The following are my opinions, based on almost one year of forum data review, regarding the ESSURE. Please SHARE, and REPOST on any of your social media.
They are my opinions and draft bullets for a possible forum FYI page.
Please feel free to comment and post on your FB pages for feedback.
Dr. Julio Novoa
1. ESSURE was released on the market based on clinical studies involving fewer than 1000 women.
2. No post insertion data involving these patients has been published even though it is estimated that up to 30% of patients in the original studies suffered from symptoms including persistent pelvic pain, irregular bleeding and pain with intercourse.
3. Original data suggested an improper incidence of ESSURE implantation of up to 14% even in the hands of an expert.
4. Current data suggests a migration rate of the ESSURE of up to 4% out of the fallopian tube and into the pelvis requiring major surgery to remove the improperly positioned device.
5. Many of the components of the ESSURE device, including the PET fibers are listed as toxic and are generally prohibited from being used in the body.
6. Current data suggests a failure rate of up to 9% leading to pregnancy which is up to 15x higher than traditional laparoscopic tubal ligation.
7. Current data suggests that when pregnancy does occur, it leads to either an ectopic pregnancy, miscarriage or ESSURE induced abortion of pregnancy in up to 50% of cases as well as preterm deliveries. So, YES, the ESSURE can cause an unintended abortion.
8. ESSURE is being improperly advertised as a NON-SURGICAL procedure. The procedure requires the use of the invasive surgical device, called an OPERATIVE HYSTEROSCOPE in order to place the devices. Billing and Coding, as well as Hospital privileges code the ESSURE as a SURGICAL procedure. In other words, the placement of the ESSURE is a SURGICAL PROCEDURE.
9. Patient surveys regarding the placement of the ESSURE in an office or while awake describe both the placement of the ESSURE and the Hysterosalpingraphy Confirmation Test (HSG) as extremely painful or excruciatingly painful.
10. Most patients are unaware that, despite the known risks of the ESSURE device, they are not able to sue the manufacturer for complications associated with the device.
11. The ESSURE device is specifically designed to produce a CHRONIC and PERMANENT INFLAMMATORY Response which can cause both local and SYSTEMIC AUTOIMMUNE Reactions.
12. Patient surveys suggest an increased risk of Adenomyosis and/ or Endometrosis of between 3-8x higher than normal.
Regarding your GYN
1. Most GYN doctors are certified with as little of 6 hours of training in how to insert the ESSURE device.
2. Most GYN doctors are not certified by Bayer to manage the complications of the ESSURE device.
3. GYN doctors face a conflict of interest when recommending the ESSURE device over traditional tubal ligation because they are paid 3-5x more for placing the ESSURE as compared to the amount of time and compensation associated with a traditional tubal ligation or hysterectomy.
4. Many GYN doctors promote the placement of the ESSURE while awake or while in the office, because they receive higher compensation, even though, the placement of the ESSURE devices while awake can be excruciatingly painful.
5. Most GYN doctors have little or no experience in the management of complications of the ESSURE device, including the removal of the ESSURE devices.
6. Many GYN doctors are not obtaining the proper Informed Consent from their patients and are not going over the potential and known risks of the devices as delineated in the Physicians Clinical Manual.
7. Many GYN doctors are recommending the DaVinci Robotic Hysterectomy for definitive management of the complications of the ESSURE device. However, many expert surgeons feel that the DaVinci is not only unnecessary but excessive costly and even dangerous in the hands of some GYN surgeons as compared to traditional laparoscopic techniques.
8. Many doctors are incorrectly managing irregular bleeding associated with the ESSURE by recommending long courses of birth control pills, Depo Provera, the Mirena IUD or the Novasure.
9. Many doctors are failing to properly inform their patients about the risks associated with the ESSURE and Post Tubal Ligation Syndrome.
10. Many doctors are recommending the Novasure to manage abnormal bleeding following the placement of the ESSURE WITHOUT properly informing the patient about the risks of POST ABLATION TUBAL LIGATION SYDROME (PATLS).
11. Due to the improper training and limited experience regarding the complications of the ESSURE, a significant number of GYN doctors are ignoring the complications of the ESSURE and actually making things worse by failing to properly treat their patients symptoms or by performing incorrect surgery to correct the patients condition.