William Maisel, deputy director of the FDA Center for Devices, stated “The clinical effectiveness of surgical mesh for transvaginal repair of pelvic organ prolapse has not been demonstrated,” this according to Bloomberg. In response Johnson & Johnson, and other manufactures of vaginal mesh products have agreed to more safety studies as well as further labeling changes to properly inform potential recipients of the true risks and the alleged benefits of vaginal mesh products. Besides Johnson

The New York Times reports that the government’s system for regulating many medical devices, like artificial hips, should be abandoned and replaced because it fails to examine their safety and effectiveness before sale, according to one of the nation’s top scientific groups. The report calls for and integrated premarket and post-market approach to insure that a device is safe and effective for the life of a device. As expected the medical device industry rejected the

The FDA has issued a warning to women with breast implants alerting them to the likely need for additional surgery within eight to ten years of implant.  According to FDA spokesperson  “breast implants are not lifetime devices. Breast implants have been controversial and have resulted in substantial litigation over their safety.  Earlier in 2011, the FDA warned of a small correlation between breast implants and anaplastic large-cell lymphoma (ALCL). Helpful links: FDA Chicago Tribune, You

Once again the issue of how implant devices are selected for insertion into patients is analyzed in a recent New York Times article, Sales Tactics on Implants Raises Doubts.  The article focused on how Biotronick, a manufacturer of pacemakers and defibrillators, created sham medical studies and consultancy arrangements as a means to funnel money to doctors to increase sales of Biotronick medical devices. According to the New York Times article, Biotronick developed financial relationship with

The New England Journal of Medicine reports that at an April 13, 2011 hearing before the Senate Special Committee on Aging focused on a Government Accountability Office report identifying safety concerns about the FDA’s process for approving medical devices. According to the report, the FDA has reclassified only 1 of 27 types of high-risk devices that, in 2009, could still enter the market through the less stringent 510(k) process instead of being submitted to the