Rep. Rosa DeLauro spoke out against Essure during a meeting of the Appropriations Committee on February 25, 2016. The video – a short four-minutes – shows her impassioned speech, her tough questions to the FDA and the agency’s unsurprising lackluster responses.
Though the numbers Rep. DeLauro opened with were lower than the actual numbers (but matched the “officially reported” numbers), the rest of her speech was spot-on.
She referenced language in the 2016 Omnibus Appropriations Act that directed the FDA to issue recommendations on how to address concerns about Bayer’s “permanent” birth control device, Essure. The FDA has until March 1 (tomorrow) to do so.
Rep. DeLauro had previously asked for an investigation into Essure with the request that the device be taken off the market during the investigation to “save women’s lives.”
She directed a couple pointed questions to Dr. Stephen M. Ostroff, the acting commissioner for food and drugs, about the upcoming recommendations.
“Are you gonna issue them?” and “Are we gonna take this product of the market to save women’s lives?”
Ostroff’s answers were… lame at best. First, he cited the agency’s 2017 budget request which includes money for a “National Medical Device Evaluation System.” This system, he said, will provide the FDA better post-market monitoring ability and would assist it in being able to address concerns such as those surrounding Essure.
Ostroff’s numbers pertaining to fetal deaths were so far off base as to be almost fictional.
Rep. DeLauro was understandably unimpressed with Ostroff’s answers. She strongly urged the FDA to remove Essure from the market until the FDA investigation is concluded.
Her closing remarks made me want to give her a standing ovation, despite the fact that I would have looked quite silly doing so alone in my office.
She said, “Don’t tell me on March 1st that we’re gonna continue to study this effort to make sure that we have all of these various pieces in place while women are suffering out there in the hundreds of thousands! Not 2, 3, 10, 12, 100, [but in the] hundreds of thousands!”
Further, the removal options are quite limited for those women suffering from this defective device:
If you have been injured by Essure, there are groups you can join where you will find excellent information and support.
There is even a Facebook group for the men who stand beside the women in their lives who suffer from Essure side effects: the Mad Men of Essure.
The largest group, with over 27K members, is Essure Problems.
There are numerous other Essure Problems groups for other states and countries. You need only search for “Essure” or “Essure Problems” on Facebook to find them.