Informed consent is a patient right, but the recent FDA warning against using laparoscopic morcellators in hysterectomies due to an increased risk of spreading uterine sarcoma suggests that informed consent is, more often than not, uninformed consent. Johnson & Johnson already had warnings available to physicians in its instructions about morcellators.
A patient will probably never see the instructions physicians are privy to, and are thus dependent on the physician to discuss the risks of use. How many women even know what a morcellator is, much less know that one was used during her procedure? There are so many possible complications of surgery that a surgeon will never cover them all with a patient.
Ask any RN and they will tell you physicians are not the best educators. Even if the surgeon does discuss the risks of surgery, the patient is going to probably receive assurance that the risks are low.
The patient thus receives a double message: first, that there is a risk and second, that the odds of the risk are low. Patients are vulnerable and even a “fully informed” patient is never really fully informed because no patient wants to believe that they are going to be the odd statistic. We cannot expect the consumer to protect herself or to have the understanding needed to make fully informed decisions.
The FDA, device manufacturers, and healthcare system and providers should be the ones responsible for removing risky devices from the healthcare system. Even now, Johnson & Johnson is not recalling the devices and not all surgical facilities have stopped using them. Johnson & Johnson has simply taken morcellators off the market while waiting to see what the FDA and other governing bodies recommend. Other manufacturers are obviously waiting in the wings to see how this disaster plays out.
This form of inaction by the FDA, morcellator manufacturers, healthcare facilities and providers puts the burden on the consumer to make choices. If all of these experts can’t make up their minds what to do about the serious risks of morcellators, how is a consumer qualified to do just that? To say that a patient is informed of the risks of medical devices is a misstatement.
As many as 400,000 Americans die every year from medical errors in hospitals. Let’s not allow the medical device manufacturers to add to this carnage.
I’m Just Sayin’
P.S. Comment and share your opinion on whether patients are really informed.