According to the FDA, “less than 1% of case report form data pertaining to pain, bleeding, device placement/movement and pregnancy were changed during the clinical trials.”
One patient who reported falsified medical records says when she wrote “extreme pain,” the word “extreme” was crossed out and her comfort level was rated as “excellent.”
After asking doctors to remove Essure, the woman was withdrawn from the clinical trial. Her records indicate she was “lost to follow-up” — something she says is inaccurate.
Earlier this year, a study of Essure found that data on 11% of clinical trial participants was “lost to follow-up.”
Despite problems with the clinical trials, Essure was approved with a special clearance that gave its manufacturer immunity from lawsuits. That immunity is being challenged by women who experienced severe side effects.
In February 2016, the FDA ordered Bayer to add a “Black Box” warning and conduct a post-marketing surveillance study.
Last month, the FDA accepted Bayer’s plan to study two groups of 1,400 women between 21 and 45 years old who choose to be sterilized with Essure or a traditional “tube tying” procedure.
Bayer will release a 6-month report in March 2017 and a one-year report in September 2017. The study will continue through 2023.
The FDA required the surveillance study after receiving 9,900 adverse event reports from Essure’s approval date in November 2002 through December 2015. The most common problems include:
- Abdominal pain
- Heavier menstrual bleeding or irregularities
- Headache
- Fatigue
- Weight changes
- Nickel allergy
- Migration of the device
- Breakage of the device
- Improperly positioned device
- Problems inserting or removing the device
Source: MassDevice