1. Why I Fight to Improve the FDA, and
You Should Too
Diana Zuckerman, PhD, President
National Research Center for Women & Families
Cancer Prevention and Treatment Fund

2. Unsafe Medical Products
in the News
Medtronic Agrees to With Warning, a
$23.5 Million Settlement
in Kickback Case Hip Device Is
Trial of Synthetic Withdrawn
Mesh in Pelvic
Surgery Ends Early

3. Defective Medical Devices
Hit Prime Time

4. Low Risk Devices

5. Moderate Risk (510k)

6. 95+% are Reviewed as 510(k)
IOM: No evidence of safety or efficacy
Must be Substantially Equivalent to
“predicate device or devices”
 No clinical trials
 No inspections
 No studies are required post-market
 Can’t be rescinded

7. High Risk Medical Devices
(pacemaker, heart, infusion pump)

8. Highest Risk Devices: PMA
Premarket Approval
 Reasonably Safe
 Reasonably Effective
Based on one clinical trial (not double
blind ) with smaller sample than
required for prescription drug data

9. FDA Approval of
Drugs and Devices
Does NOT mean
 Nobody will die or be harmed
 This product is safe for long-termuse
 This product is more effective than other
products on the market

10. 510k Substantial Equivalence
 Similar “intended use”
 Similar material or mechanism of
action
 Similar risk: benefit ratio

11. Are these substantially
equivalent?
=
?
Vitek (teflon) TMJ implants Dow silicone sheet

12. Are these substantially
equivalent?
=
?

13. GAO Report
510(k) Reviews in 2003-2007
 FDA Cleared 90% of 13,000+
medical devices

14. More Recalls
 Almost half a billion 510(k) devices were
recalled as high risk in late 2010 and
early 2011, including contaminated
alcohol swabs that killed this 2-year old
boy and then infected others.
1

15. More Recalls
 GAO’s estimates that 3,000+ recalls from
2005 through 2009 were high-risk or
moderate-risk recalls
 Divide 3000 by the device industry’s
estimate of 20,000 device submissions.
1
 RESULTS: 15% were recalled!

16. Deaths reported on FDA web site
 4,556 deaths for medical devices in
2009 (increased 60% compared to
2006).
1

17. Improving Safety
 Clinical trials
 Inspections
 Any flaws can be caught sooner with
post-market studies, registries,
surveillance

18. Conclusions
 Can’t have evidence-based medicine
with no evidence
 IOM says that over 95% of new medical
devices have no clinical trials and are
not proven safe or effective
 Clinical trials are
less stringent for
devices than for prescription drugs

19. Consumers Should Care
 Half billion
510(k) devices were recently
recalled as high risk
 Approx 15% of regulated devices are
recalled as high or moderate risk

20. Diana Zuckerman, PhD
President
National Research Center for Women &
Families
Cancer Prevention and Treatment Fund
www.center4research.org
www.stopcancerfund.org