It’s Patient Safety Day 2018! The Patient Safety Action Network wants to talk to you about medical device safety. Here is the list we collectively created last March within our “top patient safety opportunities”:
Poor vetting of new medical devices
Continued use of known unsafe devices, e.g., surgical mesh, breast implants, Essure
Inadequate warnings, information for patients on risks for use of certain devices
Inability to sanitize/sterilize reusable devices
Promoting use of devices that are very expensive and show no improvement over older devices, e.g., robotic vs laparoscopic surgeries
Think about this: When problems are revealed about your medical implant or you begin having adverse reactions, you are stuck with it; you cannot remove it without a surgical procedure. Many have discovered that getting an implant removed can be a very difficult endeavor – surgical mesh can break apart and become so embedded in bodily tissues that it has been compared with getting gum out of one’s hair. Many women who opted for the non-surgical Essure to prevent future pregnancies had painful and debilitating reactions to the device and ended up having hysterectomies because removing these coils in their fallopian tubes is extremely difficult and poses new serious risks to patients.
Medical devices can provide life-saving and life-changing help to many patients, but most people have no idea that when their surgeon recommends use of a device or medical implant, they are often participating as subjects in a grand scientific experiment.
For most medical devices, the process for bringing them to the market does not even require an “approval” by the FDA. By law, these devices are “cleared” by the agency to be used on patients as long as they are substantially similar to some prior device. Take an example of hip and knee implants – if the design is basically a ball and socket then it is similar, regardless of whether it is made of material never tested in the human body. The unfortunate results of an estimated one million metal on metal hip devices being implanted in patients is a good example of how flawed this process can be.
Linda Radach was one of them. Now, 12 years and 4 corrective surgeries later she still suffers from the effects of that initial device: “In 2006 when I was told my hips needed to be replaced, my surgeon recommended a new metal on metal technology. At the time I had no reason to question him. When the first hip implant failed within three years, it became apparent that something was seriously wrong, and yet there were no reasonable explanations provided. The tissues in my hip joints were damaged and toxic levels of cobalt and chromium from the implants also entered my blood stream, creating havoc with my health. I have learned the hard way that the most important action a patient can take is to do their own research upon an implant recommendation and to be informed. It is essential to ask questions to your doctor, and to persist until you have all of the answers you need to make a fully informed decision.”
Linda’s experience points to other critical information that patients need to know about new devices. They can even be cleared based on similarity to another device that was removed from the market due to safety concerns. In 2011, the Institute of Medicine studied this process extensively and found that it was “flawed based on its legislative foundation.” The IOM called for a new framework, stating “resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.” In 2012, many of us went to Congress to try to change this process. The FDA and Congress ignored these experts (and us).
The few devices that are categorized as high risk or innovative are required by law to show the FDA evidence of their safety and effectiveness. (Not many are truly innovative.) Typically, even these are not adequately tested enough to ensure safety. Part of the problem is the difficulty in conducting comparative studies with these devices in enough patients who are tracked for long enough to see what happens when left in the human body for years. For medical device studies, it may be unethical or even impossible to conduct blind, randomized control trials using a placebo or to implant the device into healthy subjects.
Since the “pre-market” system for vetting medical devices is often absent any serious scientific evidence, it is critical to have a “post-market” oversight structure that alerts the FDA, physicians and the public/patients when patterns of problems arise. While Congress has recognized this need for more than a decade, the U.S. still doesn’t have a nationally coordinated, publicly accessible system that adequately tracks and responds to adverse events in a timely manner. The FDA does have a website where patients and doctors can report these events, which is a very good way to bring issues to their attention. One can look up problems reported about your implant on the FDA site but it is not very consumer friendly or thorough. Unfortunately, it is clear that the agency is not using this information in a timely and proactive manner. While women have been reporting problems with vaginal surgical mesh and Essure devices, the agency has taken years to respond with warnings to the public and medical community and to impose requirements on device companies.
However, sometimes Margaret Meade’s quote,“Never doubt that a small group of thoughtful, committed, citizens can change the world. Indeed, it is the only thing that ever has,” is proven true. Just last week, after years of activists turning their pain into organizing, raising public awareness, and pressuring FDA and the maker of Essure to remove it from the US market, Bayer announced that effective the end of this year, it will no longer sell Essure in this country.
In recent years, the FDA finally implemented a system requiring that each device have a unique device identifier, but the law doesn’t require health care providers to document these in patients’ records or billing records (which are publicly accessible and can be used by researchers). Nearly every consumer product on the market – from aspirin to toasters - can be and is traceable when things go wrong. The FDA should to do the same with medical implants.
So, that brings us back to our top opportunities for improvement in the safety of medical devices listed above. Except for changing the approval process, which requires action by Congress, these are very concrete problems that FDA could solve now.
Please educate those you know, and talk to your doctor about this if they are interested in using a device as part of your care. You can raise these issues to your elected officials in Congress and urge them to address these problems. Lastly, you can also forward them this blog.
Please leave comments below for a continued dialogue. We would like to hear your ideas for solutions to these “opportunities for improvement".