1. Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) November 17, 2005 Diana Zuckerman, Ph.D. President National Research Center for Women & Families www.center4research.org

3. What happens when their devices fail 10-20 years later?

5. Guidance for Industry FDA issued a guidance document in Sept 2005 regarding race and ethnicity data in clinical trials FDA issued a guidance document in Sept 2005 regarding race and ethnicity data in clinical trials FDA does not have regulations or guidance to require adequate participation levels of: FDA does not have regulations or guidance to require adequate participation levels of: racial and ethnic groups racial and ethnic groups age groups age groups women and men women and men

6. FDA Regulations: Drugs vs. Devices Sponsors of NDAs must present a summary of safety and effectiveness data by demographic subgroup (age, gender, race) Sponsors of NDAs must present a summary of safety and effectiveness data by demographic subgroup (age, gender, race) IND holders must submit annual reports with information about the age, gender, & race of subjects enrolled in clinical studies IND holders must submit annual reports with information about the age, gender, & race of subjects enrolled in clinical studies There are no similar requirements for medical devices There are no similar requirements for medical devices

7. NIH Policy Could Provide a Model for MDUFMA NIH policy requires the inclusion women & minorities in all research involving human subjects NIH policy requires the inclusion women & minorities in all research involving human subjects Exception to policy Exception to policy To protect the health of the human subjects To protect the health of the human subjects If such research is not needed If such research is not needed

8. The Diversity of Cosmetic Surgery Patients is Increasing Rapidly In 2000, people of color accounted for 14% of all cosmetic-surgery procedures In 2000, people of color accounted for 14% of all cosmetic-surgery procedures In 2005, people of color accounted for 20% of all cosmetic-surgery procedures In 2005, people of color accounted for 20% of all cosmetic-surgery procedures

9. Risks vs. Benefits Cosmetic products are being approved without any useful information on people of color Cosmetic products are being approved without any useful information on people of color These products are not life-saving These products are not life-saving These products are often used off-label These products are often used off-label

10. Possible Racial Concerns Racial/Ethnic groups respond differently to medical treatments and devices Racial/Ethnic groups respond differently to medical treatments and devices African Americans African Americans Implants: Keloid Scarring Implants: Keloid Scarring Laser treatments: hypo-pigmentation Laser treatments: hypo-pigmentation Susceptibility to autoimmune disease Susceptibility to autoimmune disease

11. Keloids Occurs after an incision Occurs after an incision More likely for: More likely for: Blacks and African Americans Blacks and African Americans Asian Americans Asian Americans

12. Keloid Pierced ear keloid Pierced ear keloid Post-op keloid

13. Granuloma

14. Necrosis on Forehead

15. Auto-immune Disease African Americans are more at risk for auto- immune disease African Americans are more at risk for auto- immune disease Implanted medical devices may increase the risks of auto-immune symptoms Implanted medical devices may increase the risks of auto-immune symptoms

16. What about Breast Implants? 300,000+ U.S. women each year 300,000+ U.S. women each year PMAs include less than a dozen African Americans and Asian Americans PMAs include less than a dozen African Americans and Asian Americans Reconstruction is popular among African American women Reconstruction is popular among African American women Augmentation is popular among Asian American women Augmentation is popular among Asian American women

17. Sample Photo from Implant Maker’s Website

18. Capsular Contracture scar tissue around implants

19. Necrosis in 22 Yr old Woman with implants for one week

20. Medical Devices Are Often Advertised for Non-FDA Approved Uses Example: Sculptura Example: Sculptura Before

22. Post-market Surveillance An FDA study of all 127 premarket agreements (PMAs) approved between 1998 and 2000 found that 45 required post-approval studies. An FDA study of all 127 premarket agreements (PMAs) approved between 1998 and 2000 found that 45 required post-approval studies. Only 19 of the 45 legally required studies (42%) were mentioned in annual reports. Only 19 of the 45 legally required studies (42%) were mentioned in annual reports. For the 11 PMAs where the results were due, final results had not been submitted in 6 (54%) cases. For the 11 PMAs where the results were due, final results had not been submitted in 6 (54%) cases. That means no long-term safety information for consumers. That means no long-term safety information for consumers.

27. NAS Report Finding The FDA cannot “reliably identify required post market studies that included questions related to children’s growth and development or active lifestyles.”

29. NAS Report Recommendations Use post-market studies as a condition of approval Use post-market studies as a condition of approval FDA require longer post-market studies to take into account children’s growth and development FDA require longer post-market studies to take into account children’s growth and development Require annual reports on adverse event analyses Require annual reports on adverse event analyses

31. Dr. Jane Henney Former FDA Commissioner “It is only through the participation of the many populations that will ultimately receive a new product that we can ensure that the medical products we approve are appropriate, safe, and effective for all Americans, and not just a narrow cut of our country’s population.” “It is only through the participation of the many populations that will ultimately receive a new product that we can ensure that the medical products we approve are appropriate, safe, and effective for all Americans, and not just a narrow cut of our country’s population.”

32. Diana Zuckerman, Ph.D. President National Research Center for Women & Families dz@center4research.orgwww.center4research.org