Recently, the original documentary "The Truth of Cutting-Edge Medical Care " (also known as the Bleeding Edge) by American media giant and Netflix, the world's largest paid video website, has caused a heated discussion. The documentary explores the unknown interests of the US medical device industry. It tells the medical equipment industry worth hundreds of billions of dollars. How to put the risk on the patients and expose the dark side of some unknown products in the market. At present, the documentary scores 8 on the watercress. .6 points.
“Esure ruined my life and made me miserable,†said respondent Angie.
Essure is a female contraceptive device developed and launched by Bayer and is the only non-surgical contraceptive approved by the FDA. According to Bayer Essure's official website, Essure is an alternative form of contraception for tubal ligation. Once implanted in a woman, it can achieve permanent contraception and is currently used by about 750,000 women. The most important feature is that there is no need for surgery. Only the coil made of special material is implanted into the fallopian tube via the vagina. The tissue generated around the coil forms a natural barrier between the egg and the sperm, thus achieving contraception, while the seemingly high-tech back. But it hides a lot of hidden worry.
Angie said that after Essure's birth control surgery, he often felt abdominal pain and even hemorrhage. Ultrasound found that Essure, which should have been placed in the fallopian tube, slipped into the uterus. After that, Angie performed surgery to remove Essure and fallopian tubes. Ligation, hysterectomy (because of debris in the body), repair of the vaginal stump twice (because of poor healing after uterine surgery), etc. However, not only Angie, many women have had Angie's experience, these women said, After the implantation of Essure, they developed symptoms such as pain, bleeding, and even pregnancy.
In fact, more and more suspected adverse events related to Essure have been complained or reported by patients. These adverse events are related to the occurrence of pain, discomfort, vaginal bleeding, syncope, etc., but also the fallopian tube caused by the breakage of the device in the body, uterine bleeding, etc., and even cause fatal and unexpected pregnancy. Some female patients have complication due to Essure's rupture in the body, and surgery has to be performed to remove the broken fragments. This year, the US FDA issued an order to Essure to announce a “unique type of sales restriction†for the device and to provide timely information to the patient about equipment risks and benefits. Bayer announced in September last year that it would stop at Essure is sold outside the US, but the company claims that the purpose of doing so is not a product security issue, but a commercial consideration.
The experienced orthopedic surgeon, Tower, faces a series of out-of-control problems after hip replacement.
“After a year and a half of surgery, I have had health problems that have never been seen before, such as hand shake, tinnitus, poor memory, decreased vision, and even over time, there has been a problem of psychological loss of control,†Tower said.
Finally, blood and urine tests showed that the cobalt content in the Tower exceeded 100 times, and the culprits of all this were hip replacement surgery, because the hip prosthesis was made of cobalt-chromium alloy, and then Tower performed a hip replacement and replaced the cobalt-chromium prosthesis with a plastic-to-ceramic prosthesis. During the procedure of the replacement surgery, the doctor was surprised to find that the original prosthesis resembled a metal-slurry crankshaft. The box, the key ligament, that is, the hip joint capsule that maintains the hip, has dissolved, which directly led to a series of complications of the Tower. "After a month and a half, I quickly recovered. The symptoms of psychological imbalance disappeared, my ability to think was restored, and other bad symptoms disappeared miraculously."
As a doctor, Tower was keenly aware that patients who had undergone cobalt-chromium implant surgery had similar conditions to their predecessors, and as long as the problem of cobalt metal was removed, the patient gradually got better.
Unfortunately, most patients are unaware of these symptoms, which are Alzheimer's or a precursor to Parkinson's disease. According to the Organisation for Economic Co-operation and Development, there are currently more than 10 million people implanted in the world. The hip, knee, and shoulder prosthesis with cobalt is even more frightening because the manufacturer may recall a part of the hip prosthesis containing cobalt because it may cause damage to the surrounding tissue. However, the medical device industry still treats patients. Cobalt-containing hip prostheses are recommended.
Even the Da Vinci surgical robot (the more formal name is the endoscopic surgical instrument control system), which can achieve precise operation in the past two years, is also controversial in this film. Many American women are accepting it. After the uterus removal surgery of the Da Vinci robot, the probability of vaginal rupture of the patient through robotic surgery is 3 to 9 times higher than that of the conventional surgery! Many female patients who received the Da Vinci robotic surgery said: "My whole life has been ruined", "My life direction has completely changed because of the Da Vinci surgical robot", "I regret to choose Da Vinci." Robots perform surgery"...
All of this is related to the promotion of medical equipment manufacturers and the unqualified training of surgeons. It is understood that in order to truly use Da Vinci surgical robots for surgery, doctors must undergo more than nine weeks of training, and many doctors only carry out training. Several exercises began to perform surgical operations on patients, and medical device salespeople often conceal this vital link in order to sell products as quickly as possible.
How do these devices that cause great harm to patients enter the market?
The documentary interviewed many scientists and industry veterans who said there were many reasons, such as:
The backwardness of the regulatory mechanism is different from the management system of drugs, foods and biological agents. After the introduction of the medical device amendment in 1976, the medical devices on the market began to be regulated by the FDA. Nowadays, the complexity, quantity and type of medical devices are In the rapid development, but the United States still uses the management framework 40 years ago, which has been seriously out of touch with the reality;
The approval mechanism is unreasonable. Generally speaking, all new unlisted devices are subject to pre-market approval (PMA). Similar to new drug applications, PMA must be tested in the human body, then data is aggregated, and finally by FDA scientists. To assess whether the device is safe and effective (it is necessary to mention that some scientists who have raised concerns about the product have been fired. According to a US Congress investigation, the FDA installed a monitor called Spector on the scientists' computers. Software, in order to retaliate against the problematic person), but because medical devices are updated every year, medical device manufacturers believe that the cost of doing human trials for each change is too high, so they constantly lobby the government departments not to carry out standard replacement. Congress has set up a 510(k) process, in which the manufacturer only needs to prove that the device is basically equivalent to another device already on the market, that is, the front-based device. It is worth noting that even a device has problems. And recalled, can still be used as a comparison standard, and up to 98% of medical devices are through 510 (k) flow Of reaching the market;
Many FDA officials do not understand the medical industry at all , and even work for medical device companies after leaving the company.
All of the above reasons have led to a large number of unqualified medical devices flowing into the market, causing inextricable pain for patients, as one scientist said in the documentary: When citizens' health and profits meet, profits will always be victorious. That side.
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