Ten Years After Dr. Cutler Warned Women Against Vaginal Mesh Devices For Prolapse, FDA Bans Those Products As Unsafe For Women
In her 8th book Hormones and Your Health: The Smart Woman's Guide to Hormonal and Alternative Therapies for Menopause (2009) Dr. Winnifred Cutler reported hearing a gynecologic surgeon informing other surgeons of her horrific 3 to 4-hour surgeries removing eroded surgical mesh tape causing great pain, internal bleeding and infection in women who had been suffering from pelvic prolapse. FDA had “approved’ those mesh sling tapes as “devices” via the relaxed standards of the Medical Device Act. About 50 surgeons in the audience raised their hands to agree they also had experienced difficult mesh repair surgeries. That meeting of the American College of Ob/Gyns was in 2007.
Dr. Cutler’s 2009 book castigated those mesh tape devices and warned women to be reluctant to provide their informed consent to have them surgically implanted for prolapse.
A decade later, on April 16, 2019 FDA banned the sale and distribution of those surgical mesh devices stating “…the manufacturers…have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”.
An estimated 100,000 product liability lawsuits have been filed by women against those manufacturers by early 2019.
Dr. Cutler’s book explains that the Medical Device Act only provides a voluntary adverse experience reporting by surgeons encountering difficulties with or patients’ complaints about mesh tapes implanted by them. Fear of malpractice suits may inhibit such reports. Dr. Cutler strongly urges women to take ownership of your health and your body. Learn how to do Kegel exercises to keep your muscles strong. Avoid surgery if you can and do not give surgeons your informed consent without full explanations and your own independent research on nonsurgical alternatives…