My name is Linda MacDonald Glenn. I am testifying today on behalf of the Institute for Ethics and Emerging Technologies, a nonprofit, nonpartisan public policy institute dedicated to ensuring that men and women's voices, health, and life experiences are brought to bear on ethical issues in health care and technology.
I am a biomedical ethicist, attorney, educator, and patient advocate. I spent twenty years as a counselor at law, a government adviser, and general practitioner. I was then drawn to the field of biomedical ethics, and went back to school to switch my career. After graduating with an LLM in Biomedical Ethics from McGill University in 2002, I went to the American Medical Association, where I was a senior fellow at the Institute of Ethics, and shortly thereafter was named a Women’s Bioethics Project Scholar, because of my research on the impact of emerging technologies on women. I now am a faculty member at Albany Medical Center, with the Alden March Bioethics Institute. I have no financial conflicts of interest.
In 2006, when the FDA approved silicone gel breast implants made by Allergan and Mentor for cosmetic use, it was with the proviso that doctors advise their patients to obtain MRIs every two years starting the third year after the surgery; And to advise their patients that breast implants don't come with a lifetime guarantee. With issues of long term safety and informed consent as primary concerns, the FDA required manufacturers to follow their pre-existing study groups of silicone patients for ten years and to create a database to track 80,000 new patients. More research was needed to prove safety, and that research was also needed so that women could make informed decisions.
There were many unanswered questions then, and unfortunately they remain unanswered today. And, given that Mentor has already lost track of 79% of the women in their so-called required ten-year study, we know that they will never be able to answer those questions.
On page 17 of the Executive Summary provided to this panel, the FDA concluded "As follow-up has lagged, the FDA recognizes that these studies may not provide the data necessary to definitively anwer questions about rare associations." -- That shows a misunderstanding of the problems with low follow-up. It's not just the rare diseases, it is the accuracy of complication rates that is questionable when your sample may not be representative of all women with those implants.
When you lose half or more of your sample, you can't assume the people in the study have the same experiences as those who dropped out.
Informed consent of clinical treatments is one of the cornerstones of contemporary medical ethics – informed consent is so much more than a patient’s right to choose. If it were only about the right to choose, the FDA would not have the authority to regulate medical products. Informed consent is an ongoing process, not a piece of paper or a discrete moment in time – merely giving information is too passive a process. As our information and knowledge changes, so must the process and the conversation.
The two-year studies the companies conducted for previous approval showed a significant increase in several autoimmune symptoms, such as joint pain and chronic fatigue. Those increases were maintained when age was statistically controlled.
Since those data were analyzed by FDA six years ago, two odd things happened:
- First, those findings, which were in official FDA documents on the FDA web site, were not included in the patient booklets that the FDA requires the companies to give to patients.
- Second, it seems that those questions were not included in the longer-term follow-up of the Core studies for the two companies.
So, as this committee considers what research is needed now, I have three recommendations:
1. Since the implants made by both companies were approved contingent on post-market studies, and since Mentor has completely failed to conduct those studies in a way that can provides useful safety information, I ask this panel to advise the FDA to rescind approval for Mentor breast implants.
2. This panel should recommend that Allergan be given an additional year to prove that they are taking these post-market research requirements seriously. However, I do not believe that Allergan’s online questionnaires are an appropriate way to gather accurate medical information about women with implants.
3. This panel should recommend better-designed studies that Mentor and Allergan should pay for, but not control or analyze. These studies should take a careful look at the psychological benefits, if there are any, of breast implants. And, they should study the impact of breast implants on patients with a family history or personal history of autoimmune symptoms before they got breast implants, to see if those patients are more vulnerable to autoimmune reactions to the implants.
In terms of ethically sound decision making, the path this Committee ought to take is clear. Silicone breast implants should only remain on the market if companies abide by the post-market requirements to provide data on long-term safety and efficacy. Mentor has not done so. Allergan might still prove itself, although the current methodology is questionable.
Thank you for your thoughtful consideration in listening today.
Follow up note: A number of well known individuals, such Diana Zuckerman, president of the National Research Center for Women & Families,, and Dr. Susan Wood, associate professor at George Washington University's School of Public Health and former assistant commissioner for women's health at the FDA, also testified. The story has been covered by a few news outlets, including CNN and NPR. I'll post an update when the committee makes its recommendations.