September 21, 2015 — San Diego CA. The FDA public hearing in Washington, D.C. this week will offer women who suffered adverse effects from the Essure device a chance to be heard. However, Pope Francis’s visit to the nation’s capital make some fear that their voices will be slightly muffled. We beg to differ.
What is Essure?
Approved by the FDA back in 2002, Essure consists of a small, flexible nickel coil that is inserted into each fallopian tube and causes tubal blockage. The implants are placed without a skin incision, through the vagina. Marketed as a quick and easy procedure, Bayer leads women to believe they will be up and moving just a few days after the implantation. This is not the case for some women.
What are Essure’s side effects?
Thousands of women have experienced debilitating side effects from the Essure implant:
- Pelvic pain
- Uterine cysts
- Loss of libido
- Excessive bleeding
- Painful intercourse
- Perforation/migration of the coils
These are just a few of the adverse events that have been reported to the FDA involving Essure. To see a more comprehensive list, click here.
Essure and the FDA
Essure is the only permanent, nonsurgical device approved by the FDA. While the agency claims it will be difficult to confirm the device caused any events solely on information provided in voluntary complaints filed, the regulatory history of the device speaks for itself. Essure has had to update labeling at least three times. In 2011, they updated labeling to include a nickel sensitivity warning, in 2012 to include results of a five-year follow up that found some women still became pregnant, and again in 2013 to add risks of chronic pain and device migration.
What will the FDA Essure meeting entail?
Thursday, September 24th, the public hearing will be held by the FDA and the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee in order to review and evaluate data related to the safety and effectiveness of Essure.
A major issue, which is likely to be brought up in the meeting, is the lack of post-market studies evaluating the long-term and real-life experiences of patients and clinicians following FDA approval of products. The FDA committee will make final recommendations based on the information presented at the hearing.
Some experts suggest that the FDA post-market surveillance systems could be made worse by the 21st Century Cures Act, which is a federal bill designed to speed the development and approval of devices and drugs. Under the current system, it takes years of gathering evidence before FDA warnings are issued on devices or drugs that cause problems.
Essure Women Fighting Back
The women suffering from this dangerous device will not be silenced. The FDA hearing this Thursday directly coincides with Pope Francis’ first-ever address to the U.S. Congress. It’s a widely known fact that The Catholic Church does not approve of any medical birth-control method and some Essure patients believe the FDA deliberately scheduled the hearing during the Pope’s visit. The FDA hearing was scheduled before the Pope’s schedule was made public.
Essure women are coming together to stage a hunger strike outside of the FDA building to ensure the Pope’s visit does not muffle their demand to recall the device. The Essure Problems group wants to keep the focus on the 750,000 women who use the Bayer product.
These women are prepared to do what is necessary to convince the FDA to recall Essure from the market. We are proud to announce that two members of National Injury Help will be attending the FDA hearing this Thursday. We will be the eyes and ears for women who cannot attend the hearing, providing live updates on the blog, and on our Facebook page and Twitter. Keep yourself updated and informed about this crucial day in history for Essure.
If you or someone you love is suffering side effects from the Essure Implant, contact our Essure lawyers today, click the banner below to access the Essure Claim Evaluation form.
Source: Modern Healthcare