Today’s complex high-tech devices continue to cause cybersecurity vulnerability issues, but it’s the medical devices that live on or inside patients, like implants and pacemakers, that are posing a special challenge for the healthcare industry.
The problem arises when those medical devices are recalled and the manufacturing company must track down each device to notify a patient of the potential risk.
Companies selling breast implants are especially vulnerable to this challenge now because of breast implant anaplastic large cell lymphoma (BIA-ALCL), an increasingly prevalent complication first reported by the Food and Drug Administration (FDA) in 2011. In July of 2019, the FDA announced a voluntary recall of Allergan’s BIOCELL® textured breast implants and tissue expanders.
The recall followed an FDA analysis that revealed 573 global medical device reports of BIA-ALCL and 481 were reported to have Allergan breast implants. And while the company may have taken vigorous steps to reach patients, many to this day have yet to be notified. According to the company, this is due to “incomplete device tracking data for around 52,000 BIOCELL® breast implant units.”
Unfortunately, this recall and others have revealed a dangerous deficiency in medical device tracking. In fact, medical devices have been linked to more than 83,000 deaths and more than 1.7 million injuries in the past decade, according to the International Consortium of Investigative Journalists. While efforts are being made to create an effective tracking system, the harsh reality is the system remains flawed.
In response, Allergan announced on June 1 a multi-channel campaign that will enable the company to contact patients who may not be aware of the BIOCELL® Recall. The campaign will include widespread digital and social media advertisements in several languages that will inform patients of the voluntary recall and direct them to the company’s website to register their implants and identify their type.
The campaign could be a game-changer for the entire medical industry, setting an important precedent for future medical device recall communication. And as consumers continue to pressure regulators, companies and manufacturers will be held responsible for implementing similar campaigns to notify customers and patients of recalled products.
If you’re a company in this industry, our advice for you is to re-evaluate your tracking systems to improve them. Then, start thinking about putting together a campaign that will allow you to notify all patients in the event of a recall.
Medical devices now touch the lives of billions of people and this issue is only going to grow in scope and complexity.