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Medical devices for the treatment of prolapse and urinary incontinence …
the ANSM asks patients and health professionals to report any adverse effects – Information point
Medical devices for the treatment of prolapse (organ descent) and urinary incontinence, also known as "mesh", are in the form of implantable pelvic reinforcement strips and implants. Nearly 50,000 devices are installed each year in France.
These devices are currently being discussed in some countries. In the United Kingdom, in July 2018, the government asked for a temporary restriction on the use of badl pelvic reinforcement implants, pending recommendations to regulate surgical practices. In the United States, on November 20, the FDA announced the holding in February 2019 of a committee of experts dedicated to the safety and effectiveness of these devices.
The National Agency for the Safety of Medicines and Health Products (ANSM) has been monitoring these implantable devices for several years. The Agency has at this stage investigations of few reported reports and asks patients and health professionals to report any undesirable effects on the reporting portal.
ANSM has also decided to meet soon patients and health professionals (urologists, gynecologists, general practitioners, nurses, midwives …) with a view to a shared reflection on the interest of these medical devices and medical devices. risks related to their use. This meeting will be followed by an action plan adapted to the situation in France.
Reminder of ANSM actions
The ANSM conducted a first survey of materiovigilance in 2005. The experts had then estimated that the frequency of complications was similar to that observed in the scientific literature.
At the end of this survey, the Agency participated in the working group of the Haute Autorité de Santé (HAS) on the evaluation of reinforcement implants for the treatment of female urinary stress incontinence and for the treatment of prolapse. pelvic organs of the woman whose findings have allowed to update indications, technical characteristics and conditions of management of these implants. These recommendations were published in July 2007.
The ANSM conducted a second survey of materiovigilance in 2016 which shows few reports of incidents with these devices. According to this survey, when there are complications, these occur mainly in the year following the operation. The complication rate observed during the period of this survey (October 1 to December 31, 2016) is estimated at 1.43%.
ANSM has conducted a review of the market since 2016 to identify the different devices used in France. This confirms increasing sales volumes and the need to investigate in more detail the devices themselves but also clinical practices.
Since 2017, the ANSM participates with its European counterparts in a task force for the control of medical devices marketed in Europe.
A campaign of inspections of manufacturers marketing these devices in France is currently underway to verify the conformity of manufacturing processes and products.
In addition, the ANSM is financing a VIGIMESH clinical study, launched in 2017 and coordinated by the University Hospital of Poitier (Professor Xavier Fritel), as part of a call for projects. The objective of this French observatory is to identify in several hospitals short and long-term complications after pelvic reinforcement surgery with or without implant placement. The first results presented show, on 1124 operations, a rate of severe complications of 3.8%. The final results are expected at the end of 2019.
23/11/2018 Medical devices for the treatment of prolapse and urinary incontinence: the ANSM asks patients and health professionals to report possible adverse effects – Information point
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