Implants under scrutiny
They are intended to relieve pain and restore the quality of life. If an implant turns out to have a flaw, however, the consequences can be dire – and not just for the patient. Serial losses that can rapidly spiral into the billions make it imperative that insurers exercise the utmost care in underwriting.
Implants are a growth market
Not all operations proceed without complications and assure a future free of complaint. In addition to the unavoidable risks associated with any surgical intervention, product defects have frequently led to pain, the stress of additional treatment or even to replacement of the implant long before the end of its expected service life. The early failure of implants has given rise to costs exceeding US$ 100m for the indemnification of claims and/or product recalls. Prominent product liability cases have also led to lengthy discussions as to whether current licensing and certification procedures for implants still offer patients enough protection against product risks.
Implants are in the highest risk class
An implant has to be licensed or certified before it can be sold. From a regulatory standpoint, implants are classified not as medicinal products (drugs), but as medical devices and are therefore also governed by different laws and regulations. For example, there is frequently no requirement for clinical trials for this product group. Medical devices are normally classified in risk classes I, II or III, with class I comprising low-risk products such as dressings, walking aids and wheelchairs. Products categorised as class II are those deemed to entail moderate risk. Risk class III covers products entailing the highest risk, such as artificial hips and knees, cardiac pacemakers and breast implants. The higher the risk class, the tougher the licensing and certification requirements are.
Certification in Europe
Licensing in the US
Loopholes instead of clinical studies
Quality and risk management
ISO 14971, an international standard for medical products, offers a risk management guideline. In addition to describing the basic requirements, it covers all relevant aspects of risk management, such as risk analysis, risk assessment, controlling risks, acceptance of the residual risk and reporting. Corresponding documentation should be available to underwriters for detailed examination. In case of doubt, they should not rely solely on this documentation, but consider an on-site analysis of the risk.
In analysing a risk, one can distinguish between the general aspects that describe the basic conditions and an individual analysis that focuses much more strongly on the product itself, its production and its use.
A product with the potential for major loss
Ultimately, “removing” an implant because the product has been recalled means additional time in hospital for the patient and normally involves considerably higher costs than when recalling and removing technical parts in the automotive industry, for example. High claims for damages can become an incalculable burden for the manufacturer.
Risk monitoring at Munich Re