New Review Shows FDA is Missing Crucial Safety Information on Breast Implants

January 5, 2012
FOR IMMEDIATE RELEASE
FOR MORE INFORMATION:

Emily Moore at 202 223 4000 or EM@center4research.org

New Review Shows FDA is Missing Crucial Safety Information on Breast Implants

Washington, D.C.–As the scandal about dangerous breast implants spreads to many countries across the globe, the FDA can be proud that the agency did not approve implants made by that company, France’s Poly Implant Prothese (PIP).

A closer examination of the data regarding the FDA-approved breast implants made by Mentor and Allergan, however, indicates numerous errors and missing information in the FDA’s most recent research summary (published online in June 2011), as well as in the information the agency provided to their Advisory Panel that met to discuss breast implants in August 2011.

In an 11-page summary provided to the FDA by the National Research Center for Women & Families on January 5, 2012, the Center pointed out their concerns about “missing information and inaccurate or misleading data that were provided to the FDA Advisory Panel on breast implants and that are included (or missing) in the June 2011 summary on the FDA web and in other recent FDA materials.” The Center raised the following concerns and questions

  • Missing information about signs and symptoms of connective tissue disease from 2005 and the most recent follow-up data, and an inaccurate summary of earlier findings
  • Missing information about poor outcome on Quality of Life measures from 2005, and missing follow-up data
  • Inaccurate cumulative complication rates for at least some outcomes
  • Inaccurate and misleading presentation of rupture data, which should be presented per patient rather than per implant.
  • Questions about which complications are presented per implant or per patient and questions about whether women with complications at 3 or 4 years were excluded from the 8- and 10-year follow-up samples.

As NRC President Dr, Diana Zuckerman pointed out: “Many of these issues were raised by our Center before the August meeting or during the public comment period during the meeting, but 5 months later they have still not been corrected or addressed.   For that reason, we have written a more detailed analysis with all the documentation FDA needs (based on FDA’s own documents) to review these matters.  As we have shown in our analysis, the companies’ own data indicate that it is unlikely that breast implants offer the quality of life benefits promoted by plastic surgeons and manufacturers, and at the same time their risks are more serious and probably more systemic than patients have been told.”

Key Members of Congress have also expressed concerns about the reported errors and the implications for women’s health.  Senator Olympia Snowe (R-Maine) remarked “When making such a significant medical decision, patients rightfully deserve and fully expect to have a complete picture of the risks and benefits of these implants.  Regrettably, the effort put forward on post-market studies thus far has been severely lacking, and these critical questions on complications and rupture rates must be answered without delay.”

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For more Information regarding Senator Snowe’s concerns, contact Chris_Averil@snowe.senate.gov

For information regarding the concerns of Rep. Rosa DeLauro (D-CT), contact Kaelan.Richards@mail.house.gov