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Found 335 results
  1. Content Article
    Pharmaswiss Česka republika s.r.o. and distributor Bausch & Lomb UK Limited is recalling all unexpired batches of Emerade 500 micrograms and Emerade 300 micrograms adrenaline auto-injectors (also referred to as pens) from patients. This is due to an issue identified during an ISO 11608 Design Assessment study where some auto-injectors failed to deliver the product or activated prematurely. Specifically, the 1-metre free-fall (vertical orientation) pre-conditioning resulted in damage to internal components of the auto-injector, leading either to failure to deliver the product or premature activation. This damage was not visibly apparent following the pre-conditioning but was evident only on subsequent functional testing. It is unclear what impact this has on auto-injectors in clinical use, however as a precautionary measure and owing to the inability to identify this issue before the auto-injectors are used, the auto-injectors are being recalled. Healthcare professionals should inform patients, or carers of patients, who carry Emerade 300 or 500 microgram auto-injector pens to obtain a prescription for and be supplied with an alternative brand. They should then be informed to return their Emerade 300 or 500 microgram pens to their local pharmacy.
  2. Content Article
    Should new draft legislation around the use of mesh in women regarding incontinence or prolapse and a new guidance on a national registry meaning every woman choosing mesh in the future must be logged on a database be extended? Haydn Wheeler argues that a broader database is in need.
  3. 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.
  4. 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.
  5. Content Article
    Central line–associated bloodstream infections (CLABSI) account for many harms suffered in healthcare and are associated with increased costs and disease burden. Central line rounds, like medical rounds, are a multidisciplinary bedside assessment strategy for all active central lines on a unit. The project team designed a HIPAA-protected, text-based process for assessing central lines for risk factors contributing to infection. Staff initiated a consultation via a virtual platform with an interdisciplinary team composed of oncology and infectious disease experts. The virtual discussion included recommendations for a line-related plan of care.
  6. News Article
    The US Food and Drug Administration (FDA) is warning healthcare providers, parents and caregivers of pediatric patients (children) who receive enteral feeding that there is a risk of strangulation from the use of enteral feeding delivery sets. The feeding set tubing can become wrapped around a child’s neck and cause strangulation or death. The FDA has received reports of two toddlers who died after being strangled by the tubing. Recommendations for parents and caregivers of children who use enteral feeding delivery sets: Be aware that the feeding set tubing can get wrapped around a child’s neck, which can lead to strangulation or death. To the extent possible, avoid leaving the feeding set tubing where infants or children can become entangled. Discuss with your child's health care provider: If your child has been tangled in their tubing before. Steps you can take to help ensure that tubing does not get wrapped around your child’s neck, such as keeping the tubing away from the child as much as possible. Any other concerns you may have about the risk of strangulation from feeding set tubing. If your child is injured by feeding set tubing, please report the event to the FDA. Your report, along with information from other sources, can provide information that helps improve patient safety. Recommendations for healthcare providers: Review this topic and the information noted above with your colleagues, care teams, and caregivers of pediatric patients who use enteral feeding delivery sets, to ensure they are aware of the potential risk of strangulation with the associated tubing and are taking appropriate measures to keep the tubing away from the child as much as possible. When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety. If a patient experiences an adverse event related to enteral feeding set tubing, you are encouraged to report the event to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Read full story Source: FDA, 8 February 2022
  7. News Article
    Anne Monie is one of hundreds of Scottish women to have suffered painful, life-changing side effects from mesh implants. She was fit and healthy when she went to her doctor with anterior prolapse and mild stress incontinence in 2010. But an operation to fit transvaginal mesh left her in agony. With nowhere to turn for help in Scotland, the 69-year-old spent £19,000 travelling to the US to get her implant removed. Anne spoke to BBC Scotland as the Scottish Parliament looks set to pass a bill which would see her and others reimbursed for the cost of private surgery. That may bring financial concerns to an end - but she is by no means cured. And she worries about other women still trying to go through the mesh-removal process. Anne was offered a simple "gold standard" transvaginal mesh procedure when she first sought medical help 12 years ago. But after the operation to fit it, she began to suffer from a range of problems and was left in chronic pain. After years of frustration, she paid to go to Missouri to have mesh removal surgery with world-renowned expert Dr Dionysios Veronikis. "It's a massive amount of money to be paying out, especially when you're retired. But then, what price do you put on health?" Read full story Source: The Guardian, 25 January 2022
  8. News Article
    Women requiring the surgical removal of mesh implants have said "very little" has happened since a landmark Scottish government announcement in the summer. The pledge means patients can now receive free treatment from specialists in America and England. But campaigners said initial assessments in Glasgow were taking up to two years. The Scottish government said it was working with NHS Specialist Services to improve waiting times. Implant use was stopped in Scotland after hundreds of women were left with painful, life-changing side effects. In July, the Scottish government announced surgery and travel costs to Spire Health Care in Bristol and the Mercy Hospital in Missouri in the United States would be covered. The cost of each procedure is estimated to be £16,000 to £23,000. Marian Kenny, who is waiting on surgery to remove a mesh implant. joined the protest outside the New Victoria Hospital and admitted she felt "deflated" by the lack of progress in recent months. She told BBC Scotland: "For so much of this fight, we have been fighting to get it stopped and this is the only time we have been fighting for ourselves. We don't want to be guinea pigs any more." Health Secretary Humza Yousaf acknowledged the pain, suffering and distress mesh survivors have been through. He said he hoped to finalise contracts with the clinics in Bristol and Missouri "as quickly as we possibly can". Mr Yousaf added: "I would hope to have an update relatively soon. "I know they have been waiting too long and I promise them I don't want them to be waiting any longer than they have to." Read full story Source: BBC News, 24 November 2021
  9. News Article
    A review into whether medical devices are equally effective regardless of the patient's ethnicity has been ordered by Health Secretary Sajid Javid. Research suggests oximeters, which are clipped to a person's finger, can overstate the level of oxygen in the blood of people from ethnic minorities. Ministers want to know whether bias could have prevented patients receiving appropriate Covid treatment. Mr Javid said any bias was "totally unacceptable". But the doctors' union the British Medical Association (BMA) said the review should not simply look at equipment, but also "structural issues" within healthcare that affect ethnic minorities. Mr Javid announced the review in the Sunday Times, saying he was determined to "close the chasms that the pandemic has exposed". Asked later on the BBC's Andrew Marr show whether he thought people had died of Covid because of pulse oximeters, Mr Javid said: "I think possibly yes, yes. I don't have the full facts." He said there was racial bias in some medical instruments, adding: "It's unintentional but it exists." "And the reason is that a lot of these medical devices, even some of the drugs, some of the procedures, some of the textbooks, most of them are put together in majority white countries and I think this is a systemic issue around this," he said. Read full story Source: BBC News, 21 November 2021
  10. News Article
    Thousands of women are being missed off the breast implant registry, new figures suggest. Data from NHS Digital, which manages the register, implies that around 8500 women across England and Scotland have not been added to the register after they were fitted with an implant last year. The register was recommended as a result of the breast implant scandal which saw some women fitted with faulty implants. It records the details of every person who has breast implant surgery in case of a product recall or another safety concern. But the latest figures suggest that many are being missed off the register and NHS Digital has asked women undergoing such treatment to ensure their surgeon has registered their details. The figures show that operations on 10,500 people were recorded in 2020. But officials have estimated this represents around 55% of the total number of cases. This means that approximately 8485 people were not added. Lee Martin, NHS breast surgeon and chairman of the Breast and Cosmetic Implant Registry steering group, said: "We want all patients, past and present, to be aware that the registry exists and ensure they are included by speaking to their surgeons." "As a surgeon, I know first-hand the importance of patient information being included on the registry, it's crucial in providing good patient care and provides patients with assurance that they will be followed up with if there are issues with their breast implants in the future." Read full story Source: Medscape, 10 November 2021
  11. News Article
    The High Court in Canberra, Australia, has ruled against big pharma giants Johnson and Johnson's application to appeal the Federal Court’s decision in favour of the survivors of their defective medical devices in November 2019. This means the decision of the Full Federal Court, in favour of the Lead Applicant and group members, will stand. Shine Lawyers', which has led the class action, has launched further actions against American Medical Systems (AMS), another manufacturer of mesh and tape implants supplied in Australia. The AMS implants, which are used to treat pelvic organ prolapse and stress urinary incontinence, have left many Australian women with severe complications. The legal group has also moved against Boston Scientific for defective vaginal mesh and sling implants received by women in Australia and opened a second Ethicon / Johnson & Johnson’s on behalf of women implanted with a defective mesh product on or after 4 July 2017. The class actions were filed in the Federal court and MIA believe other class actions, including hernia mesh, are underway. Kath Sansom, founder of the Sling the Mesh campaign, said "Brilliant news from Australia! Johnson & Johnson Loses High Court Appeal against the pelvic mesh verdict of 2019. This means J&J can no longer appeal the verdict! I realise compensation may still take time to be awarded to the 10,000+ mesh injured but at least the appeals are over! Congratulations to all the Australian mesh campaigners!" Read press release
  12. News Article
    "What has happened to us is home-grown, institutionalised female genital mutilation," says Mary Lodato, 63, a mother of three and a university researcher, from Kettering in Northamptonshire. "It has been a systemic failure in health and care and it was totally avoidable." What Mary is referring to are complications due to implanted surgical mesh, designed to treat post-childbirth pelvic damage in women, which has left thousands effectively crippled as the material disintegrated inside their bodies, and sheared into the tissue, causing a range of devastating symptoms including pain, difficulty walking and sexual dysfunction. An eight-year Good Health campaign to get official recognition of the problem led to the establishment of a government inquiry under the leadership of former Conservative health minister Baroness Julia Cumberlege. Although the inquiry report was published in July 2020, some of its key recommendations have still not been implemented, leaving thousands of women suffering and not getting the help they need. Seven specialist NHS mesh removal clinics were meant to open in April this year in London, Cambridge, Manchester, Newcastle, Nottingham, Sheffield and Leicester. But the affected women claim a shortage of specialists has meant that only two are functioning — at University College London Hospital and Southmead Hospital in Bristol (which was not on the original list). They also say that it's extremely difficult to get a referral to one of these new centres and even if they do, waiting times can stretch into years. "To the doctors who originally treated us, these operations weren't anything major — but to us it was a catastrophically painful loss of work, family life and intimacy," says Mary. Mary's story is one familiar to almost 10,000 women who have joined an anti-mesh group called Sling the Mesh, and a number of other support organisations. Read full story Source: Mail Online, 1 November 2021 Blogs from Kath Sansom, Sling the Mesh Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies Ineffective medical device recalls are a patient safety scandal
  13. News Article
    A decade after scientists identified a link between certain implants and cancer, the US Food and Drug Administration has ordered “black box” warnings and a new checklist of risks for patients to review. Federal regulators have placed so-called black box warnings on breast implant packaging and told manufacturers to sell the devices only to health providers who review the potential risks with patients before surgery. Both the warnings and a new checklist that advises patients of the risks and side effects state that breast implants have been linked to a cancer of the immune system and to a host of other chronic medical conditions, including autoimmune diseases, joint pain, mental confusion, muscle aches and chronic fatigue. Startlingly, the checklist identifies particular types of patients who are at higher risk for illness after breast implant surgery. The group includes breast cancer patients who have had, or plan to have, chemotherapy or radiation treatments. That represents a large percentage of women who until now were encouraged to have breast reconstruction with implants following their treatment. Reactions to the new requirements were mixed. While some doctors welcomed the new warning system, others worried that the potential risks and side effects would not be conveyed adequately by plastic surgeons who were eager to reassure patients the procedure is safe and that the new checklist would be handled in a dismissive manner. But Dr. Mark Clemens, a professor at M.D. Anderson Cancer Center in Houston who serves a liaison to the F.D.A. for the American Society of Plastic Surgeons Society, said the black box warning and checklist represented “a huge step forward for patient safety and implants.” Read full story Source: The New York Times, 27 October 2021
  14. News Article
    As part of wide-reaching work being carried out to review the methods and processes the National Institute for Health and Care Excellence (NICE) uses to develop guidance, the organisation has launched a public consultation on proposals for changing how it selects the topics it will develop guidance on. Covering guidance on medicines, medical devices and diagnostics, the proposals clarify the criteria which would see a device or diagnostic selected for NICE guidance development. In particular, these include where costs and impacts are expected to be significantly cost-incurring or cost-saving – or there is uncertainty around the likely cost or the impact it would have on the healthcare system. With regard to medicines, the new proposals would confirm the commitment made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access that pledged NICE would appraise all new active substances and significant licence extensions for existing medicines, except where there was a clear rationale not to do so. Similarly, all new or significantly modified interventional procedures that would protect patient safety will be selected if they are available to the NHS or independent sector, or set to be used outside of formal research. This proposed approach would move away from the 15 criteria currently used to select topics for evaluation by NICE’s Centre for Health Technology Evaluation and provide a clearer and simpler process. Helen Knight, Programme Director for Technology Appraisals and Highly Specialised Technologies at NICE, said: “Topic selection plays an important role in the development of NICE guidance and is designed to ensure that the guidance we produce is on topics that support healthcare professionals and others to provide care of the best possible quality. “These proposals will ensure we can continue to meet these ambitions at a time of unprecedented change in the healthcare system.” The consultation on the proposals runs until 19 November. This will be followed by a separate public consultation on the case for change to its processes in February and March 2021. Read full story Source: NHE, 12 October 2020
  15. News Article
    The system for introducing new medical technologies into the NHS remains complex, crowded, and difficult to manage, according to a new report by the Medical Technology Group (MTG). The paper also calls for innovative treatments with medical devices to be given the same support as new pharmaceutical medicines. Current NHS mechanisms to support the uptake and use of innovative technology are severely limited in scope and are focused on ‘picking winners’ rather than the broad system-wide adoption of new technology, the report states. It points to the Accelerated Access Pathway, for instance, which supports fewer than 10 technologies each year; and the lack of a clear mechanism to support the widespread uptake of innovative products across the NHS. And the absence of a broad, national commissioning policy means patients sometimes miss out on the benefits of established technology due to a regional variation in access. Read full story Source: BBH, 24 March 2021
  16. News Article
    Devices which measure blood oxygen levels could be giving “seriously misleading” results for Black and minority ethnic people, possibly contributing to increased Covid-19 mortality, experts have warned. Pulse oximeters attach a clip-like device to a person’s finger, toe or earlobe and send a beam of infrared light to measure oxygen levels in the blood. The resulting reading can be used to monitor oxygen levels of people with a variety of conditions, including by people at home with coronavirus, and to assess patients in hospital. At the moment, coronavirus patients who call an ambulance but are not yet deemed sick enough to go to hospital are being given new home oxygen monitoring kits to help spot those who may deteriorate earlier, and over 300,000 oximeters have been sent out by NHS England. But a new paper cites a “growing body of evidence” that pulse oximetry is less accurate in darker skinned patients. This could be contributing to health inequalities such as the increased COVID-19 mortality rates of ethnic minority patients, according to a review conducted for the NHS Race and Health Observatory. It is now calling for the Medicines and Healthcare products Regulatory Agency (MHRA) to urgently review pulse oximetry products for ethnic minority people used in hospitals and by the wider public. Read full story Source: The Independent, 27 March 2021
  17. News Article
    Sajid Javid has said medical device manufacturers should check their products work well for people of all ethnic backgrounds, citing problems that those with dark skin have experienced when using pulse oximeters. Several studies have found oximeters are not as good at identifying hypoxia in people with darker skin. The devices have been widely used during the covid pandemic to monitor people at risk of deteriorating at home. They are meant to trigger a response when needed. Official guidance was updated this summer to encourage caution in their use. The health and social care secretary has identified health inequalities as one of his priorities. He gave the issue as an example of racial bias in healthcare when speaking at the Conservative party conference on Tuesday evening. He said: “It turned out that pulse oximeters, all of them that exist in the world, were giving often the wrong reading for people with dark skin, because they were designed by companies where basically all they were thinking about were white people. Why is that? Because the companies, their market was white countries with a majority of white people.” Mr Javid, who has a British Pakistani background, continued: “They just weren’t thinking whether these things could work on people with a skin colour like mine or just darker skin, and that’s not right. Read full story (paywalled) Source: HSJ, 6 October 2021
  18. News Article
    Spire Health Care in Bristol and the Mercy Hospital in Missouri have been awarded contacts by the Scottish government to perform surgical mesh removal for Scottish women, with costs for travel and surgery covered by the hospitals, the BBC reports. Each procedure has been estimated to cost between £16,000 and £23,000, with contracts to remove the mesh outside of Scotland expected to start later in the summer. Marian Kenny, 62, from Glasgow has said, "It has given me and lots of other women hope - and that's not something I've had in my life for quite some time." Read full story. Source: BBC News, 12 July 2021
  19. News Article
    A year on from the vaginal mesh scandal and ministers have failed to take action. The new health secretary Sajid Javid has been called on to intervene by families, lawyers and campaigners and has been asked to implement recommendations made by the Cumberlege Inquiry. Emma Hardy, chair of the All-Party Parliamentary Group on Surgical Mesh Implants has said “Women deserve better than the government’s refusal to implement the Baroness Cumberlege recommendations. The recommendations will not only make life better for those living with mesh complications, but they will also improve patient safety for everyone in the future.” Read full story. Source: The Independent, 08 July 2021
  20. News Article
    A call for action on the one-year anniversary since the Cumberlege report was published will be happening in Parliament today and is being led by MP Emma Hardy and Shadow Health Minister Alex Norris. Emma Hardy, chair of the All-Party Parliamentary Group (AAPG) has said “Women deserve better than the Government’s refusal to implement the Baroness Cumberlege recommendations. The recommendations will not only make life better for those living with mesh complications, they will also improve patient safety for everyone in the future.” Read full story. Source: Medical Plastics News, 07 July 2021
  21. News Article
    Baroness Julia Cumberlege has said she is angry and frustrated at the lack of progress being made after she led a critical review into how the health service treats female patients. During her review, she spent 2 years speaking to 700 women and their families who experienced complications linked to two drug treatments and a medical device. The four UK governments are still considering her recommendations and say they will respond fully later this year. Read full story. Source: BBC News, 08 July 2021
  22. News Article
    Naga Munchetty speaks out about her experience having the IUD fitted after reading an article on another woman's experience and how painful it had been. She describes her experience having a coil fitting left her feeling "violated, weak and angry". Read full story. Source: BBC News, 21 June 2021
  23. Event
    This Westminster Health Forum policy conference: will examine what is needed to improve diagnostic speed and outcomes. It will also be an opportunity to discuss the future outlook for medical device regulation in the wake of Brexit, with the MHRA having consulted on a more transparent and flexible approach. Further sessions look at supporting continued research and innovation, with the Government launching strategic and funding plans, including investment in modernising diagnostics as part of wider efforts to address waiting lists. Additional areas for discussion include: industry partnerships staff recruitment and retention learning from the response to COVID-19 opportunities for driving efficiencies. Keynote sessions with: Professor Sir Mark Caulfield, Professor of Clinical Pharmacology, Queen Mary University of London; Chief Executive Officer, Barts Life Sciences; and former Chief Scientist, Genomics England Dr Sarah Byron, Programme Director, Centre for Health Technology Evaluation, NICE Professor Louise Jones, Chair, Genomics and Reproductive Science Specialty Advisory Committee, Royal College of Pathologists; and Professor of Breast Pathology, Barts Cancer Institute Stephen Lee, Director, Diagnostics Regulation, Association of British Healthcare Industries Professor Michael Messenger, Principal Scientific Advisor for In Vitro Diagnostics, MHRA Doris-Ann Williams, Chief Executive, British In Vitro Diagnostics Association Register
  24. Event
    until
    On Wednesday 26th January from 10:30-12:00, the All-Party Parliamentary Group for First Do No Harm (APPG FDNH) will hold a virtual public meeting on the topic of redress schemes for those who have suffered avoidable harm linked to pelvic mesh, sodium valproate and Primodos. This meeting will be an opportunity to hear from representatives of various patient groups about what victims need and what they are missing from current support mechanisms. Officers and members of the APPG FDNH will also provide an update on the Health and Care Bill, which will have passed through Committee in the House of Lords earlier that month. The meeting will be Chaired by Baroness Cumberlege (Co-Chair, APPG FDNH), who will be joined on a virtual panel by representatives of the following patient groups, as well as Officers and members of the APPG FDNH: Sling the Mesh Organisation for Anti-Convulsant Syndrome (OACS) Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT) Independent Fetal Anti-Convulsant Trust (IN-FACT) Attendees will have the opportunity to put forward questions during the meeting and are invited to follow the event on social media by using #Redress and #FirstDoNoHarm. Those interested in attending are welcome to express their interest by emailing the APPG FDNH Secretariat via fdnh@luther.co.uk.
  25. Content Article
    Mesh survivors Katherine Cousins and Mary McLaughlin talk about their ongoing fight for justice for women suffering due to vaginal mesh.
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