Thursday , August 18 2022

News Press Releases and Medical Devices for Urinary Disease Treatment … – ANSM


Medical treatment for prolapse and urine …

ANNS requests patients and health professionals to report any adverse effects – information points

In the form of implants (implantation) and implants of implanted pelvis arrays, as well as medical devices for the treatment of urine, as well as "grid". Approximately 50,000 units per year will be installed annually in France.

These devices are currently being discussed in some countries. In the United Kingdom, until July 2018, the government required a temporary restriction on the use of vaginal implants before waiting for recommendations on surgical practice. In the United States on November 20, the FDA announced in February 2019 the Committee of Experts on Safety and Efficiency of these Devices.

The National Agency for Drugs and National Healthcare Products (ANSM) has been monitoring these implants for several years. During this period the Agency has studied several reports and asked patients and health professionals to report any negative impact on the reporting portal.

In addition, ANNS has shown interest in patients and healthcare providers (healthcare workers, gynecologists, general practitioners, nurses, obstetricians …). risks associated with their use. This meeting will include an action plan adapted to the situation in France.

Remembrance of ANSM actions

ANSM conducted its first materialization research in 2005. Experts estimate that the frequency of complications later appears to be evident in scientific literature.

Based on the results of this poll, the Agency has participated in the Haute Autorité de Santé (HAS) working group on the treatment of women's urinary sterility and valve implants for prolapse treatment. the indicators of women's pelvic organs allowed to update the technical characteristics and management conditions of the implants. These proposals were published in July 2007.

The ANMS conducted a second survey of the material situation survey in 2016, indicating that there were fewer cases with these devices. According to this study, they occur mainly during one year after surgery. During the study period (from October 1, 201 to December 31, 201), the complication rate is estimated to be 1.43%.

ANSM has been reviewing the market since 2016 to identify various devices used in France. This reassures sales volumes and more detailed device learning, as well as clinical experience.

Starting from 2017, ANSSA will participate in a European Working Group on Medical Controls, which will be sold in Europe together with European partners.

In France, there is a verification campaign for manufacturers of these devices to check the compliance of production processes and products.

In addition, ANSM finances VIGIMESH clinical trials launched in 2017 and co-ordinates the Poitier University Hospital (Professor Xavier Fritel) as part of the project call. The purpose of this French Observatory is to identify short-term and long-term complications after implanting hips in multiple hospitals or implanted hip-stroke operations. The first results show that 1124 surgeries were 3.8%. The final results are expected at the end of 2019.

23/11/2018 Medicinal Drugs for Prolapse and Urine Treatment: ANSM asks patients and healthcare providers to report potential adverse effects – Information point

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