FDA orders all transvaginal repairs of the mesh product used for pelvic organ prolapse to stop selling and distributing their products in the USA immediately.
SANTA BARBARA, CA, UNITED STATES, April 16, 2019 /EINPresswire.com/ — A major move by the FDA today orders that manufacturers of all transvaginal repairs of the mesh product used for pelvic organ prolapse (POP) to stop selling and distributing their products in the United States immediately.
Dr. Greg Vigna, MD, JD, practicing physician, national pharmaceutical injury attorney, damages expert, and woman’s advocate states, "The vaginal mesh debacle continues with the use of transobturator devices which are equally as defective as the transvaginal mesh devices used for pelvic organ prolapse. He states, “Recent testimony from an authority on sling related complications puts catastrophic pain syndromes at a rate of 10 to 1 transobturator slings compared with retropubic slings. Understanding that the catastrophic pain syndrome from retropubic slings is as debilitating as transobturator slings.”
Dr. Greg Vigna MD, JD states that, "Studies show that pudendal neuralgia occurs years after implantation related to shrinkage of the transobturator sling. These devices are supposed to be ‘tension free’, but they are under tension related to adhesion to the inferior ramus bone of the pelvis. Over the years, these devices shrink over 30% and lead to traction on the obturator nerve, pudendal nerve, and muscles of the pelvis that control sexual function, mobility, and bowel and bladder function.”
Dr. Vigna states, “I have written for years that these devices need to go away. The vaginal mesh debacle has destroyed a generation of women. Led to divorce, homelessness, and unnecessary pain.” Additionally, Dr. Vigna explains, "I have written previously that it is not difficult for a Pharmaceutical Manufacturer to devise a study that gets them to their desired result of getting the device sold and implanted. The results are foreseeable that these biased studies led to thousands of injuries world-wide as they didn't check for safety because they seemingly didn't care."
To read the FDA announcement, follow this link: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM636114.htm?utm_campaign=04162019_PR_FDA%20takes%20action%20on%20tranvaginal%20mesh%20for%20POP%20repair&utm_medium=email&utm_source=Eloqua
For TVM resources and how Dr. Vigna can help, visit https://pudendalportal.lifecare123.com.
Source: EIN Presswire