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Found 820 results
  1. Content Article
    This blog on the Sling the Mesh website provides an overview of research by Professor Carl Heneghan, Director of the Centre for Evidence-Based Medicine at Oxford University, into regulatory issues relating to pelvic mesh. It outlines issues uncovered by Professor Heneghan and his colleagues, including the fact that clinical trial data was not required in the regulation of mesh and that early evidence of complications was ignored in the approval of subsequent devices.
  2. News Article
    The rising prevalence of hernia disorders, technological advancements in hernia repair devices, growing adoption of mesh in hernia repair surgeries, rising geriatric population and high adoption of hernia repair surgical procedures are some of the key factors driving the global hernia repair devices market, reports Yahoo News. Leading players operating in the global hernia repair devices market are adopting both organic and inorganic growth strategies such as collaborations, acquisitions, and new product launches to garner a higher market share. For instance: In February 2023, TELA Bio, Inc announced the launch of two additional configurations of its OviTex LPR device. The new configurations are 15 x 20 cm and 15 x 25 cm ellipses designed for ventral and incisional hernias. In December 2022, Deep Blue Medical Advances announced that they have received an additional 510(k) clearance from the US FDA for its T-Line Hernia Mesh for the subway technique in open hernia surgery. However, in a recent Tweet, campaign group Sling the Mesh voice their concerns:
  3. News Article
    Women’s lives are being put at risk by substandard mental health care during their pregnancy and in the first year after childbirth in most parts of the UK, a report has found. About one in every five women develops a mental illness at some point during the perinatal period, the stage from pregnancy up to a year after giving birth. However, none of the health and social care boards in Northern Ireland or Wales met the national quality standards created by the Royal College of Psychiatrists’ Perinatal Quality Network (PQN). Maternal deaths due to mental health problems are also increasing, with maternal suicide being the lead cause of deaths in the first year after childbirth. Despite this, the report by the Maternal Mental Health Alliance (MMHA) found that many specialist perinatal mental health services do not receive adequate attention or investment, or meet the quality standard of care. The minimum standard of care that women, babies and families should receive is defined as PQN standards type 1. In England, only 16% of the specialist perinatal mental health community teams met these standards. Read full story Source: The Guardian, 2 May 2023
  4. News Article
    Women are dying or suffering avoidable harm because of a failure to recognise ectopic pregnancy, one of the country’s leading experts on maternal health has said. Speaking to the Guardian, Prof Marian Knight of the University of Oxford, who leads a national research programme on maternal deaths, called for action to improve diagnosis of the acute, life-threatening condition, in which a fertilised egg implants itself outside the womb, normally in the fallopian tube. Ectopic pregnancies are never viable and if left untreated can result in the tube rupturing, causing potentially fatal internal bleeding. “We could prevent more women from dying from ectopic pregnancy because of lacking of basic recognition and management of the condition,” said Knight. The warning comes as new data obtained by freedom of information request suggests that dozens of women have experienced “severe harm” after being admitted to hospital with ectopic pregnancies in the past five years. The Mbrrace report, published last year, said eight women died from ectopic pregnancies between 2018 and 2020, all but one of whom had received suboptimal treatment. In three instances, better care might have saved their lives, the report concluded. “There’s no doubt that in the [maternal deaths] inquiry we are still seeing the same messages of ectopic pregnancy not being recognised,” said Knight. “That people either don’t pick up on the fact that they’re pregnant or get single-minded about one diagnosis.” Read full story Source: The Guardian, 1 May 2023
  5. Content Article
    In this blog, Patient Safety Learning considers key patient safety issues relating to complications from surgical mesh implants, highlighting further sources of opinion and research on the hub.
  6. Content Article
    On the 20 January 2023 the Health and Social Care Select Committee published a reported with reviewed the progress that the UK Government has made in implementing the recommendations of the Independent Medicines and Medical Devices Safety Review, sometimes referred to as the Cumberlege Review. This paper sets out the UK Government’s response to the recommendations set out in this report. Related reading: Health and Social Care Select Committee: Follow-up on the IMMDS report and the Government’s response (20 January 2023) Patient Safety Learning: Response to the Select Committee report on the Independent Medicines and Medical Devices Safety Review (20 January 2023)
  7. Content Article
    In this blog, Carl Heneghan, Professor of Evidence-based Medicine at the University of Oxford and Clinical Epidemiologist Tom Jefferson look at the long-term consequences of inadequate regulation and approval of pelvic mesh devices. They argue that regulators and health systems around the world failed to heed the early warnings, which lead to thousands of women being irreversibly harmed. They highlight that as early as 1999, a study of 34 women who had ProteGen mesh implants showed that 50% of mesh devices had eroded through the vaginal wall. Boston Scientific voluntarily recalled 20,000 devices as a result. In spite of this, the FDA continued to approve vaginal mesh devices, citing ProteGen as their predicate device.
  8. Content Article
    Joint safety alert from the British Menopause Society, Faculty of Sexual & Reproductive Healthcare, Royal College of General Practitioners, Royal College of Obstetricians & Gynaecologists, Society for Endocrinology and the Royal College of Nursing Women’s Health Forum.
  9. Content Article
    Exposure to ionising radiation during image guided procedures has been associated with a higher incidence of breast cancer in female healthcare workers. Lead or lead equivalent gowns are used to reduce radiation exposure during image guided procedures, but studies have shown that current gowns provide inadequate protection to breast tissue as they leave the upper outer quadrant and axilla exposed. Isobel Pilkington and colleagues discuss the risk and the steps that must be taken to ensure full protection of breast tissue in this BMJ Editorial.
  10. Content Article
    We often hear the mesh scandal blamed on poor surgeon skill. We also hear the argument that high use mesh implanting surgeons are likely to have fewer patients suffering mesh complications, than a less experienced surgeon. However, this study published in JAMA in October 2018, based on NHS data, shows that high mesh implanting surgeons produce the same or even more mesh complications compared to low volume implanters.
  11. News Article
    An MPs' report is calling for faster progress to tackle "appalling" higher death rates for black women and those from poorer areas in childbirth. The Women and Equalities Committee report says racism has played a key role in creating health disparities. But the many complex causes are "still not fully understood" and more funding and maternity staff are also needed. The NHS in England said it was committed to making maternity care safer for all women. The government said it had invested £165m in the maternity workforce and was promoting careers in midwifery, with an extra 3,650 training places a year. Black women are nearly four times more likely than white women to die within six weeks of giving birth, with Asian women 1.8 times more likely, according to UK figures for 2018-20. And women from the poorest areas of the country, where a higher proportion of babies belonging to ethnic minorities are born, the report says, are two and a half times more likely to die than those from the richest. Caroline Nokes, who chairs the committee, said births on the NHS "are among the safest in the world" but black women's raised risk was "shocking" and improvements in disparities between different groups were too slow. "It is frankly shameful that we have known about these disparities for at least 20 years - it cannot take another 20 to resolve," she added.
  12. Content Article
    In the UK, maternal mortality for Black women is currently almost four times higher than for White women, and significant disparities also exist for women of Asian and mixed ethnicity. In this report the Women’s and Equalities Select Committee reviews what is currently understood about the reasons for disparities in maternal deaths, analyses Government and NHS action to date and existing recommendations for change and consider the ongoing challenges to addressing disparities.
  13. News Article
    The deaths of 650 patients treated by a breast cancer surgeon who was convicted of maiming hundreds are being investigated, it has been reported. Once one of the country’s leading doctors, Ian Paterson carried out thousands of operations before he was jailed for uneccesarily performing hundreds of life-changing surgeries. The Sunday Times has now revealed medical experts are sifting through the records of women who were cared for by the disgraced surgeon over more than twenty years. He is currently serving a 20-year jail term, having been found guilty of 17 counts of wounding with intent. Many of the procedures, which took place between 1997 and 2011, had “no medically justifiable reason”, a court heard. According to The Sunday Times, 27 inquests have been opened in cases where coroners “believe there is evidence to have reason to suspect that some of those deaths may be unnatural”. Read full story Source: The Independent, 16 April 2023
  14. News Article
    “You’re just unlucky,” the doctor told me. Whichever GP I saw, wherever I was, male or female, I would be asked the same questions. Do you drink alcohol? Are you sexually active? Is your underwear too tight? If I heard another woman being relentlessly quizzed like that today, I’d probably call it victim blaming." "... when you’re told, over and over, that it’s just bad luck and that some women suffer more than others, you believe it. You put your trust in the professionals. You don’t advocate for yourself because you don’t understand that there’s anything that needs fighting for." Claire Cohen, 39, had spent much of her life since her mid-teens in acute pain, begging for help. Now she’s finally been diagnosed with endometriosis, she looks at how medicine is still failing to treat a condition that can have a devastating effect on one in ten women Read full story (paywalled) Source: The Times, 13 April 2023
  15. Content Article
    Outpatient and daycase hysteroscopy and polypectomy (OPHP) are widely recognised methods for the treatment of endometrial polyps. There have been concerns regarding pain affecting satisfaction and tolerability of the outpatient procedure. Dr Bhawana Purwar and colleagues from the Royal Wolverhampton Hospitals NHS Trust conducted a service evaluation of their outpatient hysteroscopy and polypectomy (OPHP) and compared it with their daycase procedures. They concluded that the OPHP is cost-effective and efficient method with reasonable acceptability. It is well tolerated with remarkable success rates and excellent patient satisfaction. As compared to daycase group, it requires less time for recovery and sooner returns to work.
  16. Content Article
    There has been increasing public concern that COVID-19 vaccination causes menstrual disturbance regarding the relative effect of vaccination compared to SARS-CoV-2 infection. The objectives of this study, published in Science Direct, were to test potential risk factors for reporting menstrual cycle changes following COVID-19 vaccination and to compare menstrual parameters following COVID-19 vaccination and COVID-19 disease.
  17. Content Article
    In this special edition episode of 'I forgot to ask the doctor', host Dr Gail Busby interviews Professor Justin Clark and Dr Helgi Johnannsson about the options for pain relief for the important procedure of hysteroscopy. 
  18. Content Article
    Cervical cancer disparities persist for Black women despite targeted efforts. Reasons for this vary; one potential factor affecting screening and prevention is perceived discrimination in medical settings. This US study in the Journal of Racial and Ethnic Health Disparities aimed to describe experiences of perceived discrimination in medical settings for Black women and to explore the impact on cervical cancer screening and prevention. The authors concluded that Black women engaging in healthcare are experiencing perceived discrimination in medical settings. They suggest that future interventions should address the poor quality of medical encounters that Black women experience.
  19. Content Article
    In this article for Chamber UK magazine, Lyn Brown MP warns that hysteroscopy could be the next big women's health scandal and calls for dramatic improvements in care. She describes the accounts of women being encouraged to undergo hysteroscopy without anaesthesia and appropriate pain relief, and how lack of informed consent is leaving women feeling violated and scared to undergo future gynaecological procedures. She also describes how she raised the issue in the House of Commons and outlines the failure of the Royal College of Obstetrics and Gynaecology's new 'Good Practice Paper' to properly address the decision making process and acknowledge the severity of the pain experienced by many women who undergo hysteroscopy. The article can be found on page 64 of the e-magazine.
  20. Content Article
    Research paper by Toye et al. published in the Lancet on the experience of women reporting damage from vaginal mesh.
  21. News Article
    Doctors are warning that embarrassment about naming parts of the female anatomy is putting women's health in jeopardy. Dr Aziza Sesay said the hyper-sexualisation of women's bodies and anatomy "perpetuates the taboo, stigma and embarrassment". She said it could lead to women not getting the medical help they need. She said a lot of women's health conditions are often considered benign - meaning they're not life-threatening - but that she disliked the term as it minimised "how much it will affect someone's life". Dr Sesay is one of a number of women's health specialists who are due to appear at Cardiff's Everywoman Festival on 24 June, where topics will range from periods to menopause. The festival is the brainchild of colorectal surgeon, Julie Cornish, who works for Cardiff and Vale health board. She said "embarrassing" symptoms are all too often never discussed. "It's not uncommon to see patients who waited 10, 15 years with symptoms," she said. "It's got to the point where they've had to stop working, or their relationship has broken down. "People retire early, they stop working or stop socialising. And that delay often means it's more severe. They might need surgery rather than simple physiotherapy, dietary tricks or modifications that could've worked so easily early on." Read full story Source: BBC News, 3 April 2023
  22. Content Article
    The following account has been shared with Patient Safety Learning anonymously. We’d like to thank the patient for to sharing their experience to help raise awareness of the patient safety issues surrounding outpatient hysteroscopy care.
  23. Content Article
    Footage from the Black Maternal Health Conference UK 2023 is now available for download. Sessions highlight the gaps within the system and disparities - and provide nuance, to further reiterate the importance of Black women receiving health care that is respectful, culturally competent, safe and of the highest quality. Hosted by Sandra Igwe, Chief Executive of The Motherhood Group. You can purchase the full recording, or specific sessions, from the event via the link below.
  24. News Article
    A woman whose daughter took her own life after being left in chronic pain caused by giving birth has spoken of her family's heartbreak. Sara Baines, 34, from Flintshire, died in September last year leaving her family devastated. This week an inquest heard Sara suffered from chronic pain due to complications resulting from surgical mesh that was implanted after she gave birth in 2011. Her mother, Alison Sharrock, says Sara was failed by the health system on multiple occasions. Sara bled heavily whilst giving birth and suffered a second-degree tear. She had to have two surgeries to repair the tear, neither of which was completely successful. Sara found herself completely incontinent, at the age of 24. In 2015, Sara was advised to have mesh fitted. Alison said: "We were told the mesh was a 'quick-fix'. It felt like the answer to all her problems and she was thrilled. She had surgery but afterwards, though the incontinence improved, she had terrible abdominal pain." The pain became so severe that Sara was offered a hysterectomy, aged 28. Afterwards, the pain only intensified, and her general health deteriorated. She suffered water infections, skin rashes, gum disease and unexplained pain. Unable to eat or sleep, she became depressed and anxious. "She felt nobody was really listening to her. She felt she was gaslighted and fobbed off," said Alison. Kath Sansom, founder of Sling The Mesh which has almost 10,000 members suffering irreversible pan and complications from surgical mesh implants, said: "Our hearts go out to Sara's family. Nine out of 10 people in our support group were not told any risks of having a plastic mesh permanently implanted." Read full story Source: Mail Online, 24 March 2023 Further reading on the hub: Doctors’ shocking comments reveal institutional misogyny towards women harmed by pelvic mesh “There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery ‘Mesh removal surgery is a postcode lottery’ - patients harmed by surgical mesh need accessible, consistent treatment
  25. News Article
    The link between menopause and poor mental health should be reviewed, the health watchdog has said, after an inquiry into a woman’s suicide found staff lack training to spot the risks. Frances Wellburn, 56, took her own life in 2020 after she was incorrectly assessed as being a “medium risk” of suicide by Tees, Esk and Wear NHS Trust (TEWV). A national study by the Health and Safety Investigation Branch (HSIB), prompted by her death, warned that this was a national problem, with funding and capacity problems driving staff to use ineffective “checklist” tools when assessing suicidal patients. HSIB also found staff were not trained to spot mental health risks associated with menopause, and menopause is not routinely considered a contributing factor among women with low mood who need help. It said that women are often prescribed antidepressants when hormone replacement therapy (HRT) would be more appropriate. In Ms Wellburn’s case, HSIB found TEWV staff had failed to take into account that she was going through menopause when they assessed her as being at medium risk of self-harm. This went against national guidance, which states scales should not be used to predict future suicide or self-harm. Read full story Source: The Independent, 23 March 2023
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