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An independent UK safety review concluded that there must be an immediate suspension and a break in the use of surgical mesh for the treatment of stress urinary incontinence (SUI). The NHS agreed.
Baroness Julia Cumberlege, president of the journal said: "We firmly believe that the mesh should not be used to treat women with urinary stress incontinence until we we can manage the risk of complications much more effectively.We have not seen evidence on the benefits of mesh that outweigh the severity of human suffering caused by mesh complications. "
She informed the Ministry of Health and Human Services and NHS England that surgical mesh should not be used to emphasize urinary incontinence until a set mitigate the risk of injury. Baroness Cumberlege said that these conditions should be fulfilled by March 2019. The ministry and NHS England have accepted the recommendation.
In December 2017, Medsafe used the provisions of the Medicines Act 1981 to request safety information from four suppliers of surgical mesh products in New Zealand. The law allows the Director General of Health to request safety information from a provider if there is reason to believe that a medical device is dangerous.
Medsafe reviewed the information provided and concluded that strengthened warnings or limited indications were appropriate for certain products. A working group of Mesh Down Under members as well as representatives of RANZCOG and USANZ surgical colleges have been finalizing a patient information document advising patients of the potential risks and benefits of polypropylene. "The New Zealand document is based on the patient information booklet of the UK's National Health Service (NHS), with localized content," says Carmel Berry, co-founder of Mesh Down Under. "We have worked to verify some specific facts and, just like the Independent Safety Review of England, we do not find enough evidence of safety or likelihood of complications in published research."
In 2014, Mesh Down Under activists asked the New Zealand Health Select Committee to commission a comprehensive independent investigation into the use of surgical mesh in New Zealand.
Although this was not the case, the committee made a number of recommendations to the government, all of which were accepted on August 25. 2016.
Then the Minister of Health, Jonathan Coleman, said, "The Department of Health will review and consult options for a register of registration of the use of surgical mesh." [19659002] "But the reality is now almost 2 years later. The ministry continues to "consult on options" and work on a real registry has not even begun, "said Berry. And now, the Australian Senate Inquiry and the UK Independent Review are asking for local registries. "If the registry had been established in 2014 when we asked for it, we would have at least 4 years of robust data from New Zealand to refer to the creation of the patient information document helping to health professionals in obtaining informed consent. "Carl Heneghan, professor of evidence-based medicine at the University of Oxford, told Kath Samson, leader of the British campaign Sling the Mesh Campaign, that "the ban on stitches for urinary stress incontinence reflects inadequate database that leaves risky mesh devices on the market, the lack of long-term evidence to inform their use and the inadequate response of health professionals to emerging misdeeds
"We need to learn from serious lessons and not repeat the mistakes of the past, including listening to patients when health care goes bad and ensuring health care is based solely on high quality research evidence. "
Patricia Sullivan of Mesh Down Under wrote to the Minister of Health to inform development in England." We fully support a similar suspension / break in the use of polypropylene mesh for the IUUE treatment in New Zealand until a similar list of conditions is met, "she said." This announcement from England is timely because the "Cost / benefit analysis requested by the MS for a surgical register of meshes is now late and we fear that once again the urgency of data collection for this women's issue will be ruled out".
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1. Surgeons should only undertake SUI operations if they are properly trained, and only if they undertake these operations on a regular basis
.2 They report all procedures to a database or national registry. 19659002] 3. A record of operations is kept to ensure that each procedure is notified and that the woman has been identified as having undergone surgery
4. Reporting of complications via VAC and Medsafe is linked to the registry and is mandatory
5. Identification and accreditation of specialized centers for SUI mesh procedures, for removal procedures and other aspects of care for those who are affected by surgical meshes.
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