO 2002.…”

Section: Introductionmentioning

confidence: 98%

See 1 more Smart Citation

Concentration-dependent cytotoxicity of copper ions on mouse fibroblasts in vitro: effects of copper ion release from TCu380A vs TCu220C intra-uterine devices

Cao

Zheng

et al. 2012

Biomed Microdevices

114

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Sustained release of copper (Cu) ions from Cu-containing intrauterine devices (CuIUD) is quite efficient for contraception. However, the tissue surrounding the CuIUD is exposed to toxic Cu ion levels. The objective for this study was to quantify the concentration dependent cytotoxic effects of Cu ions and correlate the toxicity due to Cu ion burst release for two popular T-shaped IUDs - TCu380A and TCu220C on L929 mouse fibroblasts. Fibroblasts were cultured in 98 well tissue culture plates and 3-(4,5-dimethylthiazol- 2-yl)-2,5-diphehyltetrazolium bromide (MTT) assay was used to determine their viability and proliferation as a function of time. For cell seeding numbers ranging from 10,000 to 100,000, a maximum culture time of 48 h was identified for fibroblasts without significant reduction in cell proliferation due to contact inhibition. Thus, for Cu cytotoxicity assays, a cell seeding density of 50,000 and a maximum culture time of 48 h in 96 well plates were used. 24 h after cell seeding, culture media were replaced with Cu ion containing media solutions of different concentrations, including 24 and 72 h extracts from TCuIUDs and incubated for a further 24 h. Cell viability decreased with increasing Cu ion concentration, with 30 % and 100 % reduction for 40 μg/ml and 100 μg/ml respectively at 24 h. The cytotoxic effects were further evaluated using light microscopy, apoptosis and cell cycle analysis assays. Fibroblasts became rounded and eventually detached from TCP surface due to Cu ion toxicity. A linear increase in apoptotic cell population with increasing Cu ion concentration was observed in the tested range of 0 to 50 μg/ml. Cell cycle analysis indicated the arrest of cell division for the tested 25 to 50 μg/ml Cu ion treatments. Among the TCuIUDs, TCu220C having 265 mm(2) Cu surface area released 9.08 ± 0.16 and 26.02 ± 0.25 μg/ml, while TCu380A having 400 mm(2) released 96.7 ± 0.11 and 159.3 ± 0.15 μg/ml respectively following 24 and 72 h extractions. The effects of TCuIUD extracts on viability, morphology, apoptosis and cell cycle assay on L929 mouse fibroblasts cells, were appropriate for their respective Cu ion concentrations. Thus, a concentration of about 46 μg/ml (~29 μM) was identified as the LD50 dose for L929 mouse fibroblasts when exposed for 24 h based on our MTT cell viability assay. The burst release of lethal concentration of Cu ions from TCu380A, especially at the implant site, is a cause of concern, and it is advisable to use TCuIUD designs that release Cu ions within cytotoxic limits yet therapeutic, similar to TCu220C.

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Section: Introductionmentioning

confidence: 97%

Section: Introductionmentioning

confidence: 98%

Concentration-dependent cytotoxicity of copper ions on mouse fibroblasts in vitro: effects of copper ion release from TCu380A vs TCu220C intra-uterine devices

Cao

Zheng

et al. 2012

Biomed Microdevices

114

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“…Over the years, however, it has been demonstrated that the GyneFix is a very effective contraceptive. Furthermore, this study also shows that even highly fertile young parous and nulligravid/nulliparous women using the GyneFix are no more susceptible to pregnancy than other age groups, in contrast with the pregnancy rates observed in young women using conventional IUDs [8,15,17,23,[27][28]. Comparative clinical trials have shown that the occurrence of pregnancy is rare with the device in situ, and that rates are lower than those of the TCu380 and Multiload 375 IUDs [10,28,29].…”

Section: Discussionmentioning

confidence: 78%

The frameless GyneFix® intrauterine implant: A major improvement in efficacy, expulsion and tolerance

Kets¹,

Vrijens²,

Trappen³

et al. 1995

Adv Contracept

Self Cite

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

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“…Some years ago, Thiery et al [3] published their ten-year experience with the TCu220C, and an eight-year evaluation of the MLCu250 IUD was reported in this journal [4]. Later, the recommendation changed.…”

Section: Introductionmentioning

confidence: 99%

MLCu250 IUD: A decade of experience

Batar

1988

Adv Contracept

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The paper summarizes the author's ten-year experience with 1446 interval insertions of the MLCu250 Standard type device. The 120th month was completed by 106 patients and the cumulative woman-months of use were 78,078. For evaluating the overall performance, gross cumulative and yearly specific life table termination and continuation rates were calculated as suggested by Tietze. The cumulative pertinent rates at the end of the ten-year follow-up period were as follows: pregnancy, 9.9; expulsion, 8.8; bleeding/pain removal, 33.4; and removal for other medical reasons, 24.5. The gross annual rates for the same conditions at the end of the first year of use were: 2.4, 4.4, 5.1 and 1.2, while at the 120th month they were: 0.8, 0.0, 6.1 and 5.5, respectively. The continuation rate was 83.7 at the 12th month, and 26.7 at the end of the 10th year. Based on this evaluation, the MLCu250 Standard IUD has a good overall performance and a longer life span than was previously expected.

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A decade of experience with the TCu220C

Cited by 12 publications

References 7 publications

Concentration-dependent cytotoxicity of copper ions on mouse fibroblasts in vitro: effects of copper ion release from TCu380A vs TCu220C intra-uterine devices

Concentration-dependent cytotoxicity of copper ions on mouse fibroblasts in vitro: effects of copper ion release from TCu380A vs TCu220C intra-uterine devices

The frameless GyneFix® intrauterine implant: A major improvement in efficacy, expulsion and tolerance

MLCu250 IUD: A decade of experience

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