Investigation in France on vaginal implants for deception and unintentional injuries

The same “tearing inside” pains, the same feeling of having been cheated on and then abandoned. Subjected to serious side effects since the placement of vaginal implants, some forty patients obtained the opening of an investigation in Paris, believing that they had not been informed of the risks of irreversible complications.

In December 2019, Catherine M. emerged from an operation that lasted about thirty minutes with a strip, a small polypropylene net installed under the urethra, which was supposed to solve her stress urinary incontinence.

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

“I’ve always trusted doctors,” he says bitterly. However, very quickly, his state of health deteriorated: a sharp “electric pain” in the pelvis and left hip, “as if torn, radiating to the foot.”

Impossible to sit, have sex life, walk. He followed a six-month sick leave, a depression: “I blame them for not letting me know we couldn’t remove it,” she said.

Suburethral straps and pelvic buttress prostheses, placed vaginally or abdominally, are medical devices developed since the late 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 aggravation” according to the High Authority for Health (HAS). Once placed, they are incorporated into the tissues.

According to the website of the National Agency for the Safety of Medicines and Health Products (ANSM), around 50,000 devices are sold in France annually, 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 the implant removed, which had become too painful, often without success. Marie-Christine S. has thus been subjected to seven operations since she had the prosthesis placed in 2002, according to the elements presented to the court.

“These are really sacrificial bodies,” Me Laure Heinich gets emotional.

Amélie (first name changed), 40, underwent surgery in November 2019 for a prolapse. “I have an implant that I never wanted, I never had a consent document,” she laments, very emotional.

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

“It destroyed my life,” adds Stéphanie Neplaz, who feels she was used as a “guinea pig” during the placement of an incontinence strip after her pregnancy in 2016.

They are all part of the forty women, from 40 to 80 years old, who signed two complaints against X -in 2020, then in 2021- for events ranging from 1995 to 2019.

A preliminary investigation has been open since April 20, 2021 for aggravated deception and involuntary injuries, entrusted to the Office for the fight against attacks on public health (OCLAESP), according to the Paris prosecutor’s office, requested by AFP.

Were the lab instructions honest and complete? Have surgeons informed their patients about the risks? Did they place the implants correctly? Were the controls of the health authorities sufficient?

– “Good faith” –

The plaintiffs contend that the laboratories knowingly downplayed or even concealed the risks posed by their devices, in particular the difficulties, even inability, to recall them.

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

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

Its marketing did not require marketing authorization but CE certification (European conformity). The first material surveillance surveys in 2005 and then in 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, vaginally placed stents were classified as “high risk” in 2016 and banned in 2019.

A year later, the pharmaceutical group Johnson & Johnson was sentenced there to pay 344 million dollars for misleading and misleading advertising in the marketing of pelvic implants from its subsidiary Ethicon.

Then the US company Boston Scientific paid $189 million to settle the lawsuits.

– 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 in 2007 required “comparative clinical data to confirm the interest” of vaginally placed prolapse implants, according to an assessment available online.

Its use has been suspended since a ministerial decree of February 2019. On the other hand, abdominal and suburethral placement strips continue to be authorized and marketed, according to a list from the Ministry of Health dated August 31.

“The problem of urinary strips is radically different in terms of liability than 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 are always used first.

According to HAS recommendations, surgeons should only place implants as a last resort, “provide full information to patients” and “associate” them with the decision. “The thing was very framed”, we underlined in the HAS.

The ANSM did not respond to AFP requests.

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