Biomedical subjects
Publications and source records attributed to W A Van Os.
Because of the continuing controversy on the breast cancer risks associated with the use of combined oral contraceptives (OCs), the medical literature was reviewed to assess the risks of this cancer to OC users. This review found that the medical literature supports the view that OC use is associated with small increased risks of premenopausal breast cancer. There is no consensus as to which subgroups of women might be at an increased risk.
The concept of 'cause' between exposure to agent X and the subsequent development of disease Y is reviewed briefly in terms of how it is used in experimental and clinical medicine, statistics and epidemiology, and in law. Some of the interrelationships of the definition of cause by these disciplines are considered.
Some of the risks which have been associated with the use of intrauterine contraception are reviewed. For users of copper-releasing IUDs, such as the Multiload Cu375 and TCu380, uterine perforations are rare, there is no evidence of an increased risk of infertility, and there probably is no increased risk of ectopic pregnancy after IUD removal. Any increased risk of pelvic inflammatory disease may be limited to the initial months of IUD use. The safety of intrauterine contraception needs to be re-evaluated for the newer IUDs, since most of the information relating to IUD safety is based on studies of devices which are no longer used or which are not in widespread use.
The English language literature on IUDs was reviewed to evaluate the uterine perforation rate associated with use of the Multiload. No reports of cervical perforation were found, and the uterine perforation rate was 0.12/1000 insertions compared to a rate of 0.68/1000 insertions for other copper-bearing IUDs. This lower rate may reflect an under-reporting of uterine perforations in the medical literature, or may represent a truly lower perforation rate due to factors related to the Multiload design and/or its insertion technique.
The Multiload IUD with an exposed copper surface area of 250 mm2 (MLCu250) was developed in 1972 and has become one of the most widely used IUDs. Modifications to the MLCu250 include an increase in the area of exposed copper wire to 375 mm2 (the MLCu375) and an increase in the diameter of copper wire from 0.3 to 0.4 mm. The Multiload has been evaluated extensively in noncomparative and comparative clinical trials. In these latter studies the MLCu250 performed better than the Cu-7 and TCu-200, and the MLCu375 performed better than the Fincoid or Nova T and about equally as well as the TCu380. Pooled data from over 26,000 insertions of the MLCu250 gave the following 3-year cumulative event rates (per 100 women): pregnancy, 2.0; expulsion, 3.1; removal for pain/bleeding, 7.1. Comparative studies of the Multiload and other IUDs have shown all IUDs in current use are associated with similar rates of pelvic inflammatory disease. IUDs such as the MLCu375 that have larger copper surface areas appear to be associated with lower ectopic pregnancy rates. Follow-up studies of women who have had their Multiloads removed indicate that use of the device does not impair future fertility or affect pregnancy outcome. All IUD users, regardless of the type of IUD used, are at risk of complications. On balance, the benefits of IUD usage far exceed the associated risks.
In this review paper some guidelines for IUD use are presented that if followed should reduce the incidence of IUD-related complications. Recent IUD developments are discussed including the levonorgestrel-releasing T, a new variation of the Multiload, and IUDs designed for postpartum insertion. Since significant improvements in IUD safety will most likely result from a better understanding of IUD-related side-effects and adverse reactions, the paper includes recommendations for future IUD research that could enhance the safety, effectiveness and acceptability of available IUDs.
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A study of conducted in the Outpatients' Gynaecological Department of St Elisabeth's of Groote Gasthuis, Haarlem, The Netherlands, to compare the performance of 14 IUCDs, namely the Multiload (ML) Cu 250-standard, the ML Cu 250-short (which has a shortened vertical stem), the ML Cu 250-mini and the ML Cu 375 (which has an increased copper area of 375 mm2). Sound length was the sole method governing insertion: greater than or equal to 7 cm with the ML Cu 250-standard and ML Cu 375, 5-7 cm with the ML Cu 250-short and less than 5 cm with the ML Cu 250-mini. All the ML Cu 250-minis and 10% of the ML Cu 250-shorts were inserted in nulliparous women. Data were recorded and evaluated over a period of 36 months according to the table method Tietze. Performance of the ML Cu 250-standard and the ML Cu 250-short were nearly similar after 3 years of use with a continuation rate of 70,6 and 70,3 and a cumulative pregnancy rate of 1,3 and 1,7 respectively. Results with the ML Cu 250-mini were less successful. The continuation rate after 3 years of use was 60,1 with a cumulative pregnancy rate of 3,1. The expulsion and removal rates because of medical reasons were twice those with the standard model. At 12 months the ML Cu 375 proved to be superior in the prevention of pregnancy compared with the ML Cu 250-standard.
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Contraceptive development, including the development of IUDs, is discussed in light of the changing regulatory role of the FDA. The paper considers how the FDA and the government affect contraceptive development. Events that led to the demise of IUD use in the United States probably will have long-lasting effects on all future contraceptive development by the pharmaceutical industry in the United States.