Massive blow for a hundred women. At the end of December, the Paris public prosecutor's office closed the investigation into aggravated deception and involuntary injuries into the consequences of the installation of medical devices supposed to treat organ descent or urinary incontinence in women, we learned. Friday January 17 in the evening from a source close to the matter.
The plaintiffs denounced serious side effects linked to the installation of pelvic reinforcement prostheses or suburethral strips. They accuse the laboratories of having knowingly minimized, or even concealed, the risks and in particular the difficulties – or impossibility – of removing them. Among the adverse effects noted: incontinence, infections, bleeding, lesions, chronic pain.
“There have been no breaches of the regulations in force, whether by the manufacturers or by the notified bodies responsible for certifying said devices,” can we read in the motivation of the prosecution. He also emphasizes that “Exploitation of the instructions showed that among most manufacturers, the question of side effects and the quasi-irreversibility of the devices were not passed over in silence.”
The public prosecutor also argues that “in the vast majority of cases, these devices are well supported and the relevance of their installation need not be called into question.” As for the health authorities, responsible for the a posteriori control of medical devices, who carried out a materiovigilance study in 2005, they were “proactive”, especially from 2018.
Appeal to the general prosecutor's office
“We learn of the dismissal of the 111 complaints filed by women whose lives have been shattered by the installation of vaginal prostheses without any information being given to them on the possible consequences on their health,” for their part confirmed the plaintiffs' lawyers, Hélène Patte, Amandine Sbidian, Dorothée Bisaccia and Laure Heinich.
“Some of them found themselves very seriously disabled,” they stressed, affirming that “the installation of these prostheses has been the subject of condemnation everywhere else in the world for the health scandal that they represent”.
They intend to make a “appeal to the public prosecutor's office so that it appoints an investigating judge from the health center of the Paris judicial court”. The plaintiffs could also turn to civil justice, to obtain compensation for the damage caused by these devices.
-Anne-Laure Castelli, plaintiff who launched the “Balance ta bandelette” collective, said “fall from the clouds” facing this ranking. “There was reason for the investigation to continue.”
Ban in the United States
Since 2020, 111 patients have filed a complaint in Paris, denouncing serious side effects linked to the installation between 1999 and 2023, by different surgeons, of suburethral strips and pelvic reinforcement prostheses of different brands, installed vaginally or abdominally. .
A preliminary investigation was opened in April 2021, for aggravated deception and unintentional injuries, at the public health unit of the Paris judicial court, entrusted to the Office for Combating Attacks on Public Health (Oclaesp).
In the United States, prostheses placed vaginally were classified as “high risk” in 2016 and banned in 2019. Procedures have also been carried out in the Anglo-Saxon world and several laboratories have paid heavy fines, notably in United States, to settle the lawsuits.
In France, the placement of implants for prolapse vaginally has been suspended since 2019. Those placed abdominally and certain suburethral strips are still authorized and their installation is now regulated.
