The same pains of “tearing from within”, the same feeling of having been duped, then abandoned.

Subject to serious side effects since the placement of vaginal implants, around forty patients obtained the opening of an investigation, in Paris, believing that they had not been informed of the risks of irreversible complications.

Tissue-embedded implants

In December 2019, Catherine M. came out of an operation lasting about thirty minutes with a strip, a small polypropylene net installed under the urethra, supposed to solve her urinary stress incontinence.

The implant had been presented as the "ideal solution, on an outpatient basis", says this fifty-year-old teacher, during a meeting with other plaintiffs assisted by their lawyers Mes Laure Heinich, Hélène Patte, Dorothée Bisaccia-Bernstein and Amandine Sbidian.

“I have always trusted doctors,” she says bitterly.

However, very quickly, his state of health deteriorates: a sharp "electric pain" in the pelvis and the left hip, "as if it were torn, which radiates into the foot".

Impossible to sit, to have a sex life, to walk.

There followed a six-month sick leave, depression: "I blame them for not having informed me that we could not remove it," she said.

Suburethral strips and pelvic reinforcement prostheses, placed vaginally or abdominally, are medical devices developed since the end of the 1990s. These implants are intended respectively for the treatment of urinary incontinence and prolapse (descent) of the pelvic organs - a phenomenon "generally not dangerous" and without "risk of rapid deterioration" according to the High Authority for Health (HAS).

Once laid, they are incorporated into the fabrics.

According to the website of the National Agency for the Safety of Medicines and Health Products (ANSM), around 50,000 devices are sold annually in France,

two-thirds to treat urinary incontinence.

In 2019, 8 of the 19 manufacturers shared almost 90% of the market.

Consent

Some patients wanted to have their implant removed, which had become too painful, often without success.

Marie-Christine S. has thus undergone seven operations since the fitting of her prosthesis in 2002, according to the elements brought to justice.

“These are really sacrificed bodies”, is moved Me Laure Heinich.

Amélie (first name changed), 40, was operated on in November 2019 for a prolapse.

“I have an implant that I never wanted, I never had a consent document,” she laments, very moved.

Among the side effects: incontinence, infections, bleeding, lesions, chronic pain.

"It destroyed my life," adds Stéphanie Neplaz, who feels like she was used as a "guinea pig" during the laying of a strip to solve incontinence following her pregnancy, in 2016. All are part of the quarantine of women, aged 40 to 80, who signed two complaints against X - in 2020, then 2021 - for facts spanning from 1995 to 2019. A preliminary investigation has been open since April 20, 2021 for aggravated deception and injuries involuntary, entrusted to the Office for the fight against attacks on public health (OCLAESP), according to the Paris prosecutor's office.

Were the laboratory instructions sincere and complete?

Have surgeons informed their patients of the risks?

Did they place the implants correctly?

Were the checks by the health authorities sufficient?

“Insufficient clinical studies”

The plaintiffs maintain that the laboratories knowingly minimized or even concealed the risks presented by their devices, in particular the difficulties - even the impossibility - of removing them.

“While sympathizing with all women who experience medical complications related to pelvic organ prolapse, Ethicon has acted in good faith based on sound scientific evidence regarding the research, development and marketing of our product,” a statement from this subsidiary of Johnson & Johnson, one of the laboratories involved.

According to the complainants, these devices have been validated in France despite “insufficient clinical studies”.

Their marketing did not require marketing authorization but CE certification (European conformity).

The first materiovigilance surveys in 2005 and then 2016 did not conclude that there was an abnormal frequency of complications, around 1.5%, according to the ANSM website.

In the United States, however, prostheses placed vaginally were classified as "high risk" in 2016 and banned in 2019. A year later, the pharmaceutical group Johnson & Johnson was ordered to pay 344 million dollars there for advertising misleading and deceptive in the marketing of pelvic implants from its subsidiary Ethicon.

Suspended use

Australia banned pelvic implants in 2017 and in 2019 Johnson & Johnson was found guilty of negligence and deceptive practices there.

And a complaint was filed in South Africa in 2021. In France, the HAS demanded in 2007 "comparative clinical data to confirm the interest" of implants for prolapse placed vaginally, according to an evaluation available online.

Their use has been suspended since a ministerial decree of February 2019. On the other hand, those placed by the abdominal route and suburethral strips are still authorized and marketed, according to a list from the Ministry of Health dated August 31.


“The problem of urine strips is radically different in terms of responsibility from that of vaginal prostheses.

The rate of complications is also radically different, ”summarizes Dr Bertrand de Rochambeau, president of the union of gynecologists and obstetricians of France, to explain that the former are still used.

According to HAS recommendations, surgeons should only place implants as a last resort, “provide complete information to patients” and “involve” them in the decision.

“Things were extremely framed”, we underline at the HAS.

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