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Government-funding program on reversal of tubal sterilization.

Three hundred and sixty-one women were provided government-funded sterilization reversal services with the technique of microsurgery. A large majority of reasons (89.8%) for requesting reversal surgery was a loss of children, and the mean interval between sterilization and reversal was 28.7 months. Two hundred and seven (69.7%) of 297 follow-up cases have experienced term delivery or intra-uterine pregnancy and 5 cases were ectopic pregnancy. The largest number of reversal clients (63.3%) were sterilized by the laparoscopic unipolar coagulation technique and the next largest group (24.2%) was sterilized by the laparoscopic banding technique. The highest pregnancy rate (77.8%) was shown in clients who had undergone laparoscopic banding technique while the lowest (65.9%) was the group of laparoscopic unipolar coagulation. A more than 60% of the clients became pregnant within 6 months of their reversal surgery, with the shortest interval being 1 month, the longest 39 months, and the mean 7.6 months. A large majority of the successful cases, 81.6%, were pregnant within 1 year of their reversal surgery.

Adult↗

Compulsory sterilization. (Letter to the editor).

Angela R. Holder's conclusion (221: 229, 1972) that a decline in forced sterilization cases exists because "any system of compulsory sterilization is too near naziism to be acceptable in a democratic society" ignores present realities. At no time in American history has there been greater acceptance of the idea that human procreation must be regulated by coercive means. Many leaders of the movement for population control, for example, openly advocate mandatory sterilization, abortion, and birth control as part of their crash program for population stabilization. Simultaneously, a growing number of those concerned with genetic "quality" demand that individual rights be subordinated or destroyed for the good of society and the species. Meanwhile, the increasing minimization of the enormous complexities of the abortion issue to a morally and medically neutral therapeutic procedure, threatens to make abortions, as well as sterilization, innocu ous public health measures that could be forced on society if circumstan ces dictate. Moreover, as the public is conditioned to believe that these measures lack ethical ramifications, the day is hastened when they can be imposed without significant opposition.

Coercion↗

The risk of death from combined abortion-sterilization procedures: can hysterotomy or hysterectomy be justified?

Clinicians have debated whether women who request permanent sterilization when they undergo elective abortion should have the two operations done concurrently. Moreover, if the procedures are performed concurrently, the appropriate surgical approach is unknown. To evaluate the latter issue, we identified all concurrent abortion-sterilization deaths in the United States in the period 1972 to 1978 from the Centers for Disease Control's nationwide surveillance of abortion mortality and divided them into two groups: those who had hysterotomy with tubal ligation or hysterectomy (H/H) and those who had curettage or instillation procedures, with tubal ligation by laparoscopy or laparotomy (other procedures). We then used data from the Joint Program for the Study of Abortion (JPSA/CDC) to estimate the number of procedures done in the United States in the period 1972 to 1978 and calculated death-to-case rates for each group. We found that the risk of dying from a concurrent abortion-sterilization procedure was 3.3 times higher if done by H/H. The relative risk for this group was highest during the first 12 weeks of gestation (4.6) and lowest at 13 weeks or later (1.3), regardless of the presence or absence of preexisting medical conditions. Except in the rare instances where the woman has an indication for hysterectomy other than fertility control, the performance of hysterectomy or hysterectomy for concurrent abortion-sterilization, particularly at less than 13 weeks' gestation, does not appear justified.

Abortion, Therapeutic↗

Experiences of legal sterilization in Scandinavia.

The three Scandinavian countries--Denmark, Norway and Sweden--all legalized voluntary sterilization in the 1970s. Previous legislation had been very restrictive, limiting access to certain defined minority groups. During the two decades with this new possibility, sterilization has been accepted as a good contraceptive alternative, equally accessible for men and women above age 25 years. The sterilization frequency varies considerably between the three countries, being most popular in Norway and Denmark. The proportion of sterilization in males versus females is 40% in Denmark, 25% in Norway and 20% in Sweden. Published follow-up studies point out risk groups for regret of the intervention, and underline the need for good preoperative counseling. The overall results are very positive.

Counseling↗

Luteal phase pregnancies in female sterilization patients.

Little is known of the incidence, predictors or outcomes of luteal phase pregnancies (LPPs) in women presenting for voluntary interval female sterilization. A series of 37 LPPs was identified from a large multicenter female sterilization data set. Each LPP case was matched with two nonpregnant (NP) controls for clinic, operator, surgical approach, tubal occlusion technique and date of surgery. The LPP cases did not have a distinct demographic or clinical profile, but were generally more fecund than NP controls. LPPs were further compared with a second unmatched group consisting of 123 true sterilization failures (TSFs), pregnancies conceived after sterilization. Women with LPPs were more likely to have their pregnancies confirmed and/or terminated in the second trimester than were women with TSFs. The majority of LPPs were carried to term; the majority of TSFs ended in induced abortion. There were 12 ruptured ectopic pregnancies among the TSFs and none among the LPPs. Programmatic implications of the results are discussed.

Abortion, Induced↗

Tubal sterilization: findings in a large prospective study.

Of the 17032 women taking part in a large prospective study of the beneficial and harmful effects of different contraceptive methods, 2243 (13%) had undergone tubal sterilization by the end of 1981 while another 3551 (21%) had husbands who had undergone vasectomy. The most commonly used female sterilization procedure was laparoscopic tubal diathermy. About 19% of all operations were carried out at the time of a delivery or during the subsequent 4 weeks. In total, 16 accidental pregnancies have occurred in the sterilized women, the failure rate during the 12 months after surgery being 0.37 per 100 woman-years and the rate during the subsequent months being 0.10 per 100 woman-years. Of the 16 accidental pregnancies, seven were ectopic. In an analysis comparing women who had undergone tubal sterilization with those whose husbands had undergone vasectomy, there was little evidence of any excess occurrence of gynaecological or psychiatric disorders in the former group.

Adult↗

Sterilization in Thailand.

Sterilization in Thailand began in the 40ies but the slow progress was due to lack of government support. In 1970 the government declared the population policy that resulted in the development of the tubal resection and vasectomy programs in the governmental hospitals and private sectors. The current total number of sterilizations reaches 200,000 cases annually with female to male ratio of 4:1. Contributions by the government and the private sectors are 80% and 20% respectively. The university hospitals have been involved in programme planning and various studies on sterilization acceptance and development of appropriate technology and delivery system. Sterilization service has been directed to the rural areas where 80% of the Thais live. All efforts are directed towards an objective to reduce the population growth to 1.2 by the end of 1990.

Family Planning Services↗

Reversal of female sterilization. Review of 252 microsurgical salpingo-salpingostomies.

Over a 10-year period from December 1972, the reversal of routine surgical sterilizations in 252 women resulted in a high rate of subsequent full-term pregnancies. The ages of these women ranged from 22 to 40 years (average, 32.5 years), and the parity ranged from 0 to 4 (average, 2.1 children). A meticulous microsurgical approach was employed for all tubal reconstructive operations. Pregnancy usually occurred within 12 months of the reconstruction (75%), but, occasionally, it occurred within the first two months (8%). In the group of 68 women, in whom the previous sterilization procedure had affected only the isthmial section of the fallopian tube, a remarkable full-term pregnancy rate of 93% was achieved. It is, therefore, recommended that all sterilization procedures in women should be performed in the mid-isthmic portion of the tube, because reversals of sterilizations in this area have the best chance of success.

Adult↗

Two-year follow-up of 3,466 sterilizations in India.

Because female sterilization is being used extensively as a method of limiting family size, its early complications as well as long-term sequelae should be carefully documented. This analysis of a two-year controlled prospective study of 3,466 sterilized women shows that the incidence of poststerilization gynecologic abnormalities was not significantly higher than what might be expected in the general population and declined markedly over time. Poststerilization surgery rates were also low. The incidence of weight gain among sterilized women was significantly higher than that of weight loss. Analysis of menstrual patterns showed no change in menstrual cycle parameters after sterilization for the majority of the cases. Both favorable and unfavorable changes in menstrual cycle parameters were reported. The two-year pregnancy rate was 0.4%. One ectopic pregnancy was reported.

Adult↗

Tubal sterilization in relation to breast cancer risk.

Tubal sterilization methods may damage surrounding tissue, potentially disrupting the ovarian blood supply and hormonal functioning, and may decrease breast cancer risk. We examined this hypothesis, within the Nurses' Health Study, among 77,511 women, aged 30-55 years and free of cancer at the start of follow-up in 1976. We documented 4,176 cases of invasive breast cancer from 1976 to 2000. Cox proportional hazards models, adjusting for multiple breast cancer risk factors, provided rate ratios (RR) and 95% confidence intervals (CI). Overall, tubal sterilization was not associated with breast cancer risk (RR=0.95, 95% CI=0.88-1.03). However, tubal sterilizations performed from 1970 to 1974 were inversely associated with risk (RR=0.84, 95% CI=0.73-0.97), while procedures performed in other years were not associated with risk. Among women with procedures performed in 1970-1974, those who were >or=35 years old at the time of sterilization were at the lowest risk (RR=0.81, 95% CI=0.66-0.98), while younger women had a suggested decreased risk (RR=0.87, 95% CI=0.72-1.06). Overall, tubal sterilization was not associated with breast cancer risk. However, a modest inverse association was observed at a time when the potentially destructive unipolar electrocautery method was commonly used, providing some support for an association between lower lifetime exposure to hormones and a decreased risk of breast cancer.

Adult↗

A comparison of laparoscopy and culdoscopy for internal sterilization.

In recent years, the increased demand for sterilization by women who have achieved their desired family size has emphasized the need to improve both existing methods of tubal occlusion and the means of access to the Fallopian tubes. Utilization of diagnostic instruments such as the laparoscope and culdoscope to perform sterilization minimizes the trauma associated with standard laparotomy and colpotomy and promises to reduce morbidity occurring as a result of sterilization. In order to evaluate and compare the improved techniques of laparoscopy and culdoscopy for elective interval sterilization, 722 women were studied between January and August of 1973 at the Siriraj Hospital in Bangkok. For 279 patients (Group I), sterilization was performed by culdoscopic tubal ligation using a modified Pomeroy technique; for 443 patients (Group II), the procedure used was laparoscopic tubal cauterization and cutting. All procedures were performed using local anesthesia on an outpatient basis. Complication rates and required surgical time were similar for both procedures and compared favorably with rates reported by other investigators. Because of a low incidence of complications and the elimination of the need for general anesthesia and hospitalization, both endoscopic procedures appear to be of particular value in developing countries where hospital facilities and physician time are in short supply.

Adult↗

Bacteriuria in intermittent catheterization users: the effect of sterile versus clean reused catheters.

Monthly urine cultures were analyzed at the University of Alberta Department of Medical Microbiology and Infectious Diseases to determine whether single-use sterile catheters and clean technique reduced the incidence of bacterial colonization in those using long-term intermittent self-catheterization. Thirty subjects with spina bifida, ages 3 years to 16 years, entered a crossover study with random assignment to 6 months of sterile single-use catheters or clean reused catheters. Seventeen subjects were catheterized by a parent or caregiver; 13 were responsible for self-catheterization and cleaning of the catheters. Six months of descriptive data were also collected at Alberta Children's Hospital from a similar group of subjects with spina bifida who used sterile catheters only. In the crossover group, 38% of all urine cultures were positive regardless of whether sterile single-use or clean reused catheters were employed. The other group using only sterile catheters had a 36% positive culture rate. No difference in positive cultures was found between males and females or between children who catheterized themselves and children whose parents catheterized them. The authors concluded that plastic urethral catheters may be reused.

Adolescent↗

The study of the sterilization effect of gamma ray irradiation of immobilized collagen polypropylene nonwoven fabric surfaces.

Exposure to gamma ray irradiation is a frequent, clean, and superior method used to prevent bacterial contamination of sterilized biomedical end products. However, the potential damage induced by gamma ray irradiation of collagen is of concern because of the decay of bioactivity, which correlates with considerable structural alterations. In this experiment, antenna-coupling microwave plasma was utilized to activate nonwoven polypropylene (PP) fabric, and then the sample was grafted to acrylic acid (AAc). Type III collagen was immobilized by using water-soluble 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide as a coupling agent. The collagen-immobilized samples, with temperatures of under 4 degrees C, were exposed to gamma ray irradiation at different dose intervals. Gamma ray irradiation was applied to evaluate the bioactivity on the collagen-immobilized nonwoven polypropylene and to determine the results of sterilization. Five kinds of sterilization index bacteria, all subject to Good Manufacturing Practice (GMP) criteria, were applied as a standard plate-count sterilization test. Our experimental results demonstrate that in human plasma incubated with various intervals of gamma ray irradiation, fibrinogen concentration decreases while platelet and red blood cell adhesion increase. However, the dose required for thrombination demonstrated a significant change in gamma ray irradiation exposure of fewer than 10 KGy (p = 0.05). The decay of bioactivity of the gamma-ray-irradiated collagen-bonded surfaces was evaluated and indicated that the decrease of R-CONHR', the degradation of amides ([broken bond]C[bond]N bonds of collagen and formation of the ROCNH(2) and O[double bond]CR' bonds), and the increase of C[bond]O, C[double bond]O bonds gradually may damage collagen by increasing the intervals of gamma ray irradiation. These effects considerably influence the bioactivity of the collagen-bonded fabric. It is clear that gamma ray irradiation exposure of approximately 10 KGy has the potential of moderating the bioactivities of collagen and therefore likely is a vital factor in the acceleration of biodegradation. The dose required for thrombination and sterilization reaches significance at 7.5 KGy.

Biocompatible Materials↗

Quantifying the effect of resin type and sterilization method on the degradation of ultrahigh molecular weight polyethylene after 4 years of real-time shelf aging.

Alternative sterilization methods including ethylene oxide, gas plasma, and gamma-radiation in an inert environment were implemented in the late 1990s, to limit oxidative degradation of ultrahigh molecular weight polyethylene (PE). There was also a simultaneous transition to PE resins that did not contain calcium stearate. Shelf storage duration of PE inserts following gamma-irradiation in air has been correlated to poor clinical performance and increased wear. This study aimed to determine how sterilization method and resin type influenced degradation of PE after 4 years of real-time shelf aging. It was hypothesized that gamma-irradiation and stearate containing resins would incur significantly more degradation than nonradiated, stearate-free resins. Gamma-irradiated PE samples in air and nitrogen had a significantly increased density and oxidation index, compared to nonirradiated PE after 4 years of shelf aging. Alternative sterilization methods such as ethylene oxide and gas plasma appeared to have significantly less oxidation regardless of PE resin type. A partial correlation demonstrated that density and oxidation index were not correlated (r(2) = 0.079) when examining the influence of sterilization method. The data supported that after 4 years of real-time shelf aging, the type of sterilization method had a larger influence on PE degradation than resin type.

Biocompatible Materials↗

Comparison of two radio-frequency plasma sterilization processes using microspot evaluation of microbial inactivation.

In this study, we evaluated gas plasma surface sterilization methods in a specific sterilizer. We have introduced a new monitoring method using 0.4 microm pore size membranes, which in this study gave the information corresponding to 3000 exposed biological indicators per treatment cycle. This enabled us to compare the fraction of inoculates that showed no growth after exposure for 30 different locations in the chamber, and hereby identify weak and strong spots in the chamber with regard to sporicidal effect. Membranes were also used to expose a broad spectrum of soil bacteria for plasma treatment at four different conditions. The organisms were identified using PCR and sequencing. The test showed that Bacillus stearothermophilus spores were inactivated at the slowest rate among the tested microorganisms. Further alpha-proteobacteria (Gram negative) seemed more sensitive than the rest of the tested organisms. The microspot evaluation approach has been a most useful tool in the assessment of sterilization performance in sterilizers that do not have clear measurable parameters related to the sterilization.

Biocompatible Materials↗

Effect of sterilization on the physicochemical properties of molded poly(L-lactic acid).

In this study, the process of manufacturing and sterilizing an orthopedic implant constructed from poly(L-lactic acid) (PLLA) was closely simulated. The hydrogen peroxide gas plasma (HPGP) sterilization process was comparatively investigated against ethylene oxide (EtO). Characterization of the physical, thermal, mechanical, morphological, and chemical properties was monitored. The results indicate that the HPGP sterilization process did not have a significant influence on M(n) or M(w) initially or through 12 weeks of in vitro conditioning when compared with EtO. Only indications of physical aging were evident in the analysis of the thermal and mechanical properties by differential scanning calorimeter and tensile testing for each sterilization processes. Using wide angle X-ray diffraction to determine morphology characteristics, it was determined that no changes were observed between the as molded, HPGP, and EtO specimens initially or through the 12 week in vitro conditioning period. Contact angle measurements revealed a significant reduction in the surface energy following treatment by the HPGP process, suggesting the formation of polar groups. However, surface chemistry analysis by ATR-FTIR indicated no significant chemical modification from either sterilization method. PLLA showed intermediate levels of residual hydrogen peroxide absorption following processing by HPGP.

Biocompatible Materials↗

Effect of sterilization on bone morphogenetic protein.

Demineralized bone matrix and bone morphogenetic protein have been used clinically to accelerate bone regeneration. However, the best method of sterilization has been the subject of controversy. Some investigators have used ethylene oxide, but others have reported that doses adequate for sterilization destroyed the osteoinductivity of demineralized bone matrix and that gamma irradiation was less harmful in this respect. We used partially purified bone morphogenetic protein and type-I collagen to investigate the effects of sterilization by ethylene oxide and gamma irradiation on the activity of bone morphogenetic protein. Osteoinductivity was reduced considerably after sterilization by gamma irradiation at 2.5 Mrad and by ethylene oxide at 37 degrees C for 4 hours and at 55 degrees C for 1 hour; however, the reduction induced by ethylene oxide at 29 degrees C for 5 hours was about half of the control values. This study showed that ethylene oxide at 29 degrees C for 5 hours can be used clinically for sterilization of bone morphogenetic protein. We also investigated the effect of gamma irradiation on bone morphogenetic protein and the collagen carrier separately and found that collagen was far more labile than bone morphogenetic protein.

Animals↗

Evaluating the effects of tubal sterilization on menstrual function: selected issues in data analysis.

We examined selected issues in data analysis in the Collaborative Review of Sterilization (CREST). CREST is a multicentre, prospective, observational study of women undergoing tubal sterilization. We analysed menstrual function after sterilization in over 5000 women who were enrolled in the period 1978-1983 and followed for 5 years with yearly follow-up interviews. To take into account the dependency among repeated responses from the same individuals, we used the generalized estimating equations (GEE) approach to longitudinal data analysis. Marginal modelling resulted in a statistically significant increase in the odds of menstrual dysfunction at 5 years after tubal sterilization. Transitional modelling produced rates of menstrual dysfunction given a woman's menstrual function at baseline, after adjusting for other baseline characteristics such as method of contraception before sterilization. To examine the direction of the bias that could result from non-random missing data, we refitted our models using imputed values. The models with imputed values showed the same trends as the original models.

Bias↗