Millions of Americans have medical devices implanted in their bodies, including artificial joints such as hip replacements, heart defibrillators, and surgical mesh. When these patients with severe arthritis, cardiac, gynecologic, and other problems were told that they needed surgery they trusted their physician/specialist and generally opted for the surgery without question.
Medical devices are currently subject to review as outlined in the Food, Drug, and Cosmetic Act Medical Device Amendments of 1976. The process which includes a provision that enables manufacturers to grandfather certain products into the market without advance safety testing is less rigorous than the process for approving drugs.
In 2011, a panel from the Institute of Medicine, (IOM) that reviewed the process of bringing medical devices to the market, found that with nearly 95% of current moderate and high risk medical devices there was not enough oversight and testing to insure the safety of these devices. What is needed, according to the IOM panel, is a complete overhaul of the FDA’s medical device regulatory system because “the current system does not protect patients from being harmed.”
A more recent study by Consumer Reports, confirms that many medical devices including internal defibrillators artificial joints, and surgical mesh have been routinely cleared for use without undergoing the safety testing that we, as patients, assume the FDA would oversee.Consumer Reports looked at three product categories: surgical mesh used for vaginal repairs, gastric lap-bands used for weight reduction and metal hips used in hip replacements. In all three situations certain brands of these products caused serious problems that resulted in extensive life-altering health issues for patients.
If there is a problem who is at fault? Often your doctor is as uninformed about the specifics of product testing by the FDA, as you are.
So what is a patient to do when confronted with surgery that requires medical devices?
Patients need to become engaged in these issues and not blindly accept that a medical device implant is the answer to their problems.
Patients need to educate themselves about medical devices that may be recommended to them: This means asking the doctor the tough questions which they often do not expect, including:
- What specific implant will be used?
- How much do you know about this product?
- What is your reason for choosing the particular brand?
- Has it ever been recalled?
- Do you, or does this hospital have a financial investment in the company that produces the device?
Patients need to check all of the resources available to them so they can gather information on a device. Despite their failure to properly test these products, or perhaps because of it, the FDA publishes a wealth of information about device safety warnings, complaints, and recalls, available at www.fda.gov. Additionally, a Google search will bring up articles and reports on devices and manufacturers who have had problems.
Patients should question their physicians on alternatives to surgery to see if there is a way to avoid devices altogether and choose a different treatment.
Patients should seek out social networks where communities of other individuals may have had experiences with a particular brand of device and find out if they had any issues.
The Consumers Union (CU) is an expert independent, nonprofit organization whose mission is to work for a fair just and safe marketplace for all consumers and to empower consumers to protect themselves. The CU has come out with a list of recommendations for strengthening medical device safety oversight. These include:
Insure that all permanent implants and all life-sustaining devices do not go through the 510(k) process. Instead, these devices should go through the Pre-Market Approval (PMA) process, which requires more rigorous testing for safety and effectiveness.
Once a device is found to be unsafe which means it has either been recalled by the FDA or the FDA has issued a warning about it, that device should no longer be allowed to be used until and unless it goes through the recommended rigorous safety testing process.
Congress needs to give the FDA the authority and the resources for the increasing the numbers and complexity of medical device applications to insure that the appropriate safety testing is completed before the device is used for treatment.
The standard for devices going through Pre-Market Approval (PMA) needs to be revised from “reasonable assurance” of safety to “substantial evidence” of safety, bringing it in line with the standard used for prescription drugs.5.
A national system for tracking devices needs to be instituted so that patients and health care providers can be contacted when problems with a particular device are identified. Currently, there is no universal way to find out which devices went into which patients.
There need to be safeguard to ensure that the FDA is fully implementing existing patient protection programs for monitoring and reporting problems such as MedWatch, MAUDE and the Sentinel Initiative. Used effectively, these programs can create an early warning system to help the FDA identify medical devices that are causing harm to patients.