After 2016, implantation of the Uphold and Restorelle Direct Fit is blatant malpractice involving both doctors and hospitals.
These influential Boards have been trusted to keep women safe and simply both have failed to intervene.”
— Dr. Greg Vigna
SANTA BARBARA, CALIFORNIA, UNITED STATES, July 5, 2019 /EINPresswire.com/ -- Dr. Frank Gamberdella, a gynecologist with 50 years of experience of clinical practice in Santa Barbara, was asked why he never implanted a vaginal mesh device, “I felt it in my hands, and it wasn’t a device that belonged near the vagina, and all the non-mesh surgeries I provided for years worked well." Unfortunately, Dr. Gamberdella has retired with scores of other physicians trained by a different generation who provided autologous slings for the treatment of stress urinary incontinence (SUI), and non-mesh surgery for pelvic organ prolapse.
The FDA moved on pelvic organ prolapse, making it a Class 3 ‘Dangerous Device’ on January 6, 2017. Then the FDA formally banned polypropylene transvaginal mesh (TVM) devices that remained on the U.S. market on April 16, 2019. A bad chapter in the Vaginal Mesh Debacle closed on that date as women will no longer suffer catastrophic pain from pudendal and obturator neuralgia caused by the likes of Boston Scientific Uphold device and Coloplast Restorelle Direct Fit used for pelvic organ prolapse. The remaining physician who were implanting these terrible devices are likely opening up their text books and going back to Dr. Gamberdella’s non-mesh surgeries.
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