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!!
Wednesday, November 28, 2012
Monday, November 26, 2012
ABDOMINAL SACRAL COLPOPEXY with MESH....NOT BETTER, NOT SAFER!
Open Letter from Lana Keeton, patient advocate and medical device expert....
[this letter and any and all content on this blog is copyright protected]
Dear Transvaginal MDL Litigators,
For those of you who don’t know me, my patient advocacy organization, Truth in Medicine, and I were instrumental in getting the FDA warnings on synthetic surgical mesh issued in 2008 and 2011. Based on that work, I appeared as a speaker on the Transvaginal Mesh Panel at Mass Torts Made Perfect April 20, 2012 in Las Vegas.
It’s important to understand, this is a bigger fight than a lawsuit and a product. Use of synthetic surgical mesh is a fatally flawed concept which remains unchallenged. Hernias, incontinence and pelvic organ prolapse are conditions caused by torn or weakened tissue. These are not diseases, only conditions. Implanting a foreign body polymer, synthetic surgical mesh, does not treat causation.
Treating the symptoms with synthetic mesh is a confounding factor in these conditions. The complications are complicated. The cause is not. It’s the device, not the doctor, not the procedure, not the patient.
ABDOMINAL SACRAL COLPOPEXY
Abdominal sacral colpopexy is not a better, safer alternative than mesh kits for pelvic organ prolapse. It has a high complication rate and a long recovery. In addition, a significant complication is stress urinary incontinence (SUI) leading to further surgery and the use of synthetic mesh slings, which is the subject of current litigation.
Recurrent prolapse: 8% - 24%
Repeat surgery: 5% - 9%
Stress Urinary Incontinence: 10%
TVT/Ob-Tape: 3% - 13%
(recommended postoperatively for SUI)
The severity of this procedure and its complications are well documented in long standing literature. It is a very intrusive procedure drastically cutting the internal pelvic organs with a long recovery period.
There are significantly better, safer surgical and non-surgical alternatives.
Please do not use this procedure in the Transvaginal Mesh Cases as a better, safer alternative! It Is Not!
[this letter and any and all content on this blog is copyright protected]
Dear Transvaginal MDL Litigators,
For those of you who don’t know me, my patient advocacy organization, Truth in Medicine, and I were instrumental in getting the FDA warnings on synthetic surgical mesh issued in 2008 and 2011. Based on that work, I appeared as a speaker on the Transvaginal Mesh Panel at Mass Torts Made Perfect April 20, 2012 in Las Vegas.
It’s important to understand, this is a bigger fight than a lawsuit and a product. Use of synthetic surgical mesh is a fatally flawed concept which remains unchallenged. Hernias, incontinence and pelvic organ prolapse are conditions caused by torn or weakened tissue. These are not diseases, only conditions. Implanting a foreign body polymer, synthetic surgical mesh, does not treat causation.
Treating the symptoms with synthetic mesh is a confounding factor in these conditions. The complications are complicated. The cause is not. It’s the device, not the doctor, not the procedure, not the patient.
ABDOMINAL SACRAL COLPOPEXY
Abdominal sacral colpopexy is not a better, safer alternative than mesh kits for pelvic organ prolapse. It has a high complication rate and a long recovery. In addition, a significant complication is stress urinary incontinence (SUI) leading to further surgery and the use of synthetic mesh slings, which is the subject of current litigation.
Recurrent prolapse: 8% - 24%
Repeat surgery: 5% - 9%
Stress Urinary Incontinence: 10%
TVT/Ob-Tape: 3% - 13%
(recommended postoperatively for SUI)
The severity of this procedure and its complications are well documented in long standing literature. It is a very intrusive procedure drastically cutting the internal pelvic organs with a long recovery period.
There are significantly better, safer surgical and non-surgical alternatives.
Please do not use this procedure in the Transvaginal Mesh Cases as a better, safer alternative! It Is Not!
Friday, November 9, 2012
BOSTON SCIENTIFIC "SHOW ME THE MONEY" STILL HARMING WOMEN 15 YEARS.....AND COUNTING
Copyrighted by Lana C. Keeton November 9, 2012
*all rights reserved
Boston Scientific brought its’ first bladder suspension sling, the Protegen Sling, to market based on a 90-day rat study, and the wide use of its Hemashield fabric for cardiovascular grafts. Nov. 15, 1996, the FDA granted clearance for the Protegen Sling but 56 serious adverse events were reported in the first 9 months on the market. 57 were reported in the next 6 months.
During a June 1998 inspection of the company’s manufacturing plant, the FDA found the company was not reporting a large percentage of adverse events. Internal company documents showed at least 233 other reports never given to the FDA. Boston Scientific had selectively reported cases of surgical removal of the mesh and omitted other equally dangerous medical complications.
So what has changed at Boston Scientific since 1998? Based on the current investigation of BSX by California Attorney General Kamala Harris and other states attorneys, not much. Boston Scientific continues to market deadly synthetic surgical mesh for pelvic organ prolapse and bladder suspension through its Urology/Women’s Health division.
Promotion of dangerous medical devices to unsuspecting patients is the norm because of lax regulatory authority, the snails pace of FDA actions and the device industry’s strangle hold over doctors, professional medical societies and billions of dollars spent on direct to consumer advertising and lobbying in Congress.
But we as patients and patient advocates have made a difference and here’s why!
We have influenced the national conversation on the regulatory process with our testimony about the failures of the 510 (k) at the Institute of Medicine in 2010 and we decreased their sales because of the FDA’s July 2011 Transvaginal Mesh Warning! Read and enjoy….
From Boston Scientifics’ 3rd Quarter 2012 Form 10Q SEC filing:
Under “Women’s Health/Urology” they say:
However, our Women's Health business declined 11 percent primarily due to continued pressures on elective procedures and lower sales levels following the FDA release of a Public Health Notice update in July 2011 regarding complications related to the use of urogynecologic surgical mesh for pelvic organ prolapse.
Under “Litigation and regulatory compliance” they state:
Our ability to minimize or avoid future field actions or FDA warning letters relating to our products and the on-going inherent risk of potential physician advisories or field actions related to medical devices;
Legislative or regulatory efforts to modify the product approval or reimbursement process, including a trend toward demonstrating clinical outcomes, comparative effectiveness and cost efficiency, as well as other healthcare reform legislation.
And we are hitting their bottom line!!
“Our accrual for legal matters that are probable and estimable was $411 million as of September 30, 2012 and $299 million as of December 31, 2011…”.
And for the early 2000’s even before the current investigations, “the total incremental tax liability now asserted by the IRS for the applicable periods is $1.162 billion plus interest.”
MOST MESH INJURED PATIENTS HAVE BEEN HORRIBLY INJURED BUT AT LEAST THERE IS HOPE OTHERS WILL NOT BE HARMED IN THE FUTURE!
*all rights reserved
Boston Scientific brought its’ first bladder suspension sling, the Protegen Sling, to market based on a 90-day rat study, and the wide use of its Hemashield fabric for cardiovascular grafts. Nov. 15, 1996, the FDA granted clearance for the Protegen Sling but 56 serious adverse events were reported in the first 9 months on the market. 57 were reported in the next 6 months.
During a June 1998 inspection of the company’s manufacturing plant, the FDA found the company was not reporting a large percentage of adverse events. Internal company documents showed at least 233 other reports never given to the FDA. Boston Scientific had selectively reported cases of surgical removal of the mesh and omitted other equally dangerous medical complications.
So what has changed at Boston Scientific since 1998? Based on the current investigation of BSX by California Attorney General Kamala Harris and other states attorneys, not much. Boston Scientific continues to market deadly synthetic surgical mesh for pelvic organ prolapse and bladder suspension through its Urology/Women’s Health division.
Promotion of dangerous medical devices to unsuspecting patients is the norm because of lax regulatory authority, the snails pace of FDA actions and the device industry’s strangle hold over doctors, professional medical societies and billions of dollars spent on direct to consumer advertising and lobbying in Congress.
But we as patients and patient advocates have made a difference and here’s why!
We have influenced the national conversation on the regulatory process with our testimony about the failures of the 510 (k) at the Institute of Medicine in 2010 and we decreased their sales because of the FDA’s July 2011 Transvaginal Mesh Warning! Read and enjoy….
From Boston Scientifics’ 3rd Quarter 2012 Form 10Q SEC filing:
Under “Women’s Health/Urology” they say:
However, our Women's Health business declined 11 percent primarily due to continued pressures on elective procedures and lower sales levels following the FDA release of a Public Health Notice update in July 2011 regarding complications related to the use of urogynecologic surgical mesh for pelvic organ prolapse.
Under “Litigation and regulatory compliance” they state:
Our ability to minimize or avoid future field actions or FDA warning letters relating to our products and the on-going inherent risk of potential physician advisories or field actions related to medical devices;
Legislative or regulatory efforts to modify the product approval or reimbursement process, including a trend toward demonstrating clinical outcomes, comparative effectiveness and cost efficiency, as well as other healthcare reform legislation.
And we are hitting their bottom line!!
“Our accrual for legal matters that are probable and estimable was $411 million as of September 30, 2012 and $299 million as of December 31, 2011…”.
And for the early 2000’s even before the current investigations, “the total incremental tax liability now asserted by the IRS for the applicable periods is $1.162 billion plus interest.”
MOST MESH INJURED PATIENTS HAVE BEEN HORRIBLY INJURED BUT AT LEAST THERE IS HOPE OTHERS WILL NOT BE HARMED IN THE FUTURE!
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