So ladies, not sure if you all remember my letter to president Obama but apparently they forwarded it to the FDA and the FDA had to respond to EVERY accusation! Lol!
This is the letter I wrote, then ill post the FDA's response......
I am writing to you today as a Representative of almost 14,000 women injured by one medical device. I am an administrator of a Facebook group called Essure Problems, and am now an advocate against a bad medical device and a faulty law. Essure is a non-incisional form of permanent sterilization that is used in lieu of a traditional tuba-ligation.
Essure consists of two metal coils inserted into the Fallopian tubes, scar tissue is induced by PET fibers (polyethylene terephthalate) to form a barrier, sealing the tubes. It was originally manufactured by Conceptus and is now owned by BAYER.
In 2002, the FDA approved Essure as a Class III device, giving it pre-market approval (PMA) and protecting it under the preemption law. This was done with studies that were conducted by the manufacturer, and most testing was done in the 3-6 month time frame. Five women were followed for 36 months on a product that was to remain permeant in a woman’s body for 40-60 years. We now have three of those five women in our group with serious health issues. Actually, we have a ton of Essure trial patients all suffering from serious complications and they all say the same thing, "The trial doctors said it was normal."
There is NOTHING normal about 20-30 year old women going into pre-menopause, living with debilitating pain, bleeding for months, dealing with autoimmune and cancer from the materials in this device! But worst of all, there is NOTHING normal about having your reproductive organs perforated, removed, or not being able to hold and play with your children! We signed up to be sterilized, NOT to die slowly, and most definitely not for a permanent birth control that controls your life!
We have reached out to the OBGYN community, the FDA, the manufacturer, and senators. We've spoken on Capitol Hill, and now I am personally reaching out to you!
We have proof the studies on Essure are biased, proof the manufacturer didn't report all of the adverse events, proof Essure and its materials are toxic to the human body, proof it's causing women as young as 20 to undergo a hysterectomy and no one will do anything because it's protected under PMA!
In 1976, the MDA act was put into place in part because of the Dalkon shield and the damages it caused women and the lawsuits it caused to the manufacturer, sinking the Robbins Company and causing manufacturets to pull their IUD's from the market in fear of lawsuits. (Source: www.heritage.org/…/killing-americans-by-stifling-medical-in….)
However, a lot of women were injured for life and some died before ever seeing anything. The MDA law is not only sexist, but it allows manufacturers to put profit over patients with the safety of knowing the PMA law shields them from liability.
In 1999, the FDA met with the OBGYN board and decided to fast track vaginal barrier methods due to "need". This cuts the rigorous FDA screening process for female contraception (Source: www.fda.gov/ohrms/dockets/ac/99/transcpt/3552t1.rtf)
In 2009, a group of people put together the Medical Device Safety Act (MDSA.) This act would allow victims of faulty medical devices to hold the manufacturers responsible. That bill died before ever making it to congress. Yet in 2012, The Medical Device User Fee and Modernization Act passed, which promised the manufacturers a more expedited FDA process by paying a fee. (Source: www.clinical-innovation.com/…/obama-signs-popular-protested….)
Because the PMA law still stands, this leaves the FDA as the governing entity of our bodies and rights as women and as people! They have sacrificed safety of the device for effectiveness and lied about how effective or safe it is!
If a manufacturer chooses to submit faulty and unpublishable studies, it does so without consequence from the FDA. If it should respond to an agency request with deficient data, it does so without reprimand or follow-up. If a company finds it disadvantageous to characterize its product, then its properties remain uncertain or unknown. If a manufacturer chooses to ignore scientifically sound testing standards, then faulty tests are conducted instead, and the results are considered legitimate.
I see women daily who are on the verge of giving up, who can't get anyone to listen, who live in pain, who are losing their organs, health and family. All for a birth control!
I'm begging you to end the "profits over patients" laws and hold the manufacturers accountable once again for their faulty products.
Thank you in advance for your time,