Vaginal implants are devices proposed to combat urinary incontinence and organ descent. Problem is, these strips can cause significant complications.
Pelvic implants intended to combat urinary incontinence or organ descent are suspected of being responsible serious complications. The complication rate varies from 1.4 to 2.8% reports the Medicines Agency. These implants have been placed under reinforced surveillance.
What is a vaginal implant?
Developed since the end of the 1990svaginal implants are medical devices designed to treat a certain type ofurinary incontinence And organ descent (genital prolapse or pelvic prolapse). There are two types of devices on the French market.
► To treat urinary incontinence: This is‘a strip suburethral placed vaginally to support the urethra.
► To treat organ descent: This is’a reinforcement implant which is placed by abdominal routemost often under laparoscopy, in order to strengthen the perineume. But this solution, which was intended to be ideal, led to complications (bleeding, infections, chronic pain, incontinence, etc.) in many women. “These prostheses are an excellent solution for women who have stress urinary incontinence because raising the urethra will cure them and offer them an excellent quality of life for many years, argues Dr Odile Bagot. However, there was indeed complications in some women which alerted the HAS a few years ago and which gave rise to recommendations”.
What are the current recommendations?
In order to limit the risks of side effects, the patient journey must be better supervised.
- Due to the numerous complications reported since 2014, vaginal implants are the subject ofreinforced surveillance. “Since the entry into force of the new European Regulation 2017/745, these medical devices belong to risk class III (high risk)”, note the ANSM.
- Early 2019, the High Authority of Health (HAS), the General Directorate of Health (DGS) and the National Medicines Agency (ANSM) analyzed the various existing vaginal implants. Half have been withdrawn from the market.
- The decree of October 23, 2020 frames the installation of suburethral stripsin particular: initial assessment in consultation, patient information, decision taken in consultation by a multidisciplinary pelvi-perineology team, trained surgeon, follow-up document for the patient.
- The decree of September 22, 2021supervising the placement of vaginal reinforcement implants via the upper route stipulates that the surgeon must be trained in laparoscopic and upper insertion in open surgery. “We realized that there were more complications among surgeons who performed this type 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 placed. “This device should only be offered if and only if rehabilitation has been correctly carried out beforehand, it is never a first-line treatment. If rehabilitation has not been sufficient and there is a real deterioration in quality of life, this urinary incontinence must be validated by urodynamic tests. If the examination shows that it is stress incontinence due to lack of transmission then there is a real indication for surgery. informs our expert.
What are the warning signs?
In a press release dated April 17, 2023the HAS reveals the signs which should alert women and encourage them to consult:
- signs of infection: fever, red scar, hot and elevated
- sexual signs, such as pain during sexual intercourse
- urinary signs: urinary burning, significant difficulty urinating, frequent urge to urinate
- digestive signs: incontinence or anal bleeding
- persistent or severe pain