The US Food and Drug Administration noted frequent complaints of a permanent contraceptive mechanism called Essure. A medical group at Weill Cornell Medicine in New York reported a 10 times higher frequency of reoperations during the first year of implantation. In Europe, the PIP breast implant remains a permanent scandal. The question here is why are approved devices causing serious security problems on the market? Clearly, strict regulatory oversight does not prevent the rise of malfunctioning medical devices. On the device manufacturer’s side, following regulations alone does not guarantee that all safety, quality, and effectiveness parameters have to be addressed.
Essure, produced by Bayer, was approved through the 510 (k) process. This route excludes medical devices from clinical testing if they are shown to be substantially the same as a similarly marketed instrument. As a result, any clinical data obtained from abbreviated studies would be insufficient to give valid and representative conclusions about the safety and performance of the devices. Should Bayer have conducted a full randomized and blinded clinical investigation instead? The answer to this should come from sensible business-based decision making, and not a general one. Fully understanding product features from a benefit and risk perspective is an important cornerstone of the medical device value proposition. Core customers for medical devices are end users and / or patients whose requirements should be given a higher priority over regulatory standards.
An explicit effective business tool for medical devices that could help address this is the ISO14971 risk management standard. The requirements of this standard are common to all medical devices regardless of risk classification and approval methodologies. It requires all device manufacturers to take all valid steps to confirm that risk levels are minimized to a minimum. Vice versa, the approval pathways for lower risk devices do not offer relief from risk reduction measures. Therefore, if a full clinical trial is required to provide a total risk / benefit profile for a device, this must be done in conjunction with the regulatory process. This implies that a risk management process for a 510 (k) approval should not necessarily be less valid than for a PMA.
Any device manufacturer that uses an abbreviated approval procedure as an excuse to reduce risk reduction will not only place a dangerous medical device on the market, but such disregard for basic total quality is itself detrimental to medical device innovation. and long-term business competitiveness.