Aside

Two questions: FDA (US) & INVIMA (Colombia)

  1. Why Essure was approved into the market?
  2. Why this device have not been withdrawn from the market?

Ramirez, Jorge H (2014): Essure Database – Search Date: September 16, 2014.xlsx. figshare.
http://dx.doi.org/10.6084/m9.figshare.1171205
Retrieved 19:44, Mar 11, 2015 (GMT)

Essure: database of biomedical studies
– New versions of this database will be uploaded in the future.
– History of changes will be available in this figshare article.
– Version 1. September 16, 2014.
Original data values downloaded from ClinicalTrials.gov and PubMed
– Google Drive Spreadsheet is open (worldwide) & comments are also allowed (1st URL).
– This archive is open, transparent, and complies with terms of service of websites in which data were originally downloaded. In addition, verification of future analysis posted in this figshare article could be done by anyone because these data was collected from publicly available databases.

Dec 29, 2014 – Update
1. Evidence does not support Bayer statements:
The use of Essure as a safe contraceptive method in women is highly questionable.
2. Bayer is withholding Essure safety data.
3. Agencies from several countries (e.g., FDA and INVIMA) acted as facilitators (not regulators): their actions accelerated the entry of Essure into the market.
4. Regulators are also withholding information involving the market approval of Essure.
5. Let’s be straight up about the Essure case — no need to be over-polite here —
This discussion is about pharmaceutical crimes committed against thousands of women. These criminal actions were only possible by the complicities of others (e.g., drug regulators and author’s of hidden clinical studies).
– I have evidence to support the above statements.
– Thousands of women have reported serious adverse events after receiving the Essure placement procedure.
– Bayer responses to these women are disrespectful, offensive, and shameful.
I am here to say that these women are real cases of serious adverse events associated with Essure:
– More than one paper will be submitted to peer-review medical journals.
– More than one post about Essure will be published in this blog (additional to journal articles).
– This is evidence of misleading advertising:
http://gilmedica.com/nuestros-productos/quirurgica/pelvis-femenina-2/essure/
Notes:
– Please take a look to other types of medical devices advertised by the company promoting the use of Essure in Colombia.
-The geographical location of Gilmedica is very close to my home.

  1 comment for “Two questions: FDA (US) & INVIMA (Colombia) – #Essure

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