European coalition of patients · 2026
Thousands of women across Europe live with serious complications from gynaecological, urological and pelvic floor implants. We ask that their voices be heard, that every implant be identifiable and that European rules be genuinely enforced.
7
European countries engaged
8
demands put forward
12
documented complications
2026
ICS congress, Maastricht
01 — The problem
In France, women carrying sub-urethral slings, mesh implants for prolapse and other gynaecological medical devices report sometimes severe complications and particularly difficult care pathways.
But these testimonies are not specific to France. We are in contact with women and organisations in Belgium, the Netherlands, Spain, Portugal, Ireland and the United Kingdom.
The same questions come back, across different health systems.
We ask simply that these situations be examined medically, scientifically and regulatorily, without patients’ voices being set aside.
Where we start
“What we live through goes far beyond our personal stories and French borders. It is the whole of Europe that is concerned.”
We are not asking for implants to be condemned as a matter of principle. We ask for an independent, transparent and evidence-based assessment that confronts patients’ experience with medical and regulatory data.
02 — The EU framework
The European Union already has a common regulatory framework for medical devices, in particular Regulation (EU) 2017/745.
Article 18 provides that information identifying an implanted device must be supplied and that patients must be able to access relevant information about their implant. This regulation is a major step forward.
But one question remains.
How can we verify that these rights are genuinely applied in practice across all Member States?
03 — Our demands
We ask that existing rules be applied, and that gaps be identified and then corrected.
Ensure that every patient can precisely identify the implanted device, its manufacturer, reference and lot number.
Enable people implanted years ago to retrieve information about their device, even where registries are incomplete.
Collect, harmonise and analyse reports from all Member States, distinguishing those submitted by patients themselves.
Assess whether sufficiently precise European data exist on complications appearing years after implantation.
Check whether each Member State has structures able to manage complex complications linked to these devices.
Identify the training and expertise available in Europe for surgeons who remove these implants.
Verify whether European obligations on information and informed consent are genuinely applied before and after implantation.
Establish how already-implanted patients are informed when a device is modified, withdrawn from the market or subject to a safety alert.
04 — Testimonies
We are not talking about abstract data. We are talking about women living today with the consequences they report after implantation, and who simply ask that their voices be heard.
The dossier submitted to the institutions brings together testimonies, medical and scientific evidence, regulatory documents and identification of the implants.
Élodie · Belgium · 2023
“She was euthanised in Belgium after the implantation of a medical device. She could no longer bear the serious consequences imposed on her body, for which she had never given informed consent.”
Like millions of women worldwide and thousands in Europe, Élodie never received an answer proportionate to what she was living through.
One journey among others · France
On 8 July 2021, a patient underwent surgery for pelvic organ prolapse. During the operation, several medical devices were implanted: double promontofixation and a sub-urethral sling for incontinence.
Following these two procedures performed on the same day, she developed severe, disabling pain and numerous functional difficulties.
“Today I am in a wheelchair, on disability and dependent, when I had a wonderful job for 28 years in the automotive industry, with significant responsibilities. I lost everything.”
Some information about her implants could only be obtained through proceedings initiated with her lawyer. Hence the question: how can a patient ensure her own safety when she does not have precise information about the device inside her body?
Testimonies collected by the coalition and published with the consent of the people concerned or their families.
05 — Campaign
Posters and creations carried by patients and member associations of the coalition. They circulate freely, online and on the ground, to name what the women concerned live through and to repeat what they are asking for.
Visuals shared with the consent of their authors.
European implantable medical device card
The implant card, required by Article 18 of Regulation (EU) 2017/745, is an essential tool for the safety and traceability of implantable devices. It must identify the device and the manufacturer and include at least the manufacturer’s website, the implantation date and blank fields for additional information. Manufacturers of implantable medical devices must provide this card to every patient after the procedure, so that essential information is quickly available in an emergency.
06 — Traceability
When a complication appears years after an operation, precise identification of the device becomes essential. The patient must be able to know:
Is there today a genuine European assessment of whether this traceability works in practice? And what happens to people implanted before current traceability systems existed?
07 — Device vigilance
When a woman experiences a complication after implantation of a medical device, she must be able to report it. For that data to genuinely contribute to patient safety, the device concerned must also be correctly identified.
Some implants are banned abroad or withdrawn from the market after complaints. Patients already implanted are not always informed.
We ask that the following be examined at European level
07 — What the authorities acknowledge
In 2020, 2023 and 2025, the French High Authority for Health (Haute Autorité de santé, HAS) published recommendations on complications of prosthetic surgery for stress urinary incontinence and genital prolapse.
It stresses the importance of recognising and investigating complications, providing appropriate care, training professionals, clearly informing patients, ensuring implant traceability and organising proper follow-up.
This shows that the problem is not a matter of isolated testimonies. Health authorities themselves acknowledge the reality and complexity of these complications.
Reference documents
One central question remains: who actually monitors how these recommendations are applied in the Member States?
09 — Mobilisation
From 6 to 9 October 2026, the International Continence Society holds its world congress in Maastricht, the Netherlands. The congress brings together professionals from around the world around urology, uro-gynaecology, continence and pelvic floor disorders.
We will be there to carry a European voice, despite the disability and mobility difficulties some of us face. Women and men affected, as well as patient representatives from different countries, will also make their voices heard.
Our mobilisation is not intended to replace scientific dialogue. On the contrary, we want that dialogue to include the voice and experience of patients.
10 — The coalition
Our goal is to bring together the voices of women concerned in several countries and to build a genuine European voice for patients carrying gynaecological, urological and pelvic floor medical devices.
Our health systems differ. Our languages differ. But the questions we ask are similar. We do not want each country to discover the same difficulties separately.
A problem affecting several European countries deserves a European response.
Countries engaged and in contact
11 — Take action
We ask French and European parliamentarians to help us bring this question to the competent European institutions. Patients must be involved in discussions that directly concern their safety.
Are the rights set out in European regulation genuinely guaranteed to every patient carrying an implantable medical device?
Write to the coalition
Patient, relative, organisation, healthcare professional, parliamentarian or journalist: your message matters. Describe your situation or your meeting request.
Prefer email? contact@europeanmeshcoalition.eu