A hundred women in France filed a complaint following the installation of implants aimed at treating their urinary incontinence or organ descents.
Each year, around 30,000 vaginal implants are placed in France. These implants aim to fight against urinary incontinence or the descent of organs and are suspected of being responsible for serious complications. In July 2024, France Inter reported that a hundred women in France decided to file a complaint against X for “deception” and “involuntary injuries” after the installation of vaginal implant. “When a doctor tells the patient that this device is permanent, she hears that she will not need to have him replaced, not that she will not be able to remove it” explains France Dumoulin, member of the collective of patients perineal French strips in Ouest France. Once established, the plastic fabric of the implant is attached to the flesh making its withdrawal. The complications rate would vary from 1.4 to 2.8% depending on the official figures from the Medicines Agency. “Rare” complications but which “can be severe” confirms the high authority of health. These implants were placed under reinforced surveillance.
What is a vaginal implant?
Developed since the late 1990s, vaginal implants were medical devices designed to treat a certain type of urinary incontinence and organ descent (genital prolapse or pelvic prolapse). There are two types of devices on the French market.
► To treat urinary incontinence: it is a sub-commissioned strip placed vaginal to support the urethra.
► To treat an organ descent: it is a reinforcement implant which is placed by abdominal route, most often under celioscopy, in order to strengthen the perineum. But this solution which was intended to be ideal led to complications (bleeding, infections, chronic pain, incontinence …) in many women. “These prostheses are an excellent solution for women who have urinary incontinence of effort because the fact of going up the urethra will heal them and offer them an excellent quality of life for many years, argues Dr. Odile Bagot. However, there were indeed complications in some women who alerted the HAS a few years ago and who have given rise to recommendations. ”
What are the current recommendations?
Due to the numerous complications reported since 2014, vaginal implants are subject to enhanced monitoring. “Since the entry into force of the new European regulation 2017/745, these medical devices belong to the III risk class (high risk)”, note the ANSM.
- In early 2019, the High Authority for Health (HAS), the Directorate General for Health (DGS) and the National Medicines Agency (ANSM) analyzed the existing vaginal implants. Half were removed from the market.
- The decree of October 23, 2020 supervises the installation of sub-European strips, in particular: initial assessment in consultation, information of patients, decision taken in consultation by a multidisciplinary team from Pelvi-perineology, trained surgeon, follow-up for the patient.
- The decree of September 22, 2021, supervising the installation of vaginal reinforcement implants by highway stipulates that the surgeon must be trained in launching by celioscopy and highly in open surgery. “We realized that there were more complications among surgeons who practiced this kind of intervention less, hence a requirement for training and skills”, comments the gynecologist.
“It is never a first -line treatment”
The indication must also be well laid. “This device should not be proposed if and only if rehabilitation has been properly carried out before, it is never a first -line treatment. If rehabilitation has not been enough and there is a real alteration of quality of life, it is necessary to objectify this urinary incontinence by urodynamic tests. informs our expert.
What are the signs that should alert?
In an April 2023 statement, the HAS unveiled the signs that must alert women and encourage them to consult:
- Signs of infection: fever, red, hot and raised scar
- sex signs, like pain during sexual intercourse
- Urinary signs: urinary burns, important difficulties to urinate, frequent desires to urinate
- Digestive signs: incontinence or bleeding at the anal level
- persistent or important pain in terms of scars or from them (abdomen, lumbar, etc.).
The surgical option in the treatment of urinary effort or prolapse incontinence must always be made in the context of a medical decision shared with the patient. The HAS reminds all patients the need to speak to a doctor of the slightest evocative sign of complications and to systematically and as quickly as possible declare all forms of post-operative complications via the signaling.gouv platform.
