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Is the Fox Minding the Henhouse?

Medical Device Watch
July 22, 2019

With the U.S. Food and Drug Administration’s (FDA) myriad of problems surrounding the monitoring and approval of faulty medical device implants, consumers may start to wonder if the FDA is nothing more than an industry puppet, with medical device manufacturers pulling all of the strings. Likely spurred by increasing public scrutiny, the FDA recently publicized more than 6 million medical device incident reports hidden from the public by device makers over the past two decades through a process known as “alternative summary reporting.”With the U.S. Food and Drug Administration’s (FDA) myriad of problems surrounding the monitoring and approval of faulty medical device implants, consumers may start to wonder if the FDA is nothing more than an industry puppet, with medical device manufacturers pulling all of the strings.  Likely spurred by increasing public scrutiny, the FDA recently publicized more than 6 million medical device incident reports hidden from the public by device makers over the past two decades through a process known as “alternative summary reporting.”      

Alternative summary reporting kept the dangers of  medical device implants hidden from consumers.  

The FDA launched the alternative summary reporting program as an initiative designed to reduce paperwork and time spent on reporting singular incidents of injury or malfunction of medical device implants.  Specifically, manufacturers were allowed to accumulate an internal list of incidents and merely submit quarterly spreadsheets reporting only summaries of commonly occurring problems. For example, breast implant incidents were previously reported through the “alternative summary reporting” process. But once the FDA began requiring more complete disclosure, the number of injuries and incidents jumped from only a few hundred per year to over 4,000 in 2017 and more than 8,000 in just the first six months of 2018.   

Alternative summary reporting being phased out by the FDA.

As a testament to the insufficiency of medical device incident reporting, the FDA has begun to phase out the program, beginning with a May 2, 2019 announcement breast implant manufacturers would now be required to file individual medical device reports that will be available to the public through the FDA’s Manufacturer and User Facility Device Experience (MAUDE).   With a slew of other devices previously reported through the alternative summary reporting process, such as pacemakers, cardiac defibrillators, surgical staplers, and tooth implants, the number of incidents is expected to grow exponentially as previously hidden reports are scoured by consumer advocacy groups. 

Investigative efforts by journalists and legal advocates force more FDA transparency.

Time will tell if the FDA’s promised reforms in medical device implant monitoring will improve device safety.  Pledged reforms include the National Evaluation System for Health Technology (NEST) and a Unique Device Identifier (UDI) barcode scanning capability for individual devices.  While the FDA has promised an operational version of NEST by the end of 2019, the program has been in the works for years with little progress.  

Patient advocates claim that these monitoring reforms promise illusory improvements in regulation of medical device implants as long as inadequacies in the actual FDA approval process, such as 510(k) “substantially equivalent” approvals, are not first remedied.  Moreover, under existing regulations, device makers will still be permitted to request exemptions or alternatives to standard FDA reporting requirements.  These requests are determined on a case-by-case basis.  With glaring oversights permitted under the alternative summary reporting and 510(k) programs, consumers might be skeptical that industry juggernauts will not soon find another loophole to loosen regulatory schemes and plus up manufacturers’ profits.  

Risks that are trifling to the industry result in daily pain and suffering for victims.

Medical device manufacturers still argue that consumers benefit overall from streamlined FDA processes, allowing a greater availability of life changing technologies to hit the market sooner.  President Scott Whitaker of AdvaMed, the U.S. trade association for device manufacturers, lauds a 2010 study that found that less than 0.5 percent of all devices approved under the 510(k) process were recalled for serious or life-threatening issues over a five year period.  However, for patients suffering from a failed medical device implant, that 0.5 percent risk translates into immeasurable daily pain and suffering.  


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Medical Device Watch is sponsored by Keefe Law Firm. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.

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