The International Consortium of Investigative Journalists (ICIJ) recently launched its latest campaign, which purports to investigate medical device safety. The “Implant Files,” however, is no more than a misguided attempt to stoke fear and doubt over the safety of medical devices that have saved and improved the lives of millions of Americans. In fact, while attempting to castigate advances in medicinal technology, the campaign itself recognizes that the data they use to support their coverage “is inconsistent and incomplete.”
Here’s the truth: nearly every American has benefited from the advancements of medical technology innovation in their life, from the NICU, to tools used during routine doctors’ visits, to hearing aids, to advanced surgical equipment, to pacemakers, to intraocular lenses, and replacement joints.
Don’t just take our word for it.
From the IJIC’s own reporting, “pacemakers and implantable cardioverter defibrillators (ICDs) have revitalized and saved millions of lives. Hip and knee replacements have kept tens of millions of people mobile and out of wheelchairs. Intraocular lenses have restored and improved the sight of millions more.” These examples don’t even begin to scratch the surface of the countless ways medical technology innovation empowers patients to live longer, more productive lives.
But instead of focusing on these successes the ICIJ uses cherry picked and often-outdated anecdotes in its campaign that simply are not reflective of the current state of the medical device industry.
In many of the examples cited, the FDA has already taken significant steps to address the concerns of patients and clinicians. For example, the ICIJ highlights metal on metal hip implants – but in January 2013, the FDA recognized certain issues with some patients and published a proposed order recommending these devices require premarket approval, the agency’s most stringent approval pathway. The final order was published in February 2016 and was effective in May 2016, more than two and a half years ago (more information here).
Further, ICIJ’s reporting fails to address cases where lawyers, finance firms and others luring patients into getting unnecessary and risky surgeries that increase the likelihood of patient complications.
While it makes for a more sensational story to paint the medical device industry and/or the FDA as the villain here, the facts speak for themselves. The FDA, which has become the world’s gold standard when it comes to patient safety, has been protecting the public health for nearly 90 years, while making safe and effective products available to patients who need them. Multiple studies have shown that less than 0.5% of 510(k)-cleared devices are subject to a serious recall and a recent study demonstrated that 98.4 percent of all 510(k) and PMA devices cleared/approved by the FDA between 2003 and 2009 have never had a Class I recall. Two studies presented before the Institute of Medicine found that in 99.6% of all medical device submissions, no safety issues were present at all. In the rare instances when there were recalls, the majority are attributed to manufacturing issues, NOT design flaws.
The medical device ecosystem is an amazing story of innovation providing cures and therapies for patients throughout the world. It is truly unfortunate that the ICIJ and its secret funders chose instead to stoke fear, mislead and besmirch an industry that is on the front lines in saving lives.