Breast Implants, Self-Esteem, Quality of Life, and the Risk of Suicide -

Women’s Health Issues, April 2016. Numerous research reviews have concluded that suicide rates are higher for women with breast implants. In addition, there is evidence of an increased risk of suicide for women who undergo reconstruction with implants after mastectomy, compared to other mastectomy patients.

Device recalls surge in recent years, prompting question: Why? -

General Surgery News, April 12, 2016. The FDA approves or clears thousands of new medical devices each year. This highly complex process of review has garnered criticism in recent years. Dr. Diana Zuckerman weighs in on the lack of quality of clinical testing and the FDA approval process.

FDA to shift clinical evidence for medical devices toward postmarket -

Medical Design Technology, April 4, 2016. The National Center for Health Research expresses that Advancing Breakthrough Devices for Patients Act of 2015 encourages companies to get medical products on the market quickly as opposed to focusing on patient safety and product efficiency.

Senate approves FDA’s ‘breakthrough pathway’ for medical devices -

Health Care Business, March 23, 2016. A bipartisan Senate committee has approved three bills that could help get medical devices to patients sooner by creating a “breakthrough pathway” through the U.S. Food and Drug Administration, but not everyone is happy about the actions.