Ennis & Ennis, P.A.
Medical Support For Essure Victims
04/26/2015 - For thousands of women suffering serious injuries after being implanted with the Essure sterilization device, one of the most frustrating obstacles they face is the lack of support by their implanting physicians. Hundreds of women with debilitating symptoms feel ignored and diminished when their own doctors readily dismiss their complaints.
Many doctors, who are handsomely compensated by Bayer for the Essure procedure, have turned a blind eye to the health and welfare of their own patients. They often feign ignorance of any problems relating to the Essure device.
Thankfully, some enlightened physicians are realizing the extent of the dangers that Essure presents and of the controversial and unethical way it came to the marketplace. One such physician is Dr. Julio Novoa from El Paso, Texas. Dr. Novoa has been in private practice since 1999 and had taken on the role of advisor and commentator to thousands of Essure women. He has generously spent about 2 hours per day answering questions regarding Essure complications.
Recently Dr. Novoa commented on the pending Citizen’s Petition to have Essure removed from the market. Dr. Novoa discussed the shortcomings and FDA errors regarding the approval of Essure. First Dr. Novoa pointed out that the FDA relies heavily on voluntary reporting by use of Manufacturer and User Facility Device Experience (MAUDE) database. However, the FDA appeared to have ignored Bayer’s admission that it had over 16,000 adverse reports that it had collected which failed to be included in the MAUDE reports. These reports continue to grow daily and their numbers have increased by over 200%.
The information relied on by the FDA in approving Essure was flawed and based on clinical trial with on 745 patients, not all of whom completed the trials. Such pertinent information was skewed, which vastly changes the efficacy and safety of the product. For example:
- Essure is a difficult device to place, even by experts and has a 14% insertion failure rate;
- FDA clinical trials data shows that Essure has adverse side effects over 30% of the time;
- FDA website shows an effective pregnancy prevention rate of 99.83%. The failure rate is actually between 4-9% resulting in numerous E-babies being born.
- When pregnancy occurs, nearly 45% of the time it is an ectopic pregnancy or results in numerous complications.
- Bayer advertises Essure as a non-surgical procedure. However, Essure requires the use of an operative hysteroscope to be placed.
- Bayer advertises the insertion procedure can be done in office under a local anesthesia, despite reports from women describing the procedure as agonizing, excruciating and even tortuous.
- Finally, the FDA has failed to address the significant increase in surgeries, literally hundreds each month, to remove the Essure device due to the significant and debilitating complications it causes.
Dr. Novoa clearly has stepped up to the plate in support of the thousands of women injured by Essure. It is hoped as physicians and the public become more educated regarding the dangers of this device, other physicians will follow suit and demand that the FDA and Bayer recall the Essure device from the marketplace.
If you or a loved one has been injured by an Essure device, contact Holly Ennis at Ennis & Ennis, P.A. for a free confidential consultation.