The name of Dr. Julio Novoa is not well known outside of the El Paso area – except by women who have been injured by the birth control device known as Essure, a product of Bayer's Conceptus division. Dr. Novoa is a leading advocate for these women, and he has a message for his colleagues and organizations: if you implant an Essure device into a patient and that patient is injured as a result, you bear liability.
The reason has to do with the recent “Black Box” warning that is now required on all Essure packages by the FDA, as well as the “Patient Checklist” that helps patients to make an informed decision. It is admittedly a good step forward – but it lacks the force of law. Therein lies the rub. Although the FDA has mandated the new warnings, doctors and organizations like Planned Parenthood are under no legal obligation to disclose this information to patients.
In order to give “informed consent” to a medical procedure, a patient must be made fully aware of any side effects, complications or possible injuries that may happen as a result. In order to make that informed consent legal, the patient needs to sign a form, which is then kept with the patient's medical records.
In the case of Essure, that form would be the Patient Checklist. However, many doctors and other women's health care providers are simply ignoring this. For example, in a recent New York Times article, Planned Parenthood stated that while its care providers will inform women of the risks, patients will not be asked to sign any documents related to the procedure. Other OB/GYNs, such as Dr. Christopher Zahn, complain that the checklist is an added burden and based on anecdotal rather than scientific evidence.
“There’s no question there are complications, but there are risks and benefits to everything we do in medicine, and we don’t have good data to establish the magnitude of the problem,” Zahn said.
Now, Dr. Novoa has a message for Dr. Zahn as well as Planned Parenthood and the American College of Obstetricians and Gynecologists (ACOG). That message is: if you do not have the patient sign an informed consent form, you are leaving yourself open to liability. It doesn't matter if a patient sees the checklist – the only acceptable proof in a court of law is that patient's signature.
Why are doctors and women's care facilities ignoring this issue? According to Dr. Novoa, it's the same disease that afflicts the entire U.S. health care system: the profit motive. If health care providers were to make prospective patients fully aware of Essure risks, virtually none of them would choose to have the procedure. And unfortunately, Bayer gives these providers plenty of financial incentive to offer Essure to their patients.
For example, a fairly safe and routine tubal ligation, taking approximately two hours, puts about $300 in the physician's pocket. However, with an Essure procedure – which takes about ten minutes – the doctor nets around $1500 on top of the cost of the device itself, which is between $1200 and $1500. In addition to that, Bayer sales representatives offer numerous “perks,” including free medical equipment, to facilities and practitioners who recommend Essure to their patients.
Now, Dr. Novoa has a message to all them: keep your Hippocratic Oath, make sure your patients are fully informed of all the risks and sign a document to that extent – or be prepared to pay a heavy cost in civil litigation.