Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration Ellen Pinnow, MS, Naomi Herz, BS, Nilsa Loyo-Berrios, PhD, and Michelle Tarver, MD, PhD Women may respond differently to medical devices due to factors such as genetics, body size, hormones, or other intrinsic sex-specific or extrinsic societal […]
FDA, medical devicesReprinted from FDA Voice By: Michelle McMurry-Heath, MD, Ph.D. , August 30, 2013 Here’s ‘HoW’ Women differ from men in anatomy, physiology, risk factors and disease symptoms. They are also likely to use more medical devices over the course of their lives than men do. That is why FDA is actively trying to learn more […]
FDA, medical devices
SS Dhruva, RF Redberg The Safety and Effectiveness of Medical Treatments can differ in men and women formany reasons related to different epidemiologic characteristics, physiology, and body size. In general, women have higher bleeding rates and procedural morbidity and mortality than men, which means that their risk/benefit ratios for many implanted medical devices can […]
Clinical trials, medical devicesWomen Show Greater Rate of Failure after Total Hip Arthroplasty Maria C. S. Inacio, MS; Christopher F. Ake, PhD; Elizabeth W. Paxton, MA; Monti Khatod, MD; Cunlin Wang, MD, PhD; Thomas P. Gross, MD, MPH; Ronald G. Kaczmarek, MD, PhD; Danica Marinac-Dabic, MD, PhD; Art Sedrakyan, MD, PhD. Published online February 18, 2013 Abstract Importance The […]
aging, medical devices, Musculoskeletal