Vaginal implants: towards a new public health scandal?

Vaginal implants towards a new public health scandal

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    in collaboration with

    Dr Ghada Hatem (Gynecologist)

    Medical validation:
    November 17, 2023

    Upsetting testimonies of serious complications linked to the placement of vaginal implants are increasing. Even if they are rare, their seriousness calls into question the continued existence of these devices on the market, the training of practitioners, listening to victims and the absence of alternatives for patients.

    In 2020, 21 women filed a complaint after applying these famous strips… followed by 57 others in recent weeks. These implants cover two indications. They may be indicated in cases of urinary incontinence, which affects between 25 to 40% of women. This then involves a suburethral sling, an implant to support the urethra, placed vaginally in around 30,000 women per year. The other indication concerns the management of organ descent to strengthen the perineum (after a difficult childbirth or with aging), with the placement of the implant through the abdominal or upper route, most often carried out by laparoscopy.

    Rare but dramatic complications

    Victims of bleeding and debilitating pain, the victims describe a daily life that has become hellish. Their testimonies in the media and on their Facebook group sends shivers down your spine.

    • Stéphanie Dupin, 42, had “mild urinary incontinence” and was given a vaginal implant by her surgeon, supposed to be “quick and painless”, she said on the microphone of France Inter. A few operations later, and while her incontinence is still not resolved, this application of strips turns into a nightmare: Stéphanie Dupin has seen her urethra severed and must undergo repair, then a transplant. Now 50% disabled, this executive assistant can no longer work full time and is suffering permanent pain “in the pelvis, thighs, very severe pain which prevents me from moving normally, which makes me limp , which leave me lying down for part of my time.
    • Anabela managed to have her prosthesis removed in Toulouse after years of suffering, she hopes that the pain will disappear soon.Don’t let other women experience what we experienced!” she declares in The Parisian.
    • Elodie learned that she had been given a pelvic implant to strengthen her perineum without having spoken to her about it first. The pain was so “that after four years of agony, her husband accompanied her to be euthanized this summer in Belgium“, precise the Parisian. These prostheses against organ descent will be banned (belatedly) in February 2020 in France, as the number of complications was so high. From 2017 in Australia, these devices could only be implanted as part of clinical studies.

    Because the problem is not specific to France, it is making headlines in the United States, in England… Across the Channel, many women are affected and one of them has just obtained almost a million euros in repairs.

    Implants that were not designed to be removed

    But how can we explain this record number of after-effects? Are they the consequence of a lack of information? Poor training of practitioners? Defective devices?…

    The material used, propylene (for the prostheses still used) is known and normally well tolerated but in a minority of women, the body will identify the strip as a foreign body and will cause contraction of the muscles around it, the surrounding tissues may be affected… The risk of complications for an implant against prolapse at one year is more than 3% according to the latest results of the VIGI-MESH survey set up in 2018.

    The main problem is that these prostheses were not designed to be removed. Only a few practitioners risk it with complex procedures, sometimes adhesions to the bone or damage that removal of the prosthesis alone cannot resolve.

    Devices under surveillance for more than 10 years

    These devices quickly received particular attention.

    • In France, these implants have been subject to special monitoring since 2014 by the National Health Product Safety Agency at the national level, then at the European level.
    • In 2017, the Vigimesh study is monitoring patients who have undergone surgery and those who have suffered complications (it is coordinated by the Poitiers University Hospital). Its financing is provided by the ANSM from 2017 to 2022. Today, according to Xavier Fritel, head of the Vigimesh monitoring register interviewed by ReleaseSince then, we have been looking for new funding to continue to follow the women“.
    • At the beginning of 2019, the High Authority for Health (HAS), the General Directorate of Health (DGS) and the National Medicines Agency (ANSM) reviewed the various existing medical devices. Results: half are withdrawn from the market.
    • In October 2020, a stopped has regulated the installation of these vaginal implants: the patient must be informed of the risks, the decision of such an indication must be taken during a multidisciplinary consultation meeting, the patient receives a tracking document and must benefit from a follow-up consultation the month following implantation, the surgeon must be sufficiently trained…
    • The decree of September 22, 2021, governing the placement of vaginal reinforcement implants via the upper route, specifies that the surgeon carrying out the placement of these implants must be trained in this installation by laparoscopy and via the upper route in open surgery.
    • Questioned by our colleagues from Le Parisien, the High Authority of Health reportedly indicated that it will re-evaluate these implants against incontinence from spring 2024.

    Prostheses placed vaginally have been banned in the United States since 2019, the same thing more recently in the United Kingdom.

    The training of practitioners in question

    For Dr Ghada Hatem-Gantzer, obstetrician-gynecologist, recalls that these devices are useful for thousands of women each year. These dramatic complications remain isolated. The training of the surgeons who placed this implant is also questioned.

    Complications suffered after installation are not very common. As proof, this strip has been given to thousands of women, who have experienced it well. It helps prevent you from peeing on yourself, which is quite comfortable. Despite everything, it is true that some women complain of significant pain. For still others, the strips, once applied, come out through the vagina. In my opinion, the health professionals who carried out the installation did not do it with enough rigor. While it sounds simple on paper, it actually requires some expertise” underlines the expert.

    This is also the opinion of Xavier Deffieux, gynecologist-obstetrician at the Antoine Béclère hospital in Clamart, collected by France Inter who emphasizes that it is a question of“a surgical technique which has a very good benefit-risk balance” and for which the “recommendations have evolved considerably, particularly following complaints and their media coverage“.

    Indeed, in April 2023, the High Authority of Health will develop recommendations to precisely regulate the management of complications. They remind in particular that the patient must receive information before the operation, a traceability document must be systematically given to her after each operation, post-operative follow-up includes at least two compulsory consultations, the first in the month following the operation, the second 1 year later.

    Gynecologists call for a national plan

    On November 16, the National College of French Gynecologists and Obstetricians (CNGOF) called for a national plan for the management of perineal disorders including prolapse, incontinence and the after-effects of childbirth. According to this union, this plan “must be developed and managed in collaboration with the supervisory authorities, patient associations but also learned societies and academies of medicine and surgery, as well as the various health professionals involved.s”.

    It should, according to them, guarantee the management of complications in multidisciplinary centers involving at least gynecologists, urologists, algologists, rehabilitation specialists and radiologists, sufficient training for the health professionals in charge, multidisciplinary meetings for the indication of implants , to make a national register of operated patients and their possible complications compulsory… So many provisions already in place.

    The real new suggestion is to develop, reimburse and better evaluate alternatives to these devices within the framework of reinforced research programs (for example peri-urethral injections, not reimbursed). It is indeed time… as it is time more generally to take better account of chronic pain in women.