The International Consortium of Investigative Journalists reveals, through the operation "Implant Files," how medical implants are not adequately tested before being marketed. If you could not see Marie Maurice and Edouard Perrin's research published on France 2 on Tuesday in "Cash Research", franceinfo has selected excerpts.
A laboratory that puts an implant in the market without knowing its life and without carrying out any clinical trial? It's possible. a Collective survey entitled "Implant files", about medical devices, and performed by the International Consortium of Investigative Journalists (ICIJ), of which "Cash Investigation" is a partner, reveals that for The market in France is a medical device (stent, valve, breast prosthesis, vaginal prosthesis, etc.), studies are superfluous. A simple file sent to a certification body may be sufficient. The magazine of France 2 "Cash investigation"I dedicated a number to this survey on Tuesday, November 27. Here are the sequences that should not be missed.
The testimonies of two vaginal prosthesis carriers who live a calvary.
Each year, almost 50,000 women undergo a vaginal prosthesis to treat organ loss or incontinence. This is the case of Natacha and Cathy This medical device, which consists of a synthetic mesh that supports the bladder, often works. But not in your case.
As soon as it is implanted, this prosthesis makes Natacha suffer. "At the level of the leg, I have all the time the shots of electricity, pains like a toothache, a thing that does not stop ", She says. Once in place, it happens that the net retracts and then pulls the meat, which can be very painful. The doctors tried to remove this prosthesis … but it was not designed to be explanted. Natasha is now condemned to live with her pain.
Three years after the installation of a vaginal prosthesis, in 2010, the first pains also appear in Cathy. "Every time I urinated, I cried, I moaned, I was about to faint", she testifies today. A radio concludes that parts of your prosthesis move in your vagina and bladder. It is operated several times, but the surgeon can not remove all the pieces.
When "Cash Investigation" launches its fake implant business.
To verify the safety of the process of placing implants in the market, "Cash Investigation" has tried the crazy bet to obtain the authorization of the National Agency for the Safety of Medicines and Health Products (ANSM) for a fictitious vaginal prosthesis.
The show team followed the process and the ANSM response arrived by email: "You will receive an acknowledgment as soon as we have registered your medical devices, but you do not have to wait for this document to put your medical devices on the market." Yes: in France, medical devices do not need a marketing authorization (MA), unlike medicines. The ANSM is just a registration chamber for implants. Registering a prosthetic can is possible.
The leading manufacturer of vaginal prostheses knew the risks of complications.
"Cash research" has discovered internal documents from Ethicon, which makes the most famous vaginal prosthesis, Prolift. At the time the company is in the design phase of the product, during the 2000s, these documents indicate that "Long-term clinical data will not be needed to launch the product".
During the one-year study that takes place, the Complications of future prostheses already appear. But for a senior Ethicon executive, these effects are "the price to pay" for some of the women who will be operated on. "They did not warn doctors, they did not warn patients" These possible complications, argues the lawyer Adam Slater, who has already managed to obtain damages from the company for three women suffering from a vaginal prosthesis.
"The first patients, (…) are guinea pigs", according to the inventor of the main vaginal prosthesis.
Professor Bernard Jacquetin is the inventor of the future Prolift prosthesis on behalf of Ethicon. In 2005, in a letter sent to the company, he warned the manufacturer against the risks of pain with his prosthesis: "I do not want my wife to undergo this intervention."
Now, he believes that the problem is "behind us". The complications found by some patients. "we [ont] Permitted much progress in the knowledge of perineal pain ".Defend the scientist with "Cash Research". What about the first patients, who still have pain? Are they guinea pigs? "Unfortunately if", recognizes Bernard Jacquetin. "Can you understand that one day, once you have an innovation … In fact, the first patients, we can say that they are guinea pigs, people who are suffering from the plaster of innovations, yes. (…) But how to avoid it? "
The testimony of a victim of breast implant lymphoma.
Clara worked as a caregiver in a hospital in the suburbs of Washington in the United States. In May of 2018, doctors diagnosed a stage 4 lymphoma, the highest, related to it. textured breast implants. This medical device has already caused the death of 16 women around the world.
Clara is now under chemotherapy. It is in the gym that is measured by the disease: "I really want to run, but I can not breathe, so I'm trotting in. Actually, I have clots in my lungs and if I'm pushing too hard, it's hard to breathe." The last time I did that, I ended up in the emergency room, so … ", She testifies.
The longevity of this heart valve is unknown.
It is a strange object, half ring, half crown: a valve that is deposited in the heart, without surgery. This valve is called Tavi (Implantation of a transcatheter aortic valve). This innovation was originally intended for elderly and inoperable patients. Nowadays, manufacturers want to extend it to younger patients. The key: a market of 5 billion euros. But she presents a pproblem: the life of this valve is little known, while it is not possible to eliminate it.
There is one Study of the manufacturer of the valve, of the company. Edwards. But this one does not follow. The valve only for one year, once put. A time too short for Truly studies his longevity, complaint. Rachid Zegdia cardiac surgeon in the region of paris He has been investigating the Tavi for ten years. But do not worry, says its manufacturer: if the Tavi is aging badly, manufacturers can re-implant one inside the first prosthesis.
Interview with the Minister of Health, Agnès Buzyn.
In England, the use of vaginal prostheses has been suspended since July 2018. Liken Australia, where most vaginal implants have been suspended, and where the Minister of Health has apologized to women who have suffered these devices. Asked about the health emergency of these medical devices, the Minister of Health, Agnès Buzyn, assures that "discover the subject" because the "warning devices" The medical conditions are not the same everywhere. But she promises "look[r] What are alerts? of the ANSM. And ensures "That medical devices are not sufficiently regulated and that it is a concern for the minister that I am."
Regarding lymphoma related to breast implants, the minister wants to reassure patients. "Today I tell women that the risk of having a lymphoma related to a breast implant is very low, we are about 50 cases for 500,000 women, it is still a very rare disease (…) By against the lowest risk of warning in a chest, of course, it is necessary to consult immediately. "
"In the 48 hours prior to our interview."There have also been two new announcements on the subject, says Elise Lucet: the launch of a public ANSM hearing on the use of breast implants, which now recommends the use of breast implants with a soft envelope. and a statement from the French scientific societies that decide to stop implanting certain breast prostheses.