U.S. medical devices which won CE Mark approval in the European Union prior to gaining FDA clearance have a nearly 3 times higher rate of safety alerts and recalls, according to a new study published in The BMJ.
Researchers, led by Harvard’s Thomas Hwang, examined press releases and announcements of approvals, as well as public FDA and European regulatory authority databases for U.S. approvals, safety alerts and recalls to gauge different rates of recalls and alerts dependent upon where the devices 1st won approval.
Data indicated that 67% of the 309 devices identified in the study were approved in both the U.S. and the EU, with 63% of those devices 1st winning CE Mark approval in the European Union.
Devices which won initial approval in the EU were associated with a 2.9 times greater rate of safety alerts and recalls, and a 4.6 times greater rate of recalls alone, according to the report.
“Devices approved first in the EU are associated with an increased risk of post-marketing safety alerts and recalls. Poor trial publication rates mean that patients and clinicians need greater regulatory transparency to make informed decisions about treatment,” authors wrote in the study.
Authors referenced a particular drug eluting stent, which won CE Mark approval in 2006, but was recalled 1 year later after the results of a U.S. pivotal trial showed the device was associated with “significantly increased rates of major adverse cardiac events, including myocardial infarction and target vessel revascularization.”
The higher rate of recalls and alerts could be a result of more strenuous testing required to hit the U.S. market, with the FDA maintaining stricter guidelines and requiring high risk devices to demonstrate “reasonable assurance of safety and effectiveness” before they can be used by patients. For the EU, devices can be marketed if they perform “as intended” and are likely to be safe, authors wrote.
“Patients and clinicians need access to, and balanced presentation of, the available evidence of the safety and effectiveness of novel devices, as well as clear communication about the evidentiary gaps. Our findings suggest that products introduced earlier in their development cycle are also more likely to increase the risk of harms, underscoring the urgent need for transparency to make truly informed decisions,” study authors wrote.