Wellness

[Mindy D]

Medical devices are not stringently regulated by the FDA in the same way that drugs are. Current regulations miss the mark to adequately protect the public. This has resulted in nightmares affecting the lives of patients harmed by these devices and treatments. Just a few examples include: the hip replacement product DuPuy Synthes, gynecological mesh implants by Johnson & Johnson, Bayer’s contraceptive implant, Essure, and hip replacement implants that resulted in cobalt poisoning. Many products have permantly injured patients or have caused them to undergo multiple revision surgeries. Making things worse, medical corporations take advantage of these inadequate regulations. I urge anyone considering any type of implantation or robotic surgery to view the film, “The Bleeding Edge,” before doing so. Bayer has removed the Essure implant. Many more of these harmful devices have also been removed. The stories about the individual cases  resulting from some of the problem devices are shocking. You can see images of some of these fails online in Google Images, in the documentary and on multiple sites for professionals in the medical industry and news articles written for the general public.  “60 Minutes” did a report on the mesh implants.“Entertainment Weekly” added the documentary their list of of documentaries that have changed the world. The documentary is available on Netflix @and Amazon Prime.

✅Currently, my husband’s cousin is sitting, waiting to hear what he is supposed to do about his recentl surgery to repair his fractured femur. Screws used in the surgery have come undone and are in danger of poking through his skin. 

[Goldengate8361]

Medical device companies are, in fact, heavily regulated. This post is, unfortunately, not grounded in factual information.

[Mindy D]

For more reading.https://www.nytimes.com/2019/05/04/opinion/sunday/medical-devices.html

[patbz]

@Mindy D :  Where do you find this stuff you cut and paste?  Why do you need to share it (as another poster stated, your info is wrong!!)?

[Mindy D]

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  @Goldengate8361 wrote:
  

  Medical device companies are, in fact, heavily regulated. This post is, unfortunately, not grounded in factual information.

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There are gaps and inadequacies in the regulation of these devices. For example, if a device that is similar to a device already on the market is requested for approval (it’s called the 510 loophole) the newer device is not required to go through testing. The vaginal mesh implants have been disintegrating internally. The materials used in the manufacture of some of them were not tested. Check into this and you will be surprised with what you discover. From the National Institute of Health on just the vaginal mesh issue comes this review of the literature. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3424888/

From the FDA page on the issue. https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/pelvic-organ-prolapse-pop

Below is quoted from https://www.litigationandtrial.com/vaginal-mesh-implant-erosion-recall/

“Any surgical mesh used to repair pelvic organ prolapse or stress urinary incontinence is at a risk of erosion, failure, and the need for repair.

Put simply, the use of surgical mesh as a treatment in the vaginal and pelvic area has never been adequately tested to ensure it is effective and safe. In 1990s, gynecologists started using surgical mesh for their procedures, and soon thereafter medical device manufacturers used the “510(k) clearance” loophole (discussed more below) to get the FDA to approve their use without testing. Shockingly, the pelvic mesh that is causing concern now is substantially similar to the “ProteGen” vaginally implanted mesh that was recalled from the market more than ten years ago due to similar vaginal wall erosion issues. In light of the ProteGen problems from more than ten years ago, the vaginal mesh implant companies should never have sold their products in the first place and the FDA should not have approved them for sale.”

[Mindy D]

[Love my grandkids]

@Mindy D You post a lot of "information" about medical stuff I notice.

I NEVER click on links posted by a total stranger.

And I can't read your posts as they are all run-on with no breaks and I don't believe a lot that you post is based in fact.

You seem to have a big problem with anything medical.

[Mindy D]

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@Love my grandkids wrote:

@Mindy D You post a lot of "information" about medical stuff I notice.

I NEVER click on links posted by a total stranger.

And I can't read your posts as they are all run-on with no breaks and I don't believe a lot that you post is based in fact.

You seem to have a big problem with anything medical.

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If you have a Netflix, why not watch “The Bleeding a Edge” to learn more about this issue. It’s also available on Amazon Prime.

[Trinity11]

I am not sure why some are questioning what you post @Mindy D but my experience is that everything so far has been based on fact.

I knew quite a few people in my support groups that had implants for interstitial cystitis that failed. I lead a group for diabetes and many of us had issues with our insulin pumps. I, personally, had a blood sugar of 30 when the paramedics got to me when my insulin pump failed. I nearly lost my life. We have had numerous posts on this forum about failed devices. We had a woman a few years ago who had a pain pump that didn't work properly and she suffered greatly. She hasn't posted in quite some time.

[Mindy D]

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@Trinity11 wrote:

I am not sure why some are questioning what you post @Mindy D but my experience is that everything so far has been based on fact.

I knew quite a few people in my support groups that had implants for interstitial cystitis that failed. I lead a group for diabetes and many of us had issues with our insulin pumps. I, personally, had a blood sugar of 30 when the paramedics got to me when my insulin pump failed. I nearly lost my life. We have had numerous posts on this forum about failed devices. We had a woman a few years ago who had a pain pump that didn't work properly and she suffered greatly. She hasn't posted in quite some time.

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Thank you. I try to use the most trusted sites, provide quotes and factual details from sources, post links, verify everything I post from these sources and clearly point out when something I write is my personal opinion or comes from a personal experience, anecdotal experience, versus a professional resource, such as a scientific study or informational sources diseminated from government agencies or from medical and science sites. Moreover, I strive to add information, quotes and links to sources that are for the professional in science and healthcare, the lay reader, and for those that want an overview of a topic. I try to include links to original research, including abstracts and full studies. My posts are longer because the subject matter requires more information.

I am truly sorry for your insulin pump failure. I hope readers on the forum will become their own advocates and become as knowledgeable as possible about conditions that affect them and their loved ones.