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Can bad implants trigger chronic diseases and even cause cancer?
This issue has been a concern for silicone implants almost since their introduction in the 1960s. It is therefore possible that the advisers of the Food and Drug Administration (US) will resume the debate at hearings on Monday and Tuesday.
But this time, women who testify that their implants have made them ill can not be considered as anecdotal cases, not too worked, or motivated by a clbad action.
International health authorities now recognize that rough surface implants – filled with gel or saline – can cause very rare lymphoma, a type of cancer of the immune system. Since the first warning issued by the FDA in 2011, nearly 700 cases and 17 deaths have been reported worldwide. Three months ago, Allergan withdrew its leading brands of textured implants from the European market after French regulators announced the suspension of their approval.
More and more scientific evidence is linking silicone gel implants to autoimmune disorders and more debilitating symptoms such as fatigue, pain and thought problems – as legions of women have been claiming for years 1990, at the time of the first FDA hearings.
Jan Willem Cohen Tervaert, an immunologist at the University of Alberta in Canada, and Mark Clemens, a plastic surgeon at the University of New Zealand, will hear two scientists at the forefront of lymphoma research and bad implants". Texas MD Anderson Cancer Center.
"The scientific literature of the late last century has been largely sponsored by the industry," said Cohen Tervaert in an interview. "Now, serious researchers show a different point of view."
It remains to be seen whether the two-day meeting will have an impact on the FDA's regulations or on implacable demand for implants. Every year, about 300,000 American women widen their bads and 100,000 cancer patients rebuild their bads with prostheses.
But as more and more women come to regret their decisions, they use social media to organize and demand major changes. Terri McGregor, 54, of North Bay, Ontario – who nearly died in 2015 – helped lobby the FDA for more than a year to hold the meeting. Activists want textured implants removed from the market. And they want a more rigorous informed consent process, as their experiences suggest that surgeons often omit or downplay the risks for women planning to be implanted.
"We think that no woman will ever say," I choose implants with a risk of cancer, "said McGregor." We say that when someone determines the risk badessment for us, instead of giving us the information we need, this is not acceptable. "
Implants filled with silicone gel were put on the market in 1962, before the FDA was empowered to regulate them.
In 1992, as more and more women accused gel implants of having serious but enigmatic health problems, including autoimmune diseases, the Commissioner for Food and Drugs, David Kessler, banned implants filled with gel, except in the framework of approved studies. The ban has alarmed women and sparked a flood of liability lawsuits because of the product that bankrupted Dow Corning Corp., a major manufacturer of implants, and led to a multi-billion dollar settlement in criminal actions.
At the time, as today, implant regulation involved public opinion, law, policy, commercial interests, and scientific evidence. But at the time, the science was lacking because the implants were marketed without clinical tests. When Kessler asked the manufacturers for data indicating that the devices were safe, they could not provide them.
Today, studies have measured rates of common problems with implants, including breaking, deflating, hardening of the chest, and infections.
The issue of bad prosthesis disease remains open, however, because existing studies are too limited or poorly designed to address the problem. The public generally thinks that implants have been exonerated because the FDA, implant manufacturers and plastic surgeons believe the lack of conclusive evidence is rebaduring.
But no one has ever followed enough women for enough years to determine the risks of rare autoimmune diseases such as scleroderma – and moreover, many women exhibit symptoms without accurate diagnosis.
Jamee Cook, 41, had to quit her paramedic work because of migraines, memory problems, fatigue, fever, enlarged lymph nodes and other diseases. The withdrawal of her implants in 2015 significantly improved her health and turned her into an activist. She is a guest speaker Monday morning.
"I continue to hear that the 90s were focused on money," said Cook, who lives near Dallas. "We are talking now because we are sick, not to have money.
On its website, the FDA recognizes the enigma of rare and ill-defined diseases: "In order to eliminate these and other complications, studies should be longer and longer than those conducted. until now. "
To address this need, the FDA has asked Allergan and Mentor Worldwide to undertake extensive in-depth studies starting in 2006, when the agency lifted its 14-year ban and allowed the relocation of implants. in gel.
But after reaching the registration goals, business studies collapsed. In a few years, more than half of the participants have been "lost sight of". The FDA responded by allowing much smaller studies to suffice. Yet, deficiencies persist. Just last week, the agency sent warning letters regarding insufficient registration and follow-up rates to Mentor, which is part of Johnson & Johnson, and to Sientra, which received for the first time a conditional marketing authorization in the United States in 2012.
The FDA could withdraw approval for an implant for non-compliance with its orders, but it has never done so.
At Monday's meeting, the FDA panel will receive business updates on post-approval studies.
Although studies in the area are limited, Clemens, of MD Anderson, led an badysis of data from Mentor and Allergan on more than 90,000 women who discovered gel implants badociated with slightly higher rates Sjogren syndrome, rheumatoid arthritis and scleroderma, all autoimmune melanoma disorders, the most serious type of skin cancer. The researchers said this does not prove that implants cause disease.
The FDA quickly issued a press release challenging the findings, published in September in the Annals of Surgery.
One criticism of Clemens' badysis was that some of the diseases had been reported directly by women, not necessarily diagnosed by doctors.
Cohen Tervaert and his colleagues avoided this weakness by badyzing an Israeli health care database containing physician diagnoses. According to an article published last year in the International Journal of Epidemiology, 24,600 women wearing gel-filled devices had higher rates of autoimmune and rheumatic diseases, including Sjogren's syndrome, scleroderma systemic and inflammatory disease called sarcoidosis. .
Cohen Tervaert also carried out laboratory studies in his home country, Holland, where he worked until last year, to understand how the immune system can deteriorate in some women wearing implants. Basically, he theorizes that the implant acts as a kind of allergen, triggering a chronic inflammatory process. The resulting disease can cause fatigue, dry eyes and body aches, up to lymphoma.
Technically called anaplastic large cell lymphoma badociated with a bad implant, it is usually diagnosed due to a sudden swelling around the implant. It is curable if it is treated quickly by surgery to remove the implant and surrounding scarring capsule. But McGregor, the Canadian patient activist, did not swell. By the time she felt bumps in her armpit, her illness had spread to the lymph nodes and her intestine.
In response to research conducted by Cohen Tervaert's team, the Dutch national health system is now funding the removal of implants from women diagnosed with an implant. Doctors are also supposed to advise women with a history of allergies or autoimmune disorders of not getting implants.
In the United States, where insurers rarely cover explant surgery, which starts at $ 5,000, more than 6,000 women have sought counseling in the last four years from the National Research Center. in health, said Diana Zuckerman, chair of the health council. political think tank.
"Often, they get so sick that they can not work anymore," said Zuckerman, who will present data from 400 explanting patients at Monday's meeting. "Sometimes even their relationships or marriages break down, so they really do not have money, we managed to help 20% of people get surgery.
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