Hi Everyone,

Today I’m bringing to your attention the important and potentially life-saving information on the FDA medical device approval flaws. Red flags are flying up everywhere when it comes to medical device approval and it is one scary, scary thought. As most of us assume, any medical device that gets inserted into our body has been through rigorous testing and approval to be deemed safe for use on the open market. Unfortunately it is a severely unregulated and under-tested system which is downright dangerous and worrying to the health of the general public. The FDA (US Food and Drug Administration) is the most important consumer regulation but the system in place for medical device regulation and approval doesn’t work.

After watching an eye-opening and petrifying documentary called “The Bleeding Edge” I was compelled to write about it, in order to help spread the word for anyone who hasn’t already watched the documentary. The Bleeding Edge is directed by Kirby Dick, a two-time Academy award nominated and two-time Emmy award-winning documentary film director. He holds the Nestor Almendros Prize for Courage and Filmmaking, the Upton Sinclair Award, and the Ridenhour Documentary Film Prize, for his previous documentaries. It is produced by Amy Ziering, a two-time Emmy award–winning and Academy Award-nominated documentary filmmaker. She has won Emmy’s for Best Documentary and Outstanding Investigative Journalism and was nominated for an Oscar for her previous documentaries. Amy Herdy is also a producer of The Bleeding Edge. She is a documentary film producer and author, specializing in investigative reporting for more than twenty years. She received an Emmy for an investigative television series among other notable awards from The Society of Professional Journalists, Radio-Television News Directors Association, Associated Press, The American Society of Newspaper Editors awards and Military Reporters & Editors.

The medical device industry is worth $400 billion and according to the documentary, in the past 10years, 70 million Americans have been implanted with a medical device of some kind. The sad and worrying truth is that the process of the FDA medical device approval is flawed. There are very little regulations, hardly any proper clinical trials and no proper rules in place regarding the production and sale of these devices. The documentary follows the lives of a few of the victims of these cleverly-marketed, recommended by Doctors, medical devices, who have had their lives ruined and are in severe physical pain daily, with irreversible internal damage, physical and emotional scars. Most are unable to work, enjoy life or even function properly due to the debilitating after-effects of these FDA approved medical devices which were gladly recommended and even advised by their trusted Doctors.

Prior to 1976, the medical device industry wasn’t controlled at all, so there were many and varied gimmick products being marketed to vulnerable people everywhere. The Medical Amendment of 1976 was formed in order to help ‘stamp out quackery’ and bring control to the market. This, at least got rid of some of these random and useless so-called medical devices. Unfortunately, it wasn’t nearly enough, as they needed to protect the many genuine and proven medical devices that were already on the current market and essential to the medical world so they made a kind of ‘equivalence requirement’ rule. This new rule stated that if the proposed medical device is similar to a device already on the market, the company can simply request a Premarket Notification form for submission to the FDA for premarket approval. All they have to do is give evidence of the device being equivalent to one or more medical devices already on the market. Here are the requirements in order to qualify. The device –

• has the same intended use as the predicate; and
• has the same technological characteristics as the predicate; or
• has the same intended use as the predicate; and
• has different technological characteristics and does not raise different questions of safety and effectiveness; and
• the information submitted to FDA demonstrates that the device is at least as safe and effective as the legally marketed device.

If the FDA agree with all of the above points, they will clear the device for use on the open market. It is that simple! They may then begin manufacturing and selling that device. The FDA clearly has medical device approval flaws as demonstrated by the clear lack of regulation above. Red flags all around.

The Bleeding Edge really opens your eyes to the reality of these flaws and shows first hand how the system is failing people in their droves. Once these devices get onto the market, there is very little to get them taken off the market, even if there are thousands of complaints and defaults. Some devices get recalled after failing and even if the device is recalled for being dangerous, another device can still be produced based on that defective one, because of a loophole in the system. Once the device is considered a substantial equivalent to an already approved and marketed device, it can be cleared for production and manufacture.

A prime example of this insufficient testing and trial of a medical device was the use of metal on metal hip replacements. One of the first victims to appear on the documentary was a 20 years qualified Doctor himself. Dr. Stephen Tower is an orthopedic surgeon in Anchorage, Alaska who loves sports and staying active, especially biking who ended up needing a hip replacement himself. He looked into the different kinds available on the current market and decided on the metal on metal hip replacement joint. It was one of the newer types on the market and seemed a viable option. He went ahead and got the replacement and began his recovery. He noticed he was slow to recover and was very weak, unable to do any activities and rather than improving in strength, he seemed to deteriorate. Apart from the lethargy he was experiencing, he began having psychological issues. He hit rock bottom at one point at a medical conference. While staying at a hotel, he completely trashed a hotel room in rage. His wife was called and she said he knew he was losing his mind so decided to see a neurologist among other specialists. He was told he had excess cobalt in his system. He knew it had to be the hip replacement that caused it since he had been experiencing symptoms ever since. He decided to have it removed so went for surgery. It was then they discovered that there was a mass of metal ‘sludge’ formed in and around the hip replacement. This excess cobalt in his system had caused serious psychological, neurological and physical problems.

After the surgery to remove the metal on metal hip replacement, his health improved drastically and he went on to make a full recovery quickly. The scary thought is, what if he wasn’t clever enough to realise that the hip replacement was causing him to lose his mind? His symptoms were similar to those of Alzheimers, Parkinsons and Dementia. People could have been misdiagnosed all over the world because of an excess of cobalt from a metal hip replacement!

From then on, he would always ask any patient who came to him with symptoms of neurological problems such as those above, if they had in fact had a metal hip replacement done. Remarkably, there were, so he brought them along to a leading neurologist to have brain scans done in order to show similarities if there were any. Almost all of the patients he brought for the brain scans had the exact same results from the cobalt poisoning. They had the hip replacements removed and recovered the same as he had. He then went on to warn the FDA of his findings but they never replied. They are refusing to give support. This means that people are being diagnosed with permanent mental conditions that are reversible. This is unacceptable and needs to be addressed. 10,000,000 people worldwide have hip replacements containing cobalt.

People are still being recommended NEW technology and that new technology is being marketed as better and more advanced. Unsuspecting victims are happily taking what seems the improved option in terms of technology and advancement but actually they are being lured into a false sense of security. NEW does not mean properly tested. New devices are being pushed for profit with the use of glossy images and convincing videos. Even Doctors are being duped or paid generously for promoting such devices. Some are on great commission for promoting the devices. Corporate greed takes over all morality and ethics in those cases. Often times, there are just not enough bad reviews or complaints for the reason that the device is so new to the market that things may not have started to go wrong yet.

This was the case for the women victims of the Essure permanent birth control device. It is an implant which claims to be a minimally invasive procedure. It is marketed as a quick and relatively painless alternative to surgical fallopian tube tying. It looks like a small coil and they promoted it as being as easy as walking in and out of a day clinic. This was appealing to women and so it took off in a big way. Unfortunately, there were not enough tests, if any proper tests were even conducted, to ensure the safety. One woman, who had been working in a medical centre where they facilitated the the insertion of the Essure device was so impressed that she decided to have it herself. The company then approached her and offered her a lot of money to set up an online page and go around America promoting Essure by speaking at conferences and events as testimony to the device and how it works. Sadly, she ended up becoming a victim herself and faced serious health problems a few years down the line. She was overcome with guilt, on top of her own health problems, but the emotional repercussions of having promoted such a device really got the better of her. She was able to unite with a large community of women against Essure who were able to support her in her plight. She couldn’t have known the dangers.

Angie Firmalino was a woman who was implanted with Essure in 2009 and has never recovered. She began researching Essure online and found that there were many more victims who had experienced the horrible debilitating side effects which left them unable to lead normal lives, work or even get around. She was receiving no support from Essure or the medical centre she went to and was brushed off, so decided to probe further. When she realised the sheer amount of women affected she decided to set up an online site called Essure Problem. It now has over 38,000 women advocates against the medical device clearance procedure. Together they formed the nonprofit organization Advocating Safety in Healthcare E-Sisters (ASHES) in 2015. ASHES educates people on the potential dangers of medical devices. The group provides guidance on how to conduct research on devices and clinicians, advocates on behalf of those harmed by devices, helps people find doctors, and offers emotional and mental health support within the patient community. Together they protest regularly and most recently outside Bayer (producers of Essure) and confronted the Doctors outside who recommend Essure, who downplayed their conditions or else just ignored them. All of this is seen on the documentary which is helping to name and shame them, thankfully. Essure is now available in Europe and is still going strong, leaving more women in hopeless and potentially dangerous, vulnerable situations. On a recent check of their main website they have covered themselves by announcing as Important Safety Information:

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device.

What they fail to mention is that the process of removal of the devices through surgery is highly invasive, can lead to debilitation, womb removal and permanent physical harm among other medical and emotional problems.

One of the victims, Ana Fuentes became unable to keep a job due to her debilitating health and without any health insurance, Ana had to make the decision to place her children with church foster families. Thankfully, since The Bleeding Edge filming, Ana has been able to secure a place to live via a local California homeless assistance program and has been reunited with her four daughters. It is possible to support Ana through the link at the bottom of this post.

On their Important Safety Info Warning they almost make out like it is normal for a perforated uterus and/ or fallopian tunes or inserts of the device to the abdominal or pelvic cavity and that it is a simple procedure to have it removed, which is even scarier. The moral of the many harrowing stories here is to be extremely careful when choosing, being recommended or advised about having any medical device inserted. Make sure there is plenty of long term hard evidence that it is safe. Get a few opinions from expert Doctors if needs be.

Here are a few medical devices to watch out for that can have serious problems –

• Vaginal mesh
• Hernia mesh
• Metal-on-metal hip replacement
• Stents
• Pacemakers
• IVC blood clot filters

Tammy Jackson had pelvic mesh treatment for stress urinary incontinence. After 21 surgeries, Tammy is now waiting for a kidney transplant and yet another partial mesh removal surgery.

Obtaining FDA approval should be a difficult and lengthy process but unfortunately it is not. There are many FDA medical device approval flaws. So many red flag warnings. If you are  jellyfish lover  than you can check this site.

Check it out and watch the documentary on Netflix here.