Another Boston Scientific Product Advisory

Well, Boston Scientific (Guidant) issued another product advisory on April 5th. This one relates to certain low-voltage capacitors on certain ICDs and CRTDs. By "certain," I mean it affects devices within every product line they currently sell - Vitality, Vitality 2, Renewal 3, and Renewal RF.

I'll start the the discussion by giving an overview of capacitors. Simply put, capacitors are used in an electrical circuit as an energy storing tool. A good discussion of capacitors is at How Stuff Works - Capacitors.

In its letter, Link Boston Scientific states that, "These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than three months. Device replacement indicators continue to function normally." They go on to state that there have been, "No confirmed reports of shortened ERI to EOL time while implanted." However, Nineteen (19) of approximately 73,000 devices in this population worldwide have been confirmed to have accelerated battery depletion, which could have resulted in shortened ERI to EOL time." Finally, there have been no patient deaths.

They recommended reviewing every patient's chart to assess battery voltage. If the device hits MOL2 within 27 months (32 months for EL devices), then the patient should be followed monthly until ERI is reached.

The burden this places on physicians and clinics is tremendous. Going through every chart to ascertain battery voltage and time since implant is time consuming. Who must go through charts - the reps or staff? Additionally, asking a patient to come in every month is extremely inconvenient to the patient. What if that patient can't drive? Does a family member have to take time off to bring the patient in?

I bet the FDA will classify this advisory as a recall. Once that happens, Boston Scientific will change its tune and offer a free device to any patient that wants one. Of course other manufacturers will offer programs where they will pay unreimbursed medical expenses and offer discounts to hospitals if a physician/patient decides they don't want to replace the Boston Scientific device with another BSX device.

Product advisories are a fact of life in the medical device business. That being said, Boston Scientific has had a quite a few the past 2 years. Many at BSX believe that “the world is against them.” That their quality system is robust and Barry Meiers (New York Times) and other are simply making a mountain out of a mole hill. I disagree and think the problems may be indicative of a failure of the internal control systems. I wonder if the relentless desire to sell the company off at the highest price (in 2004-05) didn’t have an effect on the reporting of problems internally. I don’t claim to know what happened at internal meetings, but, the sheer number of advisories/recalls lends credence to this hypothesis.

I think this latest advisory may be the proverbial “straw that breaks the camels back,” as far as some customers are concerned. How often can a physician say to him/herself, “Hey, it’s just a small problem, the risks are being overblown.” At this point, I think some customers may simply decide that they will no longer use Boston Scientific.