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Found 335 results
  1. News Article
    A surgeon has said it would have been "cruel and unacceptable" to have woken up a patient to get consent for a mesh operation. Anthony Dixon is accused of failing to provide adequate clinical care to five patients at Southmead Hospital and the private Spire Hospital in Bristol. He had pioneered the use of artificial mesh to lift prolapsed bowels. Mr Dixon appeared at a Medical Practitioners Tribunal Service (MPTS) hearing in Manchester on Thursday. He faces charges of performing procedures that were not "clinically indicated", failing to carry out tests and investigations and failing to obtain consent from patients. It followed complaints many had suffered pain or trauma after having pelvic floor surgery using artificial mesh, a technique known as laparoscopic ventral mesh rectopexy (LVMR). Giving evidence, he was asked why he did not consider waking up one female patient who underwent an LVMR, to get her consent to surgery. Mr Dixon said it would have meant giving her more drugs for pain relief and could have "multiplied the risks" to her. He is also accused of failing to advise patients about the risks of procedures, failing to discuss non-surgical options and dismissing patients' concerns when they experienced pain or other symptoms following surgery. Read full story Source: BBC News, 23 November 2023 Related reading on the hub: Woman’s mesh consent form was changed after signing – how can patients be better protected?
  2. Content Article
    Beyond Compliance is a service to support the safe and stepwise introduction of new or modified implantable medical devices. An independent panel of experts, known as the Beyond Compliance Advisory Group, work with the implant manufacturer to assess the relative risk of any new product, and the rate at which it should be introduced to the market. The service collects data about patients who receive these implants and about their recovery following surgery. This data is made available to clinicians using the implant, to the manufacturer, and to independent assessors from the Beyond Compliance Advisory Group, to provide real-time monitoring of the implant’s performance. The clinicians who agree to joining the advisory group are drawn from the most experienced and respected members of their field. Beyond Compliance is an optional service available to implant manufacturers. The service commenced in the field of joint replacement implants. Following the success of the introduction of Beyond Compliance to Orthopaedic there are now plans for it to be extended for use with other implantable medical devices.
  3. Content Article
    In her latest blog, Patient Safety Commissioner Henrietta Hughes discusses MHRA's Yellow Card reporting system and why, until we have mandatory reporting, including for devices that are working as designed, we will continue to see avoidable harm occurring to patients. She stresses that it is vital that the voices and views of patients, clinicians, manufacturer, and health providers participate in the design and delivery of devices. 
  4. News Article
    A woman who suffered traumatic complications from a vaginal mesh implant has been awarded a record settlement of at least £1m from the NHS. Yvette Greenway-Mansfield, 59, was given a mesh implant at Coventry’s University Hospital in 2009 and went on to suffer serious complications. Her medical negligence claim against the hospital trust found that the surgery was carried out prematurely and unnecessarily and that her consent form had been doctored to include additional risks after Greenway-Mansfield had signed it. Greenway-Mansfield said that being awarded the compensation was a “huge relief”, but added that many other women who have suffered similar damage had received little or no compensation, and criticised the government’s failure to establish a financial redress agency for victims. “I’m not the only one. There are thousands of mes,” she said. “There should be a pot of money to provide damages for these women and a care plan in place as an automatic response to mesh-damaged people. It comes down to a perception of women and women’s health problems. We’ve all had enough of it.” Read full story Source: The Guardian, 13 November 2023
  5. Content Article
    During a fellowship rotation in gynaecology, Rebekah Fenton, asked the attending physicians what pain management options they could offer patients for insertion of an intrauterine device (IUD). Their answer surprised her: none.  The research on the effectiveness of pain management techniques during the procedure were not strong enough to warrant providing potential relief.  But Fenton knew the attending physician was wrong: she'd received the drug lidocaine during a recent visit to her own ob/gyn to get an IUD placed. The local anesthetic enabled her to avoid the experiences of many patients who often withstand debilitating cramping and pain during insertion, side effects that can last for hours after the procedure has ended.  By not teaching her how to administer pain treatment options such as lidocaine gel or injection, "they made the decision for me, whether I could give patients this option," said Fenton, now an adolescent medicine specialist at Alivio Medical Center in Chicago. Related hub content: See our Pain during IUD fitting community thread.
  6. News Article
    The boss of Britain’s biggest medicines courier has been told to urgently improve its complaints system by the NHS ombudsman amid concerns patients let down by missing deliveries are repeatedly ignored. In a highly unusual development, Darryn Gibson, the chief executive of Sciensus, has received a written warning from Rob Behrens, the parliamentary and health service ombudsman (PHSO). It says patients “should not be ignored” and must be “listened to and taken seriously” or he will consider taking further action. The PHSO investigates complaints that have not been resolved by the NHS or by private providers of NHS care. Sciensus is the single largest provider of homecare medicines services to the NHS and has contracts worth millions of pounds. In an email seen by the Guardian, Behrens told Gibson he had been unable to investigate most reports received about Sciensus because patients had not been able to complete the company’s complaints process. “That is not acceptable or fair to complainants,” Behrens wrote. In a statement, Sciensus said it worked “very hard” to ensure NHS patients received their medicines on time. Its services had “a 95% satisfaction rating”, it added. The move follows a Guardian investigation that exposed how Sciensus put NHS patients at risk of harm with delayed, missed or botched deliveries of medicines for conditions including cancer, heart disease, diabetes, dementia and HIV. It also uncovered how patients’ alarm at vital drugs and medical devices not arriving at their home was often compounded by a struggle to reach Sciensus to complain and fix the problems. Read full story Source: The Guardian, 19 October 2023
  7. News Article
    A man claims he lost his sight in one eye after routine cataract surgery left him in "unbelievable" pain. John Stabler, from East Yorkshire, is set to sue the maker of an artificial lens he had fitted last year and which was later recalled over safety fears. The 63-year-old said he felt like he had been hit "with a sledgehammer" after the operation and had suffered "catastrophic" loss of income. Manufacturer Nidek said it "profoundly regrets" any patient suffering. Mr Stabler is one of 14 patients seeking compensation over the company's EyeCee One Preloaded lens. He said he had suffered permanent nerve damage to his left eye after having the lens fitted at Hull and East Yorkshire Eye Hospital in October last year. He told the BBC: "About two days after, I was getting really bad pain. It was unbelievable. It was like someone was hitting me with a sledgehammer." NHS England issued a safety alert in January 2023 after Nidek announced a "voluntary and precautionary" global product recall of its EyeCee One and EyeCee One Crystal intraocular lenses. UK distributor Bausch + Lomb said there has been "a limited number of reports of elevated intraocular pressure in patients". Read full story Source: BBC News, 19 September 2023
  8. News Article
    A new regional centre which promotes the reporting of suspected safety concerns associated with healthcare products has been launched in Northern Ireland. The Yellow Card centre for Northern Ireland will bring together a dedicated team to increase awareness, educate, and promote reporting of suspected adverse events to the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme. The Yellow Card scheme provides a mechanism for patients, care givers and healthcare staff to report suspected safety concerns associated with healthcare products. Speaking at the launch of the new service, Northern Ireland Chief Pharmaceutical Officer Professor Cathy Harrison said: “Collecting and monitoring information on possible adverse effects of medications and healthcare products is vital to ensuring patient safety. "It is fitting that the launch of the Yellow Card centre for Northern Ireland coincides with World Patient Safety Day on 17 September, with this year’s theme of "Engaging patients for patient safety". "The Yellow Card scheme puts the patient voice at its heart. By voluntarily reporting issues, patients, families and care givers can play a crucial role in their own care, and the safety of healthcare as a whole. I welcome the launch of the new regional centre and would encourage anyone who has suspected safety concerns to report them.” Read full story Source: Department of Health (Northern Ireland), 13 September 2023
  9. News Article
    Certain spina bifida-related surgeries remain suspended at Children's Health Ireland at Temple Street (CHI) for almost a year amid serious allegations that unlicensed devices made with non-medical parts have been implanted in child patients. In two cases where these devices were used, the implants had to be removed from patients after causing significant harm, while the efficacy of a third is yet to be determined. One senior member at the hospital has raised concerns about the number of repeat operations required on young spina bifida patients and associated rates of reinfection, with disquiet in the hospital eventually leading to first an internal review of operations in October 2022 and later an external probe by US clinicians. In June this year there were 287 children on waiting lists in Ireland for life-changing spinal surgery. Despite a commitment first given by then health minister Simon Harris in 2017 that no child would be on the waiting list for more than four months, there are still more than 120 children waiting more than a year for scoliosis surgery, according to the Ombudsman for Children. CHI has declined to comment on allegations that one of its surgeons has used the unlicensed, failed implants, as well as its decision to cease operations on spina bifida patients. Patient advocate Amanda Santry, who took part in the external review on behalf of Spina Bifida & Hydrocephalus Paediatric Advocacy, has said she has been denied access to the review findings and has also called for a “full investigation” into the allegations of the use of non-medical parts. Read full story Source: The Ditch, 15 September 2023
  10. Content Article
    Paula Goss had surgery to implant rectopexy and vaginal meshes which left her with severe pain and other serious complications. In this blog, Paula talks about why she set up Rectopexy Mesh Victims and Support to campaign for adequate treatment, redress and justice for people injured by surgical mesh. She outlines the need for greater awareness of mesh injuries amongst both healthcare professionals and the public and talks about what still needs to be done to enable people to access the treatment and support they need.
  11. News Article
    A group of 67 women from Greenland are seeking compensation from the Danish government over a campaign of involuntary birth control in the 1960s. At least 4,500 women, some of them teenagers, were fitted with coils under a programme intended to limit birth rates among the indigenous population. An inquiry is due to conclude in 2025, but the women, some of whom are in their 70s, want compensation now. They are seeking 300,000 kroner (£34,880; $42,150) each. Records from the national archives showed that, between 1966 and 1970 alone, intrauterine devices (IUDs) were fitted into the women, some as young as 13, without their knowledge or consent. A commission set up by the Danish and Greenlandic governments to investigate the programme is not due to deliver its findings until May 2025. "We don't want to wait for the results of the inquiry," said psychologist Naja Lyberth, who initiated the compensation claim. "We are getting older. The oldest of us, who had IUDs inserted in the 1960s, were born in the 1940s and are approaching 80. We want to act now." Ms Lyberth said that, in some cases, the devices fitted had been too big for the girls' bodies, causing serious health complications or even infertility, while in others the women had been unaware of the devices until they were discovered recently by gynaecologists. She accused the Danish government of the time of wanting to control the size of Greenland's population in order to save money on welfare. "It's already 100% clear that the government has broken the law by violating our human rights and causing us serious harm," she said. Read full story Source: BBC News, 3 October 2023
  12. Content Article
    In anticipation of an increase in patients requiring a temporary tracheostomy due to the huge surge in patients placed on ICU ventilation at the peak of the COVID-19 pandemic, the NHS England National Patient Safety Team launched a National Patient Safety Improvement programme to rapidly support the NHS to provide safe tracheostomy care.
  13. Content Article
    Patients need to be involved in all aspects of the design and delivery of healthcare and to make quality improvements that prevent harm. The Patient Safety Commissioner website shows examples of where working in partnership with patients and families, listening to patients’ voice and acting upon their concerns have made positive changes.  
  14. Content Article
    NHS England is undertaking an audit of NHS specialised hospital services for patients with complications of mesh inserted for urinary incontinence and vaginal prolapse (Mesh Centres) and would like to hear from women who have had Mesh implanted. They'd like to hear from women who have had, or have considered having treatment for their Mesh complications, both surgical (mesh removal) and non-surgical treatment (including physiotherapy and pain management, for example). As part of the audit, Sally Cavanagh who works for NHS England was asked to team up with Kath Sansom from Sling The Mesh and Paula Goss from Rectopexy Mesh Victims & Support, to develop the survey. It is designed to capture feedback about how women reached the decision to seek, or not seek surgical Mesh removal, how they made their treatment decision and their experiences with health services and health staff involved in their treatment for complications of Mesh. The deadline to submit the survey is midnight Wednesday 11 October 2023.
  15. Content Article
    In this consultation, the Department of Health and Social Care (DHSC) is seeking views on the possible introduction of regulations mandating the disclosure of industry payments to the healthcare sector. The consultation concerns the possible introduction of new secondary legislation that would place a duty on manufacturers and commercial suppliers of medicines, devices and borderline substances to report details of the payments and other benefits they provide to healthcare professionals and organisations. This consultation aims to address the second part of recommendation 8 in the Independent Medicines and Medical Devices Safety (IMMDS) Review, regarding real and perceived conflicts of interest in the health system. The proposals will enable respondents to share views on: the information they would need to provide recipients in scope payments that would potentially need to be reported the timing and content of reporting alternatives to regulation. The consultation closes at 11:59pm on 16 October 2023.
  16. News Article
    A hospital review of mesh operations by a surgeon who left dozens of patients in agony is now looking into another type of procedure he carried out. Tony Dixon, who used mesh surgery to treat bowel problems, has always maintained he did the operations in good faith. Now it has emerged that other patients who had their rectum stapled are also being written to. Spire Hospital Bristol said its "comprehensive" review remains ongoing. Mr Dixon pioneered the use of artificial mesh to lift prolapsed bowels and a review of the care he gave patients receiving Laparoscopic ventral mesh rectopexy has already concluded. Now the Spire has contacted patients who underwent a Stapled Transanal Rectal Resection (STARR operation) with Mr Dixon. Many of the affected patients have told the BBC they did not give informed consent for the procedure and are in chronic pain. Read full story Source: 11 September 2023
  17. News Article
    Patients are needlessly being put at risk of dying from heart problems because they have to wait months to be fitted with lifesaving implantable defibrillators, experts have said. Two million people in the UK live with coronary heart disease, which is a leading cause of heart failure. Those at the highest risk of dying as a result of heart failure may be offered an implantable cardioverter defibrillator device (ICD). These can kickstart the heart and may save their life. Patients have to wait at least 90 days before they can be fitted with an ICD while doctors wait to see if stents and medication might improve their health. However, a large study funded by the British Heart Foundation suggests there is little or no benefit to waiting, and the charity says lives are needlessly being put at risk as a result. Dr Sonya Babu-Narayan, an associate medical director at the BHF, said the results had significant implications. “The findings suggest that the current ‘wait and see’ approach to find out whether a patient’s heart function improves with medication and stents isn’t always best, and that an unnecessary wait could even be the difference between life and death,” she said. “The results from this large UK-wide trial could lead to re-evaluation of how best to treat people living with severe heart failure due to coronary heart disease.” Read full story Source: The Guardian, 11 September 2023
  18. News Article
    Two hundred women in the UK who claim they were left in pain after having a permanent contraception device fitted, can now take group legal action through the courts, against its manufacturer. The Essure coil "has caused irreparable damage physically and mentally", the women's lawyers say. German maker Bayer says it will defend itself vigorously against the claims. When Essure was withdrawn from sale, in 2017, the UK medicines regulator said there was no risk to safety. Lawyers in England began legal action in 2020 and now have permission to bring a group claim on behalf of 200 women. Other women wishing to join the group action have until 2024 to do so. The Essure device is a small metal coil inserted into a woman's fallopian tubes. Scar tissue forms around the coil, creating a barrier that keeps sperm from reaching the eggs. Launched in 2002, the device was marketed as a simpler alternative to sterilisation by surgery. But some women say they suffered constant pain and complications, including heavy bleeding, with some ending up having hysterectomies or the device removed altogether. Read full story Source: BBC News, 5 September 2023
  19. News Article
    The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a national patient safety alert for the NovoRapid PumpCart prefilled insulin cartridge and the Roche Accu-Chek Insight Insulin pump system following concerns raised about cracked cartridges and insulin leaks. Patients are being asked to check the pre-filled glass insulin cartridge for cracks prior to use. The cartridge should not be used if it has been dropped even if no cracks are visible. Closely follow the updated handling instructions in the pump user manual when changing pre-filled glass insulin cartridges. The device, which releases the insulin your body needs through the day and night, comprises a pump, tube, battery and a pre-filled glass insulin cartridge. In some of the reported leakage incidents, the cartridges were found to be cracked and provided an inadequate supply of insulin to patients. However, leakages also occurred in cases where no cracks in the cartridge were visible. In some patients there were consequences of not receiving enough insulin from their pump system, including reports of severely high blood sugar and diabetic ketoacidosis (a serious complication of diabetes when the body produces high levels of blood acids called ketones). Health care professionals are being advised to contact patients over the next six months using said device to discuss their individual needs and source an alternative pump where appropriate. Key patient recommendations are: Check the pump and cartridge regularly for damages, for example cracks or leakage. If you smell insulin (a strong antiseptic chemical smell) this could also indicate a leakage. Do not use the cartridge if cracks or leakage are seen or if the cartridge was dropped. Follow the instructions of your Accu-Chek Insight user manual for replacing a cartridge and for cleaning the cartridge compartment in the insulin pump. During the day and before going to sleep please carefully check that your insulin pump is delivering insulin and there are no leakages. Never change treatment delivery methods without first consulting a relevant healthcare professional. Failure of insulin delivery due to leakage may not result in an alert notification from the insulin pump and cracks and leakages may not always be visible. You should check blood glucose levels multiple times throughout your day whilst using pumps. Tell your healthcare professional immediately if you suspect a problem with your insulin delivery. Read full story Source: Gov.UK, 26 May 2022
  20. News Article
    Medical devices are one major weak point in health care cybersecurity, and both the US Congress and the Food and Drug Administration took steps towards closing that gap this week —Congress with a proposed bill and the FDA with new draft guidelines for device makers on how they should build devices that are less likely to be hacked. Devices like infusion pumps or imaging machines that are connected to the internet can be targets for hacks. Those attacks can siphon off patient data or put their safety directly at risk. Experts consistently find that devices in use today have vulnerabilities that could be exploited by hackers. The new document is still just a draft, and device makers won’t start using it until it’s finalised after another round of feedback. But it includes a few significant changes from the last go-around — including an emphasis on the whole lifecycle of a device and a recommendation that manufacturers include a Software Bill of Materials (SBOM) with all new products that gives users information on the various elements that make up a device. An SBOM makes it easier for users to keep tabs on their devices. If there’s a bug or vulnerability found in a bit of software, for example, a hospital could easily check if their infusion pumps use that specific software. The FDA also put out legislative proposals around medical device cybersecurity, asking asking Congress for more explicit power to make requirements. “The intent is to enable devices to be that much more resilient to withstand the potential for cyber exploits or intrusion,” Schwartz says. Manufacturers should be able to update or patch software problems without hurting the devices’ function, she says. Read full story Source: The Verge, 8 April 2022
  21. News Article
    Campaigners found to have been harmed by medical products have written to the health secretary warning that government inaction is "causing pain and destroying lives" by ignoring review recommendations. Some 18 months ago, an independent review recommended financial help for people damaged by some products and drugs that had been prescribed by UK doctors. The government - which set up the Independent Medicines and Medical Devices Safety Review in the first place - has chosen to ignore several of its recommendations. Alleged victims of vaginal mesh, and the drugs valproate and Primodos, have written to Health Secretary Sajid Javid and Maria Caulfield to say they feel ignored. The letter states: "Our members gave evidence to the two-year-long review, sometimes travelling long distances, often with disabilities." "Families shared intimate details of their medical problems, their daily struggles, their difficulties parenting, sometimes even their sex lives. The panel, led by Baroness Cumberlege, was set up by the government to listen, assess and direct policy towards the best course of action. "What was the point of this exercise and the hard work of the panel, if their key recommendations are then ignored by the government?" In the letter, campaigners say: "The decision not to offer an agency for redress (Cumberlege recommendation 3) means that the review has lost its teeth." "Still, no one is facing consequences of medical failures other than the patients. At a time when the public is being asked to put its faith in vaccines, this is a bad look for the government." Kath Sansom, of the campaign group Sling the Mesh, said: "Women must dutifully accept their health has been irreversibly shattered by a medical product they were told was safe, some now needing a disabled blue badge, and they must put up and shut up." Read full story Source: Sky News, 17 February 2022 MeshPrimodosSodiumValproate_LettertoMariaCaulfield_170222.pdf
  22. News Article
    Details of allegations against a surgeon who left dozens of patients in agony after undergoing mesh operations have been published. A tribunal will look at whether Tony Dixon failed to provide adequate clinical care to six patients at Southmead Hospital and the private Spire Hospital in Bristol. He had pioneered the use of artificial mesh to lift prolapsed bowels. The surgeon, who was dismissed in 2019, has always maintained the operations were done in good faith, and that any surgery could have complications. The Medical Practitioners Tribunal, which starts in Manchester on 11 September and is due to end on 23 November, will look into allegations that between 2010 and 2016 Mr Dixon failed to provide adequate clinical care in a number of areas, including: ensuring procedures for some of the patients were clinically indicated adequately advising some of the patients regarding options for treatment obtaining informed consent before performing clinical procedures adequately performing a procedure for one patient providing adequate post-operative care for some communicating appropriately with some of the patients and their family members. Read full story Source: BBC News, 24 August 2023
  23. News Article
    The use of surgical mesh to treat a common childbirth injury is now suspended in New Zealand because of safety concerns. The extraordinary step, which follows a similar move in the United Kingdom, was announced today by Te Whatu Ora. It is being celebrated by a woman who spearheaded a campaign to highlight the harrowing mesh injuries suffered by her and many other Kiwi women. “It is an acknowledgement that their concerns were not just in their heads,” Sally Walker told the Herald. “It will give us some hope.” About 100 women around the country who are on waiting lists for urogynaecological surgeries involving mesh are being contacted by doctors to tell them their operations for stress urinary incontinence are on hold. The Director-General of Health Dr Diana Sarfati said the Surgical Mesh Roundtable (MRT), an oversight and monitoring group chaired by the Ministry of Health, had been investigating a “pause” since earlier this year. The group’s assessment was that the balance of benefit and harm from the procedure would be improved by the series of additional measures already planned, and it recommended a pause until those measures were substantively in place. “After considering the MRT’s assessment, I have decided to support a pause to allow the following steps to be put in place to reduce the harms linked to the procedure as much as possible,” said Sarfati. Read full story Source: NZ Herald, 22 August 2023
  24. News Article
    Patients whose lives were damaged by surgery for bowel problems are calling for a long-awaited report to be published. More than 200 patients underwent mesh bowel operations in Bristol that they might not have needed. The surgery was carried out by Tony Dixon at Southmead Hospital and the private Spire Hospital, in Redland. A review by North Bristol NHS Trust was published in May 2022, but patients are still waiting to hear from Spire. Jill Smith, 69, from Westbury-on-Trym, paid privately to go to Spire. She said she is still in severe pain following her surgery. "Emotionally it has affected me big time. It is just horrible," she said. "The stress and panic I get going anywhere, is, 'will I have an accident or something?'." Read full story Source: BBC News, 18 August 2023
  25. News Article
    Pelvic mesh implant manufacturer Johnson & Johnson group has reached a $300m settlement in two class actions, after thousands of women worldwide reported complications from the mesh products including chronic pain, painful sexual intercourse and incontinence. It marks the largest settlement in a product liability class action in Australian history, and is subject to federal court approval. Shine Lawyers led the Australian class actions and alleged Johnson & Johnson failed to properly test the devices and played down their risk to both surgeons and patients. Women have suffered complications including mesh exposure and erosion – when the mesh pokes through the vaginal wall or cuts through internal tissue – vaginal scarring, fistula formation, painful sex, and pelvic, back and leg pains. Some of these complications may occur years after surgery and can be difficult to treat. Shine Lawyers’ Rebecca Jancauskas said the settlement would help support women’s ongoing treatment needs. “We welcome this settlement which brings the litigation to an end,” she said. “If the federal court approves the settlement our focus will shift to the important task of distributing the settlement to group members.” Read full story Source: The Guardian, 12 September 2022
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