Congresswoman Debbie Dingell
Health Subcommittee, Energy and Commerce
U.S. House of Representatives
Washington, DC
Dear Congresswoman Dingell,
As members of the Patient, Consumer, and Public Health Coalition, we write to express our gratitude as you work to protect patients by promoting post-market review of approved medical devices. Specifically, we greatly appreciate and value your leadership requesting that the Government Accountability Office (GAO) evaluate the current landscape of post-market surveillance of medical devices. The last GAO report on this issue was in 2015, and did not provide any recommendations, information on recalls, or a thorough evaluation of the gaps in active surveillance.1 We especially commend you for your statement during the House Energy and Commerce mark-up of the Food and Drug Administration (FDA) Amendments Act: “…gaps in active surveillance fail to catch adverse events caused by malfunctioning or faulty medical devices which can lead to tragic consequences for patients.” We applaud your efforts and urge you to prioritize quick action on this report and future legislation to improve post-market surveillance of medical devices.
We know all too well what can happen when a lack of adequate surveillance and slow action tragically results in serious harm or death. For example, the birth control device Essure was on the market in the United States from 2002 to 2018. After thousands of women across the country reported serious side effects from the device, the FDA required a post-market surveillance study in 2016. Although the study was never completed, the requirement prompted the manufacturer to voluntarily remove the device from the market two years later.2 The FDA has received 67,643 medical device reports related to Essure since 2002, which cited issues ranging from fragmented or dislodged devices, perforations, and the need for hysterectomies. This device, marketed as permanent birth control, also led to 4,509 pregnancies, of which 2,308 were pregnancy losses.3 When a study was eventually funded by the Patient Centered Outcome Research Institute (PCORI), the results showed a 6% pregnancy rate, instead of the < 1% pregnancy rate reported to the FDA.4 If the post-market study had been conducted immediately after approval, it could have prevented debilitating pain, numerous surgeries, unplanned pregnancies, and permanent adverse effects during the years that women did not have the information needed to make an informed health decision.
Last year, five million ventilators and sleep apnea devices were recalled by Philips due to a dangerous breakdown of foam within the devices. In the year since safety issues were acknowledged by the company in April 2021, FDA received 21,000 medical device adverse event reports, including 124 reported deaths.5 Other adverse effects linked to the device include cancer, pneumonia, asthma, infection, and chest pain. In March 2022, FDA mandated that Philips notify its distributers, healthcare providers, and patients after finding that the company did not quickly communicate the recall that began in June 2021, ten months earlier.5 An adequate surveillance and recall process could have prevented significant harm and lives lost.
In addition to the cost to patient health, there are also negative effects on the American taxpayer when unsafe and ineffective devices remain on the market. A 2017 Health and Human Services (HHS) Inspector General report found that over the course of ten years Medicare paid $1.5 billion for just seven unsafe cardiac implants that were eventually recalled after being widely sold. These devices, which failed for thousands of patients, included lifesaving cardiac defibrillators and pacemakers. In addition to the cost to Medicare, patients paid $140 million in out-of-pocket costs.6 The report detailed the need for enhanced product performance tracking to keep patients from harm. It also described how improved reporting could lead to faster recalls for malfunctioning devices.6 Meanwhile, these recommendations and findings remain largely ignored and have failed to be implemented or prioritized by previous FDA Commissioners.
Post-market surveillance of medical devices was the main priority of many patient and consumer organizations involved in the medical device user fee process as knowledgeable experts, including many of our members.7 However, our repeated requests to set aside some medical device user fees to fund post-market surveillance continues to be denied by the medical device industry representatives that negotiate with the FDA, and those negotiations continue to occur behind closed doors.
We are confident this GAO report will demonstrate the need for improvements in post-market surveillance of medical devices and help illuminate the impact of increased speed of the review of medical products, with minimal safety measures, on public health. We strongly urge you and other Members of Congress to implement any statutory changes needed based on the recommendations from this requested report. We look forward to continuing to work with you as you champion medical device safety issues for all Americans.
Please contact Thomas Eagen (te@center4research.org) at the National Center for Health Research with any questions.
Sincerely,
American Medical Student Association (University of Wisconsin chapter)
Breast Cancer Action
Breast Implant Safety Alliance
DES Action
Doctors for America
Jacobs Institute for Women’s Health
Medical Device Problems
Medshadow
Mothers Against Medical Error
MRSA Survivors Network
National Center for Health Research
National Consumers League
National Women’s Health Network
Our Bodies Ourselves
Patient Safety Action Network
The Society for Patient Centered Orthopedics
TMJ Association
USA Patient Network
US PIRG
Washington Advocates for Patient Safety
Woodymatters
- Government Accountability Office (2015) Medical Devices: FDA Ordered Post-market Studies to Better Understand Safety Issues, and Many Studies are Ongoing. https://www.gao.gov/products/gao-15-815
- U.S. Food & Drug Administration. (2020). FDA In Brief: FDA Posts Interim Results from Required Essure Post Market Surveillance Study. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-posts-interim-results-required-essure-postmarket-surveillance-study
- U.S Food & Drug Administration. (2022) Problems reported with Essure. https://www.fda.gov/medical-devices/essure-permanent-birth-control/problems-reported-essure
- Gariepy, A., Lewis, C., Zuckerman, D., et al. (2022). Comparative effectiveness of hysteroscopic and laparoscopic sterilization for women: a retrospective cohort study. Fertility and Sterility. https://www.sciencedaily.com/releases/2022/04/220412161606.htm
- Zipp, R. (2022). FDA gets over 21,000 medical device reports, including 124 deaths, linked to Philips foam breakdown. Medtech Dive. https://www.medtechdive.com/news/fda-received-over-21000-medical-device-reports-124-death-reports-philips-recall
- Schulte, F., & Jewett, C., (2017) Replacing Faulty Heart Devices Cost Medicare $1.5 Billion in 10 years. New York Times. https://www.nytimes.com/2017/10/02/health/heart-devices-medicare.html
- National Center for Health Research. (2022). Nonprofit Consumer and Public Health Organization’s Letter on MDUFA reauthorization to FDA and CDRH. http://www.center4research.org/nonprofit-consumer-and-public-health-organizations-letter-on-mdufa-reauthorization-to-fda-and-cdrh/