In a previous blog entry, we shared news that Pennsylvania congressman Michael Fitzpatrick had penned a letter to the FDA urging them to conduct an internal investigation regarding how it handled the approval of the Essure contraception device. Congresswoman Rosa DeLauro of Connecticut has also let the FDA know of her concerns about Bayer and its device.
Rep. DeLauro’s Letter to the FDA About Essure
In her letter – which you can read here – Rep. DeLauro said that she was “deeply concerned by reports from women about the severe adverse health effects they suffered” from the Essure device.
She also highlighted the thousands of adverse reports filed by doctors and patients alike to the FDA, and the actual deaths of adult women and the fetal deaths that occurred in women who became pregnant after the Essure device was implanted into their fallopian tubes.
Taking clear aim at Bayer, Rep. DeLauro wrote that after three post-approval studies, the manufacturer did not provide the FDA with the full scope of side effects being reported by many women. In fact, she stingingly wrote that “chronic pain was made to appear as being non-existent.”
She concludes her letter with a series of questions for the FDA, including:
- Why was the Sept. 24, 2015, FDA advisory committee not allowed to hear from any of the women who participated in the Essure clinical trials and experienced many of the adverse reactions?
- Why were the women who were allowed to speak to the committee only allowed three minutes to speak?
- Why were the women not allowed to respond to remarks given by Bayer representatives?
- Has the FDA requested full patient-level data sets from the clinical trials or will they continue to rely solely on Bayer’s own summaries and analysis?
When a company has elected officials demanding it be held accountable, court cases being filed in various countries and mandated black box warnings, there’s definitely a lot of fire associated with the smoke. You can count on us to keep you up to date with what’s going on with Essure.
In the meantime, we strongly encourage you to contact a personal injury lawyer if you are an Essure user.