Today’s post is a video post by Dr. Julio Novoa, an advocate for women injured by Essure. The video is published with his permission and runs about 14 minutes. It is very much worth watching. The big takeaway is this: no more plausible deniability for doctors implanting Essure.
According to USLegal.com, “Plausible deniability refers to circumstances where a denial of responsibility or knowledge of wrongdoing can not be proved as true or untrue due to a lack of evidence proving the allegation.”
Well, doctors and other organizations, such as Planned Parenthood, can no longer use this convenient excuse as a means of escaping liability for injuries caused by Bayer’s Essure “permanent” birth control device. Dr. Novoa explains why.
Essentially, despite a year of consideration by the FDA and the requirement of a Black Box Warning on Essure’s label, along with a Patient Checklist for informed consent, doctors and organizations can still choose what (if any) information they want to share with patients regarding this awful device. The FDA is toothless when it comes to forcing full disclosure. Telling patients about the Black Box Warning and using the checklist are not mandatory. However, there is a downside to this for those doctors and organizations choosing to ignore the FDA.
Medical procedures require informed consent. This means that the patient is made fully aware of all the risks and potential complications connected to the procedure. For true informed consent, a form should be signed – in this case, the Patient Checklist – and placed in the patient’s chart.
Planned Parenthood went on record in a New York Times article saying that, while they will discuss the Patient Checklist with patients, they will not have the patients sign it (or any similar forms the organization chooses to use in place of the Checklist). Effectively, Planned Parenthood’s decision leaves it wide open to legal action for injuries caused by the Essure device because they are failing to obtain proof of informed consent. Failing to do so is failing to meet the standard of care. The same applies to doctors working in private practice.
Interestingly, neither Planned Parenthood, nor the American Congress of Obstetricians and Gynecologists (ACOG), two organizations who profess to be protectors of women’s health, want Essure removed from the market. Why?
As Dr. Novoa explains, it’s all about the money. If doctors and organizations like Planned Parenthood covered the Black Box Warning and the Patient Checklist, it is highly doubtful they’d have any Essure patients. There is so much negative – and true – information in the Warning and the Checklist that it would likely scare women into choosing another form of birth control.
Why does that matter? Essure sales representatives push the financial incentives, including free medical equipment valued at $20,000.00, when meeting with doctors. As they say, “Wait! There’s more!”
Essure costs doctors and organizations roughly $1200 – $1500 per kit. Implanting doctors are paid about $3,000 per patient when the procedure is done in office. That equals $1500 pure profit. Worse, the procedure usually takes about ten minutes, which means they’re making $150 per minute to implant the Essure device.
Compare that to a laparoscopic tubal ligation for which doctors are paid roughly $300.00. As Dr. Novoa explains, by the time you factor in everything involved, it takes about two hours of the doctor’s time. This means doctors make about $150 per hour for this procedure.
Putting aside basic ethics and morality, most people would choose to make $150 per minute over $150 per hour. And there you have it: the real financial incentive that still has doctors rushing to implant as many Essure devices as possible.
Fair warning, doctors and Planned Parenthood: there is no more plausible deniability for doctors implanting Essure. You may find that your big profits end up going toward legal defense if you don’t change your ways.