Published on
Updated
Reading 3 mins.
in collaboration with
Dr Odile Bagot (Gynecologist-obstetrician)
More than forty women have filed a complaint for “deception and involuntary injuries”, due to complications suffered following the installation of sub-urethral strips. Like reinforcement prostheses, they are medical devices often presented as an easy solution to the problems of urinary incontinence and organ descent. But although thousands of operations are performed each year, they are not without risk.
After one or more deliveries or approaching menopause, it is not uncommon for a woman to suffer from urinary incontinence or a descent of organs (genital prolapse). Sub-urethral strips, placed around the urethra to treat incontinence or reinforcement prostheses intended to lift the organs, are sometimes offered as a treatment by surgeons.
Forty plaintiffs
Among these women who have undergone this type of outpatient surgery, around 40, aged between 40 and 80, have filed a complaint against X for deception and unintentional injuries twice, in 2020 more in 2021. And this, after suffering complications at the following these surgeries, for events spanning from 1995 to 2019.
These women have obtained the opening of a preliminary investigation in Paris, since April 20, 2021, for “aggravated deception and unintentional injuries“. These victims believe “that they have not been informed of the risks of irreversible complications” caused by these devices, which have been “validated in France despite insufficient clinical studies“.
No more complications
According to the National Medicines Safety Agency (ANSM), around 50,000 such devices are sold each year in France, two-thirds being sub-urethral strips. Unlike other medical devices, the marketing of these devices does not require a marketing authorization but a CE certification called European conformity.
Moreover, according to the ANSM, two materiovigilance surveys that took place in 2005 and 2016 did not conclude that there was an abnormal frequency of complications, the figure of which is around 1.5%.
permanent suffering
However, for these women, who are now taking this legal action, life has turned into a real ordeal. They report suffering from various adverse effects following the installation of these strips: for some it is incontinence, but others suffer from infections, bleeding, various lesions, chronic pain. A plaintiff even says “a sensation of quartering at the vaginal level preventing any sexual relationship” and for the most severe cases, difficulty walking.
For them, the manufacturing laboratories have “knowingly minimized or even concealed the risks” presented by their devices. More seriously, some women report never having signed a consent before the operation.
Can’t go back
Placed vaginally, these suburethral strips or these pelvic reinforcement prostheses become embedded in the tissues over time and removal is often very difficult or even impossible. When some of the complainants wanted to have their device removed because of the pain, the operations were often unsuccessful.
When asked, Dr. Odile Bagot, gynecologist and member of the Doctissimo expert committee, explains that the strips remain a good device on two conditions: “The laying of the strip must be done on a woman who has a good indication for surgery, ie urinary incontinence linked to a transmission defect. This is the case when the urinary sphincter is no longer located in the abdominal cavity. The second condition is that the surgeon knows how to perform the surgical procedure correctly. If these two conditions are met – without there being any operational risk – no problem, the strips will work well. And indeed, their removal is very complicated, because it can lead to total urinary incontinence, pain during urination, the impossibility of emptying the bladder or other problems..
Certain devices still authorized in France
Since 2019, in France, the use of reinforcement prostheses intended for the treatment of organ descent, placed vaginally has been suspended by decree. These prostheses can neither be purchased nor used by a health establishment, outside the framework of clinical research.
On the other hand, various models of implantable devices intended for the treatment of urinary incontinence via the vagina are still authorized – the famous sub-urethral strips – as well as reinforcement prostheses intended for the treatment of the descent of organs placed via the abdominal route.
However, a reassessment of these devices is planned, according to the ANSM. And the High Authority for Health (HAS) announces for its part “currently working on the management of complications of surgery with prosthesis of stress urinary incontinence and female genital prolapse”.