Tens of millions of Americans live with medical devices implanted in their bodies —artificial joints, heart defibrillators, surgical mesh and more. Sadly, most patients who received medical device implants assume that someone, somewhere, tested the devices for safety and effectiveness. But that is rarely the case. For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue. Often, the only safety “testing” that occurs is in the bodies of unsuspecting patients.
Background
In 1976, the United States Congress passed legislation which changed the landscape of how medical devices were approved in this country. The legislation included a grandfather clause provision which stated that any new device where the design is based upon that of a device approved before the 1976 passage of these regulations, would not be required to participate in Pre-Market Testing prior to approval. The medical device industry would simply need to prove on paper that a device, for which they were seeking approval from the FDA, is substantially equivalent to a previously approved device. This clause, known as the 510(k) approval process, has resulted in a flood of poorly designed and untested devices being used in patients in the United States and around the world; at great risk to the health and well-being of patients.
One example of the size of this problem is the use of metal-on-metal hip implants. An estimated 750,000 of these devices have been surgically implanted in the U.S. with insufficient knowledge of risks and incomplete testing of devices; resulting in harm to patients. In particular, women suffer harm at a rate more than double that of male patients due to female physiology and biological factors. Unsuspecting patients have suffered major adverse conditions including repeated revision surgeries, permanent disabilities, expensive medical complications, serious infections, failing health and deaths. These faulty, high risk implants and the tragic health impacts from their use have resulted in the filing of tens of thousands of lawsuits against manufacturers to compensate victims for harm done. Many Federal Court cases are proceeding across the United States
In 2011, a panel from the prestigious Institute of Medicine said the FDA should overhaul its device regulatory system because it fails to ensure patient safety before and after products go on the market. Instead, Congress has approved regulations that keep the present system virtually intact and ratified an agreement between the FDA and industry to get devices on the market even faster.
The FDA believes “the program has served American patients well,” says Jeffrey Shuren, M.D., director of the agency’s Center for Devices and Radiological Health. “As a responsible guardian of public health, the FDA believes it’s a challenge to eliminate a program without having a better alternative.”
An investigation by Consumer Reports, which included interviews with doctors and patients and an analysis of medical research and a device-safety database maintained by the FDA, shows the following alarming concerns:
- Medical devices often aren’t tested before they come on the market.
- There’s no systematic way for the government, researchers, or patients to spot or learn about problems with devices.
- Without major changes in the system, there’s not much that patients can do to protect themselves.
In addition, recent testimony concerning Johnson & Johnson’s DePuy Metal-on-Metal Hip Implants (http://www.documentcloud.org/documents/560445-testimony-on-artificial-hips.html) reveals corporate practices to influence medical device marketing and the FDA 510(k) approval process. This document provides interesting perspectives into the hypocrisy of manufacturers in providing metal-on-metal hips for surgical implantation into victim’s bodies. Vital, life-saving information has been suppressed or withheld from patients for years, often until it’s too late. Marketing data provided to doctors, surgeons and hospitals make wildly inaccurate claims for success, while all over the world the failure rates in these cases are/were enormous compared to other safer, available hip implants.
Working for Change Nationally
Some of our members have been seriously affected by faulty medical implants, including the loss of job, health, and quality of life. To improve medical device safety and reduce harm, our members were actively engaged with the June, 2012 FDA hearings on faulty medical devices (http://www.fda.gov/AdvisoryCommittees/Calendar/ucm306172.htm). Here are the videos from the two-day testimony in which our members participated:
http://fda.yorkcast.com/webcast/Viewer/?peid=12f84ea095b445d78e9b115f495392731d
http://fda.yorkcast.com/webcast/Viewer/?peid=901726ab91944b158ac705e48664921c1d
Here is one member’s Expert Panel presentation
Our members are also actively participating in the public inputs to the FDA policies on establishing guidelines for use of the 510(k) process:
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm347888.htm?source=govdelivery
Key Recommendations for HHS/FDA Immediate Implementation and Action
As a part of Consumers Union Patient Safety network, Washington Advocates for Patient Safety is working closely with Consumers Union to make patient safety the priority of the FDA medical device division, by encouraging the adoption of policies requiring safety testing on metal-on- metal hips and other high risk implants.
In particular, we support the following recommendations from Consumers Union:
- Require that implants and other “life-sustaining” devices be tested at least as rigorously as drugs.
- End the practice of “grandfathering” high-risk new implants and life-sustaining devices.
- Create a Universal Device Identification system (UDIs) for implants, so that patients can be quickly notified about recalls and safety problems.
- Create national registries so that problems can be spotted quickly and patients notified.
- Increase the user fees paid by manufacturers for regulatory review so that the FDA has enough money to do its job.
- Increase transparency in government and healthcare
Working for Change Locally
We are interested in collaborating with Washington hospital surgical centers, healthcare professionals, state legislators and state healthcare safety agencies to establish standards for safe medical device implants in WashingtonState.
WAPS is also working on educational materials from a “Patient Perspective” to promote responsible healthcare practices which are essential for health and safety, and to inform the public and prospective patients about the risks of metal-on-metal joint devices in hips and knees.
