At a recent cartilage seminar I was asked by an orthopedic surgeon about the durability of a particular type of cartilage repair, and specifically how the longevity of one type of implant might compare with another.
A fair question, but one that does not permit an easy answer. The answer is totally complicated by the size of the lesion, the location of the lesion and the stresses placed upon the new implant; not to mention how one defines durability. Implant durability is completely different issue than assessing subjective surgical results . I suppose the only unambiguous way of defining durability would be the probability of having a repeat procedure within a specific period of time. This type of scientific answer may only be possible after a decade or more experience with a given implant, and for that reason it totally eludes us in fast moving medical fields; by the time the study is complete, the product is obsolete!
We should be maintaining databases and conducting post-marketing research on all types of medical devices. Companies may be hesitant to do this unless instructed by the FDA; the fear of a product problem is naturally repugnant to the business community, although it should not be. Many companies may feel that you do not give out more information than is required. This is just wrong, it is bad medicine and it is bad business too.IMO, the regulations for medical devices should be less restrictive on product introduction and far more firm on post marketing surveillance. In that way, issues of safety and early term success are separated from questions related to long term outcome; innovation is not stifled, but there is an obligation for the company to continually reassess its product placement. This will be good for patients, in the same way 100,000 mile warranties are
good for consumers even though we all know that the parts warrantied seldom break. What the warranty really accomplishes (and medical devices are NOT going to be warrantied) is to make the company look down the road a bit, a good thing for us all.
This scenario recently happened with respect to metal on metal total hip implants. For this reason you will now find on certain TV stations lawyers trolling for clients whose implants have “failed”, and the FDA has now ordered certain post-marketing studies. We need to remove liability as a (perverse) incentive for discovering new information. It just does not serve the public well and it encourages even more secretive behavior on the part of device manufacturers rather than the open source information database we need,
I think you now see why we do not know how long any given implant will last, and why we will not have any answer any time soon. Caveat emptor!