Getting a Medical Device? Read This.

“First of All, Get a Second Opinion” is the title of Holly Finn’s most recent column in last Saturday’s Wall Street Journal.  She cites the same article I have already discussed about doctors being overly deferential toward each other and goes on to say that we are more cautious about buying blue jeans or flat-screen TV’s than about opting for medical procedures.  The main part of the article is a discussion of the second-opinion industry, which has grown up in recent years and whose services are increasingly covered by medical insurance.  Advances in medical technology mean that a patient’s data can be shared instantly with experts around the country with a response available in a couple of days.  The piece concludes with some sobering statistics.  “In an estimated 60% of cases, an alternate treatment is recommended – often one that’s more conservative and cheaper.”  At one second-opinion firm, 6 out of 10 cases reviewed had been misdiagnosed or mistreated.  At one breast clinic, second opinions led to the cancellation of 73% of 1053 surgeries in favor of less-invasive options.  This article really hit a nerve with several doctors who commented on the article and took offense at both its content and its tone.

 

Coincidentally, the night before, I had watched an episode of the PBS program “Need to Know” that dealt with medical devices.  The show, reported by Medical Correspondent Dr. Emily Senay began with an interview with Linda Gross, a former nurse, who had had a mesh device surgically implanted to correct pelvic organ prolapse.  The procedure and its consequences have been a disaster for Gross and her family and resulted in a lawsuit against the manufacturer.  Dr. Senay later spoke with Dr. Gregory Curfman, Senior Executive Editor of The New England Journal of Medicine, who said that more testing needs to be done to ensure the safety and effectiveness of such devices.  The response from a representative of the organization of medical device manufacturers was that the approval procedure should actually be faster in order to promote innovation.  

Jeff Greenfield, host of the program, then interviewed Dr. Josh Rising, who is Project Director of the Medical Devices Initiative at the Pew Charitable Trusts.  Dr. Rising, a diabetic himself, has an implanted insulin pump to regulate his blood sugar.  He said that there have been problems not only with mesh devices but also with implantable defibrillators, and metal-on-metal hip replacements.  He said that in Australia there is a registry of hip and knee replacement devices that has made it possible to track the outcomes for patients who had had the devices implanted.  Based on information from the registry, doctors in Australia stopped using metal-on-metal hip replacements years before they did in the US.  If a similar program were instituted here, according to Dr. Rising, both safety and innovation would benefit.  On the safety side, devices that caused problems could be taken off the market; for device manufacturers, there would be a source of information on how the current devices are doing so that they could plan for the next generation of products.