Has anyone seen the documentary called The Bleeding Edge on Netflix? The documentary talks about a medical device (Essure) that was cleared by FDA and implanted into women for sterilization purposes. Following implantation, these women started to experience adverse effects and most of them had to have multiple procedures to have the implant removed. Do you know examples of any other devices that have been initially approved by FDA but then were taken off the market due to unexpected results? If FDA is as strict as we believe it to be, how come recalls happen so frequently in this industry?
From doing some reading on the FDA website a ‘recall’ is when a manufacturer takes a correction or removal to address a problem with a medical device that violates FDA law. The first action called “correction” address a problem with a medical device in the place where it used or sold. This could be applicable to the type of action the actual device is intended for. For example maybe a medical device is actually considered a drug or biologic which end up changing the bodies chemical properties. The other action is removal which addresses a problem with a medical device by removing it from where it is used or sold. The severe case this is applied to is when deaths start occurring. Recalls happen for many reasons. The FDA is strict but that does not mean they will be able to prevent every problem that arises. For example metallosis from hip stems is a chronic issue they did not know such things would happen until it was placed in the body.
Hey I had a similar curiosity as well. I don't have an answer to your question but I wanted to share my curiosity as it falls along the same lines. The FDA regulates medical devices and drugs before they are sent to the market. Yet, about one third of medical devices and drugs have failed (recently) in patients or in the shelf. Where do you think the fault of these failures lie? In the manufacturer for lack of proper testing? the FDA who was supposed to inspect these devices/drugs for failure beforehand? or maybe neither, the failure was caused because of the patient's body type or conditions?
I was curious about this because I was wondering what led to the failure of the 2012 hip-implant failure by Stryker.
I think it is like other devices that can have a recall for corrective actions, but when we talk about medical devices it is more sensitive as it could cause life-threatening. The human body could have a different reaction to any implementation or even procedures. So Even FDA approve it and companies do research and test. It's still possible that it's not going to work 100% on everyone. I think that's why most doctors make patient sign the consent about side effect or complications after for such operations. So I believe even FDA approved, Thier, is no guaranty until they try and it might not work for everybody. We talked last week about the difference of time for research companies talk vs academia, and believe they issues happen when companies rush to roll out a product without the prober trials and clinical studies.
I feel that when the FDA orders a recall on products or medications, it is not because the product itself is bad but a recent batch that was rolled out that may have some sort of defect that could cause harm to people. For example, Levothyroxine is a generic medication for Synthroid, which is a thyroid medication. While the medication itself has been safe for years and millions of people take it, sometimes a batch of the medication at a certain strength ships out with a defect, which happened recently and we had to stop filling prescriptions that called for that medication. Another more recent example would be the recall of certain manufactures of Valsartan which were recalled because of some ingredients that could cause cancer. What I'm trying to point out here is that when the FDA initially approves a product, it is not that they always miss something but that defects happen over time and that they take control before things get out of hand.
I have actually been meaning to watch that documentary. I think the same question applies to the pharmaceutical industry. There have been many recalls of drugs as well, even though it takes years for them to get on the market. I think the problem lies in trying to create a universal path for getting medical devices on the market. Even with the different classes in place, there are just too many products for the FDA to thoroughly oversee. In addition, the medical device and pharmaceutical companies are constantly trying to influence the people who decide on the process. Companies are just not held responsible for their negligence. If the situation is going to improve, there needs to be more transparency between the companies and the consumers.
I have watched that documentary "The Bleeding Edge." It was very informative and also made me question some of the things you are asking as well. The FDA is seen as such a strict overseer in the medical device product development world, why is it that we hear stories of these products malfunctioning and causing detrimental side effects on consumers? The FDA has control and responsibility over so many products around the country and the world that it seems impossible to not let some products with a minor unseen flaw fall through the cracks. But that is not always acceptable, this company trusted the FDA to ensure the safety of Essure, and when it was cleared by the FDA, it went to market, and had many adverse effects on consumers leading to it inevitably being taken off the market. The classification system within the FDA regulating what tests need to be performed on medical devices based on predicate products, and potential harmfulness was designed to ensure for all products overseen by the FDA. However, it is possible that these guidelines need to be restructured to allow for a more in depth assurance of safety by the FDA and in turn, less recalls, and more customer safety.
Has anyone seen the documentary called The Bleeding Edge on Netflix? The documentary talks about a medical device (Essure) that was cleared by FDA and implanted into women for sterilization purposes. Following implantation, these women started to experience adverse effects and most of them had to have multiple procedures to have the implant removed. Do you know examples of any other devices that have been initially approved by FDA but then were taken off the market due to unexpected results? If FDA is as strict as we believe it to be, how come recalls happen so frequently in this industry?
I have not seen the documentary but I heard it was very interesting. One recall I had heard of was the Zimmer Persona Knee component recall. This implant was FDA cleared in 2012, but in 2015 Zimmer recalled it due to a high number of reported instances in which the implant was loosening and required revision surgery. Although all the necessary testing, design documents, risk documents, verifications and validations were undoubtedly completed by Zimmer in order to submit to the FDA and ultimately get FDA clearance, unforeseen failures happen sometimes. Certainly, neither a medical device company nor the FDA intends to put potentially harmful product on the market, but if companies continue to innovate and put utilize new technologies to make products, recalls are bound to happen. The main thing to keep in mind is how early are the issues able to be noticed, and is the industry learning from its mistakes.
One of the major recalls in the last few years has been the J&J/DePuy Hip Stem Recall in 2010. The hip replacement was a metal on metal implant which had a high failure rate and was leaving patients unable to walk and the residual metal ions in their body after they were removed. In January 2013, the FDA filed a proposed order for a metal on metal implant to require premarket approval (PMA) and not a premarket notification (510(k)). This lead to DePuy pulling a second metal on metal hip replacement off of the market. The final FDA order went into effect in May 2016. In the end, J&J paid nearly $1B in lawsuit settlements. This is an example of how companies attempt to present new devices as "substantially equivalent" to get it on the market with a 510(k) rather than a PMA. Although both hip implants received 510(k)s from the FDA, post-market surveillance showed that the implants were not as safe as the manufacturers claimed them to be. This resulted in a change in regulations by the FDA, and there are currently no FDA approved metal on metal total hip replacement devices on the market.
There was a recall of a Vacutainer from Becton Dickinson in the United States where a little less than a billion of these devices were recalled. The FDA identified it as a class one recall which is the most serious type of recall. This medical device was recalled because it caused chemical interference with certain tests which ultimately can affect the data collected from quality and R&D. I believe the FDA is fully not at fault for this because there are too many factors that the FDA cannot fully control by itself. The reason for a recall can also be caused by the quality department in the case where they missed a small piece of a mistake with the medical device which goes unseen throughout the whole design process. This can represent a false-positive scenario where all functions of the medical device seem functional but one very small aspect of the device can be triggered to make it fail post-release. I believe there are several factors involved which cause medical device recalls and the FDA is just one of the many.
One of the FDA announcement during the Covid-19 situation is the recall of hand sanitisers which contain methanol in them. Methanol is a dangerous substance and during these tough times where mask and hand sanitisers are indispensable, it is hard to remove the product from being circulated. It can be fatal if accidentally ingested. It is a voluntary announcement made by the company and so far no adverse response related to this recall has been reported.
Has anyone seen the documentary called The Bleeding Edge on Netflix? The documentary talks about a medical device (Essure) that was cleared by FDA and implanted into women for sterilization purposes. Following implantation, these women started to experience adverse effects and most of them had to have multiple procedures to have the implant removed. Do you know examples of any other devices that have been initially approved by FDA but then were taken off the market due to unexpected results? If FDA is as strict as we believe it to be, how come recalls happen so frequently in this industry?
I haven't seen the Netflix documentary but online I found several other examples of drugs that were approved and eventually recalled. There are over 8000 drugs that have been recalled and this is a trend that is still happening to this day. For example, the drug Sibutramine (Meridia) was on the market from 1997-2010 and it was supposed be used for appetite repression but ended up giving people a higher risk for heart disease and stroke. Even as recent as 5/19/21 a hand sanitizer was recalled by the FDA after they found methanol in it. I think there is something to be said about the process of approval for the FDA. This is an area of regulation that is super important and should be corrected expeditiously.
link1: https://www.mdlinx.com/article/10-dangerous-drugs-recalled-by-the-fda/lfc-4008
link2: https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls
On average there are around 50 to more recalls in a year within the medical device industry. I have heard about the Abbott cardiac pacemakers recall. There were over 400,000 devices created and sold. The device had issues with exposed wires that occurred with the pacemaker. As we know pacemakers are important devices as it relates to the heart. The FDA stated that this was a class 1 recall. Today there have been updates and changes created to prevent these recalls. Most recalls occur due to changes within technology over time, or different side effects that occur outside of effects noticed during the clinical trial.
Paragard has been on the market since 1988, it was considered at one point in time as a popular and effective T-shaped IUD, that gets implanted in the uterus for birth control. Approved by the FDA in 1984, with the permission of allowing the IUD to stay there as long as 10 years. This IUD was used by many females. However, over the last 20 years, there have been an influx of cases filed in regards to complications from the devices.
According to the voluntary reports filed with the FDA since 2013 regarding Paragard, there have been:
- 3,186 reports of "device breakage"
- 1,910 of those events deemed "serious"
- 102 related reports of hospitalization or life-threatening complications
As of this April batch of ParaGard T 380A Intrauterine Copper Contraceptive devices were recalled due to a lack of assurance of sterility, according to the Food and Drug Administration (FDA).
Sources:
https://www.newlandlaw.com/arlington-heights-injury-attorney/contraceptive-devices-recalled
Has anyone seen the documentary called The Bleeding Edge on Netflix? The documentary talks about a medical device (Essure) that was cleared by FDA and implanted into women for sterilization purposes. Following implantation, these women started to experience adverse effects and most of them had to have multiple procedures to have the implant removed. Do you know examples of any other devices that have been initially approved by FDA but then were taken off the market due to unexpected results? If FDA is as strict as we believe it to be, how come recalls happen so frequently in this industry?
I have never seen the Bleeding Edge on Netflix but it seem interesting. I also do not know of approved by FDA but then were taken off the market due to unexpected results. I believe that yes there are cases where unexpected things happen but those cases are very rare and in small numbers. If you follow a recipe a 5 million times something except might happen 10 or 20 of those time.
