News Press – Medical tools for the treatment of prolapse and urinary non-government … – ANSM



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Medical tools for prolapse treatment and urinary incontinence …

ANSM will require patients and health professionals to report any adverse effects – an information point

There are medical devices for prolapse treatment (organic origin) and urinary inconvenience, called "mesh", in the form of strips and pelvic enhancement implants that can be applied. Nearly 50,000 devices are installed each year in France.

These tools are currently debated in some countries. In the United Kingdom, in July 2018, the government asked for temporary restriction on the use of vaginal pelvic reinforcement implants, and awaiting proposals to rule surgery practices. In the United States, on November 20, the FDA published whether it would take place in February 2019 of a committee of experts assigned to the safety and efficiency of these tools.

The National Health and Medical Rehabilitation Safety (ANSM) National Agency has been at & # 39; Keep track of these tools that are included for several years. At this stage, the Agency has investigated reports on a few reports and asks patients and healthcare professionals to report any adverse effects on their / port of information.

ANSM also has decided to meet patients and health professionals (individuals, generators, general practitioners, nurses, midwives …) with a view to shared reflection of the interest of medical devices and medical devices. associated dangers. This meeting will be followed by an action plan changed to a situation in France.

Memories of ANSM activities

ANSM made its first survey of awareness in 2005. The scientists then went to & # 39; The likelihood of difficulties was similar to those surveyed in scientific literature.

At the end of this investigation, the Agency participated in the Haute Autorité de Santé (HAS) working group about the rehabilitation implant assessment for female women's irregular weight treatment and for prolapse treatment. pelvic organisms of women with which results have allowed upgrades, technological features and conditions of regulation of implants. These proposals were published in July 2007.

ANSM made the second survey on a care issue in 2016 which shows some episodes of events with these tools. Based on this survey, when there are difficulties, these will appear most in the year after work. The diversity observed during this inspection period (1 October to 31 December, 2016) is estimated at 1.43%.

ANSM has analyzed the market from 2016 to identify the different tools used in France. This reinforces an increase in sales numbers and the need to & # 39; More detailed scrutiny of the tools itself but also clinical practices.

Since 2017, ANSM participates with its European supporters in a business to control medical instruments that are marketed in Europe.

A campaign of checks on makers who are currently marketing these tools in France is currently in place; ensure that they negotiate manufacturing processes and results.

In addition, ANSM has funded the VIGIMESH clinical survey, launched in 2017 and coordinated by the University of Poitier Hospital (Professor Xavier Fritel), as part of a call for projects. The aim of this French theater is to identify in a number of hospitals short and long-term problems after a pelvic reinforcement laptop or not; implanting on. The first exhibits presented show on 1124 jobs, a level of serious problems of 3.8%. It is anticipated that the final results will be at the end of 2019.

23/11/2018 Medical devices for the treatment of prolapse and urinary incontinence: ANSM requires patient and health professionals to report potential adverse effects – Information point

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