Federal regulators playing fast and loose

Doctor with tablet
NEC-Medical-137 - Photo by: NEC Corporation of America

Many newspapers complained about federal regulators since the largest agencies as the Food and Drug Administration (FDA) seemingly worked carelessly in the last few years. Since the health of millions of U.S. citizen is at stake, a superficial overlook on the possible side effects of a dangerous drug or device may have disastrous consequences on patients’ health. A new study showed that many medical devices that hit the market every year are approved with little or no evidence about their purported safety, and, in many instances, they simply do not work the way they’re supposed to. According to some critics, regulatory agencies approved up to 99 percent of new medical devices without any prior clinical test to check their effectiveness and safety. Today, a team from the Yale School of Medicine found that even the remaining 1 percent of devices which are analyzed before being approved only receive a superficial look.

This 1 percent is made by all those “high risk” devices that are directly implanted inside the body of the patients by doctors, or that continuously support their lives. These devices include hip replacement prosthesis, artificial heart valves, and intraocular lenses. The research team from Yale found that these medical instruments are examined only through a single major trial before the FDA approves them. Most of these trials only include a couple hundred subjects each. One of the authors of the study, Dr. Joseph Ross, explained that the whole FDA’s approval system is built to ease the earlier access of many new devices to help people receive new therapies as soon as possible. However, the principal consequence is that data on these instruments’ safety is sorely lacking, and their long-term clinical effects are not explored at all.

To approve 28 devices, the U.S. regulatory agency only called for 33 studies – a little more than one study per device in total. An even more concerning evidence found by Yale’s team, however, was that 6 of these trials were finished five years after the new apparatus was released to the market. Most studies also never compared the device to other similar ones already approved.


The consequences for the patients who use them can be devastating. One stent used to treat brain aneurysms was found to be defective and was recalled after the FDA determined it could outright kill the patients in which it was implanted. Another one, the DePuy’s Pinnacle Complete hip replacement caused a form of heavy metal poisoning called metallosis in over 6,000 patients out of the 150,000 who were implanted with it. Since no protocol keeps in check patients who use a device, though, the real number of broken or defective ones may be significantly higher than those reported. Unlike other common household appliance and electronic devices such as cellphones, televisions, and computers, medical devices have no bar code to track them once they leave the manufacturer. Hopefully, in 2016 a new law will help reduce the actual deregulation by increasing the standards required before a medical instrument hits the market.


Article by Dr. Claudio Butticè, PharmD.



1. Consumer Reports magazine: May 2012. “Dangerous medical implants and devices – Most medical implants have never been tested for safety” http://www.consumerreports.org/cro/magazine/2012/04/cr-investigates-dangerous-medical-devices/index.htm
2. Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA. 2015;314(6):604-612. doi:10.1001/jama.2015.8761.
3. http://www.fda.gov/RegulatoryInformation/Guidances/ucm085994.htm#2
4. Fox News Health. “As lawsuits climb, J&J may have new hip trauma.” (Published July 12, 2012) http://www.foxnews.com/health/2012/07/12/as-lawsuits-climb-jj-may-have-new-hip-trauma.html
5. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369276.htm