Jump to content

Search the hub

Showing results for tags 'Medical device'.


More search options

  • Search By Tags

    Start to type the tag you want to use, then select from the list.

  • Search By Author

Content Type


Forums

  • All
    • Commissioning, service provision and innovation in health and care
    • Coronavirus (COVID-19)
    • Culture
    • Improving patient safety
    • Investigations, risk management and legal issues
    • Leadership for patient safety
    • Organisations linked to patient safety (UK and beyond)
    • Patient engagement
    • Patient safety in health and care
    • Patient Safety Learning
    • Professionalising patient safety
    • Research, data and insight
    • Miscellaneous

Categories

  • Commissioning, service provision and innovation in health and care
    • Commissioning and funding patient safety
    • Digital health and care service provision
    • Health records and plans
    • Innovation programmes in health and care
    • Climate change/sustainability
  • Coronavirus (COVID-19)
    • Blogs
    • Data, research and statistics
    • Frontline insights during the pandemic
    • Good practice and useful resources
    • Guidance
    • Mental health
    • Exit strategies
    • Patient recovery
    • Questions around Government governance
  • Culture
    • Bullying and fear
    • Good practice
    • Occupational health and safety
    • Safety culture programmes
    • Second victim
    • Speak Up Guardians
    • Staff safety
    • Whistle blowing
  • Improving patient safety
    • Clinical governance and audits
    • Design for safety
    • Disasters averted/near misses
    • Equipment and facilities
    • Error traps
    • Health inequalities
    • Human factors (improving human performance in care delivery)
    • Improving systems of care
    • Implementation of improvements
    • International development and humanitarian
    • Safety stories
    • Stories from the front line
    • Workforce and resources
  • Investigations, risk management and legal issues
    • Investigations and complaints
    • Risk management and legal issues
  • Leadership for patient safety
    • Business case for patient safety
    • Boards
    • Clinical leadership
    • Exec teams
    • Inquiries
    • International reports
    • National/Governmental
    • Patient Safety Commissioner
    • Quality and safety reports
    • Techniques
    • Other
  • Organisations linked to patient safety (UK and beyond)
    • Government and ALB direction and guidance
    • International patient safety
    • Regulators and their regulations
  • Patient engagement
    • Consent and privacy
    • Harmed care patient pathways/post-incident pathways
    • How to engage for patient safety
    • Keeping patients safe
    • Patient-centred care
    • Patient Safety Partners
    • Patient stories
  • Patient safety in health and care
    • Care settings
    • Conditions
    • Diagnosis
    • High risk areas
    • Learning disabilities
    • Medication
    • Mental health
    • Men's health
    • Patient management
    • Social care
    • Transitions of care
    • Women's health
  • Patient Safety Learning
    • Patient Safety Learning campaigns
    • Patient Safety Learning documents
    • 2-minute Tuesdays
    • Patient Safety Learning Annual Conference 2019
    • Patient Safety Learning Annual Conference 2018
    • Patient Safety Learning Awards 2019
    • Patient Safety Learning Interviews
    • Patient Safety Learning webinars
  • Professionalising patient safety
    • Accreditation for patient safety
    • Competency framework
    • Medical students
    • Patient safety standards
    • Training & education
  • Research, data and insight
    • Data and insight
    • Research
  • Miscellaneous

News

  • News

Find results in...

Find results that contain...


Date Created

  • Start
    End

Last updated

  • Start
    End

Filter by number of...

Joined

  • Start

    End


Group


First name


Last name


Country


Join a private group (if appropriate)


About me


Organisation


Role

Found 332 results
  1. News Article
    At 34 years old, Dawn Jaxson had two young daughters. Since going through childbirth she had been experiencing a prolapsed bladder and urinary incontinence. Her doctors recommended she have a vaginal mesh fitted to treat the problem, and she didn’t question their advice. But more than 15 years later, she wishes she had. “As soon as I’d actually had it fitted, I felt discomfort,” says Jaxson, now 50. “Then the pain just didn’t go.” After years of almost constant pelvic pain and “countless” medical appointments, Jaxson says: “This little tiny piece of tape is still ruining my life.” “I can literally be sat down and then out of nowhere, it will be like somebody is shoving a red-hot poker through my bladder,” she tells iNews. “Being intimate with somebody is just impossible. Sex is no joy. Imagine your worst period pain you could possibly have, and that’s what it’s like on a daily basis.” NHS Digital records show that between April 2008 and March 2017, 100,516 patients had a tape insertion procedure for stress urinary incontinence. A further 27,016 patients had a mesh procedure for pelvic organ prolapse. But the surgery was suspended in Scotland in 2014 and across the rest of the UK by 2018 following complaints about complications – and a review ordered. The review panel, overseen by Baroness Julia Cumberlege, spoke to more than 700 affected individuals and concluded that pelvic mesh procedures had caused “anguish, suffering, and many ruined lives”. In 2020, the panel set out nine recommendations to help the thousands of women affected, including the creation of specialist centres, so patients could have their mesh removed or receive further treatment. But two years on from that landmark report, women say they are still suffering debilitating symptoms and struggling to access the help they so desperately need. Kath Sansom, the founder of the campaigning group Sling the Mesh, has heard many similar stories from among the group’s 9,700 members. “The lack of action on financial redress is the biggest disappointment for women,” she says. “Pelvic mesh caused lifelong damage, and worse, the majority of us were not given any information on the risks. It’s not our fault this happened to us." “Some women have been left disabled in wheelchairs or walking with sticks. Others have had organs removed where mesh has turned brittle and sliced into them. Seven in 10 have lost their sex life. Everyone suffers chronic pain in varying degrees. Women have lost jobs, marriages, homes, and their quality of life.” Read full story Source: iNews, 18 August 2022
  2. News Article
    Lamborghinis and ski trips to the Swiss Alps were among the incentives a pharmaceutical giant developed to market a surgical device that has ruined the lives of hundreds of Australian women. Documents obtained by the ABC show the extent to which Johnson and Johnson oversold its surgical mesh products, which are used to treat incontinence and prolapse after childbirth. They paint a picture of a company that tried to sell surgeons a jet-setting lifestyle where they could insert four devices "before lunch" and notch up $10,000 in surgeries in a single morning. The mesh devices have left at least 3,000 Australian women with serious side effects including chronic pain, infections and inability to have sex, and are the subject of both a Senate inquiry and a class action. New court documents released in the class action against Johnson and Johnson show that as early as 2009, concerns were raised inside the company that it was making "a huge mistake" by commercialising its latest brand of mesh, was "rushing to market", and opening up the use of the product to "unqualified surgeons". Lawyers from Shine, who are representing the women in the class action, claim the pharmaceutical giant did not investigate proper clinical trials on the possible complications of the mesh. Read full story Source: ABC News, 13 August 2022
  3. News Article
    Pelvic mesh campaigner Kath Sansom has met with the health secretary Steve Barclay to discuss financial redress for those suffering complications from the procedure. The UK government decided last year not to provide compensation to women whose lives had been affected by vaginal mesh implants. But Kath Sansom, a Cambridgeshire mum and former journalist for this news outlet, has continued campaigning and says she will put pressure on the health secretary to revisit the issue. It also comes as the government revealed victims of the 1970s and 1980s blood scandal will receive compensation for the impact it has had on their lives. Ahead of her meeting with the Secretary of State for Health, she said: “We [mesh injured] deserve to be compensated based on the fact we are suffering lifelong damage from a health treatment that caused avoidable harm. “It is not our fault this happened to us and the State should take responsibility.” Former Health Secretary Matt Hancock issued a public apology when a public inquiry in 2020 revealed a shocking extent of patient failings and lack of regulation for mesh victims. “The State has apologised for the suffering of the mesh community, which is an acknowledgement of responsibility,” Kath added. Read full story Source: Cambs Times, 5 August 2022
  4. News Article
    A leading colorectal surgeon whose former employer, North Bristol NHS Trust, faces negligence claims from dozens of his ex-patients has failed in his bid to keep legal action he is taking against the trust a secret. A review by the trust found that 203 women on whom the surgeon Tony Dixon performed pelvic mesh procedures between 2007 and 2017 came to harm. The trust faces legal claims from many of them. Trust board members were told in May that the trust had notified the 203 women that “although their laparoscopic ventral mesh rectopexy operation was carried out satisfactorily, they should have been offered alternative treatments before proceeding to surgery,” and that those patients were defined as suffering “harm.” Dixon sued the trust in the High Court to try to stop it releasing two documents to solicitors acting for ex-patients, as part of the disclosure process in litigation. Read full story (paywalled) Source: BMJ, 27 July 2022
  5. News Article
    Medicines and medical devices valued at over £850,000, totalling more than 285,000 items, have been seized by officers from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as part of a global operation to tackle the illegal sale of medical products, with UK seizures estimated to be worth around 9% of the global total. In the UK, 48 social media accounts unlawfully offering to supply medicines were also shut down. Officers from the MHRA Criminal Enforcement Unit searched five premises in the West Midlands and London, with two suspects arrested. During the global week of action coordinated by Interpol, which ran from 23-30 June, this year’s ‘Operation Pangea’ saw countries across the world joining forces to seize non-compliant medical products. The operation also involved the arrests of several suspected organised criminals. In the UK, anti-depressants, erectile dysfunction tablets, painkillers, anabolic steroids and slimming pills were among the medicines seized. Andy Morling, Deputy Director (Criminal Enforcement) at the MHRA, said: "Criminals illegally trading in medicines and medical devices are not only breaking the law but they also have no regard for your health. Unlicensed medicines and non-compliant medical devices pose serious risk to public health as both their safety and efficacy can be compromised." Read press release Source: MHRA, 20 July 2022
  6. News Article
    A pilot scheme to reduce infections following catheter insertions has shown a 100% fall within a hospital trust. NHS Supply Chain is now encouraging acute trusts in England to take advantage of the scheme which has shown to not only reduce infection rates but shorten patient length of stay and save clinicians’ time. Catheter associated urinary tract infections (CAUTIs) are not uncommon and can cause patients significant pain, discomfort, confusion and anxiety for family and friends. They further impact healthcare with increased antibiotic use, prolonged hospital stays, increased clinical activity and risk of complaints and litigation. University Hospitals of North Midlands NHS Trust had audited its urethral catheterisation practice, and the way catheterised patients w19 July ere cared for in clinical areas. The audit highlighted a wide variation in care delivery leading to inconsistent outcomes for patients and staff. After reviewing the available options, the University Hospitals of North Midlands NHS Trust decided to pilot the BARD® Tray which contains all the essential items to catheterise or re-catheterise a patient in one pack and includes the catheter with a pre-connected urine drainage bag. This unique ‘closed system’ prevents ingress of bacteria and helps avoid catheter related infection. NHS Supply Chain: Rehabilitation, Disabled Services, Women’s Health and Associated Consumables worked alongside supplier Beckton Dickinson to provide the tray products required by the trust. During the three-month pilot, catheter related infection rates fell by 100% at the trust which coincided with a reduction in complaints and a reduced length of hospital stay for patients. Clinicians reported that the pack was intuitive and saved around five minutes per catheterisation, which during the pilot process meant saving 83 hours from 1,000 catheterisation procedures. While the BARD® Tray was more expensive than the individual components that were currently purchased, the pilot study demonstrated the clinical and financial value that was delivered by the tray being implemented across an organisation. The overall cost of components is slightly cheaper, but due to reduced catheterisations, consumables spend fell by 24%. Read full story Source: NHS Supply Chain, 19 July 2022
  7. News Article
    The NHS have duped thousands of women into believing the most common incontinence mesh operation is safe, by not adding loss of sex life into its risk figures, campaigners say. The move keeps figures low so surgeons can reassure women that it is a safe day case operation. The discovery is buried in a report from five years ago, and when questioned on it, the MHRA, tasked with making sure implants are safe for patients, passed the buck and blamed the report authors. The revelation comes after a debate in Westminster, where health minister Jackie Doyle Price said there was not enough evidence to suspend the plastic implants and quoted a risk of 1-3%. However, those figures were blown out of the water just weeks before the debate in a landmark study using the NHS’s own hospital re-admission figures which show TVT mesh tape risk is at least 10%. Campaigners say even that is not a reflection of the true scale of the mesh disaster because it does not take into account women going to doctors for pain medication or those suffering in silence. Read full story Source: Cambs Times, 31 October 201t
  8. News Article
    A jury ordered Becton, Dickinson and Co to pay $255,000 to a man who sued the company, alleging he had been injured by its hernia repair surgical mesh, according to a court filing. The verdict in Columbus, Ohio federal court comes in the second bellwether trial in a multidistrict litigation over the company's hernia mesh products, which were sold by C.R. Bard Inc before its 2017 acquisition by Becton Dickinson. The first bellwether trial last year ended with a verdict in favour of the company. More than 16,000 cases have been consolidated before Chief U.S. District Judge Edmund Sargus in Columbus, in the third-largest pending MDL nationwide. Plaintiffs claim that the mesh products caused infections, pain, inflammation and other problems. The verdict came in a case brought by Antonio Milanesi, who had Bard's Ventralex mesh implanted during a hernia repair in 2007, and his wife, Alicia Morz De Milanesi. They claimed that Milanesi developed an infection and bowel abscess because of the mesh, requiring a second surgery in 2017. Like other plaintiffs in the MDL, the Milanesis say the mesh products are defectively designed because their polypropylene material degrades when in implanted in human tissue. Read full story Source: Reuters, 16 April 2022
  9. News Article
    The Scottish government has signed a contract to allow NHS patients to visit a US expert for mesh removal surgery. Patients can book appointments with Dr Dionysios Veronikis in Missouri with their travel and accommodation costs paid for by the NHS. The cost of each procedure is estimated to be £16,000 to £23,000. Transvaginal implant use was stopped in Scotland after hundreds of women were left with painful, life-changing side effects. NHS National Services Scotland said it would work with NHS Greater Glasgow and Clyde and local health boards to take forward arrangements for those who wish to travel to the US for the procedure. Health Secretary Humza Yousaf said: "I fully understand that women want mesh removal surgery undertaken by surgeons who enjoy their full confidence and a range of measures are now in place to ensure this happens. "I am determined to ensure that those with mesh complications get the treatment they want and need." Read full story Source: BBC News, 12 July 2022
  10. News Article
    Women who underwent damaging surgery in Irish hospitals have accused health authorities of dragging them into a "nightmare" of "gaslighting, ignorance and disrespect". Having had vaginal mesh implants, the women told an Oireachtas committee that they were "maimed" and then led on "a fool's errand" when they sought support from the HSE. The Health Committee heard from members of Mesh Ireland and Mesh Survivors Ireland who represent around 750 women. While the HSE said that it would be "extremely difficult" to provide accurate figures, it estimates that around 10,000 women had this surgery in Ireland. More than one in ten have suffered complications, Dr Cliona Murphy, Clinical Lead for the National Women and Infants Health Programme, revealed. Mary McLaughlin, Mesh Ireland, said that at one point, "I lay in bed 16 hours a day", because of the pain she was in. She demanded dignity and respect for survivors in the face of this "global scandal". The women are calling for access to a US-based expert in complete mesh removal, to mirror schemes in Scotland and the Canadian state of Quebec. Read full story Source: RTE, 29 March 2022
  11. News Article
    Women continue to file vaginal mesh lawsuits against Boston Scientific and other manufacturers, years after most products were removed from the market due to an alarming number of complications and health risks associated with the designs. In a complaint (PDF) filed last month in the U.S. District Court for the Southern District of Indiana, Tanya Davis indicates that problems with Boston Scientific Obtryx II mesh placed in her body only four years ago has left her with severe injuries, including pelvic pain and dyspareunia, abdominal pain, urinary problems, prolapse and incontinence. The lawsuit names Boston Scientific Corporation as the defendant. Transvaginal mesh products like the Obtryx II have been marketed and sold by Boston Scientific Corporation and a number of different companies over the past decade, for treatment of pelvic organ prolapse or female stress urinary incontinence. Most of the products were introduced under a controversial FDA “fast track” approval process, which allowed manufacturers to introduce new products based on the design of prior mesh, without conducting thorough research to evaluate the safety or effectiveness of the specific designs. Following widespread reports of vaginal mesh complications, including infections, erosion of the mesh into the vagina and organ perforation, the FDA required manufacturers to conduct post-marketing research and most companies decided to withdraw their products. According to the lawsuit, Davis received an Obtryx II System in May 2018, to treat her urinary incontinence. However, after experiencing painful and debilitating complications, Davis had vaginal mesh explanted in May 2020; just two years after it was implanted. “Neither Plaintiff nor her physicians and/or healthcare providers were warned that the Obtryx II was unreasonable dangerous or of the risks of the product, outlined herein, even when used exactly as intended and instructed by Defendant,” the lawsuit indicates. “To the contrary, Defendant promoted and sold the type of product implanted in the Plaintiff and thousands of women like Plaintiff, to healthcare providers as a safe alternative to other procedures that did incorporate Defendant’s products.” Read full story Source: About Lawsuits, 10 May 2022
  12. News Article
    New plans to strengthen the regulation of medical devices to improve patient safety and encourage innovation have been published. Following the UK’s exit from the European Union (EU), the Medicines and Healthcare products Regulatory Agency (MHRA) has a unique opportunity to improve how medical devices and in vitro diagnostic medical devices (IVDs) are regulated in the UK. The package of reforms will apply to medical devices such as hearing aids, x-ray machines and insulin pumps; new technologies such as smartphone apps and Artificial Intelligence (AI); as well as certain cosmetic products like dermal fillers. The new measures include: Strengthening the MHRA’s powers to act to keep patients safe. Giving the public and patients greater assurance on both the performance and safety of the highest-risk medical devices, such as those which need to be implanted. Increasing the scope and extent of regulation to respond to public need. Enhancing systems that are already in place to better protect users of medical devices and certain cosmetic products, and providing greater assurance of their performance and safety. Addressing health disparities and mitigating identified inequities throughout medical devices development and use. Mitigating against inequities in medical devices, ensuring they function as intended for diverse populations. The government has launched a review into the potential equity issues in the design and use of medical devices to tackle health inequalities and will update in due course. Making the UK a focus for innovation, and the best place to develop and introduce innovative medical devices. Ensuring the new regulatory framework encourages responsible innovation so that patients in the UK are better able to access the most advanced medical devices to meet their needs. Setting world-leading standards and building the new UKCA mark. Transforming a new stamp of certification, replacing the CE mark, into a trusted brand that signifies global safety, health and environment protection standards have been met for medical device products. This will in turn boost the MHRA’s global reputation and growing partnerships with other regulators. Health and Social Care Secretary Sajid Javid said: "Now we have left the EU, these new changes will allow innovation to thrive and ensure UK patients are among the first to benefit from technological breakthroughs." "We are now able to introduce some of the most robust safety measures in the world for medical devices to ensure patients are protected." Read press release Source: Gov.UK, 26 June 2022
  13. News Article
    The UK is set to play a greater international role in making sure medicines and medical devices are regulated safely and efficiently worldwide, the Medicines and Healthcare products Regulatory Agency (MHRA) announced after being accepted as a full member of three international work-sharing partnerships. Two of these, the International Medical Device Regulatory Forum (IMDRF) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are focused on improving the harmonisation and convergence of medicines and medical devices regulation globally. Through these partnerships, the MHRA will share expertise with other leading organisations, support the development of regulatory guidelines and drive greater harmonisation of regulation around the world. This will help deliver timely access to innovative medical products not just in the UK but globally. The MHRA has also been accepted as a member of the US-based Medical Devices Innovation Consortium (MDIC). This public-private partnership brings together representatives of regulatory bodies, industry, non-profits, and patient organisations from different countries to improve the processes for development, assessment, and review of new medical technologies. This enables transformational medical technology to get to the people who need it sooner, by shortening the path from innovation to safety to access. Read full story Source: Gov.uk, 16 June 2022
  14. News Article
    Two years ago, it seemed that thousands of British women afflicted with crippling pain, ruined sex lives, shattered relationships and wrecked careers would finally get justice and practical redress. A government-commissioned report, following a campaign backed by Good Health, recognised that the plastic mesh tape surgeons had used to treat their incontinence and prolapse had caused some women catastrophic harm. How many women’s lives have been ruined by this mesh is unknown, but Baroness Cumberlege, who led the official review, estimated it to be ‘tens of thousands’. The use of the mesh for stress urinary incontinence was paused in July 2018 as recommended by the inquiry’s preliminary report — then the concluding report, in July 2020, said that this pause should continue until strict requirements on safety and recompense are met. These include the establishment of specialist centres to remove mesh from afflicted women, and financial compensation from government and mesh manufacturers for women affected, as well as the setting up of a database of victims to ascertain the numbers involved and their injuries. The final report also urged that the watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), which had approved the use of mesh tape in the 1990s, should be reformed to improve its vigilance on such problems. Matt Hancock, then Health Secretary, apologised for the women’s pain. ‘We are going to look carefully at the recommendations,’ he told reporters in July 2020. ‘We need to take action.’ But words can be cheap: a Good Health investigation has found none of the recommendations has been implemented properly and the use of mesh in women is continuing. Read full story Source: MailOnline, 6 June 2022
  15. News Article
    The U.S. Food and Drug Administration (FDA) is providing an update on reports of squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants. Previously, on 8 September 2022, the FDA released a safety communication informing the public of reports of cancers, including SCC and various lymphomas, in the capsule that forms around breast implants. The various lymphomas are not the same as the lymphomas described previously by the FDA as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This update includes information from the FDA’s review of literature and medical device reports (MDRs). The FDA is aware of 19 cases of SCC in the capsule around the breast implant from published literature. There have been reports in the literature of deaths from progression of the disease. While the FDA continues to believe that occurrences of SCC in the capsule around the breast implant may be rare, the cause, incidence and risk factors remain unknown. Read full story Source: US FDA, 8 March 2023
  16. News Article
    Elon Musk's attempt to implant microchips into human brains has been rejected by US medical regulators over concerns about the safety of the technology. Mr Musk's Neuralink business, which is hoping to insert tiny chips into people's skulls to treat conditions such as paralysis and blindness, was denied initial permission for clinical trials last year. US medical regulators were said to have "dozens" of concerns over the risks posed by the device, Reuters reported. Concerns include fears that tiny electrodes could get lodged in other parts of the brain, which could impair cognitive function or rupture blood vessels. Neuralink's chips are designed to be threaded into the brain using tiny filaments and harness artificial intelligence technology to pick up brain activity using a so-called "brain computer interface". Read full story (paywalled) Source: The Times, 3 March 2023
  17. News Article
    A misplaced medical tube contributed to the death of the first child in the UK to die after contracting Covid, a coroner has found. Ismail Mohamed Abdulwahab, 13, of Brixton, south London, died of acute respiratory distress syndrome, caused by Covid-19 pneumonia, on 30 March 2020, three days after testing positive for coronavirus. He had a cardiac arrest before he died. Ismail’s death prompted widespread alarm about the potentially lethal impact of Covid on children. Hours before Ismail died, an endotracheal tube (ET) used to help patients breathe was found to be in the wrong position. A consultant in paediatric intensive care decided to leave it and monitor him. Giving his judgment on Thursday, senior coroner Andrew Harris said: “I am satisfied that he [Ismail] would not have died when he did were it not for the tube misplacement.” On Wednesday, the inquest at London Inner South London coroner’s court heard evidence from Dr Tushar Vince, a consultant in paediatric intensive care at King’s College hospital who treated Ismail on 29 March after he had been intubated. Asked by Harris if it would be reasonable to put the positioning of the ET on the death certificate as one of the causes, Dr Vince said: “I think it would be reasonable to consider it, yes.” She said: “I was so focused on the lungs I just didn’t see how high this tube was and I’m so sorry that I didn’t see it.” Read full story Source: The Guardian, 2 March 2023
  18. News Article
    Sam Hindle has 23cm of polypropylene mesh in her body and lives in constant fear that it will become unstable and cause irreversible damage. "You are in your own Battle Royale, strapped to a time bomb, and thinking when is it going to go off," she told the BBC. Sam, 46, is one of hundreds of women in Scotland who have suffered life-changing symptoms since they had a transvaginal mesh implant. After years of campaigning by the women, the Scottish government has promised it will cover the costs of mesh removal at private clinics in the UK and US. But Sam has been waiting more than two years just for a referral to the Complex Mesh Surgical Service in Glasgow to start the process. The Scottish government announced last year that it had signed a contract to allow NHS patients to visit a US expert for mesh removal surgery The contract with Gynaecologic and Reconstructive Surgery of Missouri, where Dr Dionysios Veronikis operates, follows a similar contract agreed with Spire Healthcare in Bristol. The cost of each removal procedure is estimated to be £16,000 to £23,000. But in order to access such treatment, women have to be assessed by the national service in Glasgow. Women like Sam say there are waiting years to just get referred for assessment. With further delays for appointments and then waits for surgery. Read full story Source: BBC News, 2 March 2023
  19. News Article
    A mother-of-one died after a breathing tube was put into her food pipe, despite staff raising concerns it was inserted incorrectly, an inquest heard. Emma Currell, 32, had just received dialysis and was heading home to Hatfield, Hertfordshire, in an ambulance when she had a seizure. An anaesthetic team was called to sedate her as her tongue had swelled and she was bleeding from the mouth. Dr Sabu Syed, who was a trainee anaesthetist, told the hearing: "I used suction to remove blood and I was able to push the tongue to the side and got a partial view." She said she believed she inserted the tube into the trachea - the windpipe - and had asked her senior colleague Dr Prasun Mukherjee to check the position of the tube. "Dr Mukherjee was busy doing other tasks," she added. Technician Nicholas Healey said he flagged his concerns when there was no carbon dioxide reading on the ventilator, which was not faulty. He said that both he and Dr Syed had raised concerns about the tube being in the wrong place. The court heard the hospital had drawn up a guideline checklist for trachea procedures since Ms Currell's death and staff were due to have "no trace = wrong place" training on the warning signs of incorrect insertion. Read full story Source: BBC News, 27 February 2023
  20. News Article
    Wearable fitness and wellness trackers could interfere with some implanted cardiac devices such as pacemakers, according to a study. Devices such as smartwatches, smart rings and smart scales used to monitor fitness-related activities could interfere with the functioning of cardiac implantable electronic devices (CIEDs) such as pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronisation therapy (CRT) devices, the study published in the Heart Rhythm journal found. Researchers found that the electrical current used in wearable smart gadgets during “bioimpedance sensing” interfered with proper functioning of some implanted cardiac devices from three leading manufacturers. Lead researcher, Dr Benjamin Sanchez Terrones, of the University of Utah. said the results did not convey any immediate or clear risks to patients who wear the trackers. However, the different levels of electrical current emitted by the wearable devices could result in pacing interruptions or unnecessary shocks to the heart. Further research was needed to determine the actual level of risk". “Our research is the first to study devices that employ bioimpedance-sensing technology as well as discover potential interference problems with CIEDs such as CRT devices. We need to test across a broader cohort of devices and in patients with these devices. Collaborative investigation between researchers and industry would be helpful for keeping patients safe,” Sanchez said. Read full story Source: The Guardian, 22 February 2023
  21. News Article
    A hernia mesh lawsuit recently filed by a Washington woman alleges that a Strattice “pig skin” mesh product used during her hernia repair was defective and failed, resulting in the need for two additional revision surgeries. The Strattice Reconstructive Tissue Matrix is a hernia repair mesh introduced in 2008, which is constructed from porcine, or pig skin. The mesh is then preserved in a phosphate buffered aqueous solution. It is marketed as a cross-linked graft device, which is intended to chemically link the proteins in the tissue together. However, a growing number of lawsuits allege that the design actually increases the risk of foreign body responses, infections and other complications. Hundreds of injuries and several deaths have been linked to the Strattice hernia mesh made from pig skin, according to the lawsuit. Read full story Source: About Lawsuits.com, 20 January 2023
  22. News Article
    Patients across the UK are set to benefit from access to safe, effective and innovative equipment and medical devices as part of the first ever medical technology (medtech) strategy published today. The blueprint for boosting NHS medtech will focus on accelerating access to innovative technologies, such as the latest generation of home dialysis machines that enable patients to manage their own health at home and in their day to day lives. It also sets out steps which need to be taken to ensure patients can access safe, effective and innovative technology through the NHS, which can help diagnose, treat and deliver care more quickly, freeing up clinician time. The NHS spends £10 billion a year on medtech including syringes, wheelchairs, Minister of State for Health Will Quince said: "The UK’s innovative spirit delivered revolutionary technology during the pandemic - from COVID tests and ventilators - and we want to harness this in promoting cutting-edge medical advancements to improve patient care. The NHS spends around £10 billion a year on medical technology and I’m looking forward to working with industry to use this as we focus on reducing hospital stays, enhancing diagnosis, preventing illness and freeing up staff time. This new medtech strategy will help build a sustainable NHS with patients at the centre so people can continue to access the right care at the right time." The key aims of the strategy are to: boost the supply of the best equipment to deliver greater resilience to health care challenges, such as pandemics, and enhance NHS performance through modernised technology which will enable faster diagnosis, treatment and ultimately discharge to free up hospital beds. encourage ambitious, innovative research to secure the UK’s position as a global science superpower and attract vital investment for the UK economy and create jobs across the country. In 2021, there were already around 60 different research programmes supporting innovative technologies, representing over £1 billion of funding. increase understanding and awareness of medtech by clinicians which will lead to more informed purchasing on new products and deliver better value for taxpayer money and better services for patients. build on the Life Sciences Vision to improve collaboration between the NHS, the National Institute for Health and Care Excellence (NICE) and the Medicines and Healthcare products Regulatory Agency (MHRA) as an innovation partner to ensure patients can access the right products safely. Read full story Source: DHSC, 3 February 2023
  23. News Article
    Every year, millions of people live fuller lives because of a medical device implanted somewhere in their body - from hip joints, to teeth, to heart valves. Known as Foreign Body Response (FBR), inflammation and scarring around an implant is natural, but in some cases, it can severely damage healthy tissue and can even lead to death if the implant is not removed. FBR-related implant failure rates range widely among different medical devices, but reducing those rates has been difficult because scientists still don’t understand the underlying biology that causes FBR. Now, researchers from the University of Maryland have discovered the molecular basis for FBR, identifying a key biological pathway that future drug therapies could target to reduce the risk of implant rejection. Shaik O. Rahaman, an associate professor in the Department of Nutrition and Food Science in the College of Agriculture and Natural Resources at UMD, and his colleagues identified a specific cellular signaling system that kicks in when the body recognises the inherent difference in stiffness between an implant and the surrounding tissue. This system detects the mismatch and triggers inflammation and scarring, which is part of the body’s normal defense system. But in FBR, the signaling system can set up a cycle of chronic inflammation and continual scar-tissue build-up that leads to implant rejection. “This is a huge leap forward in this field,” Rahaman said. “So far, the medical industry has been making biomedical implants randomly, out of materials they think might work without knowing the molecular basis of the foreign body response that leads to rejection. We don’t know why it happens, and until we do, we can’t effectively develop strategies to prevent it.” Read full story Source: College of Agriculture and Nature Resources, 19 January 2023
  24. News Article
    Mesh campaigners claim Scotland's Health Secretary Humza Yousaf refused to meet them to hear their concerns. Patients blame surgical mesh products for leaving them disabled and in chronic pain and want the Scottish Government to hold an independent review into the use of the products. However, followihttps://www.dailyrecord.co.uk/news/mesh-campaigners-claim-humza-yousaf-29075491ng a debate in the Scottish Parliament earlier this month, the Health Secretary denied their request. Campaigner Roseanna Clarkin, of the Scottish Global Mesh Alliance, said Yousaf has refused several requests for meetings with campaigners spanning nearly two years. Roseanna, who has been left with crippling pain after mesh was used on her umbilical hernia in 2015, has blasted him for “ignoring” those affected by mesh procedures. From the late 90s until 2018, women in Scotland were treated with polypropylene mesh implants for stress urinary incontinence and pelvic organ prolapse. In some, it caused severe pain and life-changing side effects. While the Independent Medicines and Medical Devices Safety Review called for a pause in use of vaginal mesh, the products are not banned for all procedures. The Scottish Global Mesh Alliance were behind the petition calling for an independent review which was debated at Holyrood. They want to suspend the use of all surgical mesh and fixation devices while a review is carried out. Roseanna said: “Why do they assume mesh in another part of the body would respond differently and not cause extreme pain and serious infections?” Read full story Source: Daily Record, 29 January 2023
  25. News Article
    Ministers are considering putting a cancer warning on all breast implants a decade after women had ‘a cocktail of chemicals intended for mattresses’ put into their bodies. Experts and MPs are calling for tighter regulation and better support after the PIP faulty breast implant scandal left women – including breast cancer survivors – ‘suffering and dying in silence’. Health minister Maria Caulfield pledged on Monday to consider a so-called ‘black-box’ warning on breast implant packaging like in the US. It came during a debate on the faulty breast implant scandal which saw 47,000 British women given ‘ticking time bomb’ implants made by Poly Implant Prothese (PIP). PIP implants were outlawed in 2010 when they were revealed to be made with substandard silicone and up to six times more likely to rupture. Victims of the scandal have reported a wide range of serious side-effects as experts say they are linked to a raft of health problems including the new form of cancer. Anyone with a PIP implant can officially apply to have it removed by the NHS, but Labour MP Fleur Anderson said: ‘Many applications have been turned down, leaving women with a ticking time bomb in their body. ‘They are unable to afford to get their implants removed privately, are worried that they will rupture further, and are experiencing clear side-effects.’ The MHRA acknowledged the risk of cancer for all breast implants but said PIP implants are not at greater risk than any other. Read full story Source Mail Online, 31 January 2023
×
×
  • Create New...