PVDF meshes produce less scarring due to their higher biocompatibility, reducing the incidence of postoperative chronic pain complications Compared with traditional polypropylene meshes, PVDF meshes demonstrated better biostability, less focal inflammation or fibrosis in host tissue, and lower bending stiffness in a previous study … Therefore, it appears that PVDF meshes produce less scarring [...]
In the JMIG study, 7 out of 125 women reported groin pain within 6 weeks of receiving an Altis Sling. “125 women underwent a midurethral single incision sling…In the hospital based Ambulatory Surgical Unit… 2 patients reported unanticipated Adverse Events (AE’s) …The office based Ambulatory Surgical Unit…7 patients reported unanticipated AEs”….The Journal of Minimally [...]
Dr. Greg Vigna, “The utility of the Coloplast Altis sling and Boston Scientific Solyx is questionable at best. The FDA still does not support their safety or efficacy despite the FDA’s Obstetrics and Gynecology Device panel recommending more studies of mini-slings for stress urinary incontinence in 2011. Their utility has been called to question [...]
The Coloplast Altis sling and the Boston Scientific Solyx sling remain on the market despite the continued FDA position. “Women have not been warned of the FDA’s current position that ‘The safety and effectiveness of mini-slings for female SUI have not been adequately demonstrated' which is a big problem for the implanting doctors," states [...]
The utility of the Coloplast Altis sling and Boston Scientific Solyx is questionable at best. Dr. Greg Vigna, “The utility of the Coloplast Altis sling and Boston Scientific Solyx is questionable at best. The FDA still does not support their safety or efficacy despite the FDA’s Obstetrics and Gynecology Device panel recommending more studies [...]
We are now reviewing cases of neurological injuries suffered by Ovarian Cancer Survivors related to toxic effect of chemotherapeutic agents & radiation therapy. “We are now reviewing cases of the neurological injuries suffered by Ovarian Cancer Survivors related to toxic effect of chemotherapeutic agents and radiation therapy. Injuries include Cisplatin related peripheral neuropathies and [...]
Unfortunately, the misrepresentation by Ethicon continues to be recirculated in the literature. “Dr. Amy Gee, your article ‘Where Are We Now? Urogynecologic Mesh’ takes us back to 2004 and does not represent the current knowledge that is known by some members of your field. There was deceptive advertising and misrepresentation as part of their [...]
PVDF has proven safe and effective especially when compared with polypropylene “The most appropriate biomaterial is one that simply works with as little inflammatory response as possible. PVDF is superior to polypropylene as it has reduced inflammatory response, less scarring, and superior safety to polypropylene. Does the FDA not trust AUGS to reasonably study [...]
For nearly a year, we have been waiting for the data comparing retropubic slings to transobturator slings. “We have been waiting for the underlying data for the New England Journal of Medicine, March 31, 2022 article that destroyed the utility of the Altis sling as groin pain was not reduced when compared with full-length [...]
Nearly 200,000 transvaginal mesh devices are placed into women each year, which cause foreseeable and unavoidable neurological injuries and life-altering pain.Nearly 200,000 transvaginal mesh (TVM) polypropylene sling devices are placed into women in the United States each year, many of which cause foreseeable and unavoidable neurological injuries and lifealtering pain syndromes. Very few women are [...]