February 14, 2011. Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices that the FDA deems to involve low or moderate risk.
Read More »Our Research & Training
We conduct research on the safety and effectiveness of medical products such as Alzheimer’s drugs, cancer drugs, and medical implants and devices used for a wide range of health problems, such as heart disease and joint replacement. In addition to the free information on this website and on www.stopcancerfund.org, we also publish articles in major medical journals and health policy journals.
These are the summaries of studies we’ve done, and here are the articles we’ve published in medical journals and health policy journals in the last few years.
Are you a reporter or medical writer interested in our free Health Research Training Workshop? Learn more here.
Reasonably Safe? Breast Implants and Informed Consent
Reproductive Health Matters, May 2010. Every year, more than 300,000 women in the United States and many more worldwide undergo breast implant surgery.
Read More »Teenagers and Cosmetic Surgery: Focus on Breast Augmentation and Liposuction
Journal of Adolescent Health, October 2008. Two of the most popular and controversial cosmetic procedures for adolescents are liposuction and breast implants. It this review article, the procedures are discussed. In addition, the physiological and psychological reasons to delay these procedures, including concerns about body dysmorphic disorder and research findings regarding changes in teenagers’ body image as they mature, are described.
Read More »Reconstructive Breast Implantation After Mastectomy
Archives of Surgery, July 2006. Henriksen et al provided useful data on the short-term complications of breast reconstruction with implants.
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