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One in ten Americans will have a medical device implanted into their body and virtually everyone will be treated with a medical device at some point in their life. While these devices can be life-saving, a new documentary on Netflix, “The Bleeding Edge,” displays the not-so-great side of the industry in which some of these devices can also be life-threatening.
The documentary explores the idea that profits often come before patients. To further discuss this issue, The Doctors are joined on Skype by the Director of John Hopkins’ Appropriateness in Medicine Project Dr. Martin Makary.
Dr. Makary shares his findings from a recent study asking doctors about the appropriateness of medical devices and using them for patient care. Of the 21,000 doctors across the U.S. who participated, they reported that 11% of all procedures are unnecessary in their opinion and 21% of all medical care. While technology and new devices are exciting, the question is, are they all necessary?
The doctors in the survey also felt in most cases this was being fueled by a consumerist culture. Patients now will demand care using certain devices they’ve heard about. However, Dr. Makary says it’s a false perception that technology will solve all of our problems.
Dr. Markary warns patients of the one-hammer approach meaning a doctor treats every patient the same way. It’s important for patients to get second opinions as well as ask about treatment alternatives.
The Doctors then discuss the lax methods in which these products are brought to market. Dermatologist Dr. Sonia Batra notes theres a loophole in which these medical devices just need to show an equivalent to something already on the market to get approved by the FDA. This stands even if the equivalent product has been taken off the market because it was found to be ineffective! Once on the market, there is no market surveillance.
The Doctors are joined by orthopedic surgeon Dr. Hooman Melamed who shares how many doctors are greatly profiting off of participating in medical device studies and offering them to patients. In a lot of these cases, the patients are the guinea pig. Dr. Batra shares findings from CNN that one birth control device company gave 2.5 million dollars in payouts to over 11,000 doctors associated with it before it got recalled. Dr. Melamed warns patients to make sure they trust their doctors.
Dr. Batra lets viewers know the vast majority of medical devices on the market are safe and effective but they need to be cautious and become informed consumers.
Dr. Markary doesn’t want to fully fault the FDA; he says it was never in their charter to monitor the entire field of medicine after a device is approved. “Patients have to realize it’s up to them to ask the right questions,” Dr. Markary says.
Below are some questions patients should ask their doctors about medical devices:
• What is the patient satisfaction with this device (or procedure)?
• How many of these procedures have you done before?
• How many of these devices have you removed?
• How often do you do this procedure?
• What are the other device options? Do you perform them?
• What are the risks if I don’t get this device or procedure? (Make sure you get a quantifiable response, not simply something like “you will die”)
• What are the risks if I wait?
Here are some other ways patients can protect themselves:
• Always get a second opinion, possibly a third. If one doctor specializes in a certain procedure or with a certain device – make sure to seek an opinion from someone who has a different specialty.
• Don’t always go with the “expert” – they may not be trained in the most current techniques.
• Insist to get a copy of every medical record, test, procedure done. Ask for video of any procedure.
Use Dr. Makary’s Patient Checklist to do your due diligence as a patient:
• Pick a primary care doctor by:
o Asking for recommendations from local doctors or nurses
o Ask friends and family
o Use the 1st appointment to see if they’re a good listener
• Good questions to ask a doctor after a new diagnosis
o Would they recommend a specialist?
o Will further testing add anything to care?
o What are good alternatives to the main treatment?
o Is there more information available from the hospital/doctor?
o Are there non-profit organizations for this condition?
• Always good to get a second opinion for major procedure, treatment or therapy
o Doctor should feel comfortable with it
o If your doctor has explained things clearly & you feel comfortable, it may not be necessary
o If insurance doesn’t cover a second opinion, you can pay for one on your own
• To find a reliable second opinion:
o Ask generalist for referrals
o Use sites like pubmed.gov for rare conditions
o Search for websites and societies that treat t
o Watch out for marketing
o Remember – “centers” are created to attract business, but one doctor doesn’t equal a “center”
o Top scores in magazine ratings are often paid for
• When to medicate:
o Ask what the probability of something bad happening if you don’t take medicine
o Ask if there’s another medicine with fewer side effects
o Ask about the difference for a lower cost alternative
• What to ask a surgeon before going under the knife:
o How many surgeries performed a year
o Ask if there’s a less invasive surgery
o Ask for top 3 surgery risks
o Ask how long you’ll be in the hospital
o Ask if you’ll need to be local after hospital discharge
o Ask what’ll happen if you don’t have surgery
o Run an older doctor’s advice by a younger doctor, who may know newer techniques
Dr. Travis notes documentaries, such as this one, usually have an element of shock and awe to grab viewers attention and get people talking. There is truth to it, but this should not scare you from using any or all medical devices. The Doctors reached out to the FDA and were given the below statement:
While FDA chose not to participate in an interview for this documentary, we provided the filmmakers with extensive responses to their questions in order to help ensure that the filmmakers could provide a balanced viewpoint of medical devices, which provide lifesaving benefits to millions of Americans. We are disappointed that the information we provided was not reflected in the film. We recognize that such devices, as with any medical product, have their risks and that discussion and recognition of these risks is vitally important. But the film inaccurately portrays several areas related to the FDA’s regulation of medical devices, among other inaccuracies, most importantly, our mission to protect patients and provide them with timely and sustained access to high-quality, safe, and effective medical devices.
FDA regulates a wide range of medical devices, including, pacemakers, cardiovascular stents, respiratory ventilators, breast implants, diagnostic tests and relatively simple devices such as tongue depressors and elastic bandages. Medical devices are classified based on the risks associated with the use of the device. Devices are classified as Class I, Class II, or Class III, Class I being the lowest risk and Class III the highest risk. Class III devices go through premarket approval, the most stringent type of application process where the manufacturer must demonstrate using scientific evidence from clinical trials that their device is safe and effective for its intended use. These devices include many implants, those that support or sustain life or prevent significant impairment to human health or those that present a potential, unreasonable risk of illness or injury. There are various processes that FDA uses to review information about medical devices before they can be marketed in the U.S. Regardless of which process is followed, FDA strives to permit marketing of only those devices with a favorable benefit-risk profile.
However, not all information regarding benefits and risks for a given device are generally known before the device reaches the market. Often the true benefit-risk profile of a device cannot be fully understood until it can be evaluated when used in routine clinical practice. This is why the FDA uses a variety of postmarket surveillance data sources to monitor the safety and effectiveness of medical devices, including analyzing reports of problems that are submitted to our public database, reviewing results from Post-Approval Studies, and evaluating the available clinical literature. We can also order companies to conduct postmarket (522) surveillance studies of a class II or class III device if we have new concerns about a product’s safety. We can also take actions to restrict the use of a device to protect patient health. For example, in April the FDA issued an order restricting the sale and distribution of the Essure device; it was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device's safety and effectiveness.
In the long term, we are in the process of building a collaborative National Evaluation System for health Technology (NEST). NEST will link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records, and medical billing claims. Full implementation of NEST will improve surveillance, signal management and mandated postmarket studies, and has the potential to support studies designed to answer specific device safety questions.
We have also embarked on a continuing effort to prioritize and enhance our approach to medical device safety, encompassed in a Medical Device Safety Action Plan announced in April. The plan outlines how the FDA will encourage innovation to improve safety, detect safety risks earlier and keep doctors and patients better informed. Our plan would establish a robust medical device patient safety net in the U.S. We are taking steps to streamline and modernize how we implement post-market actions to address device safety issues to make our response to risks more timely and effective.