The medical device industry is a 400 billion dollar powerhouse and has been known to have big profit-oriented stockholders. Sadly, with the financial mindset, dysfunctional devices have slipped through the FDA and affected many individuals in negative ways. In 2018 "Bleeding Edge", a documentary was released on Netflix explores multiple devices and the people who received them. Multiple women and their complications with medical devices approved by the FDA came with life-changing consequences including; infertility, emergency surgeries, and loss of the ability to have intercourse. The medical devices being assessed in the film: Bayer's permanent birth control device Essure, vaginal mesh, the Da Vinci Surgical System, and chrome-cobalt hip-replacements. The purpose of the film was to encourage further testing before products are released on the market, and like other countries, remove the dangerous ones when people speak out against them.
The device Essure has not been removed from the market, but as of 2020, Bayer had agreed to pay a 1.6 billion dollar settlement for the nearly 39,000 claims. The majority of the complaints were; Hysterectomy, pain, bleeding, nickel sensitivity, unwanted pregnancy, weight gain, autoimmune disorders, and perforation. In defense, Bayer used a legal defense called preemption, since the FDA approved Essure at the federal level, it gave Bayer protection from claims that the company failed to warn the public of risks. As of 2020 all complaints and faulty reports are still voluntary, and like many women claim in the documentary, the technicalities about if the device is faulty or not can determine what the data says. If you were to receive Essure permanent birth control and DIDNT get pregnant but an injury had occurred, then in the eyes of Bayer, the device itself wasn't a fail. In addition to the malpractice of Bayer, according to the journal of gynecology, Bayer tried to “shift blame to the gynecologist to absolve itself of liability” (2019).
As future physicians, how can we interpret the FDA's data if there have been issues pointed out by the public. How do you protect yourself and your patients when you choose to treat them? In the documentary, some doctors were clueless about the pain they had caused patients due to their full trust in the FDA. I wonder if it is possible to justify your treatments outside of the FDA regulations and approval, to do this, how much time would you have to put in towards research? It is important to acquire the skills to decipher through the overwhelming amount of information available to us, especially for our generation of doctors entering the world where [a guess to] an answer is a simple google search away. Ultimately, I think it comes down to the importance of reporting faulty medical devices as our commitment to beneficence, and encouraging integrity in the statistics being reported to the FDA.
Here is a video of FDA, CEO talking about Essure and other devices and why they are still on the market due to preemption:
https://www.drugwatch.com/essure/lawsuits/#:~:text=Former%20FDA%20program%20manager%20Madris%20Tomes%20highlights%20the%20devices%2C%20including%20Essure%2C%20that%20are%20still%20on%20the%20market%20due%20to%20FDA%20preemption.
Dick, Kirby, 'Bleeding Edge' Netflix Original (2018)
Llamas, Michelle, Essure Lawsuits, (2020)https://www.drugwatch.com/essure/lawsuits/
I found your post to be very interesting because it is not something I have previously thought about. After reading what you had to say I looked up some examples of medically faulty devices and I saw a super interesting one on the da Vinci Robotic Surgery system. This system was created to help aid surgeons in either routine checkups or more complex surgeries such as heart, head, and neck. In reports by the FDA, the system had higher numbers of injuries and death for complex surgeries than routine ones. This made sense to me, but when I looked closer, I found that the reasons for this was because sometimes the robot, mid surgery, would show an error message. They would have to reboot it, and that took time. You can imagine that in a heart surgery, they do not have the time to wait around for a robot to restart and I had to almost laugh at the absurdness of the whole situation. The time it took for the robot to restart cost precious minutes in the progress of the surgery which sometimes led to death.
ReplyDeleteIn other instances, the da Vinci system nicked important organs which caused patients to die from blood loss. In one surgery, a hysterectomy, medical personal reported that the robot was not stopping and cut more tissue than needed. The energy used burned various other organs around the area of the intended surgery.
I always thought that certain jobs, such as routine surgeries or surgeries in general, would eventually be done by robots because of their ability to be consistent. It was eye opening to see that technology has a LONG WAY to go before humans are replaced. It also made me question the ethics of using a robot in a surgery. If there is a chance that they can fail, continue to operate when they should stop, or other robot apocalyptic reasons, should they still be used when a person’s life is at stake? Do robots or medical technology in general truly do more than a trained surgeon?
I think it goes back to your question of how much time should go into research and how many “mistakes” should the medical community allow before the use of devices that are defective are taken off the market. I think in the scenario with the robot, if it is faulty, it should not be used at all on humans or even animals until the basic programming can be addressed. I do not think devices should be used just to “see” as some drugs would be in some instances for clinical trials because the da Vinci robot truly caused some people to die because of its errors. When a drug goes to the clinical trial stage it has gone through testing prior and it is something that will only help the patient more not potentially kill them.
Again, this was a super interesting topic regarding the ethics of the advancement in technology and it is something I never really had thought of prior!
This is the link to the interesting article that talks about the various examples and defective da Vinci Robotic System: https://www.drugwatch.com/davinci-surgery/complications/
This topic is so interesting to learn about. I was shock to find out all the FDA approved medications that were recalled in the recent years and some medical devices. Many pain medications were on the list such as Vioxx Which is a COX inhibitor that caused serious cardiovascular problems and strokes. It made me wonder what is the process for FDA approval and what do they monitor and who is responsible for making such decision.
ReplyDeleteAny FDA approved drug has to prove that its benefits outweighs drug’s risk. That means it could still have risks but if the benefits outweigh the risk it is okay to put in the market. Most birth control in the market has risk of blood clots, and seldom stroke as well but due to its benefit outweighing the risks they are still in the market.
I was also very surprised to see a growing list of recalled drugs by FDA in the last year. In 1992, FDA established Accelerated Approval Pathway that allows some drugs to get expedited due to its clinical benefits, but this has also caused overload of work on FDA.
Here is the process of drug approval process with FDA. Typically when drug is developed by a company, company seeks approval for sale in the US. First step, FDA guidelines says all novel drugs must be first tested on Animal for toxicity (we can certainly talk about the ethical issues with animal testing). Once that is completed, company submits Investigational New Drug application which includes, results from animal testing, drug’s composition, manufacturing and how is this drug going to be tested on human.
If that application is approved, company can move to phase 1, which has 20-80 healthy volunteers used that emphasized on safety. This phase helps to determine potential side effects, how long this drug stays in the body and process for excretion. If company pass that phase, they are moved to phase 2, where 100s of patients are used to obtain data on if that drug worked in people with certain disease or conditions. This trial also uses placebo drug to determine the benefit from the drug vs placebo. If the company passes the phase 2, are moved to phase 3, which is the most critical phase because here 1000 of patients are used to gather safety and effectiveness of the drug, how this effects different population and the safe dosages as well as how it interacts with other drugs. If the company is able to pass all three phases, FDA meets with the company and gives a go for NDA application.
This is the second set of application and more in-depth which includes all the data collected so far, how this drug behaves in the body and how it us manufactured. NDA application takes 60 days for FDA to decide wether to file the application, send for revision or reject. If approved FDA can review drug’s labeling, appropriate drug information on the label. Phase 4 is the post-approval risk assessment to make sure the drug that is out is safe for long term used.
This whole process could take more than a decade for certain drugs, but for others it could be less than a year depending on the importance of the drug availability for the public. COVID-19 vaccines from Moderna and Pfizer have been topic of discussion in the last 6 months due to its short approval period making some people skeptical about getting the vaccine.
Very interesting topic, definitely learned a lot about the FDA approval process!
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ReplyDeleteThis blog presents a question that I have asked myself time and time again. Why do we have so much faith in the FDA? I appreciate the fact that we have a system in place whose responsibility is geared to protect public health by ensuring the safety, efficacy and security in regulating a host of functions. A regulatory framework is very important for our society, but what happens when self-interest, politics, money, and greed deteriorate an altruistic foundation.Things become murky, and there aren’t any entities in place to check and balance the FDA and hold them accountable. According to a review by Bruce Patsner, M.D., J.D. the FDA has often marketed products such as drugs, biologics, and devices with little to no regard to its consequences on the people. He continues to argue that the FDA is failing to fulfill the primary purpose it was institutionalized for in the first place, and perhaps the CMS, another Department of Health and Human Services could possibly serve as a check on FDA shortcomings. Another question I ask is why are these medical devices and prescriptions sold for half the price in third world countries. Having a global perspective highlights the misuse of the FDA power as well. I hope we can implement the proper changes needed for our system to prosper and value what is most important.
ReplyDeleteBL618:
DeleteThis is something I wanted others to think about! Because although those who work as practicing medical professionals do their best (hopefully) to treat patients, there is still the business side of medicine.
Nearly every hospital has the people who are making money from the illnesses people face, it part with haggling with pharmaceutical companies to provide treatment. If there is so many money hungry people behind the scenes what role can the hospital medical staff have in balancing care and acting as a working cog of a business?
Not to mention if we factor in insurances, risks of being sued, and the lives who your patient effects. The FDA is supposed to be a safe place where doctors can feel more secure in choosing their treatment options, so when that has failures, it’s so scary!
BL618:
DeleteThis is something I wanted others to think about! Because although those who work as practicing medical professionals do their best (hopefully) to treat patients, there is still the business side of medicine.
Nearly every hospital has the people who are making money from the illnesses people face, it part with haggling with pharmaceutical companies to provide treatment. If there is so many money hungry people behind the scenes what role can the hospital medical staff have in balancing care and acting as a working cog of a business?
Not to mention if we factor in insurances, risks of being sued, and the lives who your patient effects. The FDA is supposed to be a safe place where doctors can feel more secure in choosing their treatment options, so when that has failures, it’s so scary!