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!