Kip Petroff No Comments

Medical Device Makers should follow Frozen Treat Makers’ Recall Strategy

Two makers of ice cream and frozen yogurt products issued voluntary recalls of ALL their frozen treats this week amid fears of potential listeria contamination. This has provided a glimpse into the way two different frozen food companies have contemporaneously handled similar product safety crises. There will undoubtedly be some who will criticize the frozen treat companies for being too slow or not responsive enough to their respective crises, but even those critics would have to agree that medical device companies could learn from following the frozen treat companies’ recall strategies.

Blue Bell Creameries, the famous century old Texas ice cream maker, announced a voluntary recall of all its products on the market on Monday. This was after at least ten reported illnesses and three reported deaths associated with listeria contamination. Jeni’s Splendid Ice Creams issued a similar listeria-related recall of all its ice cream and frozen yogurt products and closed all of its retail stores on Thursday. Jeni’s did this even though the company says it is not aware of any reports of customer illness.

Amidst notorious vehicle recall scandals and pharmaceutical product failures and finger pointing, these frozen food companies have aggressively removed all their products from the marketplace. And if that wasn’t enough, they have also taken steps to keep the public fully informed. Blue Bell has pledged to continue the dairy product blackout until it could be “completely confident that our products are safe for customers.” Jeni’s has proclaimed that the company’s “top priority is guaranteeing the safety of all consumers” and says it will not reopen stores or restock shelves “until we are 100 percent confident every item we sell is safe.” These are reassuring, widely publicized statements from companies facing consumer confidence crises the likes of which neither of them have ever seen before. They are sending the message that they sincerely care about customer safety and will not sell their treats again until everything is completely okay.

I recently spoke with two people who received surgically implanted bilateral metal on metal hip implants roughly five years ago. Each has had one device fail, requiring painful removal and revision with a new device that isn’t working very well. They are both also having trouble with the original metal implant remaining in their bodies. Both received their metal on metal hips from the same doctor and he performed both of their revision surgeries, noting “mechanical failure” in their medical records. Neither was aware that the device had already been withdrawn from the market until they spoke with me three years later.

Strangely, the market withdrawal was very visibly listed on the FDA’s “RECALLS” page, drawing suspicion from consumer watchdogs and understandably causing confusion among concerned patients.

And here is some food for thought: All modern implanted medical devices are registered to the patient through a sophisticated serial number system that details information about the product and connects it to information about the patient and their surgeon. Ice cream obviously is not trackable like that. It is much easier and way more important to identify and contact those with medical devices than those who purchased frozen treats.

And there are other very important differences between ice cream and surgically implanted medical devices. Ice cream sits in the freezer, and if it is not eaten, a recall simply means walking to the freezer, perhaps taking a photo of the container before trashing it, and requesting a refund. Unless someone becomes sick, the trashcan is basically the end of the line for that tub of creamy goodness. But a device that has been surgically implanted cannot simply be tossed in the trash. Folks in this situation have a world of problems the ice cream eater doesn’t encounter.

For those device wearers who have had no ill effects, they are left with painful questions: Should I replace a device that is recalled but which is apparently giving me no obvious problems? What if I wait, and I begin experiencing problems in a few years, perhaps when I’m older, less healthy, and with different insurance? Should I go ahead and have surgery today as a precaution? Can I trust my original surgeon now that I know he or she didn’t tell me that my original device was removed from the market? How will my insurance handle all this? In addition, the revision surgery itself is very painful, and recovery is long and requires a great deal of rehabilitation and therapy. And devices that replace removed devices frequently have more complications than the original one.

And for those whose replacement devices are failing, revision surgery is imminent. And in these cases, removal might reveal that the device has caused additional internal damage. Often tiny bits of metal shavings (the result of the metal on metal failure) have worked their way loose and migrated away from the device, embedding themselves in what had previously been healthy tissue. Removal requires cutting open healthy tissue to forcibly dig out the failed device along with troublesome metal particles of all sizes. The device itself is sometimes cracked and broken during the removal surgery, which inevitably leaves additional metal debris behind.

All victims of failed medical devices wish it was as simple as tossing a carton of questionable Cookies ‘n Cream in the trash. How they wish it only involved a $5 refund coupon rather than tens of thousands of dollars in new medical bills, not to mention all the pain, missed work, unreimbursed deductibles, etc.