Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry.

OBJECTIVE: To assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse. DESIGN: Prospective longitudinal cohort study using a surgical registry. SETTING: Thirteen public hospitals in France. POPULATION: A cohort of 1873 women undergoing surgery between February 2017 and August 2018. METHODS: Preliminary analysis of serious complications after a mean follow-up of 7 months (0-18 months), according to type of surgery. Surgeons reported procedures and complications, which were verified by the hospitals' information systems. MAIN OUTCOME MEASURES: Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life-threatening complication requiring resuscitation, or death. RESULTS: Fifty-two women (2.8%, 95% CI 2.1-3.6%) experienced a serious complication either during surgery, requiring the discontinuation of the procedure, or during the first months of follow-up, necessitating a subsequent reoperation. One woman also required resuscitation; no women died. Of 811 midurethral slings (MUSs), 11 were removed in part or totally (1.4%, 0.7-2.3%), as were two of 391 transvaginal meshes (0.5%, 0.1-1.6%), and four of 611 laparoscopically placed mesh implants (0.7%, 0.2-1.5%). The incidence of serious complications 6 months after the surgical procedure was estimated to be around 3.5% (2.0-5.0%) after MUS alone, 7.0% (2.8-11.3%) after MUS with prolapse surgery, 1.7% (0.0-3.8%) after vaginal native tissue repair, 2.8% (0.9-4.6%) after transvaginal mesh, and 1.0% (0.1-1.9%) after laparoscopy with mesh. CONCLUSIONS: Early serious complications are relatively rare. Monitoring must be continued and expanded to assess the long-term risk associated with mesh use and to identify its risk factors. TWEETABLE ABSTRACT: Short-term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.

Do social inequalities in cervical cancer screening persist among patients who use primary care? The Paris Prevention in General Practice survey.

OBJECTIVE: Social inequalities in cervical cancer screening may be related to either lack of access to care or inadequate delivery of preventive care by providers. We sought to characterize social inequalities among women consulting general practitioners with a wide range of social position indicators. METHODS: In 2005-06, 59 randomly recruited general practitioners from the Paris metropolitan area enrolled every woman aged 50-69 years seen during a two-week period. Cervical cancer screening status (overdue if the last cervical cancer screening had been more than 3 years earlier) was analyzed for 858 women in a logistic mixed model that considered: occupational class (in 5 levels, based on last occupation), education, income, characteristics related to family, housing, neighborhood, household wealth (social allocations, perceived financial difficulties in 4 levels, income tax), employment status, supplementary health insurance, and social network (4 levels). RESULTS: The rate of overdue patients did not vary between general practitioners (21%). social position indicators associated with overdue status (odds ratio between 2 adjacent decreasing social levels) were occupational class (1.20, 95% CI: 1.03-1.41), social network (1.52, 95% CI: 1.18-1.94), financial difficulties (1.42, 95% CI: 1.07-1.88), neighborhood safety (2.15, 95% CI: 1.10-4.20), and allocations (3.34, 95% CI: 1.12-9.96). CONCLUSIONS: Even among women visiting general practitioners we observed marked social inequalities that persist above and beyond occupational class.

[Characteristics and determinants of initiation of premenopausal use of oral progestagens in the French E3N cohort]. / Caractéristiques et déterminants de l'initiation d'un traitement progestatif oral dans la cohorte française E3N.

OBJECTIVE: To describe the characteristics and determinants of initiation of use of progestagens alone - i.e. without concomitant use of estrogen - among French premenopausal women. METHODS: Forty-one thousand six hundred and three women from the French E3N cohort were included in our analyses. Prevalence of use was calculated from 1992 to 2005. Determinants of progestagens alone initiation were investigated prospectively from 1992 to 2005, using multivariable Cox proportional hazards models. RESULTS: Fifty-eight per cent of women who had reached menopause between 1992 and 2005 ever used progestagens alone during their premenopause. Between 1992 and the end of 1990s, the increase in the prevalence of progestagens alone use in our cohort was close to 50%. Initiation of progestagens alone was significantly associated with a high level of education (postgraduate compared to high-school graduate: Hazard ratio [HR]: 1.09 95% confidence interval [CI]: 1.01-1.18), with a normal body mass index (overweight and obese women compared to normal-weight women: HR=0.84, 95% CI: 0.79-0.90 and HR=0.79, 95% CI: 0.69-0.89 respectively), history of gynecological disorders (mastalgia, benign breast disease and benign uterine or ovarian disease [HR=1.38, 95% CI: 1.27-1.49, HR=1.18, 95% CI: 1.13-1.24 and HR=1.60, 95% CI: 1.52-1.68 respectively]) and with recent gynaecological screening (as measured by recently performed mammogram or Pap smear HR=1.11, 95% CI: 1.05-1.17 and HR=1.38, 95% CI: 1.27-1.49 respectively). CONCLUSION: Since, at least in France, use of progestagens alone at premenopause is common, evaluation of its risks and benefits is of public health importance.

[Alternatives to hormone replacement therapy for menopause: an epidemiological evaluation]. / Les alternatives au traitement hormonal substitutif de la ménopause: le point épidémiologique.

OBJECTIVE: Recent results put into question the risks/benefits ratio of hormone replacement therapy and emphasize the importance of precise knowledge of the effects of other treatments that exist for postmenopausal symptoms or diseases. Our aim is to analyze their effect. METHODS: A review of randomized trials or epidemiological studies was undertaken. RESULTS: Bisphophonates, calcitonin, parathormone, strontium ranelate, calcium and vitamin D have specific effects on bone. The efficacy of bisphophonates for prevention and treatment of osteoporosis has been proven and parathormone and strontium ranelate seem promising. These treatments are useful for women at high risk of osteoporosis who do not suffer from menopausal symptoms. Tibolone, SERMs and phytoestrogens exert effects on various tissues. SERMs are very promising, but they do not improve climacteric symptoms and their long term effects are still unknown. Tibolone has beneficial effects on climacteric symptoms and on bone loss, but recent results concerning its effects on the risk of breast cancer call into question its interest. The beneficial effects of phytoestrogens on bone and on vasomotor symptoms need to be confirmed. CONCLUSION: At this time, none of the existing treatments for postmenopausal symptoms or diseases is ideal. The existence of several options for treatments of symptoms or diseases of the postmenopause is helpful as it affords several choices for physicians and for women who sometimes need to be treated for many years. However several questions remain unanswered concerning the long term effects of these treatments.

[Compliance with hormone replacement therapy in menopausal women: results of a two-year prospective French study comparing transdermal treatment with fixed oral combination therapy]. / Observance du traitement hormonal substitutif de la ménopause: résultats d'une étude prospective française de deux ans, comparant un traitement transdermique et une association fixe par voie orale.

OBJECTIVES: To evaluate rates of continuation with hormone replacement therapy (HRT) at 2 years in 2 cohorts of female patients, one of which was treated with a set combination of oral oestradiol valerate and medroxyprogesterone acetate and the other with percutaneous 17 beta-oestradiol gel combined with an oral progestogen selected by the prescribing doctor. PATIENTS AND METHODS: A prospective, randomised, open study, including 885 patients followed for 2 years whose 477 were in the oral HRT cohort and 408 were in the dermal cohort. Randomisation was done by group with prescription of the selected HRT for the cohort. The 2 treatment groups were compared using chi(2) tests and Fisher's exact test for qualitative variables, Student's t test or Wilcoxon's test for qualitative variables and Kaplan-Meier survival curves for continuation of HRT, with comparisons using the log-rank test. The prognostic value of baseline parameters on subsequent continuation of HRT was studied using the Cox model (Wald test, odds ratio). RESULTS; Among the 885 treated patients, 711 received the HRT assigned to their cohort (382 in the oral HRT cohort, 329 in the dermal HRT cohort). After 2 years, 77.9% of the patients in the oral HRT cohort and 73.4% of the patients in the dermal HRT cohort were continuing to take their prescribed HRT (P = 0. 076): 37.9% of patients in the oral HRT cohort and 20.2% of patients in the dermal HRT cohort (P < 0.001) continued taking their treatment without any modification. CONCLUSION: Although there was no significant difference in the level of compliance in the 2 groups, it is nonetheless worth noting that the HRT compliance with a sequential fixed estroprogestogen combination was, in this trial, at least equal to that with the free combination of a transdermal estrogen and a progestogen whose nature, dosage and sequence duration are selected by the prescriber. On the other hand, treatment modifications occurred more frequently in the cutaneous HRT group, which is logical as free combination affords to adapt the treatment to each patient.

Bone mass measurements around menopause and prevention of osteoporotic fractures.

The objective of this work is to try to answer the question: is it useful to recommend bone densitometry at the time of the menopause as a screening test for women at high risk of osteoporotic fractures? This analysis is based on a review of the literature for the period 1981-1993, considering published articles in English or French. Prospective studies demonstrate that low bone mass (BM) in women who have been menopausal for more than 10 years is actually a risk factor for fracture, with a fracture risk multiplied by about two for a decrease in BM of one standard deviation. At present no studies have shown this association when BM determinations have been realised at the age of 50 years. The use of BM measurements remains difficult in practice because there is no international consensus concerning the definition and the value of a threshold for a high fracture risk. Concerning the efficacy of preventive interventions applied following the identification of a low BM, i.e. hormonal replacement therapy (HRT), data are lacking concerning the magnitude of its efficacy on fracture prevention and in the presence of an already decreased BM. Moreover osteoporosis is not the only indication for HRT, which may be prescribed for other consequences of the menopause. There is not enough evidence for the screening, by BM measurements, of high risk fracture at the time of the menopause. These measurements may help women who hesitate to take HRT, but they do not seem to improve compliance with the treatment to a large extent. Knowledge concerning osteoporosis and its prevention remains a major determinant in the use of preventive measures.

Determinants of hormonal replacement therapy in recently postmenopausal women.

Although the efficacy of hormonal replacement therapy (HRT) on the consequences of the menopause is not questioned, it appears that in Europe and in the USA only a small proportion of women are users of HRT. In this study, we examined the prevalence and the determinants of HRT among 1986 French menopausal women, aged 45 to 55 years, presenting to a preventive medicine centre. Overall, 8.1% of women reported current use of HRT. The estrogen preparation most commonly reported was transcutaneous 17 beta-oestradiol. The first determinant of current HRT was birth-place. Women born in France were nearly four times more likely to be on treatment than foreign-born women. A surgical menopause multiplied the probability of current HRT by 2, as did a high level of education. An age at first pregnancy of more than 20 and less than 4 children were also positively linked with HRT use. Even in this population of recently menopausal women, volunteering to undergo health evaluation, the prevalence of HRT was low. The reservations towards HRT may be partly due to the women themselves, and partly due to the physicians. It seems very important to inform the medical profession about the risks and benefits of HRT, and to understand more precisely the reasons why so few women use HRT.

[Post-menopausal osteoporosis. Epidemiologic aspects]. / Ostéoporose post-ménopausique. Aspects épidémiologiques.

The purpose of this study is to point out the epidemiological features concerning the frequency and seriousness of post-menopausal osteoporosis, and concerning screening and prevention of osteoporotic fractures. Osteoporosis is a condition very widespread, characterised by fragility fractures. It has been estimated that in France one million of women suffer from vertebral fractures. Osteoporosis can alter the quality of life in various ways. Its cost is high, representing 4 billions francs a year in France only for hip fractures. The only preventive treatment that has been agreed on universally is oestrogen therapy. The fact that this treatment is not systematically recommended does not explain that only 8% among french menopausal women take oestrogen. The factors available at present to identify women at high risk of osteoporotic fractures are risk factors evaluated by clinical history, biological markers of bone formation and measurements of bone mass. None of these risk factors have enough sensibility and specificity to define accurately risks groups. Furthermore it is necessary to specify the effects of treatments associating oestrogens and progestogens prescribed in France, in particular effects on the risks of cardio-vascular diseases and breast cancer.