Pause on the use of vaginally inserted surgical mesh for stress urinary incontinence

The UK government and NHS have accepted the recommendation from the Independent Medicines and Medical Devices Safety Review, 17 July 2018

Following their acceptance of the recommendation from the Independent Medicines and Medical Devices Safety Review, the government and NHS have paused the use of vaginally inserted surgical mesh for stress urinary incontinence until a set of conditions to ensure that patients receive safe and high-quality care are met. This pause has been extended to include vaginally inserted surgical mesh for pelvic organ prolapse and will be implemented through a high vigilance programme of restricted practice.

These procedures have not been banned and during this pause, they will continue to be used when there is no viable alternative and after close and comprehensive consultation between patient and clinician.

There has not been any new evidence which would prompt regulatory action and the position of MHRA remains the same on these medical devices. We continue to work with other regulators in the EU and wider, as well as colleagues across the health sector, to monitor and examine evidence as it becomes available.

continue reading the GOV.UK News story, 17 July 2018.

Related

Evidence that intrauterine exposure to oral contraceptives might slightly affect pubertal timing

Pubertal development after unintended intrauterine exposure to oral contraceptives: a nationwide cohort study

2019 Study Abstract

Objective
To study the associations between exposure to oral contraceptives before conception and early in pregnancy and pubertal timing in boys and girls.

Design
Population-based cohort study.

Setting
Not applicable.

Patient(s)
Overall, 15,800 children (70%) born during 2000–2003 into the Danish National Birth Cohort were categorized according to maternal use of combined oral contraceptive pills or progestin-only pills reported around gestational week 17: no exposure (reference), exposure 4 months before conception, and exposure in early pregnancy. Children self-assessed pubertal status using Web-based questionnaires from 11 years and biannually throughout puberty.

Intervention(s)
None.

Main Outcome Measure(s)
Adjusted mean age differences (months) for attaining individual pubertal milestones and overall pubertal timing. Proportion mediated by prepubertal body mass index.

Result(s)

  • In boys, intrauterine exposure to oral contraceptives showed a tendency toward slightly earlier mean age for voice break (months, −3.8; 95% confidence interval [CI] −6.5, −1.0) and first ejaculation (months, −2.9; 95% CI −5.9, 0.1) and a mean difference of −1.4 months (95% CI −3.3, 0.4) for overall pubertal timing.
  • Girls with intrauterine exposure tended to have slightly earlier age at menarche (months, −1.9; 95% CI −4.0, 0.3) and Tanner breast stages and had a mean difference of −0.9 months (95% CI −2.7, 1.0) for overall pubertal timing.
  • Exposure before conception was not associated with pubertal timing. Prepubertal body mass index did not play a mediating role.

Conclusion(s)
This study shows some evidence that intrauterine exposure to oral contraceptives might slightly affect pubertal timing.

BPF and BPS linked to obesity in children and teens

Urinary bisphenols and obesity prevalence among US children and adolescents, 2019

Bisphenol S (BPS) and bisphenol F (BPF), used as substitutes for bisphenol A (BPA), may contribute to childhood weight gain and obesity, according to a new study published today in the Journal of the Endocrine Society, the Environmental Health News reports.
Image credit Drouin Secondary College.

“Replacing BPA with similar chemicals does nothing to mitigate the harms chemical exposure has on our health.
It will continue to be an issue given that human exposure to these compounds is likely to continue to increase in the future.”

2019 Study Abstract

Bisphenol A (BPA) has been recognized as an endocrine disrupting chemical and identified as an obesogen. Although once ubiquitous, human exposure to BPA is declining due to its substitution with other bisphenols. Two structurally similar substitutes, bisphenol S (BPS) and bisphenol F (BPF), have raised similar concerns, although fewer studies have been conducted on these newer derivatives. We used data from the US National Health and Nutrition Examination Surveys from the years 2013-2016 to evaluate associations between BPA, BPS, and BPF and body mass outcomes among children and adolescents aged 6 to 19 years. Concentrations of BPA, BPS, and BPF were measured in spot urine samples using high performance liquid chromatography with tandem mass spectrometry. General obesity was defined as ≥95th percentile of age- and sex-standardized body mass index (BMI) z-scores according to 2000 US norms. Abdominal obesity was defined as ratios of waist circumference to height ≥0.5. BPA, BPS, and BPF were detected in 97.5%, 87.8% and 55.2% of urine samples, respectively. Log-transformed urinary BPS concentrations were associated with an increased prevalence of general obesity (OR=1.16, 95% CI: 1.02, 1.32) and abdominal obesity (OR=1.13, 95% CI: 1.02, 1.27). BPF detection (vs. not detected) was associated with an increased prevalence of abdominal obesity (OR=1.29, 95% CI: 1.01, 1.64) and continuous BMI z-score (β=0.10, 95% CI: 0.01, 0.20). BPA and total bisphenols were not statistically significantly associated with general obesity, abdominal obesity, or any body mass outcome. This study suggests that BPA substitute chemicals are correlated with obesity in contemporary children.

FDA requests Allergan to recall certain breast implants and tissue expanders from market

Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders, 07.24.2019

“The U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide recall of their BIOCELL textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs. The recall helps ensure that unused products are removed from suppliers and doctors’ offices. The agency also issued a safety communication today for patients with breast implants, patients considering breast implants and their health care professionals outlining the known risks and what steps patients should consider when monitoring for symptoms of BIA-ALCL, including swelling and pain in their breasts. The safety communication also lists information about all models and style numbers included in the recall.” …

continue reading The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market: FDA Safety Communication, 25/07/2019.

Strong associations between exposure to outdoor air contaminants and pediatric asthma in urban areas

Air Pollution and Pediatric Asthma, Collaborative on Health and the Environment, 2019

Listen to Dr. Michael Brauer and Dr. Erika Garcia giving an overview of their recent studies, which both demonstrated strong associations between exposure to outdoor air contaminants and pediatric asthma in urban areas. Reference.

Air pollution has been linked to the increased prevalence of pediatric asthma and reduced lung function growth in children. Children are more vulnerable to environmental contaminants including air pollution. They breathe more air per body weight than adults and their lungs and immune system are still developing. A number of studies have also shown that in utero exposure may be associated with the later development of pediatric asthma.

Angell on Big Pharma

Some more truth about the pharmaceutical companies

Do pharmaceutical companies corrupt academic research and the clinical trial process ? You bet.

Dr Marcia Angell of Harvard Medical School and the author of The Truth About the Drug Companies talks with EconTalk host Russ Roberts about the impact of pharmaceutical companies on academic research, clinical trials and the political process. Angell argues that the large pharmaceutical companies produce little or no innovation and use their political power to exploit consumers and taxpayers. Reference.

Anti-inflammatory drugs and contraceptive pills polluting our waters – A 20year systematic review

Monitoring, sources, receptors, and control measures for three European Union watch list substances of emerging concern in receiving waters, 2017

2017 Study Abstract

Pollution of European receiving waters with contaminants of emerging concern (CECs),

  1. such as with 17-beta-estradiol (a natural estrogenic hormone, E2),
  2. along with pharmaceutically-active compounds diclofenac (an anti-inflammatory drug, DCL)
  3. and 17-alpha-ethynylestradiol (a synthetic estrogenic hormone, EE2))

is a ubiquitous phenomenon. These three CECs were added to the EU watch list of emerging substances to be monitoring in 2013, which was updated in 2015 to comprise 10 substances/groups of substances in the field of water policy.

A systematic literature review was conducted of 3952 potentially relevant articles over period 1995 to 2015 that produced a new EU-wide database consisting of 1268 publications on DCL, E2 and EE2. European surface water concentrations of DCL are typically reported below the proposed annual average environmental quality standard (AA EQS) of 100ng/l, but that exceedances frequently occur. E2 and EE2 surface water concentrations are typically below 50ng/l and 10ng/l respectively, but these values greatly exceed the proposed AA EQS values for these compounds (0.04 and 0.035ng/l respectively). However, levels of these CECs are frequently reported to be disproportionately high in EU receiving waters, particularly in effluents at control points that require urgent attention.

Overall it was found that DCL and EE2 enter European aquatic environment mainly following human consumption and excretion of therapeutic drugs, and by incomplete removal from influent at urban wastewater treatment plants (WWTPs). E2 is a natural hormone excreted by humans which also experiences incomplete removal during WWTPs treatment. Current conventional analytical chemistry methods are sufficiently sensitive for the detection and quantification of DCL but not for E2 and EE2, thus alternative, ultra-trace, time-integrated monitoring techniques such as passive sampling are needed to inform water quality for these estrogens. DCL appears resistant to conventional wastewater treatment while E2 and EE2 have high removal efficiencies that occur through biodegradation or sorption to organic matter.

There is a pressing need to determine fate and behaviour of these CECs in European receiving waters such as using GIS-modelling of river basins as this will identify pressure points for informing priority decision making and alleviation strategies for upgrade of WWTPs and for hospital effluents with advanced treatment technologies. More monitoring data for these CECs in receiving waters is urgently needed for EU legislation and effective risk management

Current uses of BPA are safe – Not

Getting a Clear View : Lessons From The CLARITY-BPA Study, 2019

Listen to Dr. Laura Vandenberg, Associate Professor and Graduate Program Director in the Department of Environmental Health Sciences in the University of Massachusetts Amherst School of Public Health and Health Sciences, analyses The CLARITY-BPA study. Reference.

Bisphenol A (BPA) is produced in high volume and is still in use in a variety of products globally. Many independent, academic studies have demonstrated an association between exposure to BPA and multiple adverse health outcomes including endocrine-disrupting end-points. However, studies included in regulatory risk assessments have been cited as evidence that current uses of BPA are safe.

The U.S. National Institute of Environmental Health Sciences (NIEHS), the National Toxicology Program (NTP), and the Food and Drug Administration (FDA) sought to address these disparities in scientific findings and put together the Consortium Linking Academic and Regulatory Insights on BPA Toxicity, otherwise known as CLARITY-BPA.

Environmental impact of estrogens on human, animal and plant life: A critical review

Water Pollution Caused by Birth Control Poses Dilemma – Environment International, 2017

2017 Study Abstract

Background
Since the inception of global industrialization, steroidal estrogens have become an emerging and serious concern. Worldwide, steroid estrogens including estrone, estradiol and estriol, pose serious threats to soil, plants, water resources and humans. Indeed, estrogens have gained notable attention in recent years, due to their rapidly increasing concentrations in soil and water all over the world. Concern has been expressed regarding the entry of estrogens into the human food chain which in turn relates to how plants take up and metabolism estrogens.

Objectives
In this review we explore the environmental fate of estrogens highlighting their release through effluent sources, their uptake, partitioning and physiological effects in the ecological system. We draw attention to the potential risk of intensive modern agriculture and waste disposal systems on estrogen release and their effects on human health. We also highlight their uptake and metabolism in plants.

Methods
We use MEDLINE and other search data bases for estrogens in the environment from 2005 to the present, with the majority of our sources spanning the past five years. Published acceptable daily intake of estrogens (μg/L) and predicted no effect concentrations (μg/L) are listed from published sources and used as thresholds to discuss reported levels of estrogens in the aquatic and terrestrial environments. Global levels of estrogens from river sources and from Waste Water Treatment Facilities have been mapped, together with transport pathways of estrogens in plants.

Results
Estrogens at polluting levels have been detected at sites close to waste water treatment facilities and in groundwater at various sites globally. Estrogens at pollutant levels have been linked with breast cancer in women and prostate cancer in men. Estrogens also perturb fish physiology and can affect reproductive development in both domestic and wild animals. Treatment of plants with steroid estrogen hormones or their precursors can affect root and shoot development, flowering and germination. However, estrogens can ameliorate the effects of other environmental stresses on the plant.

Conclusions
There is published evidence to establish a causal relationship between estrogens in the environment and breast cancer. However, there are serious gaps in our knowledge about estrogen levels in the environment and a call is required for a world wide effort to provide more data on many more samples sites. Of the data available, the synthetic estrogen, ethinyl estradiol, is more persistent in the environment than natural estrogens and may be a greater cause for environmental concern. Finally, we believe that there is an urgent requirement for inter-disciplinary studies of estrogens in order to better understand their ecological and environmental impact.

Glyphosate, Epigenetics and Transgenerational Inheritance of Disease

Assessment of Glyphosate Induced Epigenetic Transgenerational Inheritance of Pathologies and Sperm Epimutations: Generational Toxicology, 2019

Listen to Dr. Eric Nilsson, Research Assistant Professor in the School of Biological Sciences at Washington State University, presenting a recent study investigating exposure to the herbicide glyphosate in rats. The study found that the exposed rats’ subsequent grand-offspring and un-exposed great grand-offspring had higher rates of disease. Reference.

Abstract

Ancestral environmental exposures to a variety of factors and toxicants have been shown to promote the epigenetic transgenerational inheritance of adult onset disease. One of the most widely used agricultural pesticides worldwide is the herbicide glyphosate (N-(phosphonomethyl)glycine), commonly known as Roundup. There are an increasing number of conflicting reports regarding the direct exposure toxicity (risk) of glyphosate, but no rigorous investigations on the generational actions. The current study using a transient exposure of gestating F0 generation female rats found negligible impacts of glyphosate on the directly exposed F0 generation, or F1 generation offspring pathology. In contrast, dramatic increases in pathologies in the F2 generation grand-offspring, and F3 transgenerational great-grand-offspring were observed. The transgenerational pathologies observed include prostate disease, obesity, kidney disease, ovarian disease, and parturition (birth) abnormalities. Epigenetic analysis of the F1, F2 and F3 generation sperm identified differential DNA methylation regions (DMRs). A number of DMR associated genes were identified and previously shown to be involved in pathologies. Therefore, we propose glyphosate can induce the transgenerational inheritance of disease and germline (e.g. sperm) epimutations. Observations suggest the generational toxicology of glyphosate needs to be considered in the disease etiology of future generations.