Last month, a large-scale investigation dubbed the “Implant Files” and carried out by the International Consortium of Investigative Journalists (ICIJ) revealed worrying gaps in the control of implants in Europe. In this context and among these medical devices, reinforcement implants intended for the treatment of genital prolapse and female urinary incontinence are now inspected by the National Medicines Safety Agency (ANSM).
The drug gendarme thus announced in a press release that it will bring together patients and healthcare professionals (urologists, gynecologists, general practitioners, nurses, midwives) on January 22 to assess the benefits and risks associated with these implants. Following this meeting, the agency will issue recommendations on their use in France.
Growing concerns
In women, genital prolapse consists of a descent of organs, due to age or childbirth for example. It can become uncomfortable, so abdominal surgery is sometimes necessary. A prosthesis is thus implanted between the vagina and the bladder. Female urinary incontinence is an involuntary loss of urine, especially during exertion. This pathology, which would affect between 25 to 40% of women, can be disabling on a daily basis, and surgery can also be considered. Strips are thus placed to strengthen the sphincter of the bladder.
But concerns around these medical devices are growing. In 2013, the Prolift prosthesis marketed by Johnson & johnson was withdrawn from the French market, along with three other similar implants. Complaints from patients abroad reported, among other things, severe chronic pain, organ perforations or infections.
Inspections at manufacturers
“The ANSM has few reports at this stage of the investigations on reinforcement implants. This is why the agency asked, on November 23, 2018, that patients and healthcare professionals report any adverse effects occurring after fitting these medical devices ”, assures the organization in its press release. Since then, five patients have reported side effects related to these reinforcement implants.
The agency also recalls that since March 2018, inspections have been carried out at French and foreign manufacturers of devices for the treatment of prolapse and urinary incontinence. Seven companies have so far been inspected. As a result of these checks, the company CL Medical was asked to withdraw her implants from the market as she did not have a valid Certificate of European Conformity (CE). However, these evaluations have limits: the “Implant Files” revealed a dysfunction in the very issuance of this CE marking, which validates medical devices in Europe.
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