The FDA responds

For those of you following my Essure story, I wanted to let you know that I just found out that the petition that I asked all of you to sign has gotten the attention of the FDA! The FDA responds Essure concerns are being heard.

Here is a link to an article all about it.

EssureFDA Letter

I hope that this means that the FDA will do something about this dangerous product!

Also, I found this information from a member of the Essure Problems Facebook group I am a part of

Although ESSURE has preemption status which prohibits you from suing Bayer or Conceptus, if your doctor does not follow the standards of care of medicine, they can be liable.

1. Failure to Diagnosis: the most common reason to sue a doctor is for failure to diagnosis a problem.If a doctor continues to insist that the ESSURE is not responsible for your medical condition and you have surgery to remove the ESSURE with another doctor and your symptoms disappear, this may be grounds for failure to diagnosis.

2. Failure to Treat: If a doctor refuses or delays in treating a patient for problems, these is considered below the standard of care and grounds for a malpractice lawsuit. Again, if there is a delay in treatment or a total failure to treat and the ESSURE is removed and you have improvement, your previous doctor may have acted below the standard of care.

3. Failure to Obtain Informed Consent: If a doctor fails to obtain a patient’s valid consent before performing an invasive procedure, this will subject the doctor to liability for battery. • Valid consent by a patient to medical treatment may be either express or implied. • Express consent may be either oral or in writing. • Consent may not be valid if the patient is mistaken as to the essential character of the treatment due to a misrepresentation by the doctor.

• In other words, if the doctor states something that is not true, an exaggeration of the truth, or left out information that fundamentally would have changed your mind about doing the procedure, they could be liable regarding obtaining Informed Consent.

In the case of the ESSURE, there are a number of possibilities regarding this complaint.

Here is an example of a legal appeal regarding Informed Consent following the death of a patient who had a pulmonary embolus following a surgery (NOT ESSURE).–02-28-14

4. Pain and Suffering: this is a legal term for physical and emotional effects caused from an injury. In the case of ESSURE, it could include aches, temporary and permanent limitations on activities, depressing, scarring, etc…

5. Loss of consortium: this is a legal term in tort law that refers to the deprivation of the benefits of family life and relationships due to injuries. In the case of ESSURE, this is associated with the inability to function at the level prior to the insertion of the ESSURE. This also applies to the ability to have sex and often includes a suit filed on behalf of husbands when the couple is unable to have intercourse due to pain associated with the ESSURE.


Dr. Julio Novoa


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