Breaking News…..Major Victory for Women!
And for Women’s Health Care!
Dateline: Miami, November 28, 2012
By Lana C. Keeton (copyright protected)
The Center for Devices and Radiological Health (CDRH) will be up classifying all Synthetic Surgical Mesh for Pelvic Organ Prolapse repair from Class II to Class III within one year.
Even better, in the very near future, all but one of the most popular prolapse kits, will no longer be sold.
The CDRH will be announcing important new regulations in December. Companies will have to pay an upfront fee of $250,000.00 to be part of a registry along with conducting 3 year clinical trials to prove safety and effectiveness of these “kits” which is not possible and will cost them millions.
And there will be major new requirements for surgeons implanting surgical mesh in the pelvis. No longer will surgeons be able to take a weekend course taught by an industry paid “medical advisor/consultant” to start implanting a filthy petroleum waste by product into women.
Medical mercenaries will now think twice before they mutilate women internally with a foreign body polymer that shrinks, hardens and moves at will within their pelvis mercilessly destroying their lives.
Doctors on the prolapse kit bandwagon who have ignored what they earned in med school about foreign bodies, checked their medical training at the door when they walked into the operating theatre and spouted the ridiculous mantra that foreign body polymers are biocompatible and inert will now be held accountable for their actions. Praise the Lord!!
Just as I was quoted in Bloomberg News in January when the FDA mandated 522 studies of 99 synthetic surgical mesh products used for prolapse and incontinence, industry knows it will not be able to prove these “medical devices” safe or effective and it will cost them millions they are unwilling to spend.
And there it is. It was never about health. It was always about the money, no matter how many millions of people were harmed or put at risk for serious harm or even death.
Now we are seeing the death of insanity in women’s health. Another “Dalkon Shield” bites the dust.
Patients and patient advocates have won a very long and significant battle for the safety of patients who will not be harmed in the future!!
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1 comment:
Dear Lana- Congratulations and thank you for your successful and tenacious mission to protect others from the torture of failed surgical mesh.
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