Uterine devices and pelvic inflammatory disease.
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Biomedical subjects
Publications and source records attributed to E Kessel.
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Much evidence suggests that demand for sterilization is a function of supply of surgical sterilization services in less-developed countries. If such services were greatly expanded, the number of procedures performed would grow dramatically. While the prevalence of sterilization is estimated to increase from 23.5% to 28.8% of married women of reproductive age in the 1990s, there will actually be 106,432,000 more couples of reproductive age at the end of this decade than at its beginning who use either no method or a far less effective method with much lower continuation rates than sterilization--nearly a 20% increase. To achieve a mean sterilization prevalence of 47% of married women of reproductive age in the less-developed world, as now seen in the Republic of Korea and Puerto Rico, the number of sterilizations would need to be more than double the current projection for the 1990s: 328,429,000 rather than 159,000,000. The quinacrine pellet method for nonsurgical female sterilization offers hope that this enormous shortfall in sterilization services can be overcome in this decade.
OBJECTIVE: To compare the findings of the case-control and cohort studies used to indict the Dalkon Shield (A.H. Robins Company, Inc., Richmond, VA) with the findings of the Dalkon Shield clinical trials. DATA IDENTIFICATION: All published reports on the Dalkon Shield were identified through MEDLARS system (United States National Library of Medicine) searches and by cross checking all references in these reports. The same approach was used to identify all case-control and cohort studies of the purported relationship between intrauterine devices (IUDs) and pelvic inflammatory disease (PID). STUDY SELECTION: Only studies of interval patients that included 50 or more women and 6 or more months of follow up that computed standard IUD event rates (rates of pregnancy and expulsion and removal for pain and bleeding) were selected for this study. All case-control and cohort studies identified were included except two case-control studies that included women with sterile chronic salpingitis. RESULTS: The 16 case-control and 2 cohort studies found or suggested that the Dalkon Shield increased the risk of PID. The 71 clinical trials of the Dalkon Shield show that when this device is inserted by an experienced clinician it is a safe and effective contraceptive method, comparable with other IUDs used at the time. There was no evidence of an increased risk of PID found in these clinical trials. CONCLUSIONS: This study offers convincing evidence that the indictment of the Dalkon Shield was a mistake. Additionally, this study shows that physician skill and experience is far more important to successful IUD insertion than previously recognized, a finding with considerable implications for IUD study designs and for marketing strategies.
To study the sequence of histopathologic changes taking place in the cornual portion of the fallopian tube subsequent to exposure to quinacrine, 252 mg were inserted transcervically in 12 women awaiting hysterectomy for non-malignant conditions of the uterus. All patients who underwent surgery within ten days of insertion were found to have necrosis of the epithelial lining and an acute inflammatory reaction. Later on, the changes observed included progressive absorption of the inflammatory cellular exudate, progressive fibrosis, with partial or almost complete occlusion of the lumen, and failure of regeneration of the epithelial lining. Our results support other studies indicating that quinacrine can effectively produce tubal fibrosis and occlusion.
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This reassessment of IUDs as a risk factor for PID contrasts study results from prospective and case-control studies. Except for a transient increased risk after IUD insertions, increased risk is seen mainly in case-control studies after 1973, the time of a major PID epidemic and adverse publicity related to the Dalkon Shield. Removal of oral contraceptive users from case-control studies generally reduces their reported odds ratios, frequently to borderline statistical significance for studies with high accuracy of PID diagnosis. The remaining elevated odds ratios likely relate to diagnostic bias as primary care clinicians are more likely to refer patients wearing an IUD to referral centers where case-control studies are conducted. Biased case-control studies provided evidence for expensive litigation, resulting in removal of IUDs from the American market. The Food and Drug Administration requirements for postmarketing surveillance are inadequate to provide prospective data to avoid this kind of loss.
The transcervical quinacrine pellet method developed by Zipper and co-workers is potentially a much needed safe, inexpensive, and effective non-surgical method of female sterilization. This method utilizes an intrauterine device inserter to deposit 250 mg of quinacrine hydrochloride as pellets in the uterine cavity. No complications or side effects, other than temporary pain and oligomenorrhea, have been reported. Tetracycline has an established track record for safety. It also has been reported to have properties similar to quinacrine as a sclerosing agent, with potential as a non-surgical method using the quinacrine insertion technique. To expand the experience with quinacrine and to study tetracycline as an alternative, studies were undertaken under the auspices of the Indian Rural Medical Association in Calcutta, India. During the period 14 August, 1979 to 28 June, 1984, 414 women received three insertions of 200 mg of quinacrine. There were 29 failures and a three-year life table failure rate of 8.5. During the period 25 April, 1984 to 28 December 1984, 55 women received three insertions of 200 mg of tetracycline. By 1 June, 1986 there were 32 failures among the 55 cases for a failure rate of 58%. A more recent study using a single dose of 1000 mg of tetracycline also produced unacceptably high failure rates.
A tandem duplication of 5q13 to 5q22, visualized using GTG- and RBA-banding, was found in a mentally defective girl with craniofacial dysmorphy.
Report on a translocation t(22;Y)(q12;p 13) with conservation of the NOR in normal members from 2 generations of a family. The proposita has in addition a small autosomal duplication, probably (1)(q44-ter) which could explain her mental deficiency.
Report on mosaicism of an additional deleted chromosome 8 in a 12-year-old girl. She exhibits several typical but minor features of the trisomy-8 syndrome. Her IQ is 77 (Hawik).
Description of a pericentric inversion of a chromosome 14 with breakpoints at p11 and q23 leading to duplication-deficiency as a result of crossing over.
Microcephaly and craniofacial dysmorphia, cleft palate, cardiac malformation, and hypospadias are observed in a child with 46,XY,del (1)(q42).
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The intrauterine membrane (IUM) is an intrauterine contraceptive device designed to be compliant with a range of uterine shapes and sizes and with transient dimensional changes resulting from uterine motility. This compliance was expected to contribute to low rates for removal due to bleeding and pain, but the use of the IUM resulted in heavy bleeding among its early users. Consequently, two modifications of the device were made to decrease bleeding. One group of IUMs was modified by using ethylene vinyl acetate to provide a high level of lateral compliance and another was modified by using a tissue-compatible Hydron coating in order to decrease the inflammatory response of the endometrium. One hundred of each of these modified IUMs were tested along with 100 of the standard IUMs in a double-blind study conducted at the Noi Klinika in Debrecen, Hungary. The findings of this study suggested that these two modifications did not improve the over-all performance of the IUM.
Report of a supernumerary extra chromosome der(11;22)(q23;q12) resulting from a balanced translocation in the mother. The propositus suffers from mental deficiency, deafness and extreme muscular weakness and exhibits cleft palate, a labial lymphangioma and an atrial septum defect. Since the features of partial trisomy 11q23 frequently associated with a translocation t(11q;22q) bear similarities with the cases of so called trisomy 22 one might conjecture that some of these observations are in fact products of translocations including partial 11q.
The world's rate of population growth is declining. Most industrialized societies have achieved or are moving rapidly toward stationary populations, but while birth rates are also declining in many developing countries, continued growth must be expected because of the large proportions of young people in these populations. New evidence of exceptions to the classical demographic transition theory indicate that declining fertility is compatible with high mortality or low socioeconomic development if acceptable means of fertility control are readily available. "Fertility silhouettes" showing differing age-specific fertility rates indicate that present family planning programs have had a demographic impact. A review of the economic and ecologic consequences of rapid population growth justifies the conclusion that considerable effort will be required to again bring the world's population into balance with these systems. The author outlines priorities for this effort, with emphasis on the need to devise acceptable means of fertility control that will not tax the frail health care infrastructures of developing countries.