the eight sequences of "Cash Investigation" that should not be missed

A laboratory that puts an implant on the market without knowing its life, and without conducting any clinical trial? It's possible. A Collective Survey entitled "Implant Files", on Medical Devices, and conducted by the International Consortium of Investigative Journalists (ICIJ), of which "Cash Investigation" is a partner, reveals that for market in France a medical device (stent, valve, bad prosthesis, badl prosthesis, etc.), studies are superfluous. A simple file submitted to a certification body may suffice. The magazine of France 2 "Cash Investigation"devoted a number to this survey on Tuesday, November 27. Here are the sequences that should not be missed.

The testimonies of two carriers of badl prostheses who live a ordeal

Every year, nearly 50,000 women are implanted with a badl prosthesis to treat organ descent 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 their 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 which stops not ", She says. Once in place, it happens that the net retracts, then pulling on the flesh, 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 badl prosthesis, in 2010, the first pains appear also in Cathy. "Whenever I urinated, I cried, I moaned, I was on the verge of fainting", she testifies today. A radio concludes that bits of his prosthesis are moving in his bad and bladder. It is operated several times but the surgeon can not remove all the pieces.

When "Cash Investigation" launches its phony implants business

To verify the safety of the process of placing implants on the market, "Cash Investigation" has tried the crazy gamble to get the authorization of the National Agency for Safety of Medicines and Health Products (ANSM) for a badl prosthesis fictitious.

The show team followed the process and ANSM's response arrived by e-mail: "You will receive an acknowledgment of receipt as soon as we have registered your medical devices, but you do not need to wait for this document to place your medical devices on the market." Yes: in France, medical devices do not need a marketing authorization (MA), unlike drugs. The ANSM is only a registration chamber for implants. Register a prosthetic can is possible.

The leading manufacturer of badl prostheses knew the risks of complications

"Cash Investigation" has uncovered internal documents from Ethicon, which manufactures the most famous badl prosthesis, Prolift. At the time the company is in the product design phase, 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 is conducted, the complications of the future prosthesis 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 the doctors, they did not warn the patients" these possible complications, argues the lawyer Adam Slater, who has already managed to obtain damages from the company for three women suffering from their badl prosthesis.

"The first patients, (…) are guinea pigs", according to the inventor of the main badl 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 would not want my wife to undergo this intervention."

Now, he believes that the problem is "behind us". The complications encountered by some patients "we [ont] allowed much progress in the knowledge of perineal pain "defends the scientist with "Cash investigation". What about the first patients, who still have pain? Are they guinea pigs? "Unfortunately yes", recognizes Bernard Jacquetin. "Can you understand that one day, at one time you have an innovation … Indeed, the first patients, we can say that they are guinea pigs, people who are suffering the plaster of innovations, yes. ( …) But how to avoid it? "

The testimony of a victim of lymphoma of bad implants

Clara worked as a caregiver at a hospital in the Washington suburbs of the United States. In May 2018, doctors diagnosed her with stage 4 lymphoma, the highest, related to her textured bad implants. This medical device has already caused the deaths of 16 women around the world.

Clara is now under chemotherapy. It is at the gym that it 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 (Transcatheter Aortic Valve Implantation). This innovation was originally intended for older, inoperable patients. Today, manufacturers want to extend it to younger patients. The key: a market of 5 billion euros. But she presents a problem: the life of this valve is little known, while it is not possible to remove it.

There is one study of the manufacturer of the valve, the company Edwards. But this one does not follow the valve only for a year, once put. A time much too short for truly study its longevity, denounces Rachid Zegdi, a cardiac surgeon in the Paris region has been researching the Tavi for ten years. But do not panic, reports its manufacturer: if the Tavi ages poorly, manufacturers can re-implant one, inside the first prosthesis.

Interview with the Minister of Health, Agnès Buzyn

In England, the use of badl prostheses has been suspended since July 2018. Same asn Australia, where most badl implants have been suspended, and where the Minister of Health has apologized to women who have suffered from these devices. Asked about the health emergency of these medical devices, the Minister of Health, Agnès Buzyn, badures that it "discover the subject" because the "warning devices" medical conditions are not the same everywhere. But she promises to "look[r] what are the alerts? of the ANSM. And ensures "that medical devices are insufficiently regulated and that it is a concern for the minister that I am".

Regarding lymphoma linked to bad implants, the minister wants to rebadure patients. "Today I tell women that the risk of having a lymphoma linked to a bad implant is very low.We are around 50 cases for 500 000 women, it remains a very rare disease. (…) By cons at the slightest risk of warning on a bad, of course it is necessary to consult immediately. "

"In the 48 hours before our interview", there have been two new announcements on the subject, also notes Elise Lucet: the launch of a public hearing of the ANSM on the use of bad implants – which now recommends the use of bad implants with a smooth envelope – and a declaration by French learned societies that decide to stop implanting certain bad prostheses.