An interesting issue arose at the last BME seminar regarding TJA total joint arthroplasty, where joint replacement surgeries advertised individuals doing high intensity or extreme sports 129 days after surgery. The sports include skiing, water boarding, dirt biking etc. While only few in vivo studies have been conducted in very recent years, the understanding of the joint mechanics on the artificial limb during extreme activites is extremely limited. The clinical trials associated with the approval of the device did not explore the possibility of the device being used under extreme conditions and in fact traditionally such activities have been discouraged. The speaker went on to discuss the increasing number of patients who go shopping around for doctors that will give them the okay to do extreme sports.
The question I want to present to you all is, do these devices need to go through the approval process again because the intended use has changed and the conditions the device is currently being used under is outside validated conditions in the clinical studies used to get approval? While the company is not advertising this, hospitals that use the implants are.
Also, technically the device can withstand the conditions of extreme sports as advertised, but the lifespan advertised will not be true if those activities are done. Note all the components of the different advertisements are true but are not necessarily putting each other into consideration when making the claim even though it is a reasonable assumption that consumers will assume that all the benefits in the different commercials are combinable. Do the interactions of these advertisements fall under the FDA jurisdiction for looking at the claims of the device?
I think that all of this definitely should, and hopefully is, going through medical device reporting to the FDA. In my opinion, spending money and time to re-test this device is not the responsibility of the company. I think a good example is that older knee implants were not intended for the life spans that people are living. As a result, some people have to get new knee implants. I'm not sure if companies are responsible for paying for this or if companies are required to do additional testing. However, I think finding the answer to this could provide insight to the problem you proposed. To me, the most important factor is transparency and all of this information being communicated and reported. I would feel really uncomfortable if I had this implant in me and was not previously warned about certain activities wrongly affecting it.
In agreement with ashley, it is not the responsibility of the company to retest their device, especially since they are not making any claims about extreme sports. Also, according to the FDA Mission statement, "The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices". Since they are properly regulating the the safety, efficacy, and security or hip implants for intended use, secondary approval is not necessary. However, I believe to properly address this issue, the FDA would have to create a new classification for high activity implants, allowing companies to choose the rating of implant they want to produce. this would improve safety for all parties seeking a higher mobility lifestyle for the implant recipient.
as far as advertising is concerned, the FTC would likely be responsible for misleading hospital advertising since they are not actually producing the device. as stated on the FDA website, "The FTC protects consumers by stopping unfair, deceptive or fraudulent practices in the marketplace."
https://www.fda.gov/AboutFDA/WhatWeDo/
https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm
I agree and think that there should be more regulation on what patients are being told. If the company is not the one suggesting high intensity and extreme sports be performed then the claims of the company are not the issue and it may not fall under the FDA. If the company has gone through approval on the claims they are marketing with, then secondary approval is not needed. The lifespan of a joint replacement might be much shorter when the recommended use is not followed by the patient or like you said shop around for a doctor who goes against what the company says their device can do and should be used for. If studies are done by companies for their device to be used during extreme sports when that is not what their original claim stated, I think then they would need to go through the FDA and be approved for that.
If a company make any advertisement or any claim via any resources that company becomes liable to that claim in other words if company claims that's there prosthetic limb can be used for extreme sports they have to do test and trials to successfully show that implementation. FDA regulation makes company abide to any claim they make but in terms of Lifespan if they don't tell life span of the limb while using it for extreme sport it is going to fine until and unless they don't make any specific claim like Even when you use this limb for adventure sports its life span is still so many years until and unless that is proved. If company makes a claim that this can be used for adventure sports and the life span of product is so many years it doesn't mean that company just said that it can be used with adventure sports for so many years. The above claim made can be advertise as separate claims in same advertisement unitl both claims are true. Now it becomes doctors responsibility to complete understand the application and give patients the correct advise of what their opinion on the device and make sure any open ended statement are addressed before making any recommandation.
I agree that advertising is a sum of its parts. It is like the company is conveying the functions of the part that is made for. In other words, any device that is made is approved by FDA on the basis of it's functions, working and it's liability. Advertising is conveying those details to everyone. This details are necessary in order to get an FDA approval ultimately making it a part of that device. Also many companies disclose only good details which is inappropriate. There should be a full disclosure in order to avoid any type of misconceptions to the consumer or the patients.
In agreement with some of what was described in previous posts, if the manufacturer is not the one claiming that the TJA total joint arthroplasty can be used while performing high intensity or extreme sports then it would not fall within the manufacturer responsibility to retest their device (actually they may have legal rights to sue the hospital for false advertising their product!). One step the manufacturer could take knowing that their product is being misused, I believe, is to update their labeling information to make it clear that the product is not be used doing extreme sports. In another scenario if the manufacturer was the one advertising the product, then they could be charged with falsely advertising a product. The would need to retest their product in case they want to update their label to indicate it can be used to do extreme sports.
I agree that manufacturers should retest their devices and if they know their product is being misused it is their duty to fully educate the consumers the ramifications of mal intended usage. Too often nowadays we see medical devices being used for their unintended purposes in the operating room or when used in practice. To curb this, a suggested measure could be for medical device representatives to be trained on all possible forms of use for the medical device and when they are speaking with the consumers (hospital care), they can educate them of this and explain thoroughly the consequences some of these can have. Another measure would be to increase hospital oversight when using these devices to make sure these devices are not used for the wrong purposes and if they are, to remove those abusing their privilege from their position of authority.
I believe it is quite problematic if an advertisement makes claims about the extreme activity a joint replacement can withstand if that level of activity was not intended by the manufacturer. Pushing the limits of medical devices past what has been tested by the manufacturer can lead to serious injury, especially for devices which remain implanted in the patient's body, as the patient may not even be aware of the limits. I do not think though that the manufacturer is obligated to test for the conditions outside of the intended use of the implant - that is the purpose of defining the intended use limits. Rather, the manufacturer is responsible for clearly stating any contraindications that can be expected, and physicians/hospitals using the implants are responsible for communicating those risks to the patient. However, although the manufacturer is not obligated to test that the implant can withstand extreme sports, seeing that there is a growing demand from joint replacement patients who desire this level of physical activity, it may be in these companies' best interest to design and conduct clinical trials for "extreme sport"-level implants from a business perspective.
I agree with es446 that it may be in the company's best interest to design clinical trials for "extreme sport"-level implants, as many companies today have various types of product models directed towards different users. While the company is not advertising the use for extreme sports and it seems that hospitals/doctors are, there seems to be a misunderstanding between the hospital/doctors and the company selling the product and I agree with ad487 that there can be greater training for medical device representatives in communicating these factors to the hospital, however, I believe an even more effective way ties back to the BME seminar that amin-sadig attended. If doctors working at the hospitals attended such BME seminars that addressed the increasing concerns of patients misusing the product, then the doctors may be more aware of this situation and more effective in communicating the true intended uses of the product. Thus, having those who work in the hospital attend important and relevant seminars on updates or recent issues that need to be addressed could help alleviate this problem.
