A new survey reveals that American overwhelmingly support stronger oversight
of medical devices. However, Congress is currently debating weakening
these protections as it reauthorizes the existing statute governing the
approval of medical devices.
As we have previously discussed on this blog, the existing
medical device rules allow the FDA to approve a new medical device if it is similar to an existing,
previously approved device. Under this regulatory scheme, less than 1%
of new devices undergo the FDA’s more thorough Pre-Market Approval
process. The draft legislation being considered in the House would actually
make this process less rigorous by speeding up the process.
San Diego product liability attorneys, this is deeply concerning, as it would almost certainly further compromise
patient safety. According to a new Consumer Reports poll, it seems most
Below are some of the findings, as reported by
- 82% of Americans believe that preventing safety problems is more important
than limiting safety testing in order to prevent delays and encourage
- 91% of poll respondents said each implant should be safety tested before
being sold even when similar implants were in use.
- 71% said that a new device should not be allowed to be sold based on its
similarity to an existing implant that has a safety problem or has been recalled.
- 94% indicated that medical device makers should be required to do long-term
monitoring of implants if there are safety concerns or problems with a
particular device. Existing law gives the FDA only limited authority to
require such long-term safety monitoring.
- 95% said that effective consumer protections for medical implants should
include a nationwide system for tracking medical implants so patients
can be notified about safety problems or recalls. No such system currently
exists in the U.S. even though it was required by Congress’ previous
reauthorization of the law.
- 66% indicated a high level of concern about safety decisions or recommendations
made by expert committees that included doctors who had current financial
relationships with medical device makers.
Given the importance of this issue, we will be sure to keep you updated.
If you or someone you love has been seriously injured by a dangerous or
defective medical device, don’t hesitate to contact a
San Diego product liability attorney
at the Law Offices of Robert Vaage for a free consultation.