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August 19, 2019

FDA’s push for transparency long overdue

by: Fidelma L. Fitzpatrick

Acting in what it described as “the spirit of promoting public transparency,” the U.S. Food and Drug Administration recently announced that it has formally ended its secretive Alternative Summary Reporting Program (ASR), publishing for the first time nearly six million medical device malfunction reports that were submitted by manufacturers over the past 20 years.

Generally speaking, manufacturers are required to submit individual reports to the FDA for each patient who sustains an injury or complication caused by a medical product. Established in 1997, ASR allowed manufacturers – including those who produced potentially dangerous products – to bypass that standard by submitting quarterly summaries instead for cases that involve “well-known” complications. The FDA claims that this policy allowed the agency to “more efficiently review reports of well-known, well-understood adverse events.” However, the public was largely kept in the dark because this massive database was kept hidden, available only to the FDA – until now.

Medical device reporting trends

Reports are already beginning to surface of some of the shocking secrets hidden deep within the database. In particular, blood glucose meters for patients with diabetes accounted for 2.4 million reports, more than any other device, according to news reports. Notably, the vast majority of those meters were produced by LifeScan, a former Johnson & Johnson subsidiary. Nearly half a million breast implant injuries were stored in the database. Surgical staplers were another standout with 66,000 incidents reported since 2001.

The FDA’s decision to release the database in June followed an earlier investigation by Kaiser Health News that heavily criticized the program, and rightfully so. When you’re talking about medical devices, transparency is everything. Etched from metal and plastic, many of these contraptions are placed deep within our bodies, often times in invasive procedures. Large or small, they have the power to change lives – but change isn’t always for the better. It’s hardly uncommon to discover after the fact that a manufacturer has produced a device that is actually defective, that it has caused more harm than good or, worse, claimed lives. In these instances, the patients who had no choice but to place their trust in these manufacturers for the treatment they needed are the ones left absorbing the worst of the blow with unexpected hits to their health, finances, and overall wellbeing. It can be life altering, to say the least, for patients and loved ones who step in to shoulder some of the burden.  

The benefit-risk assessment

It goes without saying that every medical procedure comes with risks, but all patients are entitled to be thoroughly briefed on those risks before making the call on whether or not we’d like to move forward. Same as for doctors, patients should have access to adverse event reports and potential complications from the manufacturers. This is why transparency is so critical. It is impossible to make an informed decision without unfettered access to data detailing known risks and the frequency of complications when it comes to the devices being used on and implanted into our bodies. Also, if those numbers aren’t readily available to any and everyone, it makes it easier for manufacturers of dangerous products to float under the radar while placing lives at risk.

If you are experiencing complications from a medical device, consider reporting the effects to the FDA. Doing so can help identify potentially defective products much sooner, saving lives.

If you are considering a procedure involving a medical device, make sure to do your own research, ask any and all questions you may have about the devices and the risks, and share and discuss any concerns with your doctor.

While I applaud the FDA’s decision to prioritize transparency, it’s unfortunate that it took 20 years and an unknown number of deaths and injuries to bring us to this point. History suggests that a constant light must be shined on manufacturers to ensure public safety. When you’re talking about products that have a direct effect on our very lives, the risk is far too great not to.