Hip surgeons and their supporting practice teams typically have a complex set of relationships with one or more hip replacement manufacturers.
The purpose of this page is to give some insight into the nature of those relationships and interdependencies in the context of hip replacement recall situations.
As you would expect, all hip surgeons strive to achieve the very best outcomes possible for each of the patients in their care. As with all medical professionals the relationship between patient and his hip surgeon is one of explicit trust. Furthermore, the hip surgeon will wish to protect and enhance his professional reputation for excellent hip replacement outcomes.
Central to the hip replacement procedure is the particular brand and model of hip implant used by the orthopaedic surgeon. It is quite common and natural for a hip surgeon to develop a preference for the implant products of one particular manufacturer.
For example, the orthopaedic surgeon who carried out my recent total hip replacement only uses the hip replacement systems of one of the major global manufacturers. He has developed an enduring, strategic relationship with this manufacturer throughout his career based on his intimate knowledge of their high quality products and trust in the brand. He knows that products sourced from this particular manufacturer are a critical factor in enabling him to achieve consistently good outcomes for his patients.
All hip surgeons need to be trained in the use of hip implant products regardless of which brand they choose or prefer. For example, periodically my orthopedic surgeon will take time out from his weekly practice routine and spend time receiving classroom and practical training on new products as introduced by his preferred manufacturer from time to time.
In addition, it is quite common for orthopaedic surgeons to be an integral part of the teams of experts engaged in programs of research, funded by the manufacturers, to design and develop new hip implant systems.
When a hip implant manufacturer recalls a product it inevitably puts significant strain on the relationships between hip surgeons and that manufacturer. The surgeons will, in good faith, have used that product with their patients and suddenly they find that there was possibly a defect with the product either in the design or in the manufacturing process.
The bottom line is that a hip implant recall may damage the relationship of trust both between patients and their hip surgeons, and between the surgeons and the manufacturer.
As part of the process for surgeons to obtain informed consent prior to surgery, the surgeon will discuss with the patient the range of options available to treat the condition and for each option, outline the benefits and risks of that treatment.
If for example, the surgeon proposes one option as being the use of a metal on metal implant, then the specific risks that are inherent to some of those types of implant will be clearly explained as part of the informed consent process. The surgeon has a responsibility to ensure that the patient understands the benefits of using an implant of that type, balanced against any additional risks that are thought to be associated with some metal on metal implants.
The surgeon needs to be confident that patient has understood all of the options, weighed the relative benefits and risks of each option, and ultimately made an informed decision on which procedure for example hip resurfacing or total hip replacement; and which type / design of device is preferred.
All things being equal, the orthopaedic surgeon will have explained to the patient all risks associated with a particular type of implant that were known at that specific point in time.
When taking the patient through the informed consent process, the surgeon will largely be rely on his professional experience, combined with written information and warnings from the manufacturer summarising the risks of a particular implant or hip replacement system.
When a hip implant product is recalled, the goal posts shift. If additional risks have been identified since the product was released into the market then this new information has the effect of undermining the informed consent that was achieved prior to surgery.
It is at this point that the patient begins to look back in time and search for the root cause. The inevitable question is: 'If I'd known then (at the point I gave my consent for the surgery) what I know now… Would I have given my consent?'
This goes to the heart of whether a potential legal case for compensation will based on an allegation of:
Trust, confidence, effective risk management and good communication are all essential to the achievement of good outcomes in hip replacement surgery. Hip surgeons and manufacturers know that the chain is only ever as strong as the weakest link, and very occasionally that weakest link can be the hip implant product itself.