Hundreds of elective device implant surgeries take place each day across America. The ability to improve the quality of life for those who can benefit from implant technology is truly a miracle. For those whose lives could have been severely limited by accident or genetic anomalies, mobility and higher level functioning is now a reality.
New device implant technology is developing at an amazing rate as medical manufacturers borrow improved mechanics and materials from other specialties. They release existing technology upgrades or new designs almost as quickly as new computer software. It is not unheard of for medical implant device companies to issue rapid upgrades to prior models. Competition among these medical implant companies is fierce, and the industry caters to medical specialties in ways that blur the lines between sales and surgery, between profits and patients.
The invisible medical advisor in the room
Surgical patients are familiar with a multitude of forms they sign requiring consent and waiving liability against those involved to perform specific medical procedures. There is one major exception. In nearly every implant surgery room in the nation, there is a device implant advisor who works intimately with the surgeon—sometimes without the patient’s knowledge or consent.
Where commercial interest leaps over “do no harm”
In some cases, it could come down to profit vs. performance. Harried surgeons cannot keep up with every new or improved implant device. Doctors rely heavily on implant device reps.
For example, say a cardiac surgeon’s implant salesman arrives early and prepares trays of over 80 instruments and device parts for the patient’s surgery. The doctor prepares the site, then stands back a little to give the salesperson a better view. Using a laser pointer, the sales rep indicates an instrument which the scrub nurse hands to the doctor. The salesperson then points to the cardiac area where the instrument will be used. The salesperson talks the doctor through every step of the procedure. This goes on for hours.
Before surgery, the salesperson has privately talked the doctor into substituting a newer version of the original implant device that he says is better—even though the salesperson and the manufacturer know that older models perform better than this one; however, they are less profitable.
The patient did not, at any time, sign permission for the implant device representative to be in the operating room, much less give him permission to talk the cardiac surgeon through a high-risk heart procedure or substitute a less-effective implant device.
Though the example is hypothetical, this could be one place where medical malpractice occurs should any new device prove defective or harmful to a patient.