Comments of Sally Greenberg, Executive Director of National Consumers League, before the Food and Drug Administration panel on post-approval long-term breast implant studies
August 31, 2011
Good Morning. My name is Sally Greenberg and I am Executive Director of the National Consumers League, an organization founded in 1899 dedicated to protecting the rights of consumers and workers in the United States and abroad. NCL has throughout its history been concerned about the welfare of women and their health.
I am here today because of our commitment to patient safety and our concern that the FDA sometimes relies on post-market studies to ensure safety and effectiveness of new medical products, but then does not make sure those post-market studies are completed appropriately.
I am not an expert on breast implants, but as a consumer advocate, I know that comprehensive and well-conducted scientific research is essential to ensure the safety of all implanted medical devices. If a researcher loses track of half of the patients, those findings are not useful for determining safety.
The Mentor large study lost track of 79 percent of their patients within just 3 years. In addition, Allergan lost track of almost half their augmentation patients after only two years. The Adjunct studies were even worse, with less than one-quarter of their patients still in the studies after 5 years. In their Core study, Mentor followed only 58 percent of their patients for 8 years.
None of those studies met the very reasonable standards that the FDA has set for competent research. I understand that yesterday, several panel members asked if the FDA has ever threatened to rescind approval if a company does not complete post-market study requirements. I think that is a good question, because if these companies have a track record of poor research, study after study, what incentive do they have to improve their procedures and processes the next time a study is commissioned?
We want consumers to have safe choices, and that means that well designed and well-conducted studies are needed to provide bona fide informed consent for patients. Patients cannot make safe choices on a long-term implanted device if there are no studies of long-term risks.
I was also amazed to learn that the patients in the breast implant studies apparently paid full price for their implants and all their medical care. One of the major incentives for keeping patients in studies is to provide free medical exams. They should have provided free MRIs so that FDA would have good data on breast implant breakage and leakage.
American patients should expect better from those who are commissioned to conduct studies. The FDA should expect better.
Thank you for giving me the opportunity to speak.
About the National Consumers League
The National Consumers League is America’s pioneering consumer organization, dedicated to promoting and protecting the rights of workers and consumers in American and abroad. To learn more, please visit www.nclnet.org