Good afternoon ladies and gentlemen. My name is Dr. Julio Novoa. I am a practicing OB/GYN surgeon in El Paso, Texas, USA, and have been a medical consultant for the Essure Problems forum (USA) for over 3 years. I have removed over 50 Essure devices and have counseled over 300 women from a number of Essure social media forums for the past 3 years regarding the complications associated with the Essure device.

For those wondering if I have a monetary stake in advocating against Essure, I would like to state for the record that Essure related revenue accounts for less than 3% of annual revenue to my practice, yet is associated with greater than 50% of my personal time which is provided free of charge for women needing answers and assistance with complications associated with the Essure.

I have been advised that many ladies in the UK have been met with skepticism, hostility and outright dismissal of their problems and concerns from their doctors.

Unfortunately, my colleagues in the UK and the European Union are simply behaving in the same manner as my colleagues here in the US have done for the past 10 years.

Most if not the vast majority of the unprofessional behavior that has been seen from doctors throughout the world regarding the management of Essure is based on an outright ignorance of the side effects of the Essure.

Although there are dozens of published articles regarding the efficacy of the device in terms of sterilization, THERE ARE NO DOUBLE BLIND, PROSPECTIVE STUDIES REGARDING THE LOCAL AND SYSTEMIC FOREIGN BODY REACTIONS ASSOCIATED WITH BOTH THE METALLIC AND PET FIBER COMPONENTS OF THE ESSURE DEVICE. NONE!!!

Over the past 5 years, the US Food and Drug Administration has received over 16,000 complaints regarding the Essure device. In many cases, the complications of the Essure have been associated with unwanted pregnancy, ectopic pregnancy, Essure induced abortions, preterm delivery, stillbirth, chronic local and systemic foreign body reactions and patient death.

These complications have lead the FDA to require that a Black Box Warning (BBW) be placed on the device; as well as, the European Union to temporarily ban the sale of the Essure until more information is available regarding its safety and efficacy.

In regards to the behavior of implanting surgeons, there has very often been monetary reasons on the part of the physician for the placement of the device.

In cases of the placement of the device while the patient is awake, surveys have stated that up to 50% of patients that have had the device placed in this manner have suffered excruciating pain during insertion and in many cases, medical battery with the doctor refusing to stop the procedure due to the level of pain involved.

Current information suggests an unacceptably high risk of improper implant placement (14%), implant migration (3-4%), implant failure (9%) and implant associated side effects (up to 30%). These problems are associated with a 10-15x higher risk of complications as compared to traditional tubal ligation, and there is NO LOGICAL REASONING to justify either offering the device as an awake procedure or as a justification to offer this as an alternative to tubal ligation under general anesthesia. Ucenter Dress wedding outfits at wholesale prices

An even more troubling series of events have been documented regarding the proper management of pelvic pain, abnormal uterine bleeding and dyspareunia (pain with intercourse) due to Essure.

A significant number of doctors are incorrectly managing these complications with oral contraceptives, hormonal based intrauterine birth control (ie. Mirena IUD), uterine ablation, or dilation and currettage (D and C).

Not only are these management options often contraindicated, they unnecessarily delay the definitive management, which is very often surgical removal.

For example, uterine ablation using the Novasure, should not be offered unless the patient has been advised that both the manufacturer of the Essure and the Novasure state that a specific and potentially worse side effect of the combined procedures is POST ABLATION TUBAL LIGATION SYNDROME. Life threatening side effects with uterine ablation and Essure have occurred due to bowel burn when the electical current of the Novasure has touched an incorrectly placed Essure device.

Keeping in mind that up to 14% of patients have incorrectly placed coils and the fail safe switch off of the Novasure may not engage in the presence of an improperly place Essure leading to catastrophic thermal injury to the bowel or bladder, why is Novasure following Essure placement even an option? As a doctor, I would rather play Russian Roulette than perform a Novaure ablation on an Essure patient.

Doctors that claim that correctly placed coils (via HSG, US or CT scan) cannot cause pain or migrate are absolutely wrong.

Doctors managing abnormal bleeding with birth control pills, IUD, ablation, or D and C are wrong because the inherent cause of problems seems to be associated with the phyical presence of the coil in the fallopian tube and uterus which rarely is correctable by the aforementioned modes of treatment.

Doctors that place more than 1 device per tube; that attempt to remove the device hysteroscopically; that fragment the device while performing a salpingectomy or via a vaginal hysterectomy (rather than LAVH/BS, with the Essure removed intact inside the tubes and uterus) are guilty of malpractice.

Doctors that claim that the Essure cannot cause chronic systemic hypersensitive reactions such as cognitive changes, migraine headaches, rashes, gastrointestinal symptoms, or autoimmune symptoms that mimic lupus, chronic fatigue syndrome, chronic pain syndrome, have little or no experience with nickel allergy or foreign body reactions which has been studied as a side effect of SYSTEMIC NICKEL ALLERGY SYNDROME.

Let this be a fair warning to my colleagues that failure to properly warn patients regarding now known complications of the Essure, failure to diagnose, failure to treat and incorrectly removal of the Essure device are all grounds for potential malpractice lawsuits.

The take home message ladies and gentlemen is the fact the vast majority of OBGYN throughout the world have no idea of how to manage the complications of the Essure device.

For those doctors willing to listen to you, there is, unfortunately a steep learning curve, and for those that are dismissing your complaints, they are very often prolonging your suffering.

Your problems are not "All in your head."

Your voices are being heard and we are here to help.

If you feel like your doctor is not helping, please find a doctor with experience managing Essure related complications and removing the device.

Sincerely,

Dr. Julio Novoa