Ethicon Media Monitoring 8/1/2018

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

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1. Surgical mesh implants may cause autoimmune disorders

   Jul 31, 2018 | Medical Xpress

   By Lesley Young
   
   
   Surgical mesh implants, often used for hernia or gynecological repair, may be the reason so many patients report symptoms of an autoimmune disorder, according to a University of Alberta rheumatologist.
2. 'We can no longer rely on the FDA': The Bleeding Edge mirrors the disturbing reality of a corporatized America

   Jul 31, 2018 | Meaww

   By Namrata Tripathi
   
   
   If you thought America's federal medical agencies were pulling out all the stops to ensure your health safety, you should probably think again.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. Surgical mesh implants may cause autoimmune disorders

   Jul 31, 2018 | Medical Xpress

   By Lesley Young

   Surgical mesh implants, often used for hernia or gynecological repair, may be the reason so many patients report symptoms of an autoimmune disorder, according to a University of Alberta rheumatologist.

    "In my practice, I studied 40 patients who had mesh implants and found that almost all of them had symptoms such as chronic fatigue, cognitive impairment known as "brain fog," muscle and joint pain "fibromyalgia," feverish temperature, and dry eyes and dry mouth," said Jan Willem Cohen Tervaert, director of the Division of Rheumatology at the U of A.

    "Of those patients, 45 per cent developed an autoimmune disorder such as lupus or rheumatoid arthritis. And in the patients who had allergies before the implant, they were significantly worse after."

    Cohen Tervaert presented his study results at the 11th International Conference on Autoimmunity in Lisbon in May 2018, and will soon publish them in a leading journal.

    "My study is small; however, it is beyond coincidence that these symptoms, which often go untreated or even unacknowledged by some doctors, exist among so many mesh implant patients. A larger study is needed to confirm whether in fact the implanted mesh is to blame," he added.

    Cohen Tervaert theorized that the causal link could be the same one found to be true in silicone breast implant disease.

    "When a foreign body is put into the body, there is an instant activation of the immune system. It continues to fight the foreign body and eventually, over time, fatigues and becomes dysfunctional," he said.

    "Large-scale studies have shown that patients with breast implants have more symptoms of ASIA (autoimmune/autoinflammatory syndrome induced by adjuvants) and an increased risk to develop an autoimmune disorder. And in animal models, it has been demonstrated that these silicones can induce autoimmune diseases if the animals have the right genetics."

    What concerned patients need to know

    Cohen Tervaert said there is no need for patients with mesh implants to panic.

    "Many patients do not develop symptoms or a disease. You must have the genes in the first place."

    Concerned patients should discuss risks with their physicians about existing or future mesh implants. One guiding rule of thumb could be whether or not a patient has pre-existing allergies, added Cohen Tervaert. 

   He noted that pre-existing allergies were present in 80 per cent of breast implant patients—the same percentage who had allergies when mesh implantation caused problems in his patient group. 

   "In the Netherlands, the government informed all plastic surgeons that if patients who consider breast implants have pre-existing allergies, they should consider not doing the surgery at all. At the very least, we should be warning patients with allergies that their symptoms may worsen after a mesh is put in." 

   He added, "It is my dream that in the future, we have a genetic test that can inform people who are vulnerable to develop autoimmune disorders after implants, but unfortunately we are not there yet." 

   There is also hope for patients with mesh implants who do have autoimmune symptoms after the mesh is removed, said Cohen Tervaert. 

   "Patients who have had symptoms associated with breast implants felt much better after the implants were removed, and in some cases they reported a total cure.”

   https://medicalxpress.com/news/2018-07-surgical-mesh-implants-autoimmune-disorders.html

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2. 'We can no longer rely on the FDA': The Bleeding Edge mirrors the disturbing reality of a corporatized America

   Jul 31, 2018 | Meaww

   By Namrata Tripathi

   If you thought America's federal medical agencies were pulling out all the stops to ensure your health safety, you should probably think again. Kirby Dick’s new searing exposé on the medical device industry in the country shows how the United States has become so business-driven that it no longer cares for its citizens.

   You may think that watching a documentary about the inhumanity of a mechanized industry will not be a shocker anymore, but 'The Bleeding Edge' renders you speechless when you realize no one's really got your back. Not even the government you entrusted your health with. The documentary, in the end, emerges as a real-life, sci-fi horror film. 

   The Netflix Original documentary is about the medical device industry in the US which generates revenues of $300 billion a year by producing highly-sophisticated apparatus which are either used to assist operation procedures on people or implanted in their bodies. 

   Nearly 70 million people in America have been outfitted with internal medical devices over the last decade.

   There is, no doubt, that several of these devices assist patients by improving their quality of life. The film doesn’t deny that. It, instead, highlights the devices which have nearly destroyed people’s lives and the shocking corner-cutting regulations of the federal agencies before certain contraptions are permitted to be used on people.

   The filmmakers, in the documentary, have primarily focused on the guardian group of the medical device industry  — the US Food and Drugs Administration (FDA), along with a few medical device producing firms like Bayer and Johnson & Johnson.

   The documentary focuses on four main contraptions used in America which have caused significant harm to a large number of patients: Essure — a female sterilization device; cobalt-based joint replacements; vaginal mesh; and Da Vinci — a robotic surgical system.

   The film details the lives of multiple women and men who are living with the aftermath of implant surgeries.

   Essure gave women autoimmune diseases with broken fragments of the device still lodged in their uterus even after extraction. A surgeon’s personal account of how a cobalt-hip replacement cost him his mental sanity and resulted in elevated levels of cobalt in his blood. Vaginal mesh implants resulted in bleeding and acute pain and the lack of knowledge amongst doctors to take the device out.

   And finally, the use of the Da Vinci robotic surgical system, which resulted in botched surgeries — in one case a woman’s colon falling out of her vagina — as doctors in the documentary admitted they were not comfortable using the system until their 200th operation with the device.

   All these devices were cleared through the FDA’s regulation system and still continue to be in the US market.*

   The film, through a former FDA commissioner Dr. David Kessler, points out existing loopholes in the agency’s archaic regulation system which continues to give clearance to medical devices with a disturbing lack of research and testing: the Pre Market Approval (PMA) and the 510(k) Clearance process.

   The 510(k) is a loophole which allows the industry to argue that their gadget is safe considering that it is “substantially equivalent” to the ones previously released, even if the prior device was recalled due to malfunction. While the PMA follows a stricter set of regulations, it is still rendered regressive in the documentary through multiple examples.

   The 'Bleeding Edge' screams to be seen as it manages to do what no one has done before — take the FDA to task to an extent that it declined to give an on-camera interview for the film, similar to other big medical device companies like Bayer. The film shows that there is nearly no difference between the regulator and the industry it is assigned to regulate.

   *Bayer called off Essure from the US market a week before the release of the documentary. Thousands of women have filed lawsuits against the firm with the birth control device as their subject, claiming it has caused them injury.

   Kirby Dick, while talking to Variety‘s PopPolitics, said:

   "We don’t think it’s coincidental that they did it just a week before the release of the film on Netflix. I think they knew that the public would be outraged at the fact that they still had this product on the market.”

   https://meaww.com/we-can-no-longer-rely-on-the-fda-the-bleeding-edge-mirrors-the-disturbing-reality-of-a-corporatized-america
   

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