The Paris prosecutor’s office dismissed the investigation for aggravated deception and unintentional injuries into the consequences of the installation of medical devices intended to treat falling organs or urinary incontinence in women at the end of December, AFP learned on Friday, January 17, through a source close to the matter.
“There has been no violation of current regulations, neither by the manufacturers nor by the notified bodies in charge of certifying said devices,” reads the reasoning of the prosecutor’s office consulted by AFP.
The Prosecutor’s Office emphasizes that “the use of the instructions showed that, among the majority of manufacturers, the issue of side effects and the almost irreversibility of the devices were not overlooked.”
The prosecutor also maintains that “in the vast majority of cases, these devices are well supported and that the relevance of their installation cannot be questioned.”
As for the health authorities, responsible for post-hoc control of medical devices, which carried out a material surveillance study in 2005, they have been “proactive”, especially since 2018.
Incontinence, bleeding, etc.
Since 2020, these dozens of patients have filed a complaint in Paris, reporting serious side effects related to the installation, between 1999 and 2023, by different surgeons, of suburethral strips and pelvic reinforcement prostheses of different brands, installed vaginally or abdominally. .
In April 2021, a preliminary investigation for aggravated deception and unintentional injuries was opened in the public health unit of the Paris judicial court, entrusted to the Office to Combat Attacks on Public Health (Oclaesp).
These medical devices, developed since the late 1990s, are intended for the treatment of urinary incontinence and prolapse (descent) of the pelvic organs.
The plaintiffs maintain that the laboratories consciously minimized or even concealed the risks of their polypropylene-containing devices, in particular the difficulties – even the impossibility – of removing them. Among the adverse effects: incontinence, infections, bleeding, injuries, chronic pain.
A “life destroyed” by prostheses
“We are aware of the dismissal of 111 complaints filed by women whose lives were destroyed by the installation of vaginal prostheses without them having been informed of the possible consequences for their health,” the plaintiffs’ lawyers confirmed to AFP. Hélène Patte, Amandine Sbidian, Dorothée Bisaccia and Laure Heinich.
“Some of them were seriously disabled,” they stressed, recalling that “the installation of these prostheses has been condemned throughout the world due to the health scandal they represent.”
They intend to present an “appeal to the prosecutor’s office to appoint an investigating judge from the health center of the judicial court of Paris.”
The plaintiffs could also turn to civil justice to obtain compensation for the damage caused by these devices to their health.
A complainant says she is “falling from the clouds”
Anne-Laure Castelli, a plaintiff who launched the “Balance ta bandelette” collective, said that this classification “struggled” her. “There were reasons for the investigation to continue.”
In the United States, prostheses placed vaginally were classified as “high risk” in 2016 and banned in 2019. The procedures were carried out in the English-speaking world and several laboratories paid heavy fines, especially in the United States, to solve the problem. problem. demands.
In France, the placement of implants for vaginal prolapse has been suspended since 2019. Those placed through the abdomen and certain suburethral strips remain authorized and their installation is already regulated.
Source: BFM TV
